adis_vaccine

adis_vaccine

Immunogenicity Specimen Assessments

Structure: One or more records per subject per analysis parameter per analysis timepoint

from pharmadata import pharmaverseadam

meta = pharmaverseadam.meta('adis_vaccine')
print(f"Rows: {meta.number_rows:,}  Columns: {meta.number_columns}")
Rows: 64  Columns: 103

Variables

Show variable specs
shape: (103, 5)
variablelabeltypemandatoryrole
strstrstrstrstr
"STUDYID""Study Identifier""String""Yes""Identifier Variables for BDS Datasets"
"USUBJID""Unique Subject Identifier""String""Yes""Identifier Variables for BDS Datasets"
"SUBJID""Subject Identifier for the Study""String""No""Identifier Variables for BDS Datasets"
"SITEID""Study Site Identifier""Float64""No""Identifier Variables for BDS Datasets"
"COUNTRY""Country""String""No"null
"DOMAIN""Domain Abbreviation""String""No"null
"RFSTDTC""Subject Reference Start Date/Time""Date""No"null
"RFENDTC""Subject Reference End Date/Time""String""No"null
"RFXSTDTC""Date/Time of First Study Treatment""String""No"null
"RFXENDTC""Date/Time of Last Study Treatment""String""No"null
"RFPENDTC""Date/Time of End of Participation""String""No"null
"DTHDTC""Date/Time of Death""String""No"null
"DTHFL""Subject Death Flag""String""No"null
"REGION1""Geographic Region 1""String""No"null
"BRTHDTC""Date/Time of Birth""String""No"null
"DMDTC""Date/Time of Collection""String""No"null
"DMDY""Study Day of Collection""Int32""No"null
"AGE""Age""Float64""No""ADSL Subject Demographics Variables"
"AGEU""Age Units""String""No""ADSL Subject Demographics Variables"
"AGEGR1""Pooled Age Group 1""String""No"null
"SEX""Sex""String""No""ADSL Subject Demographics Variables"
"RACE""Race""String""No""ADSL Subject Demographics Variables"
"RACEGR1""Pooled Race Group 1""String""No"null
"ETHNIC""Ethnicity""String""No"null
"SAFFL""Safety Population Flag""String""No""ADSL Population Indicator Variables"
"PPROTFL""Per-Protocol Population Flag""String""No""ADSL Population Indicator Variables"
"ARM""Description of Planned Arm""String""No""ADSL Treatment Variables"
"ARMCD""Planned Arm Code""String""No"null
"ACTARM""Description of Actual Arm""String""No""ADSL Treatment Variables"
"ACTARMCD""Actual Arm Code""String""No"null
"TRTP""Planned Treatment""String""No""Record-Level Treatment Variables for BDS Datasets"
"TRTA""Actual Treatment""String""No""Record-Level Treatment Variables for BDS Datasets"
"TRT01P""Planned Treatment for Period 01""String""No"null
"TRT01A""Actual Treatment for Period 01""String""No"null
"TRT02P""Planned Treatment for Period 02""String""No"null
"TRT02A""Actual Treatment for Period 02""String""No"null
"TRTSDT""Date of First Exposure to Treatment""Date""No""ADSL Treatment Timing Variables"
"TRTSDTM""Datetime of First Exposure to Treatment""Datetime""No""ADSL Treatment Timing Variables"
"TRTEDT""Date of Last Exposure to Treatment""Date""No""ADSL Treatment Timing Variables"
"TRTEDTM""Datetime of Last Exposure to Treatment""Datetime""No""ADSL Treatment Timing Variables"
"AP01SDT""Period 01 Start Date""Date""No"null
"AP01EDT""Period 01 End Date""Date""No"null
"AP02SDT""Period 02 Start Date""Date""No"null
"AP02EDT""Period 02 End Date""Date""No"null
"APERSDT""Period Start Date""Date""No""Period, Subperiod, and Phase Start and End Timing Variables"
"APEREDT""Period End Date""Date""No""Period, Subperiod, and Phase Start and End Timing Variables"
"RFICDTC""Date/Time of Informed Consent""String""No"null
"ADT""Analysis Date""Date""No""Timing Variables for BDS Datasets"
"ADY""Analysis Relative Day""Float64""No""Timing Variables for BDS Datasets"
"AVISIT""Analysis Visit""String""No""Timing Variables for BDS Datasets"
"AVISITN""Analysis Visit (N)""Float64""No""Timing Variables for BDS Datasets"
"ATPT""Analysis Timepoint""String""No""Timing Variables for BDS Datasets"
"ATPTN""Analysis Timepoint (N)""Float64""No""Timing Variables for BDS Datasets"
"ATPTREF""Analysis Timepoint Reference""String""No""Timing Variables for BDS Datasets"
"APERIOD""Period""Int32""No""Timing Variables for BDS Datasets"
"PARAM""Parameter""String""Yes""Analysis Parameter Variables for BDS Datasets"
"PARAMCD""Parameter Code""String""Yes""Analysis Parameter Variables for BDS Datasets"
"PARAMN""Parameter (N)""Float64""No""Analysis Parameter Variables for BDS Datasets"
"PARCAT1""Parameter Category 1""String""No"null
"AVAL""Analysis Value""Float64""No""Analysis Parameter Variables for BDS Datasets"
"AVALU""Analysis Value Unit""String""No"null
"BASE""Baseline Value""Float64""No""Analysis Parameter Variables for BDS Datasets"
"BASECAT1""Baseline Category 1""String""No"null
"BASETYPE""Baseline Type""String""No""Analysis Parameter Variables for BDS Datasets"
"CHG""Change from Baseline""Float64""No""Analysis Parameter Variables for BDS Datasets"
"R2BASE""Ratio to Baseline""Float64""No""Analysis Parameter Variables for BDS Datasets"
"CRIT1""Analysis Criterion 1""String""No"null
"CRIT1FL""Criterion 1 Evaluation Result Flag""String""No"null
"CRIT1FN""Criterion 1 Evaluation Result Flag (N)""Int32""No"null
"DTYPE""Derivation Type""String""No""Analysis Descriptor Variables for BDS Datasets"
"ABLFL""Baseline Record Flag""String""No""Flag Variables for BDS Datasets"
"ISSEQ""Sequence Number""Float64""No"null
"ISTESTCD""Immunogenicity Test/Exam Short Name""String""No"null
"ISTEST""Immunogenicity Test or Examination Name""String""No"null
"ISCAT""Category for Immunogenicity Test""String""No"null
"ISORRES""Results or Findings in Original Units""String""No"null
"ISORRESU""Original Units""String""No"null
"ISSTRESC""Character Result/Finding in Std Format""String""No"null
"ISSTRESN""Numeric Results/Findings in Std. Units""Float64""No"null
"ISSTRESU""Standard Units""String""No"null
"ISSTAT""Completion Status""String""No"null
"ISREASND""Reason Not Done""String""No"null
"ISNAM""Vendor Name""String""No"null
"ISSPEC""Specimen Type""String""No"null
"ISMETHOD""Method of Test or Examination""String""No"null
"ISBLFL""Baseline Flag""String""No"null
"ISLLOQ""Lower Limit of Quantitation""Float64""No"null
"VISITNUM""Visit Number""Float64""No"null
"EPOCH""Epoch""String""No"null
"ISDTC""Date/Time of Collection""String""No"null
"ISDY""Study Day of Visit/Collection/Exam""String""No"null
"ISULOQ""Upper Limit of Quantitation""Float64""No"null
"LOD""Limit of Detection""String""No"null
"DERIVED""Derivation Method""String""No"null
"CUTOFF02""First Cutoff Value""Float64""No"null
"CUTOFF03""Second Cutoff Value""Float64""No"null
"SERCAT1""Pre-vaccination seropositivity status""String""No"null
"SERCAT1N""Pre-vaccination sero status (n)""Float64""No"null
"PPSRFL""Per-Protocol Record-Level Flag""String""No"null
"INVID""Investigator Identifier""Float64""No"null
"INVNAM""Investigator Name""String""No"null
"VAX01DT""Vaccination Date 01""Date""No"null
"VAX02DT""Vaccination Date 02""Date""No"null

Examples

from great_docs import tbl_explorer
from pharmadata import pharmaverseadam

tbl_explorer(pharmaverseadam.adis_vaccine.head(10))
PolarsRows10Columns103
STUDYID
str
USUBJID
str
SUBJID
str
SITEID
f64
COUNTRY
str
DOMAIN
str
RFSTDTC
date
RFENDTC
str
RFXSTDTC
str
RFXENDTC
str
RFPENDTC
str
DTHDTC
str
DTHFL
str
REGION1
str
BRTHDTC
str
DMDTC
str
DMDY
i32
AGE
f64
AGEU
str
AGEGR1
str
SEX
str
RACE
str
RACEGR1
str
ETHNIC
str
SAFFL
str
PPROTFL
str
ARM
str
ARMCD
str
ACTARM
str
ACTARMCD
str
TRTP
str
TRTA
str
TRT01P
str
TRT01A
str
TRT02P
str
TRT02A
str
TRTSDT
date
TRTSDTM
dtime
TRTEDT
date
TRTEDTM
dtime
AP01SDT
date
AP01EDT
date
AP02SDT
date
AP02EDT
date
APERSDT
date
APEREDT
date
RFICDTC
str
ADT
date
ADY
f64
AVISIT
str
AVISITN
f64
ATPT
str
ATPTN
f64
ATPTREF
str
APERIOD
i32
PARAM
str
PARAMCD
str
PARAMN
f64
PARCAT1
str
AVAL
f64
AVALU
str
BASE
f64
BASECAT1
str
BASETYPE
str
CHG
f64
R2BASE
f64
CRIT1
str
CRIT1FL
str
CRIT1FN
i32
DTYPE
str
ABLFL
str
ISSEQ
f64
ISTESTCD
str
ISTEST
str
ISCAT
str
ISORRES
str
ISORRESU
str
ISSTRESC
str
ISSTRESN
f64
ISSTRESU
str
ISSTAT
str
ISREASND
str
ISNAM
str
ISSPEC
str
ISMETHOD
str
ISBLFL
str
ISLLOQ
f64
VISITNUM
f64
EPOCH
str
ISDTC
str
ISDY
str
ISULOQ
f64
LOD
str
DERIVED
str
CUTOFF02
f64
CUTOFF03
f64
SERCAT1
str
SERCAT1N
f64
PPSRFL
str
INVID
f64
INVNAM
str
VAX01DT
date
VAX02DT
date
0 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-12-15 43 Visit 3 30 Visit 3 (Day 61) 3 SECOND TREATMENT 1 4FOLD (J0033VN Antibody) J0033VNF 21 IMMUNOLOGY 2 titer None None VISIT 1 None None Titer >= ISLLOQ Y 1 None None None J0033VN J0033VN Antibody IMMUNOLOGY 2 1/DIL 2 2 titer None None LABNAME SERUM METHODNAME None 2 30 SECOND TREATMENT 2021-12 61 100 4 4FOLD 4 8 None None Y 1328 Potter, Harry 2021-11-03 2021-12-30
1 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-12-15 43 Visit 3 30 Visit 3 (Day 61) 3 SECOND TREATMENT 1 4FOLD (I0019NT Antibody) I0019NTF 22 IMMUNOLOGY 200 titer 4 Titer value < 1:10 VISIT 1 196 50 Titer >= ISLLOQ Y 1 None None None I0019NT I0019NT Antibody IMMUNOLOGY >200 1/DIL >200 None titer None None LABNAME SERUM METHODNAME None 4 30 SECOND TREATMENT 2021-12 61 200 5 4FOLD 4 8 None None Y 1328 Potter, Harry 2021-11-03 2021-12-30
2 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-12-15 43 Visit 3 30 Visit 3 (Day 61) 3 SECOND TREATMENT 1 4FOLD (M0019LN Antibody) M0019LNF 23 IMMUNOLOGY 8 titer 150 Titer value >= 1:10 VISIT 1 -142 0.0533333333333 Titer >= ISLLOQ Y 1 None None None M0019LN M0019LN Antibody IMMUNOLOGY <2 1/DIL <2 None titer None None LABNAME SERUM METHODNAME None 8 30 SECOND TREATMENT 2021-12 61 150 4 4FOLD 4 8 None None Y 1328 Potter, Harry 2021-11-03 2021-12-30
3 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-12-15 43 Visit 3 30 Visit 3 (Day 61) 3 SECOND TREATMENT 1 4FOLD (R0003MA Antibody) R0003MAF 24 IMMUNOLOGY 98.2 titer 120 Titer value >= 1:10 VISIT 1 -21.8 0.818333333333 Titer >= ISLLOQ Y 1 None None None R0003MA R0003MA Antibody IMMUNOLOGY 98.2 1/DIL 98.2 98.2 titer None None LABNAME SERUM METHODNAME None 4 30 SECOND TREATMENT 2021-12 61 120 8 4FOLD 4 8 None None Y 1328 Potter, Harry 2021-11-03 2021-12-30
4 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-11-15 13 Visit 1 10 Visit 1 (Day 1) 1 FIRST TREATMENT 1 4FOLD (I0019NT Antibody) I0019NTF 22 IMMUNOLOGY 4 titer 4 Titer value < 1:10 VISIT 1 None None Titer >= ISLLOQ Y 1 None Y None I0019NT I0019NT Antibody IMMUNOLOGY 3 1/DIL 3 3 titer None None LABNAME SERUM METHODNAME Y 4 10 FIRST TREATMENT 2021-11 1 200 5 4FOLD 4 8 S+ 2 Y 1328 Potter, Harry 2021-11-03 2021-12-30
5 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-11-15 13 Visit 1 10 Visit 1 (Day 1) 1 FIRST TREATMENT 1 4FOLD (M0019LN Antibody) M0019LNF 23 IMMUNOLOGY 150 titer 150 Titer value >= 1:10 VISIT 1 None None Titer >= ISLLOQ Y 1 None Y None M0019LN M0019LN Antibody IMMUNOLOGY >150 1/DIL >150 None titer None None LABNAME SERUM METHODNAME Y 8 10 FIRST TREATMENT 2021-11 1 150 4 4FOLD 4 8 S+ 2 Y 1328 Potter, Harry 2021-11-03 2021-12-30
6 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-11-15 13 Visit 1 10 Visit 1 (Day 1) 1 FIRST TREATMENT 1 4FOLD (R0003MA Antibody) R0003MAF 24 IMMUNOLOGY 120 titer 120 Titer value >= 1:10 VISIT 1 None None Titer >= ISLLOQ Y 1 None Y None R0003MA R0003MA Antibody IMMUNOLOGY 140.5 1/DIL 140.5 140.5 titer None None LABNAME SERUM METHODNAME Y 4 10 FIRST TREATMENT 2021-11 1 120 8 4FOLD 4 8 S+ 2 Y 1328 Potter, Harry 2021-11-03 2021-12-30
7 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB None None VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 None None 2021-10-28 None None Visit 1 10 Visit 1 (Day 1) 1 FIRST TREATMENT None 4FOLD (J0033VN Antibody) J0033VNF 21 IMMUNOLOGY None None None None VISIT 1 None None None None None None Y None J0033VN J0033VN Antibody IMMUNOLOGY None None None None None NOT DONE INVALID RESULT LABNAME SERUM METHODNAME Y 2 10 FIRST TREATMENT None None 100 4 4FOLD 4 8 UNKNOWN 3 Y 1328 Potter, Harry 2021-11-03 2021-12-30
8 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-12-15 43 Visit 3 30 Visit 3 (Day 61) 3 SECOND TREATMENT 1 LOG10 (J0033VN Antibody) J0033VNL 11 IMMUNOLOGY 0.3 titer None None VISIT 1 None None Titer >= ISLLOQ N 0 None None None J0033VN J0033VN Antibody IMMUNOLOGY 2 1/DIL 2 2 titer None None LABNAME SERUM METHODNAME None 2 30 SECOND TREATMENT 2021-12 61 100 4 LOG10 4 8 None None Y 1328 Potter, Harry 2021-11-03 2021-12-30
9 ABC ABC-1001 1001 1001 USA IS 2021-11-03 2022-04-27 2021-11-03T10:50:00 2021-12-30T09:10:00 2022-04-27 None None NA 1947-09-21 None None 74 YEARS >64 F WHITE White NOT HISPANIC OR LATINO Y Y VACCINE A VACCINE B VAXAB VACCINE A VACCINE B VAXAB VACCINE A VACCINE A VACCINE A VACCINE A VACCINE B VACCINE B 2021-11-03 2021-11-03 10:50:00+00:00 2021-12-30 2021-12-30 09:10:00+00:00 2021-11-03 2021-12-29 2021-12-30 2022-04-27 2021-11-03 2021-12-29 2021-10-28 2021-12-15 43 Visit 3 30 Visit 3 (Day 61) 3 SECOND TREATMENT 1 LOG10 (I0019NT Antibody) I0019NTL 12 IMMUNOLOGY 2.3 titer 0.3 Titer value < 1:10 VISIT 1 2 7.66666666667 Titer >= ISLLOQ N 0 ULOQ None None I0019NT I0019NT Antibody IMMUNOLOGY >200 1/DIL >200 None titer None None LABNAME SERUM METHODNAME None 4 30 SECOND TREATMENT 2021-12 61 200 5 LOG10 4 8 None None Y 1328 Potter, Harry 2021-11-03 2021-12-30