C4591001 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS C4591001 ST1PD ST17PD ST2PD ST27PD ST214PD ST1CD ST17CD ST2CD ST27CD ST214CD ST1SE ST17SE ST2SE ST27SE ST214SE STC1SE STC17SE STC2SE STC27SE STC214SE ST1PDA ST17PDA ST2PDA ST27PDA ST214PDA ST1CDA ST17CDA ST2CDA ST27CDA ST214CDA ST1SEA ST17SEA ST2SEA ST27SEA ST214SEA STC1SA STC17SA STC2SA STC27SA STC214SA ST1PDX STC1SX RTCOV2NS C19NIG PRPDSAD PRCDCSAD C19ONST CDCONST SARSCOV2 NAATRAD HCUHSP PRSCDCAD CDCSONST SEVCVS PRSVCSAD SEVCONST HCUICU SEVCRF PRCDTH DTHODC19 SECDTH SEVCRHN SEVCVSPR MSPIS SEVPIS MEDDUR MAXSFAT SEVFATI MAXTEMP MAXSHEA SEVHEAD MAXSJP SEVJOIN DIARE MDIRE MSERE SEVREDN MAXDIAR SEVDIAR MAXCHIL SEVCHIL MAXSMP SEVMUSP DIASW MDISW MSESW SEVSWEL MAXSVOM SEVVOMI MADRE MIDRE MADSW MIDSW OCPIS OCISR OCINS MEDTFVPN OCCHILLS OCDIAR OCFATIG OCFEVER OCHEAD OCJOPAIN OCMPNIS OCVOMI OCHOFA OCHIS OCHOHE OCHOMP STPDMEDP OCHOJP OCHODI OCHOCHIL G4CRR G4CRS OCHOVO RESP HR OXYSAT DIABP SYSBP PO2FIO2 RTCOV2NS C19NIG CHILLS DIARRHEA FEVER NLTSTSML NCOUG NMUSPN NSTBRTH NSRTHROT VOMIT SARSCOV2 FATIGUE RIHNRA NNSLCONG HEADACHE NAUSEA HCUHSP HCUICU MCHVENT DEATH PRCDTH HFOXTHRP SECDTH WHEEZ NIPPV SARDFN SANDFN SAHDFN VSOPRES C19RBDIG C19S1IGG C19NIG C2NGNT50 NT50_S1 C2NGNT90 NT90_S1 Subject-Level Analysis Dataset adsl.xpt Covid-19 Efficacy Analysis adc19ef.xpt Diary and Non-event Analysis Dataset adfacevd.xpt Covid-19 Signs and Symptoms adsympt.xpt Immunogenicity Analysis Dataset adva.xpt Adverse Events Analysis Dataset adae.xpt Diary and CRF Event Analysis Dataset adcevd.xpt Concomitant Medications Analysis Dataset adcm.xpt Disposition Analysis Dataset adds.xpt Protocol Deviation Analysis Dataset addv.xpt Medical History Analysis Dataset admh.xpt Study Identifier DM.STUDYID Unique Subject Identifier DM.USUBJID Subject Identifier for the Study DM.SUBJID Study Site Identifier DM.SITEID Age DM.AGE Age Units DM.AGEU Sex DM.SEX Sex (N) Race DM.RACE Race (N) Ethnicity DM.ETHNIC Ethnicity (N) Racial Designation SUPPDM.QVAL where SUPPDM.QNAM="RACIALD" Racial Designation (N) Country DM.COUNTRY Safety Population Flag Randomized Population Flag Enrolled Population Flag Subject Death Flag DM.DTHFL Description of Planned Arm Planned Arm Code DM.ARMCD Description of Actual Arm Actual Arm Code Planned Treatment for Period 01 Planned Treatment for Period 01 (N) Planned Treatment for Period 02 Planned Treatment for Period 02 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Actual Treatment for Period 02 Actual Treatment for Period 02 (N) Planned Sequence of Treatments Actual Sequence of Treatments Date of Birth Date of Birth Imput. Flag Date/Time of Death DM.DTHDTC Date of Death Date of Death Imputation Flag Date of Randomization Randomization Number DS.DSREFID where DS.DSDECOD = "RANDOMIZED" Subject Reference Start Date Subject Reference Start Time Subject Reference End Date Subject Reference End Time Date of End of Participation DM.RFPENDTC Date of Informed Consent DM.RFICDTC Date of First Exposure to Treatment Time of First Exposure to Treatment Date of Last Exposure to Treatment Time of Last Exposure to Treatment Date of First Exposure in Period 01 Time of First Exposure in Period 01 Date of Last Exposure in Period 01 Time of Last Exposure in Period 01 Date of First Exposure in Period 02 Time of First Exposure in Period 02 Date of Last Exposure in Period 02 Time of Last Exposure in Period 02 Datetime of First Exposure to Treatment Datetime of Last Exposure to Treatment Datetime of First Exposure in Period 01 Datetime of Last Exposure in Period 01 Datetime of First Exposure in Period 02 Datetime of Last Exposure in Period 02 Vaccination Date 01 Vaccination Date 02 Vaccination Date 03 Vaccination Date 04 Age at Vaccination 01 Age Units at Vaccination 01 Age at Vaccination 03 Age Units at Vaccination 03 Pooled Age Group 1 Pooled Age Group 1 (N) Analysis Race Analysis Race (N) Pooled Race Group 1 Pooled Race Group 1 (N) End Of Study Discontinuation Date End Of Study Discontinuation Reason End Of Treatment Discontinuation Date End Of Treatment Discontinuation Reason Investigator Identifier DM.INVID Investigator Name DM.INVNAM Actual Dosing Level Planned Dosing Level Planned Dosing Level (N) Actual Dosing Level (N) Clinical disease endpoint case flag SUPPDM.QVAL where SUPPDM.QNAM="CDECASE" Reactogenicity Population Flag SUPPDM.QVAL where SUPPDM.QNAM="REACTOFL" Vaccination Date Unplanned Vaccination Date Unplanned in Period 02 Cohort Group Cohort Group (N) Study Phase (N) Study Phase Pooled Age Group 2 Pooled Age Group 3 Pooled Age Group 4 Pooled Age Group 4 (N) Pooled Age Group 2 (N) Pooled Age Group 3 (N) Age Group at Vaccination 03 Age Group at Vaccination 03 (N) Vaccination 01 Vaccination 02 Vaccination 03 Vaccination 04 Vaccination Unplanned Vaccination Unplanned in Period 02 Vaccination Time 01 Vaccination Time 02 Vaccination Time 03 Vaccination Time 04 Vaccination Time Unplanned Vaccination Time Unplanned in Period 02 Treatment Unblinded Date Re-vax Informed Consent Date End Of Open Label Treatment D/C Date End Of Open Label Treatment D/C Reason Baseline BMI Category Baseline BMI Category (N) Obese Flag for Adolescent Flag for Comorbodities N-binding Antibody Neg at Visit 1 Flag NAAT Negative at Visit 1 Flag Baseline SARS-CoV-2 Status Date of Unblinding or Visit at 1MPD2 Date of Unblinding or Visit at 6MPD2 Date of Dose 3 or Visit at 6MPD2 Date of Visit at 1M after Vax4 Date of Visit at 6M after Vax4 C19NIG Result at Visit 3 Start Date of Important PD Blood Sample Drawn before Vax 1 Blood Sample Drawn 1 Week after Vax 1 Blood Sample Drawn before Vax 2 Blood Sample Drawn 1 Week after Vax 2 Blood Sample Drawn 2 Weeks after Vax 2 Blood Sample Drawn 1 Month after Vax 2 Blood Sample Drawn 6 Months after Vax 2 Blood Sample Date before Vax 1 Blood Sample Date 1 Week after Vax 1 Additional Bld Sample Date 3W after Vax1 Additional Bld Sample Date 4W after Vax1 Additional Bld Sample Date 5W after Vax1 Additional Bld Sample Date 7W after Vax1 Blood Sample Date before Vax 2 Blood Sample Date 1 Week after Vax 2 Blood Sample Date 2 Weeks after Vax 2 Blood Sample Date 1 Month after Vax 2 Blood Sample Date 6 Months after Vax 2 Are eligible for the study at rand Have received Vax 1 as randomized Have valid and DTM immuno result 1 Have valid and DTM immuno result 2 Have BD within the timeframe 1 No important PD determined by clinician Received 2 doses as rand within window Have valid and DTM immuno result 3 Have BD within the timeframe 2 Unblinded after 1M post Dose 2 visit Exclusion Flag 1 Exclusion Criterion 1 Exclusion Flag 2 Exclusion Criterion 2 Exclusion Flag 3 Exclusion Criterion 3 Exclusion Flag 4 Exclusion Criterion 4 Exclusion Flag 5 Exclusion Criterion 5 Exclusion Flag 6 Exclusion Criterion 6 Reason for Exclusion from Safety Pop Exclusion Flag 7 Exclusion Criterion 7 Exclusion Flag 8 Exclusion Criterion 8 Exclusion Flag 9 Exclusion Criterion 9 Exclusion Flag 10 Exclusion Criterion 10 Dose 1 evaluable Immun Popu Flag Dose 2 evaluable Immun Popu Flag Dose 1 all-available Immun Popu Flag Dose 2 all-available Immun Popu Flag Evaluable Efficacy Popu Flag Dose 1 all-available Efficacy Popu Flag Dose 2 all-available Efficacy Popu Flag Screening Phase 3 3000 Subjects Flag Phase 3 30k Subjects Flag Subjects Received Placebo & unblinded Japanese Subject Flag Multiply Enrolled Subjects Phase 2/3 Pop for 12-25 Reacto Subset Pop for Non-inferiority Assessement HIV Positive Subjects Flag Subject without Evidence 1MPD2 Double Blinded Follow-up Censor Date Crossover Dose1 Censor Date Study Censor Date PD2 FU Time in Days: to Cutoff PD2 FU Time in Days: to Unblinding Post Xover D1 FUTM in Days: to Cutoff Unblinding FUTM in Days: to Cutoff PD1 FU Time in Days: to Cutoff PD1 FU Time in Days: to Unblinding PD2 FU Time Cat 1: to Cutoff PD2 FU Time Cat 1 (N): to Cutoff PD2 FU Time Cat 2: to Unblinding PD2 FU Time Cat 2 (N): to Unblinding Post Xover D1 FUTM Cat 1: to Cutoff Post Xover D1 FUTM Cat 1 (N): to Cutoff PD1 FU Time Cat 1: to Cutoff PD1 FU Time Cat 1 (N): to Cutoff HIV RNA Category HIV RNA Category (N) CD4 Category for HIV-positive CD4 Category for HIV-positive (N) Safety - excld Multi-Enrolloer&HIV&IND Safety - exclude Multi-Enrolloer&IND Random - exclude Multi-Enrolloer Study Identifier ADSL.STUDYID Unique Subject Identifier ADSL.USUBJID Study Site Identifier ADSL.SITEID Subject Identifier for the Study ADSL.SUBJID Date of Birth ADSL.BRTHDT Pooled Age Group 1 (N) ADSL.AGEGR1N Pooled Age Group 1 ADSL.AGEGR1 Sex ADSL.SEX Race ADSL.RACE Ethnicity ADSL.ETHNIC Planned Arm Code ADSL.ARMCD Description of Planned Arm ADSL.ARM Actual Arm Code ADSL.ACTARMCD Description of Actual Arm ADSL.ACTARM Parameter (N) Parameter Code Parameter Parameter Category 1 Analysis Value Analysis Value (C) Visit Number ADSYMPT.VISITNUM Visit Name ADSYMPT.VISIT Analysis Visit (N) Analysis Visit Analysis Date Analysis Relative Day Analysis Start Date Analysis Start Relative Day Analysis End Date Analysis End Relative Day Data Cutoff Date Date of Randomization ADSL.RANDDT Date of First Exposure to Treatment ADSL.TRTSDT Date of Last Exposure to Treatment ADSL.TRTEDT Vaccination Date 01 ADSL.VAX101DT Vaccination Date 02 ADSL.VAX102DT Start Date of Important PD ADSL.DVSTDT Treatment Unblinded Date ADSL.UNBLNDDT Date of Death ADSL.DTHDT End Of Treatment Discontinuation Date ADSL.EOTDCDT End Of Study Discontinuation Date ADSL.EOSDCDT Randomized Population Flag ADSL.RANDFL Evaluable Efficacy Popu Flag ADSL.EVALEFFL Dose 1 all-available Efficacy Popu Flag ADSL.AAI1EFFL Dose 2 all-available Efficacy Popu Flag ADSL.AAI2EFFL Subject Death Flag ADSL.DTHFL Prior Covid-19 Illness History Flag ADSYMPT.C19ILHFL Consider Result for Analysis Flag NVA Baseline Result Negative Flag NAAT Result At Dose 1 Negative Flag NAAT Result At Dose 2 Negative Flag Protocol Defined SYMP Present Flag Protocol Defined SYMP Date Missing Flag CDC Defined SYMP Present Flag Severe Covid PD SYMP Present Flag Severe Covid CDC SYMP Present Flag Illness Occur After Dose 1 Flag Illness Occur 7 Days After Dose 1 Flag Illness Occur After Dose 2 Flag Illness Occur 7 Days After Dose 2 Flag Illness Occur 14 Days After Dose 2 Flag First Illness Occurrence Flag PD SYMP Result Missing or Unknown Flag PD SYMP Rslt Miss/UNK With POS Rslt Flag CDC SYMP Result Missing or Unknown Flag CD SYMP Rslt Miss/UNK With POS Rslt Flag VE Prot Def Pop Incl Post D1 Flag VE Prot Def Pop Incl 7D Post D1 Flag VE Prot Def Pop Incl 7D Post D2 Flag VE Prot Def Pop Incl 14D Post D2 Flag VE CDC Def Pop Incl Post Dose 1 Flag VE CDC Def Pop Incl 7D Post Dose 1 Flag VE CDC Def Pop Incl 7D Post Dose 2 Flag VE CDC Def Pop Incl 14D Post Dose 2 Flag No Major Protocol Deviation Occur Flag Study Identifier FACE.STUDYID or VS.STUDYID Unique Subject Identifier FACE.USUBJID or VS.USUBJID Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Age ADSL.AGE Age Units ADSL.AGEU Sex ADSL.SEX Sex (N) ADSL.SEXN Race ADSL.RACE Race (N) ADSL.RACEN Analysis Race ADSL.ARACE Analysis Race (N) ADSL.ARACEN Ethnicity ADSL.ETHNIC Ethnicity (N) ADSL.ETHNICN Country ADSL.COUNTRY Safety Population Flag ADSL.SAFFL Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Date of First Exposure to Treatment ADSL.TRTSDT Time of First Exposure to Treatment ADSL.TRTSTM Datetime of First Exposure to Treatment ADSL.TRTSDTM Date of Last Exposure to Treatment ADSL.TRTEDT Time of Last Exposure to Treatment ADSL.TRTETM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Actual Treatment for Period 01 ADSL.TRT01A Actual Treatment for Period 02 ADSL.TRT02A Actual Treatment for Period 02 (N) ADSL.TRT02AN Actual Treatment for Period 01 (N) ADSL.TRT01AN Planned Treatment for Period 01 ADSL.TRT01P Planned Treatment for Period 01 (N) ADSL.TRT01PN Planned Treatment for Period 02 ADSL.TRT02P Planned Treatment for Period 02 (N) ADSL.TRT02PN Date of First Exposure in Period 01 ADSL.TR01SDT Time of First Exposure in Period 01 ADSL.TR01STM Datetime of First Exposure in Period 01 ADSL.TR01SDTM Date of Last Exposure in Period 01 ADSL.TR01EDT Time of Last Exposure in Period 01 ADSL.TR01ETM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Date of First Exposure in Period 02 ADSL.TR02SDT Time of First Exposure in Period 02 ADSL.TR02STM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Date of Last Exposure in Period 02 ADSL.TR02EDT Time of Last Exposure in Period 02 ADSL.TR02ETM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Vaccination Date 01 ADSL.VAX101DT Vaccination Date 02 ADSL.VAX102DT Cohort Group ADSL.COHORT Cohort Group (N) ADSL.COHORTN Study Phase ADSL.PHASE Study Phase (N) ADSL.PHASEN Planned Dosing Level ADSL.DOSPLVL Planned Dosing Level (N) ADSL.DOSPLVLN Actual Dosing Level ADSL.DOSALVL Actual Dosing Level (N) ADSL.DOSALVLN Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Pooled Age Group 2 ADSL.AGEGR2 Pooled Age Group 2 (N) ADSL.AGEGR2N Pooled Age Group 4 ADSL.AGEGR4 Pooled Age Group 4 (N) ADSL.AGEGR4N Pooled Race Group 1 ADSL.RACEGR1 Pooled Race Group 1 (N) ADSL.RACEGR1N Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Phase 3 30k Subjects Flag ADSL.DS30KFL Baseline SARS-CoV-2 Status ADSL.COVBLST Multiply Enrolled Subjects ADSL.MULENRFL HIV Positive Subjects Flag ADSL.HIVFL Phase 2/3 Pop for 12-25 Reacto Subset ADSL.PEDREAFL Treatment Unblinded Date ADSL.UNBLNDDT Phase 3 3000 Subjects Flag ADSL.DS3KFL Reactogenicity Population Flag ADSL.REACTOFL Age at Vaccination 01 ADSL.AGETR01 Vaccination Unplanned ADSL.VAX10U Vaccination Date Unplanned ADSL.VAX10UDT Randomized Population Flag ADSL.RANDFL Random - exclude Multi-Enrolloer ADSL.RAND1FL Safety - excld Multi-Enrolloer&HIV&IND ADSL.SAF1FL Safety - exclude Multi-Enrolloer&IND ADSL.SAF2FL Source Data FACE.DOMAIN or VS.DOMAIN Source Sequence Number Group ID Link ID Link Group ID FACE.FALNKGRP or VS.VSLNKGRP Findings About Test Name Findings About Test Short Name Parameter Parameter Code Parameter (N) Object of the Observation Parameter Category 1 Parameter Category 2 FACE.FASCAT or VS.VSSCAT Analysis Value (C) Analysis Value Analysis Value Category 1 Analysis Value Category 1 (N) Completion Status FACE.FASTAT or VS.VSSTAT Reason Not Performed FACE.FAREASND or VS.VSREASND Evaluator FACE.FAEVAL or VS.VSEVAL Analysis Visit (N) FACE.VISITNUM or VS.VISITNUM Analysis Visit Analysis Date Analysis Datetime Analysis Relative Day FACE.FADY or VS.VSDY Analysis Timepoint Analysis Timepoint (N) Analysis Timepoint Reference FACE.FATPTREF or VS.VSTPTREF Evaluation Interval Text FACE.FAEVINTX or VS.VSEVINTX Derivation Type Evaluation Interval Start Evaluation Interval End Dose EX.EXDOSE Name of Treatment EX.EXTRT Dose Units EX.EXDOSU Start Date/Time of Treatment EX.EXSTDTC End Date/Time of Treatment EX.EXENDTC Collection Type SUPPFACE.QVAL where SUPPFACE.QNAM='CLTYP' or SUPPVS.QVAL where SUPPVSE.QNAM='CLTYP' Result or Finding in Original Units VS.VSORRES where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') Original Units VS.VSORRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') Numeric Result/Finding in Standard Units VS.VSSTRESN where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') Standard Units VS.VSSTRESU where index(VS.VSTESTCD,”TEMP”) and CLTYP in ('DIARY CARD' 'CRF') Fever Temperature Category Fever Temperature Category (N) Known Value Flag Event Value Flag Day Known Value Flag Day Event Value Flag Cut after Unblinding Date Flag Occurences of Event Actual Treatment Actual Treatment (N) Planned Treatment ADSL.TRT01P Planned Treatment (N) ADSL.TRT01PN Study Identifier ADSL.STUDYID Unique Subject Identifier ADSL.USUBJID Study Site Identifier ADSL.SITEID Subject Identifier for the Study ADSL.SUBJID Date of Birth ADSL.BRTHDT Pooled Age Group 1 (N) ADSL.AGEGR1N Pooled Age Group 1 ADSL.AGEGR1 Sex ADSL.SEX Race ADSL.RACE Ethnicity ADSL.ETHNIC Planned Arm Code ADSL.ARMCD Description of Planned Arm ADSL.ARM Actual Arm Code ADSL.ACTARMCD Description of Actual Arm ADSL.ACTARM Parameter (N) Parameter Code Parameter Parameter Category 1 Parameter Category 2 Analysis Value Analysis Value (C) Visit Number CE.VISITNUM FACE.VISITNUM HO.VISITNUM IS.VISITNUM MB.VISITNUM MH.VISITNUM PR.VISITNUM VS.VISITNUM Visit Name CE.VISIT FACE.VISIT HO.VISIT IS.VISIT MB.VISIT MH.VISIT PR.VISIT VS.VISIT Analysis Visit (N) Analysis Visit Analysis Date Analysis Relative Day Analysis Start Date Analysis Start Relative Day Analysis End Date Analysis End Relative Day IS Specimen Type IS.ISSPEC where IS.ISTESTCD = "C19NIG" IS Method of Test or Examination IS.ISMETHOD where IS.ISTESTCD = "C19NIG" Specimen Collection Location MB.MBLOC when PARAMCD in ("SARSCOV2" "RTCOV2NS") MB Specimen Type MB.MBSPEC when PARAMCD in ("SARSCOV2" "RTCOV2NS") MB Method of Test or Examination MB.MBMETHOD when PARAMCD in ("SARSCOV2" "RTCOV2NS") Pre-specified PR.PRPRESP when PARAMCD in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") Standard Units VS.VSSTRESU when PARAMCD in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") Date of Randomization ADSL.RANDDT Date of First Exposure to Treatment ADSL.TRTSDT Date of Last Exposure to Treatment ADSL.TRTEDT Vaccination Date 01 ADSL.VAX101DT Vaccination Date 02 ADSL.VAX102DT Enrolled Population Flag ADSL.ENRLFL Randomized Population Flag ADSL.RANDFL Safety Population Flag ADSL.SAFFL Evaluable Efficacy Popu Flag ADSL.EVALEFFL Dose 1 all-available Efficacy Popu Flag ADSL.AAI1EFFL Dose 2 all-available Efficacy Popu Flag ADSL.AAI2EFFL Prior Covid-19 Illness History Flag Study Identifier IS.STUDYID Unique Subject Identifier IS.USUBJID Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Planned Treatment Planned Treatment (N) Actual Treatment Actual Treatment (N) Date/Time of Collection IS.ISDTC Analysis Date Analysis Relative Day IS.ISDY Analysis Visit Analysis Visit (N) Visit Name IS.VISIT Visit Number IS.VISITNUM Parameter Category 1 IS.ISCAT Parameter Category 1 (N) Parameter Parameter (N) Parameter Code Analysis Value Analysis Value (C) Baseline Value Baseline Value (C) Baseline Type Baseline Record Flag Post Baseline Record Flag Baseline and post-baseline flag Derivation Type Ratio to Baseline Source Data Source Variable Source Sequence Number Analysis Record Flag 01:Window Record Analysis Flag 03:valid value Analysis Flag 04:ge LLoQ Lower Limit of Quantitation IS.ISLLOQ Result or Finding in Standard Format IS.ISSTRESC Evaluable Immunogenicity Record Flag All-available Immunogenicity Record Flag Baseline serostatus (N) Baseline serostatus Period Period (C) Period Start Datetime Period End Datetime Baseline Value for 4 Fold Rise Ratio to baseline for 4 Fold Rise Achieve 4-Fold Rise Flag Measurement, Test or Examination Detail IS.ISTSTDTL Age ADSL.AGE Age Units ADSL.AGEU Sex ADSL.SEX Sex (N) ADSL.SEXN Race ADSL.RACE Race (N) ADSL.RACEN Randomized Population Flag ADSL.RANDFL Safety Population Flag ADSL.SAFFL Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Date of First Exposure to Treatment ADSL.TRTSDT Date of Last Exposure to Treatment ADSL.TRTEDT Time of First Exposure to Treatment ADSL.TRTSTM Time of Last Exposure to Treatment ADSL.TRTETM Actual Treatment for Period 01 ADSL.TRT01A Actual Treatment for Period 01 (N) ADSL.TRT01AN Actual Treatment for Period 02 ADSL.TRT02A Actual Treatment for Period 02 (N) ADSL.TRT02AN Planned Treatment for Period 01 ADSL.TRT01P Planned Treatment for Period 01 (N) ADSL.TRT01PN Planned Treatment for Period 02 ADSL.TRT02P Planned Treatment for Period 02 (N) ADSL.TRT02PN Date of First Exposure in Period 01 ADSL.TR01SDT Time of First Exposure in Period 01 ADSL.TR01STM Datetime of First Exposure in Period 01 ADSL.TR01SDTM Date of Last Exposure in Period 01 ADSL.TR01EDT Time of Last Exposure in Period 01 ADSL.TR01ETM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Date of First Exposure in Period 02 ADSL.TR02SDT Time of First Exposure in Period 02 ADSL.TR02STM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Date of Last Exposure in Period 02 ADSL.TR02EDT Time of Last Exposure in Period 02 ADSL.TR02ETM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Cohort Group (N) ADSL.COHORTN Cohort Group ADSL.COHORT Vaccination Date 01 ADSL.VAX101DT Vaccination Date 02 ADSL.VAX102DT Vaccination Date Unplanned ADSL.VAX10UDT Vaccination Date 03 ADSL.VAX201DT Vaccination Date 04 ADSL.VAX202DT Dose 1 all-available Immun Popu Flag ADSL.AAI01FL Dose 2 evaluable Immun Popu Flag ADSL.EVAL02FL Dose 2 all-available Immun Popu Flag ADSL.AAI02FL Dose 1 evaluable Immun Popu Flag ADSL.EVAL01FL Actual Dosing Level ADSL.DOSALVL Actual Dosing Level (N) ADSL.DOSALVLN Planned Dosing Level ADSL.DOSPLVL Planned Dosing Level (N) ADSL.DOSPLVLN Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Pooled Age Group 2 ADSL.AGEGR2 Pooled Age Group 2 (N) ADSL.AGEGR2N Pooled Age Group 4 ADSL.AGEGR4 Pooled Age Group 4 (N) ADSL.AGEGR4N Study Phase ADSL.PHASE Study Phase (N) ADSL.PHASEN Baseline SARS-CoV-2 Status ADSL.COVBLST HIV Positive Subjects Flag ADSL.HIVFL Pop for Non-inferiority Assessement ADSL.PEDIMMFL Subject without Evidence 1MPD2 ADSL.EV1MD2FL Age at Vaccination 01 ADSL.AGETR01 Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Vaccination Unplanned ADSL.VAX10U Vaccination 03 ADSL.VAX201 Vaccination 04 ADSL.VAX202 Vaccination Unplanned in Period 02 ADSL.VAX20U Vaccination Date Unplanned in Period 02 ADSL.VAX20UDT Treatment Unblinded Date ADSL.UNBLNDDT Multiply Enrolled Subjects ADSL.MULENRFL Random - exclude Multi-Enrolloer ADSL.RAND1FL Datetime of First Exposure to Treatment ADSL.TRTSDTM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Age ADSL.AGE Age Units ADSL.AGEU Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Pooled Age Group 2 ADSL.AGEGR2 Pooled Age Group 2 (N) ADSL.AGEGR2N Pooled Age Group 3 ADSL.AGEGR3 Pooled Age Group 3 (N) ADSL.AGEGR3N Pooled Age Group 4 ADSL.AGEGR4 Pooled Age Group 4 (N) ADSL.AGEGR4N Race ADSL.RACE Race (N) ADSL.RACEN Sex ADSL.SEX Sex (N) ADSL.SEXN Ethnicity ADSL.ETHNIC Ethnicity (N) ADSL.ETHNICN Country ADSL.COUNTRY Analysis Race ADSL.ARACE Analysis Race (N) ADSL.ARACEN Date of First Exposure to Treatment ADSL.TRTSDT Time of First Exposure to Treatment ADSL.TRTSTM Datetime of First Exposure to Treatment ADSL.TRTSDTM Date of Last Exposure to Treatment ADSL.TRTEDT Time of Last Exposure to Treatment ADSL.TRTETM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Actual Treatment for Period 01 ADSL.TRT01A Actual Treatment for Period 01 (N) ADSL.TRT01AN Planned Treatment for Period 01 ADSL.TRT01P Planned Treatment for Period 01 (N) ADSL.TRT01PN Vaccination Date 01 ADSL.VAX101DT Vaccination Time 01 ADSL.VAX101TM Vaccination Date 02 ADSL.VAX102DT Vaccination Time 02 ADSL.VAX102TM Safety Population Flag ADSL.SAFFL Cohort Group ADSL.COHORT Cohort Group (N) ADSL.COHORTN Actual Dosing Level ADSL.DOSALVL Actual Dosing Level (N) ADSL.DOSALVLN Planned Dosing Level ADSL.DOSPLVL Planned Dosing Level (N) ADSL.DOSPLVLN Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Date of Unblinding or Visit at 1MPD2 ADSL.V01DT Date of Unblinding or Visit at 6MPD2 ADSL.V02DT Randomized Population Flag ADSL.RANDFL Study Phase ADSL.PHASE Study Phase (N) ADSL.PHASEN Phase 3 30k Subjects Flag ADSL.DS30KFL Baseline SARS-CoV-2 Status ADSL.COVBLST Multiply Enrolled Subjects ADSL.MULENRFL Treatment Unblinded Date ADSL.UNBLNDDT Vaccination Unplanned ADSL.VAX10U Vaccination 03 ADSL.VAX201 Vaccination 04 ADSL.VAX202 Vaccination Date Unplanned ADSL.VAX10UDT Vaccination Time Unplanned ADSL.VAX10UTM Vaccination Date 03 ADSL.VAX201DT Vaccination Date 04 ADSL.VAX202DT Vaccination Time 03 ADSL.VAX201TM Vaccination Time 04 ADSL.VAX202TM Date of Visit at 1M after Vax4 ADSL.V03DT Date of Visit at 6M after Vax4 ADSL.V04DT Actual Treatment for Period 02 ADSL.TRT02A Actual Treatment for Period 02 (N) ADSL.TRT02AN Planned Treatment for Period 02 ADSL.TRT02P Planned Treatment for Period 02 (N) ADSL.TRT02PN HIV Positive Subjects Flag ADSL.HIVFL Phase 3 3000 Subjects Flag ADSL.DS3KFL End Of Open Label Treatment D/C Date ADSL.EOTXDCDT Double Blinded Follow-up Censor Date ADSL.BDCSRDT Crossover Dose1 Censor Date ADSL.X1CSRDT PD1 FU Time in Days: to Unblinding ADSL.FUP1UNB Post Xover D1 FUTM in Days: to Cutoff ADSL.FPX1CUT Unblinding FUTM in Days: to Cutoff ADSL.FUNBCUT PD1 FU Time in Days: to Cutoff ADSL.FUP1CUT Age at Vaccination 01 ADSL.AGETR01 Datetime of First Exposure in Period 01 ADSL.TR01SDTM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Vaccination Unplanned in Period 02 ADSL.VAX20U Vaccination Date Unplanned in Period 02 ADSL.VAX20UDT Random - exclude Multi-Enrolloer ADSL.RAND1FL Safety - excld Multi-Enrolloer&HIV&IND ADSL.SAF1FL Safety - exclude Multi-Enrolloer&IND ADSL.SAF2FL Study Identifier AE.STUDYID Unique Subject Identifier AE.USUBJID Sequence Number AE.AESEQ Category for Adverse Event AE.AECAT Sponsor-Defined Identifier AE.AESPID Reported Term for the Adverse Event AE.AETERM Dictionary-Derived Term Body System or Organ Class Code AE.AEBDSYCD Body System or Organ Class AE.AEBODSYS Lowest Level Term AE.AELLT Lowest Level Term Code AE.AELLTCD Preferred Term Code AE.AEPTCD High Level Term AE.AEHLT High Level Term Code AE.AEHLTCD High Level Group Term AE.AEHLGT High Level Group Term Code AE.AEHLGTCD Primary System Organ Class AE.AESOC Primary System Organ Class Code AE.AESOCCD Start Date/Time of Adverse Event AE.AESTDTC Study Day of Start of Adverse Event AE.AESTDY End Date/Time of Adverse Event AE.AEENDTC Study Day of End of Adverse Event AE.AEENDY End Relative to Reference Time Point AE.AEENRTPT End Reference Time Point AE.AEENTPT Standard Toxicity Grade AE.AETOXGR Dictionary Name and Version SUPPAE.QVAL where SUPPAE.QNAM='DICTVER' Discontinued due to AE Analysis Start Date Analysis Start Date Imputation Flag Analysis Start Relative Day Analysis Start Time Analysis Start Date/Time Analysis End Date Analysis End Relative Day Analysis End Time Analysis End Date/Time Analysis Duration (N) Analysis Duration Units Serious Event AE.AESER Congenital Anomaly or Birth Defect AE.AESCONG Persist or Signif Disability/Incapacity AE.AESDISAB Results in Death AE.AESDTH Requires or Prolongs Hospitalization AE.AESHOSP Is Life Threatening AE.AESLIFE Other Medically Important Serious Event AE.AESMIE Is AE a Result of a Medication Error SUPPAE.QVAL where SUPPAE.QNAM='AEMERES' Causality AE.AEREL Relationship to Non-Study Treatment AE.AERELNST Event Due to Other Specify SUPPAE.QVAL where SUPPAE.QNAM='AERELTXT' Action Taken with Study Treatment AE.AEACN Concomitant Medication Given SUPPAE.QVAL where SUPPAE.QNAM='AECMGIV' Was a Non-Drug Treatment given SUPPAE.QVAL where SUPPAE.QNAM='AENDGIV' Outcome of Adverse Event AE.AEOUT Discontinued because of this AE SUPPAE.QVAL where SUPPAE.QNAM='AESUBJDC' Reference ID AE.AEREFID Causality (N) Analysis Causality AE.AEREL Analysis Causality (N) Standard Toxicity Grade (N) Analysis Toxicity Grade Analysis Toxicity Grade (N) Medication Error Associated With AE SUPPAE.QVAL where SUPPAE.QNAM='AEMEFL' Time Post Dose Vaccine Studies AE Immediate flag Period Period (C) Period Start Date Period Start Time Period Start Date/Time Period End Date Period End Time Period End Date/Time Vaccine Phase Vaccine Phase(N) Within Reporting Window Flag Pre-treatment Flag AE Occured after Which Vaccination Date of Dose 3 or Visit at 6MPD2 ADSL.V02OBDT Pooled Race Group 1 ADSL.RACEGR1 Pooled Race Group 1 (N) ADSL.RACEGR1N Study Identifier CE.STUDYID Unique Subject Identifier CE.USUBJID Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Age ADSL.AGE Age Units ADSL.AGEU Sex ADSL.SEX Sex (N) ADSL.SEXN Race ADSL.RACE Race (N) ADSL.RACEN Analysis Race ADSL.ARACE Analysis Race (N) ADSL.ARACEN Safety Population Flag ADSL.SAFFL Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Date of First Exposure to Treatment ADSL.TRTSDT Time of First Exposure to Treatment ADSL.TRTSTM Datetime of First Exposure to Treatment ADSL.TRTSDTM Date of Last Exposure to Treatment ADSL.TRTEDT Time of Last Exposure to Treatment ADSL.TRTETM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Actual Treatment for Period 01 ADSL.TRT01A Actual Treatment for Period 01 (N) ADSL.TRT01AN Actual Treatment for Period 02 ADSL.TRT02A Actual Treatment for Period 02 (N) ADSL.TRT02AN Planned Treatment for Period 01 ADSL.TRT01P Planned Treatment for Period 01 (N) ADSL.TRT01PN Planned Treatment for Period 02 ADSL.TRT02P Planned Treatment for Period 02 (N) ADSL.TRT02PN Date of First Exposure in Period 01 ADSL.TR01SDT Time of First Exposure in Period 01 ADSL.TR01STM Datetime of First Exposure in Period 01 ADSL.TR01SDTM Date of Last Exposure in Period 01 ADSL.TR01EDT Time of Last Exposure in Period 01 ADSL.TR01ETM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Date of First Exposure in Period 02 ADSL.TR02SDT Time of First Exposure in Period 02 ADSL.TR02STM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Date of Last Exposure in Period 02 ADSL.TR02EDT Time of Last Exposure in Period 02 ADSL.TR02ETM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Vaccination Date 01 ADSL.VAX101DT Vaccination Date 02 ADSL.VAX102DT Cohort Group ADSL.COHORT Cohort Group (N) ADSL.COHORTN Study Phase ADSL.PHASE Study Phase (N) ADSL.PHASEN Planned Dosing Level ADSL.DOSPLVL Planned Dosing Level (N) ADSL.DOSPLVLN Actual Dosing Level ADSL.DOSALVL Actual Dosing Level (N) ADSL.DOSALVLN Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Pooled Age Group 2 ADSL.AGEGR2 Pooled Age Group 2 (N) ADSL.AGEGR2N Pooled Age Group 4 ADSL.AGEGR4 Pooled Age Group 4 (N) ADSL.AGEGR4N Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Phase 3 30k Subjects Flag ADSL.DS30KFL Baseline SARS-CoV-2 Status ADSL.COVBLST Multiply Enrolled Subjects ADSL.MULENRFL HIV Positive Subjects Flag ADSL.HIVFL Phase 2/3 Pop for 12-25 Reacto Subset ADSL.PEDREAFL Treatment Unblinded Date ADSL.UNBLNDDT Phase 3 3000 Subjects Flag ADSL.DS3KFL Reactogenicity Population Flag ADSL.REACTOFL Age at Vaccination 01 ADSL.AGETR01 Vaccination Unplanned ADSL.VAX10U Vaccination Date Unplanned ADSL.VAX10UDT Randomized Population Flag ADSL.RANDFL Random - exclude Multi-Enrolloer ADSL.RAND1FL Safety - excld Multi-Enrolloer&HIV&IND ADSL.SAF1FL Safety - exclude Multi-Enrolloer&IND ADSL.SAF2FL Actual Treatment Actual Treatment (N) Planned Treatment ADSL.TRT01P Planned Treatment (N) ADSL.TRT01PN Source Data CE.DOMAIN Source Sequence Number CE.CESEQ Group ID CE.CEGRPID Link Group ID CE.CELNKGRP Reported Term for the Clinical Event CE.CETERM Lowest Level Term CE.CELLT Dictionary-Derived Term CE.CEDECOD Preferred Term Code CE.CEPTCD Body System or Organ Class CE.CEBODSYS Body System or Organ Class Code CE.CEBDSYCD Category for Clinical Event CE.CECAT Subcategory for Clinical Event CE.CESCAT Clinical Event Pre-Specified CE.CEPRESP Clinical Event Occurrence CE.CEOCCUR Completion Status CE.CESTAT Reason Clinical Event Not Collected CE.CEREASND Analysis Severity/Intensity Severity/Intensity CE.CESEV Location of Event CE.CELOC Laterality CE.CELAT Start Date/Time of Clinical Event CE.CESTDTC End Date/Time of Clinical Event CE.CEENDTC Study Day of Start of Observation CE.CESTDY Study Day of End of Observation CE.CEENDY End Relative to Reference Time Point CE.CEENRTPT End Reference Time Point CE.CEENTPT Planned Time Point Name CE.CETPT Time Point Reference CE.CETPTREF Dose EX.EXDOSE Name of Treatment EX.EXTRT Dose Units EX.EXDOSU Start Date/Time of Treatment EX.EXSTDTC End Date/Time of Treatment EX.EXENDTC Analysis Start Date Analysis End Date Analysis Duration Units Analysis Duration (N) Known Value Flag Event Value Flag Study Identifier CM.STUDYID Unique Subject Identifier CM.USUBJID Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Sequence Number CM.CMSEQ Category for Medication CM.CMCAT Subcategory for Medication CM.CMSCAT Start Date/Time of Medication CM.CMSTDTC End Date/Time of Medication CM.CMENDTC Reported Name of Drug, Med, or Therapy CM.CMTRT Standardized Medication Name CM.CMDECOD Standardized Medication Code CM.CMCODE Pre-treatment Flag On-Period Flag On-Period 01 Flag On-Period 02 Flag Analysis Start Date Analysis Start Date Imputation Flag Analysis Start Relative Day Analysis End Date Analysis End Date Imputation Flag Analysis End Relative Day Medication Class CM.CMCLAS Medication Class Code CM.CMCLASCD WHODrug preferred name WHODrug preferred name1 ATC Level 1 Code ATC Level 1 Text ATC Level 2 Code ATC Level 2 Text ATC Level 3 Code ATC Level 3 Text ATC Level 4 Code ATC Level 4 Text ATC Level 5 Code ATC Level 5 Text Study Day of Start of Medication CM.CMSTDY Study Day of End of Medication CM.CMENDY Dose per Administration CM.CMDOSE Route of Administration CM.CMROUTE Dose Description CM.CMDOSTXT Dose Units CM.CMDOSU Dosing Frequency per Interval CM.CMDOSFRQ End Relative to Reference Time Point CM.CMENRTPT End Reference Time Point CM.CMENTPT Epoch CM.EPOCH Dictionary Name and Version SUPPCM.QVAL where SUPPCM.QNAM="DICTVER" Medication Class 1 SUPPCM.QVAL where SUPPCM.QNAM="CMCLAS1" Medication Class 2 SUPPCM.QVAL where SUPPCM.QNAM="CMCLAS2" Medication Class Code 1 SUPPCM.QVAL where SUPPCM.QNAM="CMCLSCD1" Medication Class Code 2 SUPPCM.QVAL where SUPPCM.QNAM="CMCLSCD2" Age ADSL.AGE Age Units ADSL.AGEU Sex ADSL.SEX Sex (N) ADSL.SEXN Race ADSL.RACE Race (N) ADSL.RACEN Analysis Race ADSL.ARACE Analysis Race (N) ADSL.ARACEN Safety Population Flag ADSL.SAFFL Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Date of First Exposure to Treatment ADSL.TRTSDT Time of First Exposure to Treatment ADSL.TRTSTM Datetime of First Exposure to Treatment ADSL.TRTSDTM Date of Last Exposure to Treatment ADSL.TRTEDT Time of Last Exposure to Treatment ADSL.TRTETM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Date of Unblinding or Visit at 1MPD2 ADSL.V01DT Date of Unblinding or Visit at 6MPD2 ADSL.V02DT Date of Visit at 1M after Vax4 ADSL.V03DT Date of Visit at 6M after Vax4 ADSL.V04DT Vaccination Date 01 ADSL.VAX101DT Vaccination Date Unplanned ADSL.VAX10UDT Vaccination Date 02 ADSL.VAX102DT Vaccination Date 03 ADSL.VAX201DT Vaccination Date 04 ADSL.VAX202DT Cohort Group (N) ADSL.COHORTN Cohort Group ADSL.COHORT Actual Dosing Level (N) ADSL.DOSALVLN Actual Dosing Level ADSL.DOSALVL Planned Dosing Level (N) ADSL.DOSPLVLN Planned Dosing Level ADSL.DOSPLVL Study Phase (N) ADSL.PHASEN Study Phase ADSL.PHASE Treatment Unblinded Date ADSL.UNBLNDDT Multiply Enrolled Subjects ADSL.MULENRFL Phase 3 30k Subjects Flag ADSL.DS30KFL HIV Positive Subjects Flag ADSL.HIVFL Age at Vaccination 01 ADSL.AGETR01 Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Pooled Age Group 4 ADSL.AGEGR4 Pooled Age Group 4 (N) ADSL.AGEGR4N Datetime of First Exposure in Period 01 ADSL.TR01SDTM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Actual Treatment for Period 01 ADSL.TRT01A Actual Treatment for Period 01 (N) ADSL.TRT01AN Planned Treatment for Period 01 ADSL.TRT01P Planned Treatment for Period 01 (N) ADSL.TRT01PN Actual Treatment for Period 02 ADSL.TRT02A Actual Treatment for Period 02 (N) ADSL.TRT02AN Planned Treatment for Period 02 ADSL.TRT02P Planned Treatment for Period 02 (N) ADSL.TRT02PN Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Vaccination Unplanned ADSL.VAX10U Vaccination 03 ADSL.VAX201 Vaccination 04 ADSL.VAX202 Vaccination Unplanned in Period 02 ADSL.VAX20U Vaccination Date Unplanned in Period 02 ADSL.VAX20UDT Phase 3 3000 Subjects Flag ADSL.DS3KFL Randomized Population Flag ADSL.RANDFL Random - exclude Multi-Enrolloer ADSL.RAND1FL Safety - excld Multi-Enrolloer&HIV&IND ADSL.SAF1FL Safety - exclude Multi-Enrolloer&IND ADSL.SAF2FL Vaccine Phase Vaccine Phase(N) CM Occured after Which Vaccination Study Identifier DS.STUDYID Unique Subject Identifier DS.USUBJID Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Analysis Date Analysis Start Date Analysis Start Relative Day Disposition Phase SUPPDS.QVAL where SUPPDS.QNAM="DSPHASE" Disposition Phase Code (N) Category for Disposition Event DS.DSCAT where DSCAT='DISPOSITION EVENT' Standardized Disposition Term DS.DSDECOD Standardized Disposition Term (N) Reported Term for the Disposition Event DS.DSTERM 1 Month Post Dose 2 Visit Date 6 Months Post Dose 2 Visit Date 1 Month Post Dose 4 Visit Date 1 Month PD2 Cutoff Date for Disposition Excluded from 1 Month Post Dose 2 Age ADSL.AGE Age Units ADSL.AGEU Sex ADSL.SEX Sex (N) ADSL.SEXN Race ADSL.RACE Race (N) ADSL.RACEN Analysis Race ADSL.ARACE Analysis Race (N) ADSL.ARACEN Randomized Population Flag ADSL.RANDFL Safety Population Flag ADSL.SAFFL Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Date of First Exposure to Treatment ADSL.TRTSDT Time of First Exposure to Treatment ADSL.TRTSTM Datetime of First Exposure to Treatment ADSL.TRTSDTM Date of Last Exposure to Treatment ADSL.TRTEDT Time of Last Exposure to Treatment ADSL.TRTETM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Planned Sequence of Treatments ADSL.TRTSEQP Actual Sequence of Treatments ADSL.TRTSEQA Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Cohort Group ADSL.COHORT Cohort Group (N) ADSL.COHORTN Actual Dosing Level ADSL.DOSALVL Actual Dosing Level (N) ADSL.DOSALVLN Planned Dosing Level ADSL.DOSPLVL Planned Dosing Level (N) ADSL.DOSPLVLN Vaccination Date 01 ADSL.VAX101DT Vaccination Date 02 ADSL.VAX102DT Vaccination Date Unplanned ADSL.VAX10UDT Vaccination Date 03 ADSL.VAX201DT Vaccination Date 04 ADSL.VAX202DT Vaccination Date Unplanned in Period 02 ADSL.VAX20UDT Treatment Unblinded Date ADSL.UNBLNDDT Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Vaccination Unplanned ADSL.VAX10U Vaccination 03 ADSL.VAX201 Vaccination 04 ADSL.VAX202 Vaccination Unplanned in Period 02 ADSL.VAX20U Actual Treatment for Period 01 ADSL.TRT01A Actual Treatment for Period 01 (N) ADSL.TRT01AN Actual Treatment for Period 02 ADSL.TRT02A Actual Treatment for Period 02 (N) ADSL.TRT02AN Planned Treatment for Period 01 ADSL.TRT01P Planned Treatment for Period 01 (N) ADSL.TRT01PN Planned Treatment for Period 02 ADSL.TRT02P Planned Treatment for Period 02 (N) ADSL.TRT02PN Date of First Exposure in Period 01 ADSL.TR01SDT Time of First Exposure in Period 01 ADSL.TR01STM Datetime of First Exposure in Period 01 ADSL.TR01SDTM Date of Last Exposure in Period 01 ADSL.TR01EDT Time of Last Exposure in Period 01 ADSL.TR01ETM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Date of First Exposure in Period 02 ADSL.TR02SDT Time of First Exposure in Period 02 ADSL.TR02STM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Date of Last Exposure in Period 02 ADSL.TR02EDT Time of Last Exposure in Period 02 ADSL.TR02ETM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Study Phase ADSL.PHASE Study Phase (N) ADSL.PHASEN End Of Study Discontinuation Date ADSL.EOSDCDT End Of Treatment Discontinuation Date ADSL.EOTDCDT Blood Sample Date 1 Month after Vax 2 ADSL.BLDV6DT Blood Sample Date 6 Months after Vax 2 ADSL.BLDV7DT Pooled Age Group 4 ADSL.AGEGR4 Pooled Age Group 4 (N) ADSL.AGEGR4N Pop for Non-inferiority Assessement ADSL.PEDIMMFL Multiply Enrolled Subjects ADSL.MULENRFL Phase 2/3 Pop for 12-25 Reacto Subset ADSL.PEDREAFL HIV Positive Subjects Flag ADSL.HIVFL Phase 3 3000 Subjects Flag ADSL.DS3KFL End Of Open Label Treatment D/C Date ADSL.EOTXDCDT End Of Open Label Treatment D/C Reason ADSL.EOTXDCRS Double Blinded Follow-up Censor Date ADSL.BDCSRDT Crossover Dose1 Censor Date ADSL.X1CSRDT Study Censor Date ADSL.STCSRDT Age at Vaccination 01 ADSL.AGETR01 Age Units at Vaccination 01 ADSL.AGETRU01 Random - exclude Multi-Enrolloer ADSL.RAND1FL Safety - excld Multi-Enrolloer&HIV&IND ADSL.SAF1FL Safety - exclude Multi-Enrolloer&IND ADSL.SAF2FL Domain Abbreviation Sequence Number DS.DSSEQ Study Identifier DV.STUDYID Unique Subject Identifier DV.USUBJID Domain Abbreviation Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Age ADSL.AGE Sex ADSL.SEX Race ADSL.RACE Date of First Exposure to Treatment ADSL.TRTSDT Date of Last Exposure to Treatment ADSL.TRTEDT Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Planned Treatment for Period 01 ADSL.TRT01P Actual Treatment for Period 01 ADSL.TRT01A Planned Treatment for Period 01 (N) ADSL.TRT01PN Actual Treatment for Period 01 (N) ADSL.TRT01AN Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Sequence Number DV.DVSEQ Sponsor-Defined Identifier DV.DVSPID Protocol Deviation Term DV.DVTERM Protocol Deviation Term 1 SUPPDV.QVAL where SUPPDV.QNAM='DVTERM1' Protocol Deviation Coded Term DV.DVDECOD Epoch DV.EPOCH Actual Site of Deviation Occurrence SUPPDV.QVAL where SUPPDV.QNAM='ACTSITE' Visit Designator SUPPDV.QVAL where SUPPDV.QNAM='DESGTOR' Confirmed Analysis Population Exclusion SUPPDV.QVAL where SUPPDV.QNAM='CAPE' Category for Protocol Deviation DV.DVCAT Start Date/Time of Deviation DV.DVSTDTC Study Day of Start of Deviation DV.DVSTDY Analysis Start Date Pre-treatment Flag On Treatment Flag Randomized Population Flag ADSL.RANDFL Study Phase ADSL.PHASE Study Phase (N) ADSL.PHASEN Cohort Group ADSL.COHORT Cohort Group (N) ADSL.COHORTN Actual Dosing Level ADSL.DOSALVL Actual Dosing Level (N) ADSL.DOSALVLN Planned Dosing Level ADSL.DOSPLVL Planned Dosing Level (N) ADSL.DOSPLVLN Phase 3 3000 Subjects Flag ADSL.DS3KFL Pooled Age Group 3 (N) ADSL.AGEGR3N Pooled Age Group 3 ADSL.AGEGR3 Pooled Age Group 4 (N) ADSL.AGEGR4N Pooled Age Group 4 ADSL.AGEGR4 HIV Positive Subjects Flag ADSL.HIVFL Age at Vaccination 01 ADSL.AGETR01 Datetime of First Exposure to Treatment ADSL.TRTSDTM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Datetime of First Exposure in Period 01 ADSL.TR01SDTM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Vaccination Unplanned ADSL.VAX10U Vaccination 03 ADSL.VAX201 Vaccination 04 ADSL.VAX202 Vaccination Unplanned in Period 02 ADSL.VAX20U Vaccination Date Unplanned in Period 02 ADSL.VAX20UDT Treatment Unblinded Date ADSL.UNBLNDDT Multiply Enrolled Subjects ADSL.MULENRFL Random - exclude Multi-Enrolloer ADSL.RAND1FL Study Identifier MH.STUDYID Unique Subject Identifier MH.USUBJID Subject Identifier for the Study ADSL.SUBJID Study Site Identifier ADSL.SITEID Sequence Number MH.MHSEQ Reported Term for the Medical History MH.MHTERM Dictionary-Derived Term MH.MHDECOD Preferred Term Code MH.MHPTCD Body System or Organ Class MH.MHBODSYS Body System or Organ Class Code MH.MHBDSYCD Lowest Level Term MH.MHLLT Lowest Level Term Code MH.MHLLTCD High Level Term MH.MHHLT High Level Term Code MH.MHHLTCD High Level Group Term MH.MHHLGT High Level Group Term Code MH.MHHLGTCD Primary System Organ Class MH.MHSOC Primary System Organ Class Code MH.MHSOCCD Category for Medical History MH.MHCAT Start Date/Time of Medical History Event MH.MHSTDTC End Date/Time of Medical History Event MH.MHENDTC End Relative to Reference Time Point MH.MHENRTPT End Reference Time Point MH.MHENTPT Dictionary Name and Version SUPPMH.QVAL where SUPPMH.QNAM='DICTVER' Sponsor-Defined Identifier MH.MHSPID Analysis Start Date Analysis Start Date Imputation Flag Analysis Start Relative Day Analysis End Date Analysis End Date Imputation Flag Analysis End Relative Day Comorbidity Flag Charlson Comorbidity Index Category 1 Charlson Comorbidity Index Category 2 Analysis Date Analysis Date Imputation Flag Analysis Duration (N) Analysis Duration Units Age ADSL.AGE Age Units ADSL.AGEU Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Sex ADSL.SEX Sex (N) ADSL.SEXN Race ADSL.RACE Race (N) ADSL.RACEN Analysis Race ADSL.ARACE Analysis Race (N) ADSL.ARACEN Randomized Population Flag ADSL.RANDFL Safety Population Flag ADSL.SAFFL Description of Planned Arm ADSL.ARM Planned Arm Code ADSL.ARMCD Description of Actual Arm ADSL.ACTARM Actual Arm Code ADSL.ACTARMCD Date of First Exposure to Treatment ADSL.TRTSDT Time of First Exposure to Treatment ADSL.TRTSTM Datetime of First Exposure to Treatment ADSL.TRTSDTM Date of Last Exposure to Treatment ADSL.TRTEDT Time of Last Exposure to Treatment ADSL.TRTETM Datetime of Last Exposure to Treatment ADSL.TRTEDTM Actual Treatment for Period 01 ADSL.TRT01A Actual Treatment for Period 01 (N) ADSL.TRT01AN Actual Treatment for Period 02 ADSL.TRT02A Actual Treatment for Period 02 (N) ADSL.TRT02AN Planned Treatment for Period 01 ADSL.TRT01P Planned Treatment for Period 01 (N) ADSL.TRT01PN Planned Treatment for Period 02 ADSL.TRT02P Planned Treatment for Period 02 (N) ADSL.TRT02PN Date of First Exposure in Period 01 ADSL.TR01SDT Time of First Exposure in Period 01 ADSL.TR01STM Datetime of First Exposure in Period 01 ADSL.TR01SDTM Date of Last Exposure in Period 01 ADSL.TR01EDT Time of Last Exposure in Period 01 ADSL.TR01ETM Datetime of Last Exposure in Period 01 ADSL.TR01EDTM Date of First Exposure in Period 02 ADSL.TR02SDT Time of First Exposure in Period 02 ADSL.TR02STM Datetime of First Exposure in Period 02 ADSL.TR02SDTM Date of Last Exposure in Period 02 ADSL.TR02EDT Time of Last Exposure in Period 02 ADSL.TR02ETM Datetime of Last Exposure in Period 02 ADSL.TR02EDTM Vaccination 01 ADSL.VAX101 Vaccination 02 ADSL.VAX102 Vaccination Unplanned ADSL.VAX10U Vaccination 03 ADSL.VAX201 Vaccination 04 ADSL.VAX202 Vaccination Unplanned in Period 02 ADSL.VAX20U Vaccination Date 01 ADSL.VAX101DT Vaccination Date 02 ADSL.VAX102DT Vaccination Date Unplanned ADSL.VAX10UDT Vaccination Date 03 ADSL.VAX201DT Vaccination Date 04 ADSL.VAX202DT Vaccination Date Unplanned in Period 02 ADSL.VAX20UDT Treatment Unblinded Date ADSL.UNBLNDDT Date of Randomization ADSL.RANDDT Cohort Group ADSL.COHORT Cohort Group (N) ADSL.COHORTN Actual Dosing Level ADSL.DOSALVL Actual Dosing Level (N) ADSL.DOSALVLN Planned Dosing Level ADSL.DOSPLVL Planned Dosing Level (N) ADSL.DOSPLVLN Phase 3 30k Subjects Flag ADSL.DS30KFL Study Phase ADSL.PHASE Study Phase (N) ADSL.PHASEN Pooled Age Group 4 ADSL.AGEGR4 Pooled Age Group 4 (N) ADSL.AGEGR4N HIV Positive Subjects Flag ADSL.HIVFL Pop for Non-inferiority Assessement ADSL.PEDIMMFL Multiply Enrolled Subjects ADSL.MULENRFL Phase 2/3 Pop for 12-25 Reacto Subset ADSL.PEDREAFL Phase 3 3000 Subjects Flag ADSL.DS3KFL Age at Vaccination 01 ADSL.AGETR01 Age Units at Vaccination 01 ADSL.AGETRU01 Random - exclude Multi-Enrolloer ADSL.RAND1FL Safety - excld Multi-Enrolloer&HIV&IND ADSL.SAF1FL Safety - exclude Multi-Enrolloer&IND ADSL.SAF2FL SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER CEPHEID RT-PCR ASSAY FOR SARS-COV-2 N-BINDING ANTIBODY PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE PROTOCOL DEFINED COVID-19 ILLNESS ONSET CDC DEFINED COVID-19 ILLNESS ONSET SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 COVID-19 NAAT RESULT AFTER DOSE HOSPITALIZED DUE TO COVID-19 ILLNESS? PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE CDC DEFINED SEVERE COVID-19 ILLNESS ONSET SEVERE COVID-19 SYMPTOMS - VITAL SIGNS PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE PRIMARY CAUSE OF DEATH DEATH OCCURRED DUE TO COVID-19 ILLNESS? SECONDARY CAUSE OF DEATH SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS Pain at injection site maximum severity Pain at injection site severity/intensity Medications duration Fatigue maximum severity Fatigue severity/intensity Fever maximum temperature Headache maximum severity Headache severity/intensity Joint pain maximum severity Joint pain severity/intensity Redness diameter cm Redness maximum diameter Redness maximum severity Redness severity/intensity Diarrhea maximum severity Diarrhea severity/intensity Chills maximum severity Chills severity/intensity Muscle pain maximum severity Muscle pain severity/intensity Swelling diameter cm Swelling maximum diameter Swelling maximum severity Swelling severity/intensity Vomiting maximum severity Vomiting severity/intensity Redness maximum diameter cm Redness minimum diameter cm Swelling maximum diameter cm Swelling minimum diameter cm Pain at injection site maximum severity Pain at injection site occurrence indicator Pain at injection site severity/intensity Redness occurrence indicator Swelling occurrence indicator Medications medication to treat fever or pain Chills occurrence indicator Diarrhea occurrence indicator Fatigue maximum severity Fatigue occurrence indicator Fatigue severity/intensity Fever occurrence indicator Headache maximum severity Headache occurrence indicator Headache severity/intensity Joint pain maximum severity Joint pain occurrence indicator Joint pain severity/intensity Muscle pain occurrence indicator Vomiting occurrence indicator Redness diameter cm Redness maximum severity Redness severity/intensity Diarrhea maximum severity Diarrhea severity/intensity Chills maximum severity Chills severity/intensity Hospitalized for tiredness (fatigue) occurrence indicator Muscle pain maximum severity Muscle pain severity/intensity Swelling diameter cm Swelling maximum severity Swelling severity/intensity Hospitalized for injection site pain occurrence indicator Hospitalized for headache occurrence indicator Hospitalized for muscle pain occurrence indicator Medications stop date meds given to trt/pnt symptoms Hospitalized for joint pain occurrence indicator Hospitalized for diarrhea occurrence indicator Vomiting maximum severity Vomiting severity/intensity Hospitalized for chills occurrence indicator Medications duration Redness grade 4 criteria met Redness maximum diameter cm Redness minimum diameter cm Swelling grade 4 criteria met Swelling maximum diameter cm Swelling minimum diameter cm Hospitalized for vomiting occurrence indicator RESPIRATORY RATE HEART RATE OXYGEN SATURATION DIASTOLIC BLOOD PRESSURE SYSTOLIC BLOOD PRESSURE PP ARTERIAL O2/FRACTION INSPIRED O2 CEPHEID RT-PCR ASSAY FOR SARS-COV-2 N-BINDING ANTIBODY CHILLS DIARRHEA FEVER NEW LOSS OF TASTE OR SMELL NEW OR INCREASED COUGH NEW OR INCREASED MUSCLE PAIN NEW OR INCREASED SHORTNESS OF BREATH NEW OR INCREASED SORE THROAT VOMITING SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 FATIGUE RHINORRHOEA NEW OR INCREASED NASAL CONGESTION HEADACHE NAUSEA HOSPITALIZED DUE TO COVID-19 ILLNESS? SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS MECHANICAL VENTILATION DEATH PRIMARY CAUSE OF DEATH HIGH FLOW OXYGEN THERAPY SECONDARY CAUSE OF DEATH NEW OR INCREASED WHEEZING NON-INVASIVE POSITIVE PRESSURE VENTILATION SIGNIFICANT ACUTE RENAL DYSFUNCTION SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION SIGNIFICANT ACUTE HEPATIC DYSFUNCTION VASOPRESSORS AGENTS COVID-19 RBD IgG (U/mL) - Luminex Immunoassay COVID-19 S1 IgG (U/mL) - Luminex Immunoassay N-binding antibody - N-binding Antibody Assay SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG COVID-19 RBD IgG (U/mL) - Luminex Immunoassay COVID-19 S1 IgG (U/mL) - Luminex Immunoassay N-binding antibody - N-binding Antibody Assay SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (100/10 mcg) BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) NOT ASSIGNED Not Treated Placebo SCREEN FAILURE Pre-Vaccination Vaccination 1 Vaccination 2 Follow Up 1 After unblinding and before Vaccination 3 Vaccination 3 Vaccination 4 Follow Up 3 Follow Up 2 COVID_A COVID_B COVID_C COVID_D COVID_E COVID_F SSWAB_WEEK2 SSWAB_WEEK4 SSWAB_WEEK6 SSWAB_WEEK8 V1_DAY1_VAX1_L V2_VAX2_L V201_SURVEIL_CONSENT CDC DEFINED COVID-19 ILLNESS ONSET CDC DEFINED SEVERE COVID-19 ILLNESS ONSET CEPHEID RT-PCR ASSAY FOR SARS-COV-2 COVID-19 NAAT RESULT AFTER DOSE DEATH OCCURRED DUE TO COVID-19 ILLNESS? HOSPITALIZED DUE TO COVID-19 ILLNESS? N-BINDING ANTIBODY PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE PRIMARY CAUSE OF DEATH PROTOCOL DEFINED COVID-19 ILLNESS ONSET PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET SECONDARY CAUSE OF DEATH SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS SEVERE COVID-19 SYMPTOMS - VITAL SIGNS SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 CEPHEID RT-PCR ASSAY FOR SARS-COV-2 N-BINDING ANTIBODY SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS HOSPITALIZED DUE TO COVID-19 ILLNESS? PRIMARY CAUSE OF DEATH SECONDARY CAUSE OF DEATH DEATH OCCURRED DUE TO COVID-19 ILLNESS? PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE SEVERE COVID-19 SYMPTOMS - VITAL SIGNS SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE COVID-19 NAAT RESULT AFTER DOSE PROTOCOL DEFINED COVID-19 ILLNESS ONSET CDC DEFINED COVID-19 ILLNESS ONSET PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET CDC DEFINED SEVERE COVID-19 ILLNESS ONSET SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - CROSSOVER SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - CROSSOVER Pre-Vaccination Vaccination 1 Vaccination 2 Follow Up 1 After unblinding and before Vaccination 3 Vaccination 3 Vaccination 4 Follow Up 3 Follow Up 2 UNPLANNED VISIT 0.001 UNPLANNED VISIT 1.001 V1_DAY1_VAX1_S UNPLANNED VISIT 60748.001 UNPLANNED VISIT 60749.001 UNPLANNED VISIT 60750.001 V4_WEEK3_VAX2_S V6_WEEK2_POSTVAX2_S V1_DAY1_VAX1_L UNPLANNED VISIT 60765.001 UNPLANNED VISIT 60765.002 UNPLANNED VISIT 60765.003 V2_VAX2_L UNPLANNED VISIT 60766.001 UNPLANNED VISIT 60766.002 V3_MONTH1_POSTVAX2_L V4_WEEK3_VAX2_S_R V6_WEEK2_POSTVAX2_S_R Maximum Value Derivation Technique Redness diameter cm Swelling diameter cm Redness grade 4 criteria met Swelling grade 4 criteria met Redness maximum diameter cm Swelling maximum diameter cm Chills maximum severity Diarrhea maximum severity Fatigue maximum severity Headache maximum severity Joint pain maximum severity Muscle pain maximum severity Vomiting maximum severity Fever maximum temperature Redness maximum diameter Swelling maximum diameter Medications duration Medications medication to treat fever or pain Redness minimum diameter cm Swelling minimum diameter cm Redness maximum severity Swelling maximum severity Pain at injection site maximum severity Chills occurrence indicator Diarrhea occurrence indicator Fatigue occurrence indicator Fever occurrence indicator Headache occurrence indicator Hospitalized for injection site pain occurrence indicator Hospitalized for chills occurrence indicator Hospitalized for diarrhea occurrence indicator Hospitalized for tiredness (fatigue) occurrence indicator Hospitalized for headache occurrence indicator Hospitalized for joint pain occurrence indicator Hospitalized for muscle pain occurrence indicator Hospitalized for vomiting occurrence indicator Swelling occurrence indicator Redness occurrence indicator Joint pain occurrence indicator Muscle pain occurrence indicator Pain at injection site occurrence indicator Vomiting occurrence indicator Chills severity/intensity Diarrhea severity/intensity Fatigue severity/intensity Headache severity/intensity Joint pain severity/intensity Muscle pain severity/intensity Pain at injection site severity/intensity Redness severity/intensity Swelling severity/intensity Vomiting severity/intensity Medications stop date meds given to trt/pnt symptoms Redness severity/intensity Redness maximum severity Redness grade 4 criteria met Redness diameter cm Redness minimum diameter cm Redness maximum diameter Redness occurrence indicator Redness maximum diameter cm Swelling severity/intensity Swelling maximum severity Swelling grade 4 criteria met Swelling diameter cm Swelling minimum diameter cm Swelling maximum diameter Swelling occurrence indicator Swelling maximum diameter cm Pain at injection site occurrence indicator Pain at injection site severity/intensity Pain at injection site maximum severity Fever maximum temperature Fever occurrence indicator Fatigue severity/intensity Fatigue maximum severity Fatigue occurrence indicator Headache severity/intensity Headache maximum severity Headache occurrence indicator Chills severity/intensity Chills maximum severity Chills occurrence indicator Medications medication to treat fever or pain Medications stop date meds given to trt/pnt symptoms Medications duration Diarrhea occurrence indicator Diarrhea severity/intensity Diarrhea maximum severity Muscle pain occurrence indicator Muscle pain severity/intensity Muscle pain maximum severity Joint pain occurrence indicator Joint pain severity/intensity Joint pain maximum severity Vomiting occurrence indicator Vomiting severity/intensity Vomiting maximum severity Hospitalized for diarrhea occurrence indicator Hospitalized for headache occurrence indicator Hospitalized for injection site pain occurrence indicator Hospitalized for joint pain occurrence indicator Hospitalized for tiredness (fatigue) occurrence indicator Hospitalized for vomiting occurrence indicator Hospitalized for muscle pain occurrence indicator Hospitalized for chills occurrence indicator COVID_A COVID_B COVID_C COVID_D COVID_E COVID_F COVID_A1 COVID_B1 SSWAB_WEEK2 SSWAB_WEEK4 SSWAB_WEEK6 SSWAB_WEEK8 V1_DAY1_VAX1_L V2_VAX2_L V3_MONTH1_POSTVAX2_L V4_MONTH6_L V101_VAX3 V201_SURVEIL_CONSENT CHILLS DIARRHEA FEVER NEW LOSS OF TASTE OR SMELL NEW OR INCREASED COUGH NEW OR INCREASED MUSCLE PAIN NEW OR INCREASED SHORTNESS OF BREATH NEW OR INCREASED SORE THROAT VOMITING NEW OR INCREASED NASAL CONGESTION NEW OR INCREASED WHEEZING FATIGUE HEADACHE RHINORRHOEA NAUSEA SIGNIFICANT ACUTE RENAL DYSFUNCTION SIGNIFICANT ACUTE HEPATIC DYSFUNCTION SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 CEPHEID RT-PCR ASSAY FOR SARS-COV-2 RESPIRATORY RATE HEART RATE OXYGEN SATURATION DIASTOLIC BLOOD PRESSURE SYSTOLIC BLOOD PRESSURE PP ARTERIAL O2/FRACTION INSPIRED O2 NON-INVASIVE POSITIVE PRESSURE VENTILATION MECHANICAL VENTILATION HIGH FLOW OXYGEN THERAPY VASOPRESSORS AGENTS N-BINDING ANTIBODY SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS HOSPITALIZED DUE TO COVID-19 ILLNESS? PRIMARY CAUSE OF DEATH SECONDARY CAUSE OF DEATH DEATH CHILLS DIARRHEA FEVER NEW LOSS OF TASTE OR SMELL NEW OR INCREASED COUGH NEW OR INCREASED MUSCLE PAIN NEW OR INCREASED SHORTNESS OF BREATH NEW OR INCREASED SORE THROAT VOMITING NEW OR INCREASED NASAL CONGESTION NEW OR INCREASED WHEEZING FATIGUE HEADACHE RHINORRHOEA NAUSEA SIGNIFICANT ACUTE RENAL DYSFUNCTION SIGNIFICANT ACUTE HEPATIC DYSFUNCTION SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 CEPHEID RT-PCR ASSAY FOR SARS-COV-2 RESPIRATORY RATE HEART RATE OXYGEN SATURATION DIASTOLIC BLOOD PRESSURE SYSTOLIC BLOOD PRESSURE PP ARTERIAL O2/FRACTION INSPIRED O2 NON-INVASIVE POSITIVE PRESSURE VENTILATION MECHANICAL VENTILATION HIGH FLOW OXYGEN THERAPY VASOPRESSORS AGENTS N-BINDING ANTIBODY SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS HOSPITALIZED DUE TO COVID-19 ILLNESS? PRIMARY CAUSE OF DEATH SECONDARY CAUSE OF DEATH DEATH Before Vaccination 1 1 Week after Vaccination 1 3 Weeks after Vaccination 1 4 Weeks after Vaccination 1 5 Weeks after Vaccination 1 1 Month and 3 weeks after Vaccination 1 Before Vaccination 2 1 Week after Vaccination 2 2 Weeks after Vaccination 2 1 Month after Vaccination 2 6 Months after Vaccination 2 SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay COVID-19 S1 IgG (U/mL) - Luminex Immunoassay COVID-19 RBD IgG (U/mL) - Luminex Immunoassay N-binding antibody - N-binding Antibody Assay SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay COVID-19 S1 IgG (U/mL) - Luminex Immunoassay COVID-19 RBD IgG (U/mL) - Luminex Immunoassay N-binding antibody - N-binding Antibody Assay SARS-CoV-2 serum neutralizing titer 50 to COVID-19 S1 IgG SARS-CoV-2 serum neutralizing titer 90 to COVID-19 S1 IgG SEROLOGY RELATED NOT RELATED RELATED NOT RELATED GRADE 1 GRADE 2 GRADE 3 GRADE 4 GRADE 1 GRADE 2 GRADE 3 GRADE 4 12-15 Years 16-55 Years 18-55 Years 65-85 Years >55 Years <65 Years >=65 Years 16-17 Years 18-55 Years >55 Years 12-15 Years 16-25 Years 16-55 Years >55 Years Year Period 01 Period 02 White Black or african american American indian or alaska native Asian Native hawaiian or other pacific islander Multiple Not reported WHITE BLACK OR AFRICAN AMERICAN AMERICAN INDIAN OR ALASKA NATIVE ASIAN NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER MULTIRACIAL NOT REPORTED RELATED NOT RELATED RELATED NOT RELATED BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (100/10 mcg) BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) NOT ASSIGNED Placebo SCREEN FAILURE GRADE 1 GRADE 2 GRADE 3 GRADE 4 DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 DAY 6 DAY 7 >0-2.0 >2.0-5.0 >5.0-10.0 >10.0 Underweight Normal weight Overweight Obese Missing Missing < LLOQ >= LLOQ <200 200-500 >500 CONCOMITANT IMMUNOSUPPRESSIVE THERAPY CORTICOSTEROIDS GENERAL CONCOMITANT MEDICATIONS VACCINATIONS IMMUNOGLOBULINS VASOPRESSORS AGENTS Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Stage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) Stage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO) Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Stage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) Stage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO) Stage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) Negative Positive Day Imputed Month Day Imputed 10 (*ESC*){unicode 03BC}g 20 (*ESC*){unicode 03BC}g 30 (*ESC*){unicode 03BC}g 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g Placebo 10 (*ESC*){unicode 03BC}g 20 (*ESC*){unicode 03BC}g 30 (*ESC*){unicode 03BC}g 100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}g Placebo ADVERSE EVENT COMPLETED DEATH LOST TO FOLLOW-UP OTHER PHYSICIAN DECISION PREGNANCY PROTOCOL DEVIATION SCREEN FAILURE WITHDRAWAL BY SUBJECT MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT NO LONGER MEETS ELIGIBILITY CRITERIA REFUSED FURTHER STUDY PROCEDURES WITHDRAWAL BY PARENT/GUARDIAN SCREENING OPEN LABEL TREATMENT VACCINATION FOLLOW-UP REPEAT SCREENING 1 FOLLOW-UP SCREENING VACCINATION OPEN LABEL FOLLOW-UP OPEN LABEL TREATMENT REPEAT SCREENING 1 Hispanic or Latino Not Hispanic or Latino Not Reported HISPANIC OR LATINO NOT HISPANIC OR LATINO NOT REPORTED 0-1 month 1-2 months 2-3 months 3-4 months <38.0 C 38.0 C to 38.4 C >38.4 C to 38.9 C >38.9 C to 40.0 C >40.0 C 0-1 month 1-2 months 2-3 months 3-4 months 4-5 months 5-6 months 6-7 months 7-8 months 8-9 months 9-10 months 10-11 months 11-12 months 0-1 month 1-2 months 2-3 months 3-4 months 4-5 months 5-6 months 6-7 months 7-8 months 8-9 months 9-10 months 10-11 months 0-1 month 1-2 months 2-3 months 3-4 months 4-5 months 5-6 months 6-7 months 7-8 months 8-9 months 9-10 months Left Right Deltoid No Yes Phase 1 Phase 2_ds360/ds6000 Phase 3_ds6000 Phase 3 White Black or african american American indian or alaska native Asian Native hawaiian or other pacific islander Multiple Not reported WHITE BLACK OR AFRICAN AMERICAN ALL OTHERS WHITE BLACK OR AFRICAN AMERICAN AMERICAN INDIAN OR ALASKA NATIVE ASIAN NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER MULTIPLE NOT REPORTED JAPANESE OTHER <50 >=50 Female Male M F Serum Prior Continue BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (100/10 mcg) BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) Placebo BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (100/10 mcg) BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) Placebo BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (100/10 mcg) BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) Placebo BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (100/10 mcg) BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) Placebo Day Year Percentage Beats per Minute Breaths per Minute Millimeter of Mercury Degree Celsius Yes If (index (upcase(AEACN),'DRUG WITHDRAWN') > 0 or AESUBJDC='Y') then ADESFL=”Y” else ADESFL=N. ADURN in Days: ADURN= AENDT - ASTDT+1 and ADURU =’DAYS’ AE.AEDECOD if AE.AEDECOD eq '' and not missing(AE.AETERM))) then AEDECOD=upcase(strip(AE.AETERM)) || "@@" If 0<=AETPDOS < = 30 mins (0.5 hours) then AEIMMFL=”Y” else null Note: Immediate AE is defined as AEs happened within 30 mins after corresponding vaccination Convert AEENDTC to DATE9 format Note: No imputation for AENDT, all imputing will be based on pfizer standards. Convert AEENDTC to IS8601 format. For AEs without time collected: if (ASTDT<ADSL.VAX101DT) then AENDY= AENDT – ADSL.VAX101DT; if (ASTDT>= ADSL.VAX101DT and ADSL.VAX101DT>.) and (ASTDT<ADSL.VAX102DT or ADSL.VAX102DT=.) then AENDY= AENDT – ADSL.VAX101DT + 1; if (ASTDT>= ADSL.VAX102DT and ADSL.VAX102DT>.) and (ASTDT<ADSL.VAX201DT or ADSL.VAX201DT=.) then AENDY= AENDT – ADSL.VAX102DT + 1; if (ASTDT>=ADSL.VAX201DT and ADSL.VAX201DT>.) and (ASTDT<ADSL.VAX202DT or ADSL.VAX202DT=. ) then AENDY= AENDT – ADSL.VAX201DT + 1; if (ASTDT>=ADSL.VAX202DT and ADSL.VAX202DT>.) then AENDY= AENDT – ADSL.VAX202DT + 1; For AEs with time collected: Similar logic as AEs without time, but need to compare the AE happened time with the exact time of vaccination. eg: For AE happend on the same day of the vaccination 2, if AE start time is collected, then the AE start time need to be compared with the time of vaccination 2. If AE happened before the time of vaccination 2, AENDY=AENDT-ADSL.VAX101DT+1. Otherwise if AE happened after the time of vacciantion 2 then AENDY=AENDT- ADSL.VAX102DT+1; Note: Use relative vaccination date (Last vaccination date prior to the onset of the AE) to calculate AENDY. Timepart of AE.AEENDTC If ( ASTDTM >ADSL.TRTSDTM ) and select the record with minimum positive value of ASTDTM-EX.EXSTDTC then set AETPDOS = round((ASTDTM - EX.EXSTDTM)/60,1.). if (ASTDTM < ADSL.TRTSDTM and ASTDTM is not missing then AETPDOS = round((ASTDTM - ADSL.TRTSDTM)/60,1.). Datepart(APEREDTM) for APERIOD=1, APEREDTM = ADSL.TR02SDTM -1 ; if VAX3 is missing then APEREDTM =ADSL.TR01EDTM +365 days; for APERIOD=2, APEREDTM =ADSL.TR02EDTM +365 days Timepart(APEREDTM) Numeric Code of aperiodc 1 for AEs happened before ADSL.TR02SDTM or VAX3 is missing 2 for AEs happened after or on ADSL.TR02SDTM Datepart(APERSDTM) for APERIOD=1, APERSDTM = datetime of (ADSL.TRTSDTM) for APERIOD=2, APERSDTM = datetime of (ADSL.TR02SDTM) Timepart(APERSDTM) Convert imputed AESTDTC to DATE9 format. Imputate partial start date per Vaccine Rule Book. Firstly: If Day is missing, 1st day of Month If Month is missing, 1st month of Year. no imputation for complete missing start date. Secondly: If day is missing, and at the same year and month of the vaccination, impute to the first vaccination date of that month. if month is missing, and at the same year of the vaccination, impute to the first vaccination date of that year. = "D" if day is imputed. = "M" if month and day are imputed. = "Y" if month, day and year are imputed Convert AESTDTC to IS8601 format. if (ASTDT<ADSL.VAX101DT) then ASTDY= ASTDT – ADSL.VAX101DT; else ASTDY= ASTDT – most recent dosing date before the AE + 1 Note: Use relative vaccination date (Last vaccination date prior to the onset of the AE) to calculate ASTDY. Timepart of AE.AESTDTC ATOXGR="GRADE "|| strip(AETOXGR) if VPHASEN ne . and VPHASEN not in (0, 99, 4, 100) then INWDFL = "Y" ASTDTM<TRTSDTM then PREFL="Y" the number of last vaccine before AE occurred. if AE happened in VPHASE 'After unblinding and before Vaccination 3', then set VAXNO to most latest Dose before the AE. If AE happened before vax 1 then VPHASE='Pre-Vaccination'; (Note: AE start time is collected per CRF) If AE happened on or after vax1 and (before vax2 or vax2 is missing) then VPHASE='Vaccination 1'; if AE happened on or after vax2 and before or on the same day ADSL.V01DT then VPHASE='Vaccination 2'; if AE happened after of ADSL.V01DT and before or on the same day ADSL.V02DT then VPHASE='Follow Up 1'; if AE happened after of ADSL.V02DT  then VPHASE='Follow Up 2'; if AE happened on or after unblinded date and (before vax3 or vax3 is missing) then VPHASE='After unblinding and before Vaccination 3'; If AE happened on or after vax3 and (before vax4 or vax4 is missing) then VPHASE='Vaccination 3'; if AE happened on or after vax4 and before or on the same day ADSL.V03DT then VPHASE='Vaccination 4'; if AE happened after ADSL.V03DT and before or on the same day ADSL.V04DT then VPHASE='Follow Up 3'; if AE happened after ADSL.V04DT then VPHASE='Follow Up 4'; if paramcd in ("SARSCOV2" "RTCOV2NS" "C19NIG" "PRCDTH" "SECDTH" ) then set to ADSYMPT.ADT if paramcd = "SEVCVS" then set to the earliest date from ADSYMPT.ADT when condition/s are present. if paramcd = "NAATRAD" then set from ADSYMPT.ADT of concluded NAAT result based on specifications in AVALC of this record. If both local and central results are missing/invalid, set this to null. if paramcd = "C19ONST" then set to ASTDT where PARAMCD = "PRPDSAD" if paramcd = "CDCONST" then set to ASTDT where PARAMCD = "PRCDCSAD" if paramcd = "SEVCONST" then set to ASTDT where PARAMCD = "PRSVCSAD" if paramcd = "CDCSONST" then set to ASTDT where PARAMCD = "PRSCDCAD" if paramcd="DTHODC19" then set to ADT where PARAMCD is "PRCDTH" or "SECDTH" if paramcd in ("HCUICU" "HCUHSP" "PRPDSAD” “PRCDCSAD” “SEVCRF” “SEVCVSPR” “SEVCRHN” “PRSVCSAD” “PRSCDCAD” “ST1PD” “ST17PD” “ST2PD” “ST27PD” “ST214PD” “ST1CD” “ST17CD” “ST2CD” “ST27CD” “ST214CD” “ST1SE” “ST17SE” “ST2SE” “ST27SE” “ST214SE” “STC1SE” “STC17SE” “STC2SE” “STC27SE” “STC214SE” “ST1PDA” “ST17PDA” “ST2PDA” “ST27PDA” “ST214PDA” “ST1CDA” “ST17CDA” “ST2CDA” “ST27CDA” “ST214CDA” “ST1SEA” “ST17SEA” “ST2SEA” “ST27SEA” “ST214SEA” “STC1SA” “STC17SA” “STC2SA” “STC27SA” “STC214SA” “ST1PDX” “STC1SX”) then set to null. Set as following: ADY = ADT - TRTSDT. If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. if paramcd in ("HCUICU" "HCUHSP") then set to ADSYMPT.AENDT. if paramcd in ("PRPDSAD" "PRCDCSAD") then set to the latest date from ADSYMPT.AENDT when condition/s are present. if paramcdin ("SEVCRF" "SEVCRHN" "SEVCVSPR") then set to the latest date from ADSYMPT.AENDT when condition/s are present and end dates of all contributing records are reported. if paramcd in ("PRSVCSAD" "PRSCDCAD") then set to the latest date from AENDT when condition/s are present and contributing end dates except from vital signs are present/populated. If there is a death and this record is part of last illness visit, set to date of death. if paramcd in ("ST1PD" "ST17PD" "ST2PD" "ST27PD" "ST214PD" ) then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST". if paramcd in ("ST1PDA" "ST17PDA" "ST2PDA" "ST27PDA" "ST214PDA" "ST1PDX") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "C19ONST". if paramcd in ("ST1CD" "ST17CD" "ST2CD" "ST27CD" "ST214CD" ) then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST". if paramcd in ("ST1CDA" "ST17CDA" "ST2CDA" "ST27CDA" "ST214CDA") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "CDCONST". if paramcd in ("ST1SE" "ST17SE" "ST2SE" "ST27SE" "ST214SE") then set to minimum among the following dates. DCODT, DVSTDT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST". if paramcd in ("ST1SEA" "ST17SEA" "ST2SEA" "ST27SEA" "ST214SEA") then set to minimum among the following dates. DCODT, DTHDT, EOSDCDT, UNBLNDDT, today's date. Additionally, if there is a confirmed case of illness, include ADT from records where PARAMCD is "SEVCONST". else if none of the above PARAMCDs, set to null. Set as following: AENDY = AENDT - TRTSDT. If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. if paramcd in ("HCUICU" "HCUHSP") then set to ADSYMPT.ASTDT. if paramcd in ("PRPDSAD" "PRCDCSAD") then set to the earliest date from ADSYMPT.ASTDT when condition/s are present. if paramcdin ("SEVCRF" "SEVCRHN" "SEVCVSPR") then set to the earliest date from ADSYMPT.ASTDT when condition/s are present and end dates of all contributing records are reported. if paramcd in ("PRSVCSAD" "PRSCDCAD") then set to the earliest date from ADT/ASTDT when condition/s are present. if paramcd in (“ST1PD” “ST1CD” “ST1SE” “STC1SE” “ST1PDA” “ST1CDA” “ST1SEA” “STC1SA” “ST1PDX” “STC1SX” ) then set as Dose 1 when Dose 1 date is not missing. if paramcd in (“ST17PD” “ST17CD” “ST17SE” “STC17SE” “ST17PDA” “ST17CDA” “ST17SEA” “STC17SA”) then set as Dose 1 + 7 when Dose 1 date is not missing. if paramcd in (“ST214PD” “ST214CD” “ST214SE” “STC214SE” “ST214PDA” “ST214CDA” “ST214SEA” “STC214SA”) then set as Dose 2 + 14 when Dose 2 date is not missing. if paramcd in (“ST27PD” “ST27CD” “ST27SE” “STC27SE” “ST27PDA” “ST27CDA” “ST27SEA” “STC27SA” ) then set as Dose 2 + 7 when Dose 2 date is not missing. if paramcd in (“ST2PD” “ST2CD” “ST2SE” “STC2SE” “ST2PDA” “ST2CDA” “ST2SEA” “STC2SA” ) then set as Dose 2 when Dose 2 date is not missing. Set as following: ASTDY = ASTDT - TRTSDT. If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. if index(PARAM, "SURVEILLANCE")>0 then derive AVAL by subtracting AENDT(of this record) from ASTDT (of this record). If any of the dates are missing or derived result is below 0, set to 0. Note: Create only when relevant dose is administered. else for other paramcds, set to null if index (PARAM, "SURVEILLANCE")>0 then set to null. if paramcd = "SARSCOV2" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "SARSCOV2". if paramcd = "RTCOV2NS" then set to ADSYMPT.AVALC when ADSYMPD.PARAMCD = "RTCOV2NS". if paramcd = "C19NIG" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "C19NIG" where ADSYMPT.AVISIT = "V1_DAY1_VAX1_L". if paramcd = "HCUICU" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUICU". if paramcd = "HCUHSOP" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "HCUHSP". if paramcd="PCRDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "PRCDTH". if paramcd="SECDTH" then set to ADSYMPT.AVALC when ADSYMPT.PARAMCD = "SECDTH". if paramcd="DTHODC19" then create a summary record when PARAMCD is "PRCDTH" or "SECDTH" as: Set to "Y" when following terms appear in AVALC. "COVID-19", "COVID", "COVID-19 PNEUMONIA". Otherwise set to "N". Note: Populate AVISITN and AVISIT for this summary record if death occurred after an illness visit. if paramcd = "PRPDSAD" then create a summary record for protocol defined symptoms for each collection date within a given visit as following: 1. Subset ADSYMPT to include PARAMCDs for "CHILLS", "DIARRHEA", "FEVER", "NLTSTSML", "NCOUG", "NSTBRTH", "NMUSPN", "NSRTHROT", "VOMIT". 2. Determine if any of these symptoms have occurred within an ADSYMPT.AVISIT and ADSYMPT.ADT by checking ADSYMPT.AVALC. 3. When present, create a summary record for each ADSYMPT.AVISIT and ADSYMPT.ADT by following: a. If any symptom is present (i.e., ADSYMPT.AVALC = "Y"), set this to "Y". b. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". c. If all symptoms with ADSYMPT.AVALC are missing, set this to null. if paramcd = "PRCDCSAD" then Similar to specifications of checking for protocol defined symptoms above, create a summary record for CDC defined symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "FATIGUE" or "HEADACHE" or "RIHNRA" or "NAUSEA", set to "Y". 2. If all symptoms with ADSYMPT.AVALC = "N" or null or combination of both, set this to "N". 3. If ADSYMPT.AVALC is missing for all specified ADSYMPT.PARAMCDs, set this to null. if paramcd = "PRSVCSAD" then create a summary record of severe symptoms for each collection date within a given visit as following: 1. When AVALC = "Y" where PARAMCD is "SEVCVS" or "SEVCRF" or "SEVCVSPR" or "SEVCRHN", "HCUICU" or "DTHODC19" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null. if paramcd = "PRSCDCAD" then create a summary record of CDC defined severe symptoms for each collection date within a given visit as following: 1. Set to "Y" where ADSYMPT.PARAMCD = "MCHVENT" and ADSYMPT.AVALC = "Y" or ADSYMPT.PARAMCD = "ECMO" and ADSYMPT.AVALC = "Y" or PARAMCD = "HCUHSP" and AVALC = "Y" or PARAMCD = "HCUICU" and AVALC = "Y" or PARAMCD = "DTHODC19" and AVALC = "Y". 2. If none of the above conditions are met, set to "N". 3. If results of all above conditions are null, set to null. if paramcd = "SEVCVS" then create a summary record for vital signs of severe Covid-19 illness for each collection date within a given visit as following: 1. If ADSYMPT.AVAL >= 30 where ADSYMPT.PARAMCD = "RESP" or ADSYMPT.AVAL >= 125 where ADSYMPT.PARAMCD = "HR" or ADSYMPT.AVAL <= 93 where ADSYMPT.PARAMCD = "OXYSAT" or ADSYMPT.AVAL < 60 where ADSYMPT.PARAMCD = "DIABP" or ADSYMPT.AVAL < 90 where ADSYMPT.PARAMCD = "SYSBP" or ADSYMPT.AVAL >= 300 where ADSYMPT.PARAMCD = "PO2FIO2", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null. if paramcd = 'SEVCRF" then create a summary record for respiratory failure symptoms of severe Covid-19 illness for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT. PARAMCD is "INTBTION" or "NIPPV" or "CPAP" or "OXYTHRP" or "MCHVENT" or "ECMO" or "HFOXTHRP" set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null. if paramcd = "SEVCRHN" then create a summary record for additional severe symptoms for each collection date within a given visit as following: 1. When ADSYMPT.AVALC = "Y" where ADSYMPT.PARAMCD is "SARDFN" or "SAHDFN" or "SANDFN", set to "Y". 2. If all above conditions are not met, set this to "N". 3. If results of all above conditions are null, set to null. If paramcd = “SEVCVSPR” then create a summary record for use of vasopressors for each collection date within a given visit as following: 1. When ADSYMPT.AVALC is not null where ADSYMPT.PARAMCD = "VSOPRES", set to "Y". 2. When ADSYMPT.AVALC is null where ADSYMPT.PARAMCD = "VSOPRES", set to "N". if paramcd = "NAATRAD" then create this record (per each analysis visit) when unplanned lab results are present that are not part of predose procedures or when subject reports either protocol or CDC defined symptom/s. Set AVALC in the following order. 1. If result of ADSYMPT.RTCOV2NS is missing and ADSYMPT.SARSCOV2 is missing or invalid at an unplanned visit after dose, set to null. 2. If ADSYMPT.RTCOV2NS is present and valid*, set AVALC with this result. 3. If ADSYMPT.RTCOV2NS is present but not valid* or missing and ADSYMPT.SARSCOV2 is present and valid*, set AVALC with this result. 4. When there are multiple unplanned visits present and were collapsed into an analysis visit, determine the validity of results within a given visit first and then conclude the result as POS > IND > NEG > UNK/Missing/UQ. Notes: * The result is considered valid when date of the result is up to 4 days before or after the symptom start date and up to 4 days after the symptom end date when end date is present. If the result is not valid, it is considered as missing. if paramcd = "C19ONST" then create a record for each subject when protocol defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. If AVALC = "Y" where PARAMCD = "PRPDSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK". if paramcd = "CDCONST" then create a record for each subject when CDC defined symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRCDCSAD". 2. If AVALC = "Y" where PARAMCD = "PRCDCSAD" and there exists a record where PARAMCD = "NAATRAD" and is within the given visit of onset of symptoms, set as following: a. If AVALC = "POS", set to "POS". b. Else if AVALC = "NEG", set to "NEG" c. Else if AVALC = "UNK", set to "UNK". if paramcd = "SEVCONST" then create a record for each subject when severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRPDSAD". 2. Set to AVALC of PARAMCD = "C19ONST" when protocol defined severe symptoms are present (i.e. PARAMCD = "PRSVCSAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "C19ONST". 3. Set to "NEG" when protocol defined symptoms are missing/not reported. if paramcd = "CDCSONST" then create a record for each subject when CDC defined severe Covid-19 illness symptoms are reported. 1. Set to "NEG" when AVALC = "N" or missing where PARAMCD = "PRSCDCAD". 2. Set to AVALC of PARAMCD = "CDCONST" when CDC defined severe symptoms are present (i.e. PARAMCD = "PRSCDCAD" and AVALC = "Y") and starting date is on or after onset date of PARAMCD = "CDCONST". 3. Set to "NEG" when CDC defined symptoms are missing/not reported. 1. Set to ADSYMPT.AVISIT for all other parameters except for derived records for surveillance time. 2. For PARAMCD="DTHODC19", the AVISIT is populated if death occurred after an illness visit. This last illness visit AVISIT is assigned to the record. 3. If derived parameters for surveillance time, the set to null. 1. Set to ADSYMPT.AVISITN for all other parameters except for derived records for surveillance time. 2. For PARAMCD="DTHODC19", the AVISITN is populated if death occurred after an illness visit. This last illness visit AVISITN is assigned to the record. 3. If derived parameters for surveillance time, the set to null. Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "CDCONST") case. Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms. Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. Set for all records of a subject as following: If a subject has any record with AVALC = "Y" when PARAMCD = "PRCDCSAD", set to "Y". Otherwise set to "N". Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date. 2. Otherwise set to "N". If subject reports CDC define symptoms, the following condition may overwrite the previous value. 3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date. 2. Otherwise set to "N". If subject reports CDC define symptoms, the following condition may overwrite the previous value. 3. If there is an unscheduled NAAT test after Dose 1 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates. 2. Otherwise set to "N". If subject reports CDC define symptoms, the following condition may overwrite the previous value. 3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates. 2. Otherwise set to "N". If subject reports CDC define symptoms, the following condition may overwrite the previous value. 3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of CDC defined symptoms and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set to "Y" for all records of a subject, if CDC defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and not followed by a confirmed positive case where PARAMCD is "CDCONST". Otherwise set to "N" for all records of a subject. Also set to "N" for subjects who did not report any CDC defined symptoms. Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. Set for records where PARAMCD is "SARSCOV2" or "RTCOV2NS" or "C19NIG" as following: If only one result is present per PARAMCD within a given visit set to "Y'. For unplanned results, set "Y" if result date is up to 4 days before, on/after the symptom start date and symptom end date is missing. If the symptom end date is present, the result date must be within 4 days after the end date. If multiple unplanned results qualify above condition, set to "Y" based on the result as POS > IND > NEG > UNK/missing. Set for all records of a subject based on following: If NAAT result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y". If NAAT result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N". Otherwise, set to null. Set for all records of a subject based on following: If NAAT result date is on or before Dose 2 date and AVAC = "NEG" when PARAMCD = "RTCOV2NS", set to "Y". If NAAT result date is on or before Dose 2 date and AVAC = "POS" when PARAMCD = "RTCOV2NS", set to "N". Otherwise, set to null. Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" as following: if AVALC = "POS" and is the first onset of illness after dose, set to "Y". Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following: If illness onset date is greater then 7 days post Dose 1 date, set to "Y". Otherwise set to "N". Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following: If illness onset date is greater then Dose 1 date, set to "Y". Otherwise set to "N". Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following: If illness onset date is greater then 14 days post Dose 2 date, set to "Y". Otherwise set to "N". Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following: If illness onset date is greater then 7 days post Dose 2 date, set to "Y". Otherwise set to "N". Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" or "CDCSONST" and AVALC is "POS" as following: If illness onset date is greater then Dose 2 date, set to "Y". Otherwise set to "N". Set for records where PARAMCD is "C19ONST" or "CDCONST" or "SEVCONST" as following: if DVSTDT is null, set to "Y". Also set to "Y" if DVSTDT occurs after the ADT of PARAMCDs specified above. if PARAMCD in ("C19NIG" "HCUHSP" "RTCOV2NS" "HCUICU" "SARSCOV2" "PRCDTH" "SECDTH") then set to ADSYMPT.PARAM if PARAMCD= “DTHODC19” then set to “DEATH OCCURRED DUE TO COVID-19 ILLNESS?” if PARAMCD= “PRPDSAD” then set to “PRESENCE OF PROTOCOL DEFINED SYMPTOMS AFTER DOSE” if paramcd= “PRCDCSAD” then set to “PRESENCE OF CDC DEFINED SYMPTOMS AFTER DOSE” if paramcd= “SEVCVS” then set to “SEVERE COVID-19 SYMPTOMS - VITAL SIGNS” if paramcd=”SEVCRF” then set to “SEVERE COVID-19 SYMPTOMS - RESPIRATORY FAILURE” if paramcd= “SEVCVSPR” then set to “SEVERE COVID-19 SYMPTOMS - USE OF VASOPRESSORS” if paramcd= “SEVCRHN” then set to “SEVERE COVID-19 SYMPTOMS - SIGNIFICANT ACUTE RENAL, HEPATIC, OR NEUROLOGIC DYSFUNCTION” if paramcd = “PRSVCSAD” then set to “PRESENCE OF PROTOCOL DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE” if paramcd=”PRSCDCAD” then set to “PRESENCE OF CDC DEFINED SEVERE COVID-19 SYMPTOMS AFTER DOSE” if paramcd=”NAATRAD” then set to “COVID-19 NAAT RESULT AFTER DOSE” if paramcd = “C19ONST” then set to “PROTOCOL DEFINED COVID-19 ILLNESS ONSET” if paramcd = “CDCONST” then set to “CDC DEFINED COVID-19 ILLNESS ONSET” if paramcd = “SEVCONST” then set to “PROTOCOL DEFINED SEVERE COVID-19 ILLNESS ONSET” if paramcd = “CDCSONST” then set to “CDC DEFINED SEVERE COVID-19 ILLNESS ONSET” if paramcd = ”ST1PD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS” if paramcd=“ST17PD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS” if paramcd=“ST2PD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS” if paramcd=“ST27PD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS” if paramcd=“ST214PD” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS” if paramcd=“ST1CD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS” if paramcd=“ST17CD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS” if paramcd=“ST2CD” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS” if paramcd=“ST27CD” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS” if paramcd=“ST214CD” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS” if paramcd=“ST1SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“ST17SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“ST2SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“ST27SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“ST214SE” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“STC1SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“STC17SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“STC2SE” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“STC27SE” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“STC214SE” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS” if paramcd=“ST1PDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST17PDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST2PDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST27PDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST214PDA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST1CDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST17CDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST2CDA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST27CDA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST214CDA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST1SEA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST17SEA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST2SEA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST27SEA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST214SEA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR PROTOCOL DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“STC1SA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“STC17SA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“STC2SA” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“STC27SA” then set to “SUBJECT'S SURVEILLANCE TIME 7 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“STC214SA” then set to “SUBJECT'S SURVEILLANCE TIME 14 DAYS AFTER DOSE 2 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS - ALL AVAILABLE” if paramcd=“ST1PDX” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR PROTOCOL DEFINED COVID19 SYMPTOMS – CROSSOVER” if paramcd=“STC1SX” then set to “SUBJECT'S SURVEILLANCE TIME AFTER DOSE 1 FOR CDC DEFINED SEVERE COVID19 SYMPTOMS – CROSSOVER” if index (PARAM, "SURVEILLANCE")>0 then set to "SURVEILLANCE TIME". if PARAMCD in ("C19NIG" "RTCOV2NS" "SARSCOV2" "PRCDTH" "SECDTH" “PRPDSAD” “PRCDCSAD” “SEVCRF” “SEVCVSPR” “SEVCRHN”) then set to ADSYMPT.PARCAT1 if paramcd in (”HCUHSP” “HCUICU”) then set to “HOSPITALIZATION STATUS” if paramcd = “DTHODC19” then set to "DEATH STATUS". If paramcd = “PRSVCSAD” then set to "SEVERE COVID-19 SYMPTOMS". If paramcd=”PRSCDCAD”“ then Set to "SEVERE COVID-19 SYMPTOMS". If paramcd=”NAATRAD” then Set to "CENTRAL/LOCAL NAAT RESULTS". If paramcd=”C19ONST” then Set to "ILLNESS ONSET". If paramcd=“CDCONST” then Set to "ILLNESS ONSET". If paramcd=”SEVCONST” then Set to "ILLNESS ONSET". If paramcd=”CDCSONST” then Set to "ILLNESS ONSET". Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date. 2. Otherwise set to "N". If subject reports protocol define symptoms, the following condition/s may overwrite the previous value. 3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 1 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days post Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 is negative and the test date is on or before Dose 1 date. 2. Otherwise set to "N". If subject reports protocol define symptoms and/or has , the following condition/s may overwrite the previous value. 3. If there is an unscheduled NAAT test on or before Dose 1 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptoms and start date of symptom is missing, on or after Dose 1 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates. 2. Otherwise set to "N". If subject reports protocol define symptoms, the following condition may overwrite the previous value. 3. If there is an unscheduled NAAT test after Dose 1 through 14 days after Dose 2 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 14 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set this to all records with in a subject as following: 1. Set to "Y", if subject's NVA result is negative and date of NVA on or before Dose 1 date and NAAT result at Dose 1 and Dose 2 are negative and their corresponding test dates are on or before their respective dose dates. 2. Otherwise set to "N". If subject reports protocol define symptoms, the following condition may overwrite the previous value. 3. If there is an unscheduled NAAT test after Dose 1 through 7 days after Dose 2 and the result is not negative set to "N". 4. Also set to "N" when subject reports presence of at least 1 of protocol defined symptom and start date of symptom is missing, on or after Dose 1 and within 7 days after Dose 2 and NAAT result is concluded as not "NEG" (i.e. paramcd = "NAATRAD" and AVAL ^= "NEG") within the reported AVISIT. Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and symptom/s start date is before a first positive(PARAMCD is "C19ONST") case. Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms. Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. Set to "Y" for all records of a subject, if protocol defined symptom/s are present and test result from local and/or central lab concluded as indeterminate, missing or unknown and not followed by a confirmed positive case where PARAMCD is "C19ONST". Otherwise set to "N" for all records of a subject. Also set as "N" for subjects who did not report any protocol defined symptoms. Note: If a subject has reported these symptom/s more than once at different visits, set to "Y" if any of the test results are concluded as indeterminate, missing or unknown. Set for all records of a subject as following: If PDSYMFL = "Y" and symptom start date is missing, set to "Y". Otherwise set to "N". Set for all records of a subject as following: If a subject has any record with AVALC = "Y" when PARAMCD = "PRPDSAD", set to "Y". Otherwise set to "N". Set for all records of a subject as following: If a subject has any record with AVALC = "Y" when PARAMCD = "PRSCDCAD", set to "Y". Otherwise set to "N". Set for all records of a subject as following: If a subject has any record with AVALC = "Y" when PARAMCD = "PRSVCSAD", set to "Y". Otherwise set to "N". Set for all records of a subject based on following: If NVA result date is on or before Dose 1 date and AVAC = "NEG" when PARAMCD = "C19NIG", set to "Y". If NVA result date is on or before Dose 1 date and AVAC = "POS" when PARAMCD = "C19NIG", set to "N". Otherwise, set to null. ADURN=AENDT - ASTDT+1. Exclude FADTC/VSDTC>=UNBLNDDT. AENDT is the resolution date of the reactions/events within USUBJID/FATPTREF/FAOBJ level. 1) if a reaction/event resolved before or on the last diary day: If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”. If last.FACE.FAOBJ then set AENDT to datepart of FACE.FADTC where FACE.FAOBJ in ('REDNESS' 'SWELLING') and FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FASTRESN>=2.5. For CETERM='FEVER', if last.VSTESTCD then set AENDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level. 2) if a reaction/event still happend on the last diary day AENDT was derived as missing if SUPPCE.ONGNXVIS='Y' and SUPPCE.RCENDTC is missing. AENDT was derived as numeric value of CE.CEENDTC if CE.CEENDTC is captured and not partial. If CETPTREF='VACCINATION 1' and ADSL.VAX102DT ne . and (numeric value of SUPPCE.RCENDTC>VAX102DT or SUPPCE.ONGNXVIS='Y'), set AENDT to VAX102DT. Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling): where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); Set to 'Severe' for cases in FACE: 1) where FACE.FADTC is within 7 days after each vaccination and (FACE.FATESTCD in ('DIAMETER' 'MINDIAM' 'MAXDIAM') and FACE.FASTRESN>=10.5 and FACE.FAOBJ in ('REDNESS' 'SWELLING')); Exclude FADTC/VSDTC>=UNBLNDDT. ASTDT is the first day of the reactions/events within USUBJID/FATPTREF/FAOBJ level. If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS') and FACE.FASTRESC=”Y” and FACE.FATESTCD=”OCCUR”. If first.FACE.FAOBJ then set ASTDT to datepart of FACE.FADTC when FACE.FAOBJ in ('REDNESS' 'SWELLING') and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>=2.5. For CETERM='FEVER', if first.VSTESTCD then set ASTDT to datepart of VS.VSDTC where VS.VSCAT='REACTOGENICITY' and index(VS.VSTESTCD,'TEMP') and 38.0<=VS.VSSTRESN<=42.0 within USUBJID/VSTPTREF/VSTESTCD level. Similar algorithm for readings with ASEV='Severe' (To derive start date for subjects with severe redness or swelling) where FACE.FADTC is not missing and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') and FACE.FASTRESN>10 and FACE.FAOBJ in ('REDNESS' 'SWELLING'); Exclude FADTC/VSDTC>=UNBLNDDT. This flag is derived at SUBJECT/FATPTREF/FAOBJ level: For CE.CETERM in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a reaction (FACE.FASTRESN >=2.5 and FACE.FATESTCD in ('DIAMETER' 'MAXDIAM' 'MINDIAM') ) at any day from day 1 to day 7 after each dose; else set to 'N'. For CE.CETERM not in ('REDNESS' 'SWELLING' 'FEVER'): Set to 'Y' if a subject had a reaction or an event (FACE.FATESTCD='SEV' and FACE.FASTRESC in ('MILD', 'MODERATE','SEVER', 'GRADE 4')) at any day from day 1 to day 7 after each dose; else set to 'N'. For CE.CETERM="FEVER", set to 'Y' if a subject had a record (38.0<=VS.VSSTRESN<=42.0) at any day from day 1 to day 7 after each dose within USUBJID/VSTPTREF/VSTESTCD level; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis. Note: The unplanned assessments beyond 7 days after each vaccination are excluded when deriving ADCEVD. Exclude FADTC/VSDTC>=UNBLNDDT. This flag is derived at SUBJECT/FATPTREF/FAOBJ level: Set to "Y" for a reaction or an event if a subject had a vaild record (where FACE.FASTRESC or VS.VSORRES ne missing) at any day from day 1 to day 7 after each dose for any local reacaction or systemic event, else set to 'N'. if (VAX101='Placebo' and CETPTREF="VACCINATION 1") or (VAX102='Placebo' and CETPTREF="VACCINATION 2") then TRTA='Placebo'; else ADSL.TRT01A. if (VAX101='Placebo' and CETPTREF="VACCINATION 1") or (VAX102='Placebo' and CETPTREF="VACCINATION 2") then TRTAN=9'; else ADSL.TRT01AN. DATEPART of (CM.CMENDTC) AENDTF = 'Y' if Year is imputed AENDTF = 'M' if Year is present and Month is imputed AENDTF = 'D' if only day is imputed AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT DATEPART of (CM.CMSTDTC) ASTDTF = 'Y' if Year is imputed ASTDTF = 'M' if Year is present and Month is imputed ASTDTF = 'D' if only day is imputed ASTDT – ADSL.TRTSDT + 1 if ASTDT >= TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary Derived from WHODrug Dictionary if length of DRUGNAME gt 200, then put letters gt 200 in DRGNAME1 Derived from WHODrug Dictionary If ONTR01FL or ONTR02FL= ‘Y’ then ONPERFL=’Y’ If NOT LAST PERIOD then if (ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING'))) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG)) then ONTRxxFL = 'Y' ; If LAST PERIOD then if (ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING')) ) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG)) then ONTRxxFL = 'Y' ; [xx] will replaced by 01 and 02 in the code, G_PRT_PERIOD_LAG is set as 365 if cm happend after unblinding but before vax 3 and vax 3 is not missing, then set to missing If NOT LAST PERIOD then if (ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING'))) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_PERIOD_LAG)) then ONTRxxFL = 'Y' ; If LAST PERIOD then if (ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG) > . and ((AENDT >=TRXXSDT) or (upcase(CMENRTPT)='ONGOING')) ) or (ASTDT >= TR[xx]SDT and ASTDT <= (TR[xx]EDT + G_PRT_LASTPERIOD_LAG)) then ONTRxxFL = 'Y' ; [xx] will replaced by 01 and 02 in the code, G_PRT_PERIOD_LAG is set as 365 if cm happend after unblinding but before vax 3 and vax 3 is not missing, then set to missing if ASTDT < TR01SDT then PREFL='Y' the number of last vaccine before CM occurred if CM happened in VPHASE 'After unblinding and before Vaccination 3', then set VAXNO to most latest Dose before the CM. 1. if CM happend before adsl.UNBLNDDT and VAX3 or both adsl.UNBLNDDT and VAX3 are missing; If CM happend before vax 1 then VPHASE='Pre-Vaccination'; (Note: CM start time is collected per CRF) If CM happend on or after vax1 and (before vax2 or vax2 is missing) then VPHASE='Vaccination 1'; if CM happend on or after vax2 and before or on the same day of ADSL.V01DT then VPHASE='Vaccination 2'; if CM happend after ADSL.V01DT and before or on the same day of ADSL.V02DT then VPHASE='Follow Up 1'; if CM happend after ADSL.V02DT then VPHASE='Follow Up 2'; 2. if CM happend after or on adsl.UNBLNDDT; If CM happend after or on adsl.UNBLNDDT and (before vax3 or vax3 is missing) then VPHASE=''After unblinding and before Vaccination 3'; If CM happend after or on vax3 and (before vax4 or vax4 is missing) then VPHASE='Vaccination 3'; if CM happend after or on vax4 and before or on the same day of ADSL.V03DT then VPHASE='Vaccination 4'; if CM happend after ADSL.V03DT and before or on the same day of ADSL.V04DT then VPHASE='Follow Up 3'; if CM happend after ADSL.V04DT then VPHASE='Follow Up 4'; Datepart( numeric value of DS.DSDTC) Imputation of Partial Dates: If Day is missing, 1st day of Month If Month is missing, 1st month of Year. Datepart(numeric value of DS.DSSTDTC) if ASTDT >= ADSL.TRTSDT then ASTDY = ASTDT - ADSL.TRTSDT + 1 otherwise ASTDY = ASTDT – ADSL.TRTSDT 1. find date for V3: non-missing value for ADSL.BLDV6DT, and ADDS.M1PD2DT, if both these 2 variables have values, then choose the bigger one. 2. if missing V3, and EOT=EOS and not missing, then EOT date; 3. if EOT not eq to EOS, then the later of Dose2 date or unplanned dose date +42 days 4. if only one dose, then Dose1+42+42 days. 5. cutoff to the day before not null Xover Dose1 date For DSPHASE not equal to 'SCREENING' or 'VACCINATION' or "REPEAT SCREENING 1" if ASTDT>M1P2CUT, then 'Y' if missing M1P2CUT, and subject have open label period activity, then 'Y'. Derived from SV.svstdtc where SV.visit contains 'MONTH1_POSTVAX2' or 'V7_MONTH1_S' or ('V7_MONTH1_S_R' for cohortn=1.16)； if null SV.SVSTDTC then derived from ADSL.BLDV6DT Derived from SV.svstdtc where SV.visit contains 'V103_MONTH1' Derived from SV.svstdtc where SV.visit contains 'V4_MONTH6_L' or 'V8_MONTH6_S'； if null SV.SVSTDTC then derived from ADSL.BLDV7DT； Convert DV.DVSTDTC to numeric format If ASTDT < ADSL.TRTSDT then PREFL='Y' if (ASTDTM >= APHASDTM and substr(APHASE,1,9) = 'TREATMENT' then TRPFL='Y' else TRPFL = 'N' date part of FACE.FADTC or date part of VS.VSDTC Datetime format of FACE.FADTC or VS.VSDTC 1) FACE.FATPT or VS.VSTPT; 2) For unplanned readings, ATPT is populated with DAY <#> for relative day: # = FADTC/VSDTC - date of last vaccination + 1; 3) Set to missing where FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter'). For the parameters from FACE, 1) AVAL=FACE.FASTRESN. 2) If FATEST in ('Severity/Intensity' 'Maximum Severity') then AVAL is numeric value of AVALC (NONE=0, MILD=1, MODERATE=2, SEVERE=3, GRADE 4=4). 3) If FATEST in ('Maximum Diameter') then AVAL is the maximum diameter (diameter>=2.5 cm) from day1 to day7 within a USUBJID/FATPTREF/FAOBJ. 4) FATETST= ' ' ; PARAM='Medications duration'; AVAL=end date - start date +1. *The start date is datepart of first.FACE.FADTC where FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT'. *The end date is datepart of last.FACE.FADTC where (FACE.FAOBJ='MEDICATIONS' and FACE.FASTRESC='Y' and FACE.FAEVAL='STUDY SUBJECT' and FATPT ne 'DAY 7') OR numeric value of AVALC where (FATESTCD='STPDMEDP' and FACE.FAEVAL='INVESTIGATOR'). *If ATPTREF="VACCINATION 1" and VAX102DT ne. and the end date>VAX102DT, set end date to VAX102DT. For the fever related parameters from VS (FAOBJ='FEVER'), 1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; Set AVAL to missing. 2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; AVAL is the maximum temperature where .<VSSTRESN<=42.0 from day1 to day7 within a USUBJID/ATPTREF/FAOBJ. For the parameters from FACE, 1) AVALC=FACE.FASTRESC; 2) If FAOBJ in ('REDNESS' 'SWELLING') and FATEST='Severity/Intensity' then AVALC is the serveriy derived based on the diamerter of redness and swelling (<2.5=NONE, 2.5-5=MILD, 5.5-10=MODERATE, >10=SEVERE). 3) If FATEST in ('Maximum Severity') then AVALC is the maximum serveriy from day1 to day7 within a USUBJID/FATPTREF/FAOBJ. 3) If FATEST in ('Maximum Diameter') then set AVALC to missing. 4) FATETST= ' ' ; PARAM='Medications duration'; AVALC="MISSING" when end date is missing. For the fever related parameters from VS (FAOBJ='FEVER'), derived based on VS.VSORRES where index(VS.VSTESTCD,'TEMP') and VS.VSCAT in ('REACTOGENICITY', 'REACTOGENICITY - UNPLANNED TEMPERATURE'). 1) FATEST='Occurrence Indicator'; PARAM='Fever occurrence indicator'; if input(VS.VSORRES,best.)>=100.4 and VSSTRESN<=42.0 then AVALC='Y' ; else if .<input(VS.VSORRES,best.)<100.4 then AVALC='N'. else if VSSTRESN>42.0 then set AVALC to missing. Temperatures >42.0°C (>107.6°F) are omitted from the analysis. 2) FATEST="Maximum Temperature"; PARAM='Fever maximum temperature'; Set AVALC to missing. Note: For unplanned readings, only clinical assessments within 7 days after each vaccination were involved in ADFACEVD. Exclude FADTC/VSDTC>=UNBLNDDT for DTYPE="MAXIMUM". Create AVALCAT1 if FATESTCD in ("DIAMETER" "MAXDIAM") and aval > 0: if 0 < AVAL <= 2.0 then AVALCAT1=">0-2.0" if 2 < AVAL <= 5.0 then AVALCAT1=">2.0-5.0" if 5 < AVAL <= 10.0 then AVALCAT1=">5.0-10.0" if AVAL > 10.0 then AVALCAT1=">10.0" 1) FACE.VISIT or VS.VISIT. 2) For unplanned readings, AVISIT=concatenate ('UNPLANNED VISIT', AVISITN) separated by a blank space. if FADTC/VSDTC>=UNBLNDDT. Then CUTUNBFL="Y" Set to "MAXIMUM" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level: For FATEST in ('Occurrence Indicator') and FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a event (avalc='Y' and diameter>=2.5 cm) on the day within FATPTREF/FAOBJ/FATEST level; else set to 'N'. For (FATEST in ('Occurrence Indicator') and FAOBJ not in ('REDNESS' 'SWELLING')) or (FATESTCD='MEDTFVPN' and FAOBJ='MEDICATIONS'): Set to 'Y' if a subject had a event (avalc='Y') on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'. For FATEST in ('Severity/Intensity', 'Maximum Severity') : Set to 'Y' if a subject had a event (avalc in ('MILD', 'MODERATE', 'SEVERE', 'GRADE4')) on the day within FATPTREF/FAOBJ/FATEST/FATPT level; else set to 'N'. For FATEST in ('Diameter', 'Maximum Diameter') : Set to 'Y' if a subject had a event (aval>=2.5 cm) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'. For FATEST in ('Maximum Temperature') : Set to 'Y' if a subject had a event (38.0 °C <=aval<=42.0 °C) on the day within FATPTREF/FAOBJ/FATPT level; else set to 'N'. This flag is derived at USUBJID/FATPTREF/FAOBJ level: For FAOBJ in ('REDNESS' 'SWELLING'): Set to 'Y' if a subject had a record (diameter>=2.5 cm) at any day from day 1 to day 7; else set to 'N'. For FAOBJ='MEDICATIONS': Set to 'Y' if a subject had a record (avalc='Y') at any day after each dose; else set to 'N'. For FAOBJ='FEVER' : Set to 'Y' if a subject had a record (38.0 °C <=aval<=42.0 °C) at any day after each dose; else set to 'N'. Temperatures >42.0°C (>107.6°F) are omitted from the analysis. For FAOBJ not in ('REDNESS' 'SWELLING' 'MEDICATIONS' 'FEVER'): Set to 'Y' for an reaction or an event if a subject had a record (avalc in ('MILD', 'MODERATE','SEVER','GRADE 4')) at any day after each dose; else set to 'N'. This variable is derived at SUBJECT/FATPTREF/FAOBJ level. EVENTOCC is the number of events. When a subject reported an event at least 1 day (with EVENTDF='Y'), then EVENTOCC=1; If the occurrence is consecutive >=2 days, it should be still counted once. But if the event recurred after one or more day’s disappearance, then EVENTOCC+1. For example, subject A had redness (diameter>=2.5cm) on Day 1, 2, 4, 5, 6. The symptom on Day 1-2 and Day 4-6 is counted once respectively , so EVENTOCC is 2 for subject A. Set to "7D" if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') FACE.FAGRPID or FAGRPID=concatenate (VS.VSTPTREF, VS.VSSCAT) separated by hyphen "-". 1) FACE.FALNKID; 2) VS.VSLNKID; 3) Set to missing where FATEST in ('Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). FACE.FAOBJ or set to ‘FEVER’ for fever related parameters Set to 'P0H' if FATEST in ('Maximum Severity', 'Maximum Temperature', 'Maximum Diameter') ADFACEVD includes: 1) the records from FACE domain: set to FACE.FATEST. For unplanned readings, only clinical assessments within 7 days after each vaccination are invovled. 2) the fever records from VS domain: FATEST="Occurrence Indicator"; 3) the parameters derived in ADFACEVD, their values of FATEST have 'Severity/Intensity', 'Maximum Severity', 'Maximum Diameter' or 'Maximum Temperature'. See the algorithms of AVALC for detailed derivation. 1) FACE.FATESTCD. 2) Set to 'SEV', 'MAXSEV', 'MAXDIAM', 'MAXTEMP where FATEST in ('Severity/Intensity', 'Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). Derived only for FAOBJ='FEVER'. For VSORRESU='F': if .<input(VS.VSORRES,best.)<100.4 then "<38.0 C"; else if 100.4<=input(VS.VSORRES,best.)<=101.1 then "38.0 C to 38.4 C" ; else if 101.2<=input(VS.VSORRES,best.)<=102.0 then ">38.4 C to 38.9 C" ; else if 102.1<=input(VS.VSORRES,best.)<=104.0 then ">38.9 C to 40.0 C"; else if input(VS.VSORRES,best.)>104.0 and VSSTRESN<=42.0 then ">40.0 C". else if VSSTRESN>42 then 'Missing'. For VSORRESU='C': if .<input(VS.VSORRES,best.)<38.0 then "<38.0 C"; else if 38.0<=input(VS.VSORRES,best.)<=38.4 then "38.0 C to 38.4 C" ; else if 38.5<=input(VS.VSORRES,best.)<=38.9 then ">38.4 C to 38.9 C" ; else if 39.0<=input(VS.VSORRES,best.)<=40.0 then ">38.9 C to 40.0 C"; else if input(VS.VSORRES,best.)>40 and VSSTRESN<=42.0 then ">40.0 C". else if VSSTRESN>42 then 'Missing'. Numerive Code of FTEMCAT .="Missing" 0="<38.0 C" 1="38.0 C to 38.4 C" 2= ">38.4 C to 38.9 C" 3=">38.9 C to 40.0 C" 4=">40.0 C" This flag is derived at SUBJECT/FATPTREF/FAOBJ/FATEST/FATPT level: Set to "Y" if a subject had a valid record (where the event was reported regardless if it occurred or not) at that day from day 1 to day 7 within FATPTREF/FAOBJ/FATEST/FATPT level, else set to 'N'. This flag is derived at USUBJID/FATPTREF/FAOBJ level: Set to "Y" for a reaction or an event if a subject had a valid record where AVALC in ('Y' 'N') at any day from day 1 to day 7 after each dose. else set to 'N'. If upcase(FATESTCD) = "DIAMETER" then PARAM = concatenate (FAOBJ, FATEST, "cm") separated by a blank space; else if upcase(FATESTCD) ^= "DIAMETER and FATEST ne missing then PARAM = concatenate (FAOBJ, FATEST) separated by a blank space; else if FAOBJ="MEDICATIONS" and FATEST eq missing then PARAM='Medications duration'. See the algorithms of AVALC for detailed derivation. Note: Use sentence case for param values. Set to 'REACTOGENICITY' if index(FACAT, 'REACTOGENICITY') or index(VSCAT, 'REACTOGENICITY'). if (VAX101='Placebo' and ATPTREF="VACCINATION 1") or (VAX102='Placebo' and ATPTREF="VACCINATION 2") then TRTA='Placebo'; else ADSL.TRT01A. if (VAX101='Placebo' and ATPTREF="VACCINATION 1") or (VAX102='Placebo' and ATPTREF="VACCINATION 2") then TRTAN=9'; else ADSL.TRT01AN. ADT = date part of MH.MHDTC Imputation of Partial Dates: If Day is missing, 1st day of Month If Month is missing, 1st month of Year. = "D" if day is imputed. = "M" if month and day are imputed. = "Y" if month, day and year are imputed.ADMH if MH.MHDUR exists then calculate ADURN in years and round it to 2 decimals.  AENDT = date part of MH.MHENDTC Imputation of Partial Dates: If Day is missing, last day of Month If Month is missing, last month of Year. = "D" if day is imputed. = "M" if month and day are imputed. = "Y" if month, day and year are imputed. AENDT – ADSL.TRTSDT + 1 if AENDT >= TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT ASTDT = date part of MH.MHSTDTC Imputation of Partial Dates: If Day is missing, 1st day of Month If Month is missing, 1st month of Year. = "D" if day is imputed. = "M" if month and day are imputed. = "Y" if month, day and year are imputed.ADMH if ASTDT >= TRTSDT then ASTDT – ADSL.TRTSDT + 1; else if ASTDT< TRTSDT then ASTDT – ADSL.TRTSDT; "Y" if mhterm with Comorbidities. Will apply to Phase 1 only. If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and INCL3fl="Y" and not (index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI01FL="Y"; else AAI01FL="N"; If SAFFL="Y" and randfl="Y" and vax102dt>. and INCL8fl="Y" and not ((index(SUPPDV.QNAM.CAPE, "POP3") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI02FL="Y"; else AAI02FL="N"; If SAFFL="Y" and randfl="Y" and (vax101dt>. or vax102dt>.) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI1EFFL="Y"; else AAI1EFFL="N"; If SAFFL="Y" and randfl="Y" and vax101dt>. and vax102dt>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and not((index(SUPPDV.QNAM.CAPE, "POP2") and index(SUPPDV.QNAM.CAPE, "POP5")) for subjects's all DV records) then AAI2EFFL="Y"; else AAI2EFFL="N"; Based on the actual vaccinations taken by subjects. Same as ARM if no medication error for the vaccinated subjects ACTARM=' NOT ASSIGNED ' for not assigned subjects; ACTARM=' SCREEN FAILURE ' for screen failure subjects; ACTARM='Not Treated' for not treated subjets or subjects without determined treatment; Based on the actual vaccinations taken by subjects. Same as ARMCD if no medication error for the vaccinated subjects. ACTARM=' NOTASSGN ' for not assigned subjects; ACTARM=' SCRNFAIL ' for screen failure subjects; ACTARMCD='NOTTRT' for not treated subjets or subjects without determined treatment; Derived using following derivations: if 12<=agetr01<=15 then AGEGR1='12-15 Years';(Phase 2/3 cohort) if 18<=agetr01<=55 then AGEGR1='18-55 Years';(Phase 1 cohort) if 16<=agetr01<=55 then AGEGR1='16-55 Years';(Phase 2/3 cohort) if 65<=agetr01 then AGEGR1='65-85 Years'; (Phase 1 cohort) if 56<=agetr01 then AGEGR1='>55 Years'; (Phase 2/3 cohort) Derived using following derivations: if 65<=agetr01 then AGEGR2='>=65 Years'; if agetr01<65 then AGEGR2='<65 Years'; Derived using following derivations: if 16<=agetr01<=17 then AGEGR3='16-17 Years'; if 18<=agetr01<=55 then AGEGR3='18-55 Years'; if 55<agetr01 then AGEGR3='>55 Years'; Derived using following derivations for Phase 3 subjects only: if 12<=agetr01<=15 then AGEGR4='12-15 Years'; if 16<=agetr01<=25 then AGEGR4='16-25 Years'; Derived using following derivations: if 16<=agetr03<=55 then AGETGR3='16-55 Years'; if 56<=agetr03 then AGETGR3='>55 Years'; Derive AGETR01 from BIRTHDT (after applying imputation for partial date) and date of vaccination1. For participants who were randomized but not vaccinated, the randomization date will be used in place of the date of vaccination at Dose 1 for the age calculation. If the randomization date is also missing, then the informed consent date will be used for the age calculation. Note: For example: If the vaccination 1 date is one day before the subject's 19th birthday, the subject is 18 years old. Derive AGETR03 from BIRTHDT (after applying imputation for partial date) and date of first dose of crossover period. Note: For example: If dose 3 date is one day before the subject's 19th birthday, the subject is 18 years old. if RACEN=1 then ARACE='WHITE'; if RACEN=2 then ARACE='BLACK OR AFRICAN AMERICAN'; if RACEN=3 then ARACE='AMERICAN INDIAN OR ALASKA NATIVE'; if RACEN=4 then ARACE='ASIAN'; if RACEN=5 then ARACE='NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'; if RACEN=6 then ARACE='MULTIRACIAL'; if RACEN=7 then ARACE='NOT REPORTED'; if armcd="B1_10" then arm="BNT162b1 Phase 1 (10 mcg)" if armcd="B1_100" then arm="BNT162b1 Phase 1 (100/10 mcg)" if armcd="B1_20" then arm="BNT162b1 Phase 1 (20 mcg)" if armcd="B1_30" then arm="BNT162b1 Phase 1 (30 mcg)" if armcd="B2_10" then arm="BNT162b2 Phase 1 (10 mcg)" if armcd="B2_20" then arm="BNT162b2 Phase 1 (20 mcg)" if armcd="B2_30" then arm="BNT162b2 Phase 1 (30 mcg)" if armcd="B2_P23_30" then arm="BNT162b2 Phase 2/3 (30 mcg)" if armcd="NOTASSGN" then arm="NOT ASSIGNED" if armcd="NOTTRT" then arm="Not Treated" if armcd="PLACEBO" then arm="Placebo" if armcd="SCRNFAIL" then arm="SCREEN FAILURE" if randfl="Y" then do; if (tr02sdt>. or UNBLNDDT>. ) and boostfl ne "Y" then do; if .<tr02sdt-1<"&cutoff2"d then BDCSRDT=tr02sdt-1; else BDCSRDT="&cutoff2"d; if .<UNBLNDDT-1<=BDCSRDT then BDCSRDT=UNBLNDDT-1; end; else do; if .<UNBLNDDT-1<="&cutoff2"d then BDCSRDT=UNBLNDDT-1; else BDCSRDT="&cutoff2"d; if .<eosdcdt<=BDCSRDT then BDCSRDT=eosdcdt; end; end; Note: &cutoff2 will be the data cutoff date which specified in the table footnote. Blood draw date at Vax 1 Visit If non missing blood draw date at Vax 1 Visit then bldv1fl = 'Y''; else bldv1fl = 'N'. Blood draw date at 1 Week after Vax 1 Visit If non missing blood draw date at 1 Week after Vax 1 Visit then bldv2fl = 'Y''; else bldv2fl = 'N'. For 100 ug only, blood draw date at 3 weeks after Vax 1 Visit Blood draw date at Vax 2 Visit If non missing blood draw date at Vax 2 Visit then bldv3fl = 'Y''; else bldv3fl = 'N'. For 100 ug only, blood draw date at 4 weeks after Vax 1 Visit Blood draw date at 1 Week after Vax 2 Visit If non missing blood draw date at 1 Week after Vax 2 Visit then bldv4fl = 'Y''; else bldv4fl = 'N'. For 100 ug only, blood draw date at 5 weeks after Vax 1 Visit Blood draw date at 2 Weeks after Vax 2 Visit If non missing blood draw date at 2 Weeks after Vax 2 Visit then bldv5fl = 'Y''; else bldv5fl = 'N'. For 100 ug only, blood draw date at 3 weeks + 1 month after Vax 1 Visit Blood draw date at 1 Month after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 30 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) If non missing blood draw date at 1 Month after Vax 2 Visit then bldv6fl = 'Y''; else bldv6fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened within 28-42 days post dose 2, the convalescent visit will be used to replace this one, and bldv6fl will be set to "Y".) Blood draw date at 6 Months after Vax 2 Visit. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7dt will be set to the date of the convalescent visit. If multiple records fall into such window, the one closed to 190 days post dose 2 will be chosen. If multiple records at the same day, the one with available immunogenicity results will be chosen.) If non missing blood draw date at 6 Months after Vax 2 Visit then bldv7fl = 'Y''; else bldv7fl = 'N'. (Only apply to Phase 2/3 to serology: For subjects had Visit 4 recorded as not done, and if there is a convalescent visit or vax3 visit or surveilance consent visit that happened after 42 days post dose 2, the convalescent visit will be used to replace this one, and bldv7fl will be set to "Y".) Carry BMI from SDTM.VS where index(visit, "V1_DAY1") and vstestcd="BMI" and vsdy<=1 if .<vsstresn<18.5 then BMICAT="Underweight"; else if 18.5<=vsstresn<=24.9 then BMICAT="Normal weight"; else if 25<=vsstresn<=29.9 then BMICAT="Overweight"; else if 30<=vsstresn then BMICAT="Obese"; if vsstresn=. then BMICAT="Missing"; Datepart of DM.BRTHDTC Imputation of Partial Dates: If Day is missing, 1st day of Month If Month is missing, 1st month of Year. BRTHDTF = 'M' if Month and Day are imputed in BRTHDT BRTHDTF = 'D' if only Day is imputed in BRTHDT if .<LB.LBSTRESN*1000<200 then assigned as "<200"; else if 200<=LB.LBSTRESN*1000<=500 then assigned as "200-500"; else if LB.LBSTRESN*1000>500 then assigned as ">500"; where LB.LBTESTCD="CD4" and LBSTRESU="10^9/L" and LB.LBSTAT ne "NOT DONE" and index(visit, "V1_DAY1_VAX1") and LBDY<=1 1="<200" 2="200-500" 3=">500" For Phase 1 only: SUPPDS.QVAL where SUPPDS.QNAM=’ DSRANGRP’ "Y" if subject with Medical History With Comorbodities. Terms were defined in 19 external excel files whose filename contains 'report-cci'. Subjects are considered with COVID-19 history if MH.MHDECOD in ("Asymptomatic COVID-19" "COVID-19" "COVID-19 pneumonia" "COVID-19 treatment" "Suspected COVID-19" "SARS-CoV-2 antibody test positive" "SARS-CoV-2 carrier" "SARS-CoV-2 sepsis" "SARS-CoV-2 test positive" "SARS-CoV-2 viraemia" "Multisystem inflammatory syndrome in children"). if subjects with COVID-19 history or NIGV1FL="N" or NAATNFL="N" then COVBLST="POS"; if subjects without COVID-19 history and NIGV1FL="Y" and NAATNFL="Y" then COVBLST="NEG"; For Phase 1 only: Assign actual dose level. eg: 10 ug, 20 ug, 30 ug, 100 ug/10 ug For Placebo: Assign 'Placebo' For Phase 1 only: Assign planned dose level. eg: 10 ug, 20 ug, 30 ug,100 ug/10 ug For Placebo: Assign 'Placebo' "Y" for non-phase 1 subjects that are randomized on or before 9Oct2020 and obtained IC on or after 27Jul2020. "Y" for phase 2/3 subjects had follow up 168 days after Dose 2 at the point of EOS or data cutoff and reiceved 2 planned doses of BNT162b2; else "N". If DM.DTHDTC is not missing and not partial then DTHDT=Datepart of DM.DTHDTC; Else if DM.DTHDTC is partial then impute DTHDT using imputation START rules. Partial Death Dates Imputation Rules: If day (DD) and month (MMM) are missing in DM.DTHDTC, then use first day (01) and first month (JAN) for DD and MMM respectively. If day (DD) missing then use first day (01) of the month for DD. It is recommended that the database be designed to mandate a complete death date. If there is a record for death, but the date is missing or is partial, it will be imputed based on the last contact date. If the entire death date DM.DTHDTC is missing OR If imputed Death Date (DTHDT) is ON or PRIOR to Last Know Alive Date then reset DTHDT=(Last Known Alive Date) +1 If DTHDT was imputed, DTHDTF must be populated and is required. DTHDTF = 'Y' if Year is imputed DTHDTF = 'M' if Year is present and Month is imputed DTHDTF = 'D' if only day is imputed The earliest date of important PD Assign 'Y' for participants who have a signed ICD. EOSDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” EOSDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and DSPHASE="FOLLOW-UP" and DS.DSDECOD^=“COMPLETED” EOTDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and index(SUPPDS.QNAM.DSPHASE, "VACCINATION")>0 and DS.DSDECOD^=“COMPLETED” EOTDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM.DSPHASE="VACCINATION" and DS.DSDECOD^=“COMPLETED” EOTXDCDT = DS.DSSTDTC where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” EOTXDCRS = DS.DSDECOD where DS.DSCAT=’DISPOSITION EVENT’ and SUPPDS.QNAM='DSPHASE' and SUPPDS.QVAL="OPEN LABEL TREATMENT" and DS.DSDECOD^=“COMPLETED” Subjects will be set to “N” if any of the following conditions are met: •N-Binding is POS at visit 3. •Convalescent visit with POS result in the absence of visit 3 and is within 28-42 days PD2. •Convalescent N-Binding result is POS and is before Visit 3 date or up to 7 days after Visit 3 date. •Subjects without symptoms and have unscheduled POS swab results within 1MPD2 . •Subjects with POS swab results at Dose 1/Dose 2 or POS for N-Binding at Dose 1. •Subjects with presence of symptoms on or after Dose 1 and within 1MPD2 that are without valid NEG swab results. Else "Y". Will apply to Phase 1 only. If INCL1fl="Y" and INCL2fl="Y" and INCL4fl="Y" and INCL5fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL01FL="Y"; else EVAL01FL="N"; If INCL1fl="Y" and INCL2fl="Y" and (INCL7fl="Y" and vax10udt=.) and INCL8fl="Y" and INCL9fl="Y" and (index(SUPPDV.QNAM.CAPE, "POP3")=0 for subjects's all DV records) then EVAL02FL="Y"; else EVAL02FL="N"; If SAFFL="Y" and RFICDT>. and RANDFL="Y" and ARM ne "SCREEN FAILURE" and INCL1FL="Y" and INCL2fl="Y" and (INCL7fl="Y" and (vax10udt=. or (vax10udt>vax102dt>. and vax10udt>=vax102dt+7))) and VAX102DT>. and (UNBLNDDT=. or (UNBLNDDT>=vax102dt+7>.)) and (index(SUPPDV.QNAM.CAPE, "POP2")=0 for subjects's all DV records or any records with DV date 7 days after Dose 2 and index(SUPPDV.QNAM.CAPE, "POP2")>0 ) and (index(SUPPDV.QNAM.CAPE, "POP3")=0 and index(SUPPDV.QNAM.CAPE, "POP5")=0 for subjects's all DV records)then EVALEFFL="Y"; else EVALEFFL="N"; "Y" if INCL10FL="N" if INCL1FL="N" then EXCL1FL="Y" if EXCL1FL ne "Y" and INCL2FL="N" then EXCL2FL="Y" Will apply to Phase 1 only. if (VAX101DT>. or vax102dt>.) and INCL3FL="N" then EXCL3FL="Y" Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL4FL="N" then EXCL4FL="Y" Will apply to Phase 1 only. if EXCL2FL ne "Y" and INCL5FL="N" then EXCL5FL="Y" if INCL6FL="N" then EXCL6FL="Y" if EXCL2FL ne "Y" and INCL7FL="N" then EXCL7FL="Y" if VAX102DT ne . and INCL8FL="N" then EXCL8FL="Y" if VAX102DT ne . and EXCL2FL ne "Y" and INCL9FL="N" then EXCL9FL="Y" for INCL10FL="N" and vax102dt not missing: assign to "unblinded prior to 7 days post Dose 2" for UNBLNDDT<VAX102DT+7; assign to "unblinded on or after 7 days but prior to 14 days post Dose 2" for VAX102DT+7<=UNBLNDDT<VAX102DT+14; assign to "unblinded on or after 14 days but no later than 1 month post Dose 2 visit" for VAX102DT+14<=UNBLNDDT<=V3 date; 1 for 0<=FPX1CUT/28<1; 2 for 1<=FPX1CUT/28<2; 3 for 2<=FPX1CUT/28<3; 4 for 3<=FPX1CUT/28<4; etc. "0-1 Month" for FPX1CA1N=1; "1-2 Months" for FPX1CA1N=2; "2-3 Months" for FPX1CA1N=3; "3-4 Months" for FPX1CA1N=4; etc. if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do; if tr02sdt=. then FPX1CUT=0; else if not missing(eosdcdt) and eosdcdt>=tr02sdt then FPX1CUT=eosdcdt-tr02sdt+1; else FPX1CUT="&cutoff2"d-tr02sdt+1; end; Note: only populate for subjects unblinded or received cross over doses if (UNBLNDDT>. or tr02sdt>. ) and boostfl ne "Y" then do; if UNBLNDDT=. then FUNBCUT=0; else if not missing(eosdcdt) then FUNBCUT=eosdcdt-UNBLNDDT+1; else FUNBCUT="&cutoff2"d-UNBLNDDT+1; end; 1 for 0<=FUP1CUT/28<1; 2 for 1<=FUP1CUT/28<2; 3 for 2<=FUP1CUT/28<3; 4 for 3<=FUP1CUT/28<4; etc. "0-1 Month" for FUP1CA1N=1; "1-2 Months" for FUP1CA1N=2; "2-3 Months" for FUP1CA1N=3; "3-4 Months" for FUP1CA1N=4; etc. if randfl="Y" then do; if vax101dt=. then FUP1CUT=0; else if not missing(eosdcdt) then FUP1CUT=eosdcdt-vax101dt+1; else FUP1CUT="&cutoff2"d-vax101dt+1; end; if randfl="Y" then do; if vax101dt=. then FUP1UNB=0; else if not missing(BDCSRDT) then FUP1UNB=BDCSRDT-vax101dt+1; end; 1 for 0<=FUP2CUT/28<1; 2 for 1<=FUP2CUT/28<2; 3 for 2<=FUP2CUT/28<3; 4 for 3<=FUP2CUT/28<4; etc. 1 for 0<=FUP2UNB/28<1; 2 for 1<=FUP2UNB/28<2; 3 for 2<=FUP2UNB/28<3; 4 for 3<=FUP2UNB/28<4; etc." "0-1 Month" for FUP2CA1N=1; "1-2 Months" for FUP2CA1N=2; "2-3 Months" for FUP2CA1N=3; "3-4 Months" for FUP2CA1N=4; etc. "0-1 Month" for FUP2CA2N=1; "1-2 Months" for FUP2CA2N=2; "2-3 Months" for FUP2CA2N=3; "3-4 Months" for FUP2CA2N=4; etc. if randfl="Y" then do; if vax102dt=. then FUP2CUT=0; else if not missing(eosdcdt) then do; FUP2CUT=eosdcdt-vax102dt+1; if vax10udt>. then FUP2CUT=eosdcdt-vax10udt+1; end; else do; FUP2CUT="&cutoff2"d-vax102dt+1; if vax10udt>. then FUP2CUT="&cutoff2"d-vax10udt+1; end; end; if randfl="Y" then do; if vax102dt=. then FUP2UNB=0; else if not missing(BDCSRDT) then do; FUP2UNB=BDCSRDT-vax102dt+1; if vax10udt>. then FUP2UNB=BDCSRDT-vax10udt+1; end; end; "Y" if subject with HIV positive, subjects with HIV were determined by their medical history, HIV related term were defined in an external file: 201114-hiv-preferred-terms.xlsx "Y" If unblinding date after the visit date of 1 month post dose 2. else "N" for non-missing unblinding date. Note: not populated for subjects unblnding beyond 14 days after dose 2 but missing both BLDV6DT and SV.V3. ; not populated for missing dose 2. Assign value 'Y' if meet following criteria; Else Assign value 'N'; 1. Signed IC; 2. Randomized; 3. Not screen failure; 4. Meets all inclusion criteria and meets no exclusion criteria; Receive the first dose of vaccine to which they are randomly assigned Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2 Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. Will apply to Phase 1 only. Have at least 1 valid and determinate immunogenicity result 21 days after Dose 1. Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. Will apply to Phase 1 only. Have blood collection within an appropriate window after Dose 1, with visit window 19-23 days after dose 1. Derive from SUPPDV.QNAM.CAPE. 'Y' if the subjects with all records of SUPPDV.QNAM.CAPE is "NO" or missing or CAPE indicates "POP2" only and this date of PD is earlier that VAX102DT+14 Receive 2 randomized vaccinations within the pre-defined window Vaccination window – can be 19-42 days after dose 1: if 19<=VAX102DT-VAX101DT<=42 and ARM ne "" and ((index(upcase(vax102),"BNT162B2") and index(upcase(arm),"BNT162B2")) or (index(upcase(vax102),"PLACEBO") and index(upcase(arm),"PLACEBO"))) and vax101=vax102 then INCL7FL="Y"; else INCL7FL="N"; Have at least 1 valid and determinate immunogenicity result after Dose 2 Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. N-binding is diagnostic assay and not considered as valid and determinate immunogenicity result. Have blood collection within an appropriate window after Dose 2. Phase 1 – with visit window 6-8 days after dose 2 Phase 2/3 – 28-42 days after dose 2 "Y" if SUPPDM.QNAM = 'RACIALD' and SUPPDM.QVAL = 'JAPANESE' "Y" for subjects that were multiply enrolled subjests. if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="NEG" and mb.mbdy<=1 then NAATNFL="Y"; else if index(mb.visit,"V1_DAY1_") and mb.mbtestcd='RTCOV2NS' and mb.mborres="POS" and mb.mbdy<=1 then NAATNFL="N"; Derived from is.istest='N-binding antibody' if is.isorres="NEG" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="Y"; else if is.isorres="POS" and index(visit,"V1_DAY1_") and is.isdy<=1 then NIGV1FL="N"; Note: For phase 1 BNTb2 30 ug groups subjects, repeat test results are used in Vist 1/4/7/8. "Y" if adolescent with enrolled age 12-15 meets the BMI cut off for obesity with age/sex groups. The standard for obesity is provided in an external file bmi-12-15-scale.xlsx. “Y” if (tr02sdt>. or UNBLNDDT>.) and actarm in ("Placebo"); else "N" PEDIMMFL was derived from an external excel file: c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx (there are 660 subjects in total who are based on an random selection of 280 active+50 placebo from each of the age groups). if reactofl="Y" and phasen ne 1 and agegr4n in (1 2) then PEDREAFL="Y"; "Phase 1" for subjects from Phase 1, who were picked from an external excel file: c4591001-phase-1-subjects-from-dmw.xlsx; "Phase 2_ds360/ds6000" for subjects from Phase 2, who were picked from an external excel file: first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx; "Phase 3_ds6000" for subjects from Phase 3 and included in DS6000, who were picked from an external excel file: newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx; "Phase 3" for other subjects from Phase 3 if RACE='WHITE' then RACEGR1="WHITE"; else if RACE='BLACK OR AFRICAN AMERICAN' then RACEGR1="BLACK OR AFRICAN AMERICAN"; else RACEGR1="ALL OTHERS" if RANDFL="Y" and MULENRFL^="Y" and then RAND1FL="Y"; else RAND1FL="N"; [Protocol] Randomization Date is defined usually those who have been randomized the study. (For study design where subject gets randomized multiple time then RANDDT will be derive based on 1st Randomization Date) RANDDT = MIN of DS.DSSTDTC where DS.DSDECOD = "RANDOMIZED" Assign 'Y' for participants who are assigned a randomization number and with non-missing randomization date. DS.DSSTDTC for Re-vax Informed Consent. Datepart of DM.RFENDTC Timepart of DM.RFENDTC Datepart of DM.RFSTDTC Timepart of DM.RFSTDTC Derived numeric value from LB.LBORRES where LB.LBTESTCD="HIVR_US". Assigned as "<50" if subject's LBORRES does not contain any numeric value and not equal to positive. If derived numeric value is less than 50 then assigned as "<50"; if derived numeric value is equal to or greater than 50 then assigned as ">=50". 1="<50" 2=">=50" DV.DVTERM where SUPPDV.QNAM.CAPE contain 'POP5' then RSEXSAF="Unreliable data due to lack of PI oversight"; else if only 'POP1' then RSEXSAF="Did not provide informed consent"; if SAFFL="Y" and MULENRFL^="Y" and HIVFL^="Y" and trt01a ne "" then SAF1FL="Y"; else SAF1FL="N"; if SAFFL="Y" and MULENRFL^="Y" and trt01a ne "" then SAF2FL="Y"; else SAF2FL="N"; If RANDFL='Y' and (VAX101DT ne . or VAX102DT ne . ) and (index(SUPPDV.QNAM.CAPE, "POP1")=0 for subjects's all DV records) then SAFFL='Y', else SAFFL='N' If RFICDT ne . then  SCREEN='Y'; STCSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" Datepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. Datetime of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. Timepart of EX.EXENDTC for last vaccination of double blinded period. The last vaccination is defined as latest vaccination for subjects without Vaccination 3 or as last vaccination before Vaccination 3. Datepart of EX.EXSTDTC for Vaccination 1 Datetime of EX.EXSTDTC for Vaccination 1 Timepart of EX.EXSTDTC for Vaccination 1  Datepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. Datetime of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. Timepart of EX.EXENDTC for last vaccination for subjects with Vaccination 3/4. Datepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. Datetime of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. Timepart of EX.EXSTDTC for the first Vaccination for subjects with Vaccination 3/4. Derived from DM.ACTARM. If subject received any of doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If the subject received 1 or 2 doses of placebo and no BNT, the subject will be assigned as "Placebo". If subject with all indeterminate vaccinations, set TRT01A to missing. Obtained from DM.ARM directly. Derived from EX.EXTRT where EXTPTREF in ("Vaccination 3" "Vaccination 4"). If subject received any of these 2 doses as BNT162b2, then the subject will be assigned as 'BNT162b2 Phase 1 (30 mcg)' for phase 1 subject and 'BNT162b2 Phase 2/3 (30 mcg)' for phase 2/3 subject. If subject with all indeterminate vaccinations, set TRT02A to missing. assign as "BNT162b2 Phase 1 (30 mcg)" for Phase 1 subjects and "BNT162b2 Phase 2/3 (30 mcg)" for Phase 2/3 subjects if EX.EXDOSE and EX.EXSTDTC are not missing when EX.EXTPTREF='VACCINATION 3' or 'VACCINATION 4' Datepart of max(EX.EXENDTC) by subject level Max (EX.EXSTDTC) by subject level Timepart of max(EX.EXENDTC) by subject level Datepart of min(EX.EXSTDTC) by subject level Min (EX.EXSTDTC) by subject level combination of TRT01A and TRT02A for treated subject combination of TRT01P and TRT02P for randomized subject Timepart of min(EX.EXSTDTC) by subject level DS.DSSTDTC when DSDECOD="TREATMENT UNBLINDED" Derived BE1DT from CO.CODTC from Visit 7 after second dose for phase 1 and from visit 3 for phase 2/3 Derived BE1DT2 from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3 V01DT=COALESCE(VAX10UDT+35, BE1DT, BE1DT2, VAX102DT+35, VAX101DT+58); Then, for unblinded subjects, compare V01DT with the day before treatment unblinding, set V01DT=min(V01DT,UNBLNDDT-1) Note: used for AE summary tables to cutoff AEs within 1 month after vax2 Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3 Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3 V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23); Then, for unblinded subjects, compare V02DT with the day before treatment unblinding, set V02DT=min(V02DT,UNBLNDDT-1) Note: used for AE summary tables to cutoff AEs within 6 month after vax2. Derived BE2DT from CO.CODTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3 Derived BE2DT2 from SV.SVSTDTC from visit 8 after second dose for phase 1 and from visit 4 for phase 2/3 V02DT=COALESCE(VAX10UDT+189, BE2DT, BE2DT2, VAX102DT+189, VAX101DT+189+23); Then, for subjects took dose 3, compare V02DT with the day before dose 3, set V02DT=min(V02DT, TR02SDT-1) Note: used for AE summary tables to cutoff AEs within 6 month after vax2 regardless unblinding. Derived BE3DT2 from SV.SVSTDTC from 1 month after second dose in open label period visit V03DT=COALESCE(BE3DT2, VAX202DT+35, VAX201DT+58) Note: used for AE summary tables to cutoff AEs within 1 month after vax 4 in open label period Derived BE4DT2 from SV.SVSTDTC from 6 months after second dose in open label period visit V04DT=COALESCE(BE4DT2, VAX202DT+189, VAX201DT+189+23) Note: used for AE summary tables to cutoff AEs within 6 month after vax 4 in open label period The value of N-binding test at 1 Month after Vax 2 Visit. For subjects had Visit 3 recorded as not done, and if there is a convalescent visit or vax3 visit that happened within 28-42 days post dose 2, the convalescent visit/vax3 visit will be used to replace this one. If there are two records fall in the window, the record closed to 30 days after dose 2 will be chosen. Dose 1: combined form the vaccination at dose 1 and the corresponding dosage; set to missing if the dose is INDETERMINATE. Date of the vaccination 1 (first vaccination date) Time of the vaccination 1 (first vaccination date) Dose 2: combined form the vaccination at dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. Date of the vaccination 2 (2nd vaccination date) Time of the vaccination 2 (2nd vaccination date) Unplanned Dose 2: combined form the vaccination at unplanned dose 2 and the corresponding dosage; set to missing if the dose is INDETERMINATE. Date of the unplanned vaccination 2 (3rd vaccination date in the first period) Time of the unplanned vaccination 2 (3rd vaccination date in the first period) If EX.EXTRT='BNT162b2' when EX.VISIT in ('V101_VAX3' 'V8A_VAX3'), then VAX201='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. Date of the vaccination at Visit 101 (3rd vaccination date), Datepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). Time of the vaccination at Visit 101 (3rd vaccination date), timepart of EX.EXSTDTC where EX.VISIT in ('V101_VAX3' 'V8A_VAX3'). If EX.EXTRT='BNT162b2' when EX.VISIT='V102_VAX4', then VAX202='BNT162b2 (30 (*ESC*){unicode 03BC}g)'; set to missing if the dose is INDETERMINATE. Date of the vaccination at Visit 102 (4th vaccination date), Datepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. Time of the vaccination at Visit 102 (4th vaccination date), timepart of EX.EXSTDTC where EX.VISIT='V102_VAX4'. Unplanned Dose in open label period: combined form the vaccination at unplanned dose after the first dose after crossover period and the corresponding dosage; set to missing if the dose is INDETERMINATE. Date of the unplanned vaccination 1 in open label period. Time of the unplanned vaccination 1 in open label period. X1CSRDT=min(eosdcdt, "&cutoff2"d) for subjects with ranfl="Y" and non-missing tr02sdt or non-missing UNBLNDDT and boostfl ne "Y" if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FADTC. if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HODTC. if paramcd in ("C19NIG") then Set to IS.ISDTC. if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBDTC. if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRDTC. if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSDTC. if paramcd in ("PRCDTH" "SECDTH") then ADSL.DTHDT if paramcd in ("PO2FIO2") then LB.LBDTC if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "VSOPRES") then Set to null. Set as following: ADY = ADT - TRTSDT. If ADT >= TRTSDT, ADY = ADT - TRTSDT + 1. if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CEENDTC. if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "LSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject.. if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOENDTC. if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRENDTC. if paramcd in ("VSOPRES") then set to CM.CMENDTC if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH" "PRCDTH" "SECDTH" "PO2FIO2") then Set to null. Set as following: AENDY = AENDT - TRTSDT. If AENDT >= TRTSDT, AENDY = AENDT - TRTSDT + 1. if paramcd in ("SARDFN" "SAHDFN") then Set to CE.CESTDTC. if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FASTRESC where FA.FATESTCD = "FSYMDATE" and FA.FACAT = "EFFICACY" and FASCAT = "RESPIRATORY ILLNESS" within a matching FA.VISIT of a subject. if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOSTDTC. if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRSTDTC. if paramcd in ("VSOPRES") then set to CM.CMSTDTC if paramcd in ("SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "C19NIG" "DEATH" "PRCDTH" "SECDTH" "PO2FIO2") then Set to null. Set as following: ASTDY = ASTDT - TRTSDT. If ASTDT >= TRTSDT, ASTDY = ASTDT - TRTSDT + 1. if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to VS.VSSTRESN. if paramcd in ("PO2FIO2") then set to LB.LBORRES else Set to null. if paramcd in ("SARDFN" "SAHDFN" "SANDFN" "DEATH" "HCUICU") then Set to "Y". if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASTRESC. if paramcd in ("C19NIG") then Set to IS.ISORRES. if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBORRES. if upcase(MB.MBTEST) = 'SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2' and spdevid not in ('34','44','68') set to "UNK". if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PROCCUR. if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDSTRESC if paramcd in ("HCUHSP") then set to SUPPHO.QVAL where SUPPHO.QNAM = "HCUHSP". Note: Merge SUPPHO records with HO to gather HOCAT, start/end dates and visits and only keep records where QVAL = "Y". if paramcd in ("VSOPRES") then Set to CM.CMDECOD when CM.CMDECOD is not missing. Otherwise set to CM.CMTRT. if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "PO2FIO2") then Set to null. Follow AVISITN specification from below, but assign VISIT from source data instead. Set to VISITNUM of source dataset and for any existing multiple unplanned visits that are at least 4 days apart from the end of previous unplanned visit. When multiple unplanned visits are present and start of next unplanned visit is within 3 days of end of current unplanned visit, collapse the next unplanned visit into current unplanned visit and assign current VISITNUM to the next unplanned visit. Also set any repeat visits such as "..ARx" back to its main/parent visit. Set this to "Y", if subject reported any of the following terms in MH.MHDECOD . "Asymptomatic COVID-19" "COVID-19" "COVID-19 pneumonia" "COVID-19 treatment" "Suspected COVID-19" "SARS-CoV-2 antibody test positive" "SARS-CoV-2 carrier" "SARS-CoV-2 sepsis" "SARS-CoV-2 test positive" "SARS-CoV-2 viraemia" "Multisystem inflammatory syndrome in children" Set to FA.FAOBJ when upcase(FA.FAOBJ) = "CHILLS" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "DIARRHEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FEVER" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW LOSS OF TASTE OR SMELL" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED COUGH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED MUSCLE PAIN" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SHORTNESS OF BREATH" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NEW OR INCREASED SORE THROAT" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "VOMITING" and FA.FACAT = "EFFICACY" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to "NEW OR INCREASED NASAL CONGESTION" when upcase(FA.FAOBJ) = "NEW OR INCREASED NASAL CONGESTION" or "NASAL CONGESTION" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to "NEW OR INCREASED WHEEZING" when upcase(FA.FAOBJ) = "NEW OR INCREASED WHEEZING" or upcase(FA.FAOBJ) = "WHEEZING" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "FATIGUE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "HEADACHE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to "RHINORRHOEA" when upcase(FA.FAOBJ) contains "RUNNY NOSE" or upcase(FA.FAOBJ) = "RHINORRHOEA" and FA.FAOBJ ^= "NEW OR INCREASED NASAL DISCHARGE" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to FA.FAOBJ when upcase(FA.FAOBJ) = "NAUSEA" and FA.FACAT = "EFFICACY" and FA.FASCAT = "RESPIRATORY ILLNESS". Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE RENAL DYSFUNCTION". Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE HEPATIC DYSFUNCTION". Set to CE.CESCAT when CE.CESCAT = "SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION". Set to MB.MBTEST when upcase(MB.MBTESTCD) = "SARSCOV2" and MB.MBMETHOD = "IMMUNOCHROMATOGRAPHY". Set to MB.MBTEST when upcase(MB.MBTESTCD) = "RTCOV2NS" and MB.MBMETHOD = "REVERSE TRANSCRIPTASE PCR". Set to VS.VSTEST when VS.VSTESTCD = "RESP". Set to VS.VSTEST when VS.VSTESTCD = "HR". Set to VS.VSTEST when VS.VSTESTCD = "OXYSAT" Set to VS.VSTEST when VS.VSTESTCD = "DIABP". Set to VS.VSTEST when VS.VSTESTCD = "SYSBP". Set to LB.LBTEST when LB.LBTEST = "PP Arterial O2/Fraction Inspired O2". Set to PR.PRTRT when upcase(PR.PRTRT) = "INTUBATION". Set to PR.PRTRT when upcase(PR.PRTRT) = "NON-INVASIVE POSITIVE PRESSURE VENTILATION". Set to "CONTINUOUS POSITIVE AIRWAY PRESSURE" when upcase(PR.PRTRT) = "CONTINUOUS POSITIVE AIRWAY PRESSURE" or upcase(PR.PRTRT) = "CPAP". Set to PR.PRTRT when upcase(PR.PRTRT) = "OXYGEN THERAPY" Set to PR.PRTRT when upcase(PR.PRTRT) = "MECHANICAL VENTILATION". Set to PR.PRTRT when upcase(PR.PRTRT) = "EXTRACORPOREAL MEMBRANE OXYGENATION". Set to PR.PRTRT when upcase(PR.PRTRT) = "HIGH FLOW OXYGEN THERAPY". Set to CM.CMSCAT when CM.CMCAT = "GENERAL CONCOMITANT MEDICATIONS" and CM.CMSCAT = "VASOPRESSORS AGENTS". Keep only one record per subject per CM.CMSTDTC where CM.CMTRT is not missing. Set to IS.ISTEST when IS.ISTESTCD = "C19NIG" Set to "SUBJECT IN ICU DUE TO POTENTIAL COVID-19 ILLNESS" when (HOTERM = "ICU') or (SUPPHO.QNAM = "HCUICU" and QVAL="Y"). Set to "HOSPITALIZED DUE TO COVID-19 ILLNESS?" when SUPPHO.QNAM = "HCUHSP" and QVAL="Y" Set to DD.DDTEST when DD.DDTESTCD = "PRCDTH". Note: Only bring records when ADSL.DTHDT not null or DD.DDSTRESC is not null. Set to DD.DDTEST when DD.DDTESTCD = "SECDTH". Note: Only bring records when DD.DDSTRESC is populated. Set to DS.DSDECOD when DS.DSDECOD = "DEATH". if paramcd in ("RESP" "HR" "OXYSAT" "DIABP" "SYSBP") then Set to "GENERAL VITAL SIGNS". if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to "SIGNS AND SYMPTOMS OF DISEASE". if paramcd in ("SARDFN" "SAHDFN" "SANDFN") then Set to CE.CECAT. if paramcd in ("DEATH") then Set to DS.DSCAT. if paramcd in ("HCUICU" "HCUHSP") then Set to HO.HOCAT. if paramcd in ("C19NIG") then Set to IS.ISCAT. if paramcd in ("SARSCOV2" "RTCOV2NS") then Set to MB.MBCAT. if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to PR.PRCAT. if paramcd in ("VSOPRES") then Set to CM.CMCAT if paramcd in ("PO2FIO2") then set to LB.LBCAT if paramcd in ("PRCDTH" "SECDTH") then Set to DD.DDCAT if paramcd in ("INTBTION" "NIPPV" "CPAP" "OXYTHRP" "MCHVENT" "ECMO" "HFOXTHRP") then Set to "RESPIRATORY FAILURE". if paramcd in ("CHILLS" "DIARRHEA" "FEVER" "NLTSTSML" "NCOUG" "NMUSPN" "NSTBRTH" "NSRTHROT" "VOMIT" "NNSLCONG" "WHEEZ" "FATIGUE" "HEADACHE" "RIHNRA" "NAUSEA") then Set to FA.FASCAT. if paramcd in ("HCUICU" "HCUHSP" "C19NIG" "SARSCOV2" "RTCOV2NS" "RESP" "HR" "OXYSAT" "DIABP" "SYSBP" "SARDFN" "SAHDFN" "SANDFN" "PRCDTH" "SECDTH" "DEATH") then Set to null. if paramcd in ("VSOPRES") then Set to CM.CMSCAT if paramcd in ("PO2FIO2") then set to LB.LBSCAT For Phase 1: if avisitn<4 then do; /*related to dose 1 all-available immunogenicity population*/ if aai01fl="Y" then AAIMMFL="Y"; else AAIMMFL="N"; end; else if avisitn>=4 then do;/*related to dose 2 all-available immunogenicity population*/ if aai02fl="Y" then AAIMMFL="Y"; else AAIMMFL="N"; end; For Phase 2/3: if aai02fl="Y" then AAIMMFL="Y"; else AAIMMFL="N"; Set to 'Y' for a valid result (AVAL ne .) where collected before vax1. Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so only repeated V1 results are used to derive ABLFL Set to 'Y' if a subject has results both at baseline and post-baseline. Set to 'N' if a subject only has baseline or post-baseline results. date part of IS.ISDTC Flag the record that is selected based on Windowing 1. AVISIT ne missing; 2. Vax 1 date ne missing; 3. For Visit 1, visit date should no later than Vax 1 date; 4. For Visit 3, visit date should no later than Vax 3 (re-vax) date; Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so ANL01FL is set to missing for original results. Flag the record with non-missing result (AVAL ne . ) and ISSTRESC not in ('IND', 'QNS') Flag the record with non-missing AVAL and AVAL ge LLoQ. For Period 1, min(TR01EDTM + 365days ,TR02SDTM) for subjects with TR02SDTM, TR01EDTM + 365 days for subjects without TR02SDTM; TR02EDTM + 365 days for Period 2 if adt<TR02SDT or without TR02SDT or (adt=TR02SDT and index(visit, "V3_MONTH1_POSTVAX2")) then APERIOD=1; if adt>TR02SDT or (adt=TR02SDT and index(visit, "V101_VAX3")) then APERIOD=2; null if not dosed. TR01SDTM for Period 1; TR02SDTM for Period 2, Set to 'Y' for a post-baseline result where collected after vax1 If ISSTRESC in (' ', 'IND', 'QNS') then set to missing; if ISSTRESN lt LLoQ* or ISSTRESC eq 'BLQ' then set AVAL to 0.5*LLOQ; else set to IS.ISSTRESN. *LLoQ equals the value of ISLLOQ. For N-binding antibody test, 0 for negative and 1 for positive. For parameter with paramn equal 11 and 12: AVAL is the ratio of the corresponding parameters specified in PARAM eg: For PARAMN=11 (PARAM='COV2_MNG_SERUM_NT50 to Covid 19 S1 IGG), AVAL is the ratio of the SARS-CoV-2 serum neutralizing titer NT50 to Covid 19 S1 IGG at the same time point Character value for AVAL Derive AVISIT based on IS.Visit/Visitnum for records with non-missing value (AVAL ne .) Note: For phase 1 BNTb2 30 ug subjects, repeat test results are used in Vist 1/4/7/8, so AVISITN is set to missing for original results. Note: set AVISIT='' for ISTESTCD='C19NIG' as no need to report this test. AVAL from the record with ABLFL="Y" at USUBJID/PARAM level AVAL from the record with ABLFL="Y" at USUBJID/PARAM level; if BASE<islloq or BASEC="BLQ" then BASE4F=islloq AVALC from the record with ABLFL="Y" at USUBJID/PARAM level trim(left("Study"))||' ('||trim(left(dtype))||')'; if base<islloq then BSSEROC="< LLOQ"; if base>=islloq then BSSEROC=">= LLOQ"; if missing baseline then BSSEROC="Missing" For Phase 1: if avisitn<4 then do; /*related to dose 1 evaluable immunogenicity population*/ if eval01fl="Y" then EVIMMFL="Y"; else EVIMMFL="N"; end; else if avisitn>=4 then do; /*related to dose 2 evaluable immunogenicity population*/ if eval02fl="Y" then EVIMMFL="Y"; else EVIMMFL="N"; end; For Phase 2/3: if eval02fl="Y" then EVIMMFL="Y"; else EVIMMFL="N"; if r2base4f ge 4 then fold4fl="Y" trim(left(IS.ISTEST)) || '(' || trim(left(IS.ISSTRESU)) || ')' || ' - ' || trim(left(IS.ISMETHOD)) R2BASE = AVAL/BASE for post baseline readings R2BASE4F = AVAL/BASE4F for post baseline readings IS.ISSEQ when DTYPE ne 'Derived'. TRT01A for Period 1; TRT02A for Period 2 TRT01AN for Period 1; TRT02AN for Period 2 TRT01P for Period 1; TRT02P for Period 2 TRT01PN for Period 1; TRT02PN for Period 2 Assign value 'DAYS' if ADURN is not missing Numeric Code of AEREL: AERELN=1 for RELATED; ARRELN=3 for NOT RELATED Numeric Code of AE.AETOXGR 1=Grade 1; 2=Grade 2; 3=Grade 3; 4=Grade 4 aperiodc='Period 01' when APERIOD=1 aperiodc='Period 02' when APERIOD=2 Numeric Code of AREL: If AREL = RELATED then ARELN=1; else If AREL = NOT RELATED then ARELN=3; Numeric Code of AE.ATOXGR 1=Grade 1; 2=Grade 2; 3=Grade 3; 4=Grade 4 VPHASEN=0 when VPHASE='Pre-Vaccination'; VPHASEN=1 when VPHASE='Vaccination 1'; VPHASEN=2 when VPHASE='Vaccination 2; VPHASEN=3 when VPHASE='Follow Up 1'; VPHASEN=99 when VPHASE='Follow Up 2'; VPHASEN=4 when VPHASE='After unblinding and before Vaccination 3'; VPHASEN=5 when VPHASE='Vaccination 3'; VPHASEN=6 when VPHASE='Vaccination 4; VPHASEN=7 when VPHASE='Follow Up 3'; VPHASEN=100 when VPHASE='Follow Up 4'; Assign as data cutoff date Character code for PARAM Please refer to codelist ADC19EF.PARAMCD. Algorithm for picking params/records only upto UNBLNDDT as below: If protocol-defined and CDC-defined symptoms start after unblinding date (ADSL.UNBLNDDT), then all records for that illness visit (unscheduled) are dropped. For protocol-defined and CDC-defined symptoms that start on/before UNBLNDDT: 1. Keep records even if lab results, severe symptoms, collapsed visit symptoms within that illness visit goes beyond UNBLNDDT. 2. Any scheduled visits (non-illness) with ADT/ASTDT after UNBLNDDT are dropped. Numeric code for PARAM Please refer to codelist ADC19EF.PARAMN. from ADSYMPT.VISIT for all records except for derived records for surveillance time. from ADSYMPT.VISITNUM for all records except for derived records for surveillance time. Set to ”Days” if ADURN is not missing. Carried over from EX.EXDOSE. Detailed algorithm as below: Merge local reaction records (CE.CESCAT =”ADMINISTRATION SITE” ) with EX by USUBJID and (CE.CETPTREF equals EX.EXTPTREF) Merge Systemic events (CE.CESCAT =”SYSTEMIC” ) with EX by USUBJID and (CE.CETPTREF = EX.EXTPTREF) Create ADCEVD by setting local reactions and systemic events from above step keeping from EX EXDOSE , EXTRT, EXDOSU, EXSTDTC, EXENDTC. VPHASEN=0 when VPHASE='Pre-Vaccination'; VPHASEN=1 when VPHASE='Vaccination 1'; VPHASEN=2 when VPHASE='Vaccination 2; VPHASEN=3 when VPHASE='Follow Up 1'; VPHASEN=99 when VPHASE='Follow Up 2'; VPHASEN=4 when VPHASE=''After unblinding and before Vaccination 3'; VPHASEN=5 when VPHASE='Vaccination 3'; VPHASEN=6 when VPHASE='Vaccination 4; VPHASEN=7 when VPHASE='Follow Up 3'; VPHASEN=100 when VPHASE='Follow Up 4'; DS.DOMAIN Numeric code for DS.DSDECOD .Numeric code populated for only discontinued reasons: 2=COMPLETED; 13=SCREEN FAILURE; 1=ADVERSE EVENT; 3=DEATH; 5=LOST TO FOLLOW-UP; 7=OTHER; 8=PHYSICIAN DECISION; 9=PREGNANCY; 11=PROTOCOL DEVIATION; 14=STUDY TERMINATED BY SPONSOR; 16=WITHDRAWAL BY SUBJECT; 17=MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT; 18=NO LONGER MEETS ELIGIBILITY CRITERIA; 25=REFUSED FURTHER STUDY PROCEDURES; 26=WITHDRAWAL BY PARENT/GUARDIAN Numeric code for DSPHASE: 1="SCREENING" 7="OPEN LABEL TREATMENT" 26="VACCINATION" 31="FOLLOW-UP" 101="REPEAT SCREENING 1" DV.DOMAIN Numeric Part of ATPT Numeric Code of AVALCAT1 0='>0-2.0'; 1='>2.0-5.0'; 2='>5.0-10.0'; 3='>10.0'; Carried over from EX.EXDOSE. Detailed algorithm as below: For local reaction merge FACE with EX by USUBJID and FATPTREF equals EXTPTREF For systemic events merge FACE with EX by USUBJID and FATPTREF equals EXTPTREF Create ADFACEVD by setting local reactions and systemic events from above step keeping from EX EXDOSE , EXTRT, EXDOSU, EXSTDTC, EXENDTC. Join FACE and VS with data by PARAM then set PARAMCD per value level. Join FACE and VS with data generated then assigned based on PARAM. 1) FACE.FASEQ or VS.VSSEQ. 2) Set to missing for those derived parameters: where FATEST in ('Maximum Severity', 'Maximum Diameter', 'Maximum Temperature'). if adurn ne . then ADURU= 'YEARS' Comorbidity category assigned by external source according to comorbidity-categories.xlsx, CAT1='AIDS/HIV' was assigned if the term was included in external excel file - report-cci-aids-hiv.xlsx; CAT1='Any Malignancy' was assigned if the term was included in external excel file - report-cci-any-malignancy.xlsx; CAT1='Cerebrovascular Disease' was assigned if the term was included in external excel file - report-cci-cerebrovascular.xlsx; CAT1='Congestive Heart Failure' was assigned if the term was included in external excel file - report-cci-chf.xlsx; CAT1='Dementia' was assigned if the term was included in external excel file - report-cci-dementia.xlsx; CAT1='Diabetes With Chronic Complication' was assigned if the term was included in external excel file - report-cci-diabetes-with-comp.xlsx; CAT1='Diabetes Without Chronic Complication' was assigned if the term was included in external excel file - report-cci-diabetes-without-comp.xlsx; CAT1='Hemiplegia or Paraplegia' was assigned if the term was included in external excel file - report-cci-hemiplegia.xlsx; CAT1='Leukemia' was derived if the term was assigned in external excel file - report-cci-leukemia.xlsx; CAT1='Lymphoma' was derived if the term was assigned in external excel file - report-cci-lymphoma.xlsx; CAT1='Metastatic Solid Tumor' was assigned if the term was included in external excel file - report-cci-metastatic-tumour.xlsx; CAT1='Myocardial Infarction' was assigned if the term was included in external excel file - report-cci-mi.xlsx; CAT1='Mild Liver Disease' was assigned if the term was included in external excel file - report-cci-mild-liver.xlsx; CAT1='Moderate or Severe Liver Disease' was assigned if the term was included in external excel file - report-cci-mod-sev-liver.xlsx; CAT1='Peptic Ulcer Disease' was derived if the term was included in external excel file - report-cci-peptic-ulcer.xlsx; CAT1='Peripheral Vascular Disease' was assigned if the term was included in external excel file - report-cci-periph-vasc.xlsx; CAT1='Chronic Pulmonary Disease' was assigned if the term was included in external excel file - report-cci-pulmonary.xlsx; CAT1='Renal Disease' was derived if the term was assigned in external excel file - report-cci-renal.xlsx; CAT1='Rheumatic Disease' was derived if the term was assigned in external excel file - report-cci-rheumatic.xlsx Comorbidity category assigned by external source if the term meets the second category, assigned rule following with CAT1. e.g. If a patient meets two comorbidity categories, then the first category will be assigned in CAT1 and the second one goes to CAT2 Numeric Code of AGEGR1. 1='12-15 Years'; (Phase 2/3 cohort) 2='16-55 Years'; (Phase 2/3 cohort) 3='18-55 Years'; (Phase 1 cohort) 4='65-85 Years'; (Phase 1 cohort) 5='>55 Years'; (Phase 2/3 cohort) Numeric Code of AGEGR2. 1='<65 Years'; 2='>=65 Years'; Numeric Code of AGEGR3. 1='16-17 Years'; 2='18-55 Years'; 3='>55 Years'; Numeric Code of AGEGR4. 1='12-15 Years'; 2='16-25 Years'; Numeric Code of AGETGR3. 1='16-55 Years'; 2='>55 Years'; AGETRU01='YEARS' for non-missing AGETR01. AGETRU01='YEARS' for non-missing AGETR03. Numeric Code of ARACE Same as RACEN if BMICAT="Underweight" then BMICATN=1; else if BMICAT="Normal weight" then BMICATN=2; else if BMICAT="Overweight" then BMICATN=3; else if BMICAT="Obese" then BMICATN=4; else if BMICAT="Missing" then BMICATN=5; For Phase 1 only: Numeric Code of COHORT, See details in Cohort List. For Phase 1 only: Numeric Code of DOSALVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100/10 ug, 6=Placebo For Phase 1 only: Numeric Code of DOSPLVL 1=10 ug, 2=20 ug, 3=30 ug, 5=100/10 ug, 6=Placebo Numeric Code of the DM.ETHNIC. 1 if ETHNIC="HISPANIC OR LATINO"; 2 if ETHNIC="NOT HISPANIC OR LATINO"; 3 if ETHNIC="NOT REPORTED". Assign to "not eligible for the study at randomization" when EXCL1FL="Y" Assign to "did not receive Dose 1 as randomized" when EXCL2FL="Y" Will apply to Phase 1 only. Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 1 but before Dose 2" when EXCL3FL="Y" Will apply to Phase 1 only. Assign to "did not have at least 1 valid and determinate immunogenicity result 21 days after Dose 1" when EXCL4FL="Y" Will apply to Phase 1 only. Assign to "did not have blood collection within 19-23 days after Dose 1" when EXCL5FL="Y" Assign to "had important protocol deviation(s) as determined by the clinician for XXX population(s)" when EXCL6FL="Y" as specified in SUPPDV. POP1=Safety, POP2=Efficacy (within 7 days post Dose 2) if pd start date is before vax102dt +7, POP2=Efficacy (between 7-14 days post Dose 2) if pd start date is on or after vax102dt +7 but before vax102dt+14, POP2=Efficacy (between 14 days - 1 month post Dose 2) if pd start date is on or after vax102dt +14 but before visit 3 date, POP3=Immunogenicity. For visit 3 date, it will be obtained from non-missing BLDV6DT or derived from SV.SVSTDTC from visit 7 after second dose for phase 1 and from visit 3 for phase 2/3 if BLDV6DT is missing. Note: not populated for subjects missing BLDV6DT/SV.V3 Assign to "did not receive all vaccination(s) as randomized or did not receive Dose 2 within the predefined window (19-42 days after Dose 1)" when EXCL7FL="Y" Assign to "did not have at least 1 valid and determinate immunogenicity result after Dose 2" when EXCL8FL="Y" Assign to "did not have blood collection within 6-8 days after Dose 2" for Phase 1 when EXCL9FL="Y"; assign to "did not have blood collection within 28-42 days after Dose 2" for Phase 2/3 when EXCL9FL="Y" 1 for subjects from Phase 1; 2 for subjects from Phase 2; 3 for subjects from Phase 3 and included in DS6000; 4 for other subjects from Phase 3 Numeric Code of the DM.RACEGR1. 1 if RACEGR1="WHITE"; 2 if RACEGR1="BLACK OR AFRICAN AMERICAN"; 3 if RACEGR1="ALL OTHERS" Numeric Code of the DM.RACE. 1 if RACE="WHITE"; 2 if RACE="BLACK OR AFRICAN AMERICAN"; 3 if RACE="AMERICAN INDIAN OR ALASKA NATIVE"; 4 if RACE="ASIAN"; 5 if RACE="NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"; 6 if RACE="MULTIPLE"; 7 if RACE="NOT REPORTED"; Numeric Code of RACIALD 5 if RACIALD="JAPANESE" 999 if RACIALDN="OTHER" Numeric Code of the DM.SEX. Equals 1 if SEX="M", Equals 2 if SEX="F". BNT162b1 Phase 1 (10 mcg)=1; BNT162b1 Phase 1 (20 mcg)=2; BNT162b1 Phase 1 (30 mcg)=3; BNT162b1 Phase 1 (100/10 mcg)=4; BNT162b2 Phase 1 (10 mcg)=5; BNT162b2 Phase 1 (20 mcg)=6; BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; Placebo=9 BNT162b1 Phase 1 (10 mcg)=1; BNT162b1 Phase 1 (20 mcg)=2; BNT162b1 Phase 1 (30 mcg)=3; BNT162b1 Phase 1 (100/10 mcg)=4; BNT162b2 Phase 1 (10 mcg)=5; BNT162b2 Phase 1 (20 mcg)=6; BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; Placebo=9 BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8; BNT162b2 Phase 1 (30 mcg)=7; BNT162b2 Phase 2/3 (30 mcg)=8 Character code for PARAM Please refer to codelist ADSYMPT.PARAMCD. Numeric code for PARAM Please refer to codelist ADSYMPT.PARAMN. VISIT will be missing for observations from CM, DS VISITNUM will be missing for observations from CM, DS "Period x" where x is APERIOD Numeric Code of the AVISIT. 1 if AVISIT= "Before Vaccination 1"; 2 if AVISIT= "1 Week after Vaccination 1"; 3 if AVISIT= "3 Weeks after Vaccination 1" (Note: This is the visit before vaccination 2); 3.1 if AVISIT= "4 Weeks after Vaccination 1" (Note: For 100ug only); 3.2 if AVISIT= "5 Weeks after Vaccination 1" (Note: For 100ug only); 3.3 if AVISIT= "1 Month and 3 weeks after Vaccination 1" (Note: For 100ug only); 3.9 if AVISIT= "Before Vaccination 2" (Note: For 100ug only); 4 if AVISIT= "1 Week after Vaccination 2"; 5 if AVISIT= "2 Weeks after Vaccination 2"; 6 if AVISIT= "1 Month after Vaccination 2"; 7 if AVISIT= "6 Months after Vaccination 2"; 8 if AVISIT= "12 Months after Vaccination 2"; 9 if AVISIT= "24 Months after Vaccination 2"; if BSSEROC="Missing" then BSSERON=0; if BSSEROC="< LLOQ" then BSSERON=1; if BSSEROC=">= LLOQ" then BSSERON=2; Set to 'LLOQIMP' for imputed records. Set to 'Derived' for parameters for ratios. IS.ISTESTCD Assigned based on PARAMCD: PARAMN=1 when PARAMCD="C2NGNT50" PARAMN=2 when PARAMCD="C2NGNT90" PARAMN=3 when PARAMCD="C19S1IGG" PARAMN=4 when PARAMCD="C19RBDIG" PARAMN=5 when PARAMCD="C19NIG" PARAMN=11 when PARAMCD="NT50_S1" PARAMN=12 when PARAMCD="NT90_S1" PARAMN=13 when PARAMCD="NT50_RB" PARAMN=14 when PARAMCD="NT90_RB" Numeric Code from PARCAT1. 1 if PARCAT1="SEROLOGY". Set to "IS" when DTYPE ne 'Derived'. Set to "ISSTRESN" when DTYPE ne 'Derived'. 201114-hiv-preferred-terms-pdf 201114-hiv-preferred-terms-xls Analysis Data Reviewer's Guide bmi-12-15-scale-pdf bmi-12-15-scale-xls c4591001-phase-1-subjects-from-dmw-pdf c4591001-phase-1-subjects-from-dmw-xls c4591001-subject-list-for-12-25-immuno-analysis-27jan2021-pdf c4591001-subject-list-for-12-25-immuno-analysis-27jan2021-xls comorbidity-categories-pdf comorbidity-categories-xls first-c4591001-360-participants-enrolled-v1-13aug20-update-pdf first-c4591001-360-participants-enrolled-v1-13aug20-update-xls newlist-c4591001-6k-participants-enrolled-v3-17sep2020-pdf newlist-c4591001-6k-participants-enrolled-v3-17sep2020-xls report-cci-aids-hiv-pdf report-cci-aids-hiv-xls report-cci-any-malignancy-pdf report-cci-any-malignancy-xls report-cci-cerebrovascular-pdf report-cci-cerebrovascular-xls report-cci-chf-pdf report-cci-chf-xls report-cci-dementia-pdf report-cci-dementia-xls report-cci-diabetes-with-comp-pdf report-cci-diabetes-with-comp-xls report-cci-diabetes-without-comp-pdf report-cci-diabetes-without-comp-xls report-cci-hemiplegia-pdf report-cci-hemiplegia-xls report-cci-leukemia-pdf report-cci-leukemia-xls report-cci-lymphoma-pdf report-cci-lymphoma-xls report-cci-metastatic-tumour-pdf report-cci-metastatic-tumour-xls report-cci-mild-liver-pdf report-cci-mild-liver-xls report-cci-mi-pdf report-cci-mi-xls report-cci-mod-sev-liver-pdf report-cci-mod-sev-liver-xls report-cci-peptic-ulcer-pdf report-cci-peptic-ulcer-xls report-cci-periph-vasc-pdf report-cci-periph-vasc-xls report-cci-pulmonary-pdf report-cci-pulmonary-xls report-cci-renal-pdf report-cci-renal-xls report-cci-rheumatic-pdf report-cci-rheumatic-xls