advs

advs

Vital Signs Analysis

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

from pharmadata import pharmaverseadam

meta = pharmaverseadam.meta('advs')
print(f"Rows: {meta.number_rows:,}  Columns: {meta.number_columns}")
Rows: 65,032  Columns: 105

Variables

Show variable specs
shape: (105, 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""String""No""Identifier Variables for BDS Datasets"
"COUNTRY""Country""String""No"null
"DOMAIN""Domain Abbreviation""String""No"null
"RFSTDTC""Subject Reference Start Date/Time""String""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
"SCRFDT""Screen Failure Date""Date""No"null
"FRVDT""Final Retrieval Visit Date""Date""No"null
"DTHDTC""Date/Time of Death""String""No"null
"DTHADY""Relative Day of Death""Float64""No"null
"DTHFL""Subject Death Flag""String""No"null
"LDDTHELD""Elapsed Days from Last Dose to Death""Float64""No"null
"LDDTHGR1""Last Dose to Death - Days Elapsed Grp 1""String""No"null
"DTH30FL""Death Within 30 Days of Last Trt Flag""String""No"null
"DTHA30FL""Death After 30 Days from Last Trt Flag""String""No"null
"DTHDOM""Domain for Date of Death Collection""String""No"null
"DTHB30FL""Death Within 30 Days of First Trt Flag""String""No"null
"ASEQ""Analysis Sequence Number""Int32""No""Identifier Variables for BDS Datasets"
"REGION1""Geographic Region 1""String""No"null
"DMDTC""Date/Time of Collection""String""No"null
"DMDY""Study Day of Collection""Float64""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"
"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
"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"
"TRTSTMF""Time of First Exposure Imput. Flag""String""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"
"TRTETMF""Time of Last Exposure Imput. Flag""String""No""ADSL Treatment Timing Variables"
"EOSSTT""End of Study Status""String""No""ADSL Subject-Level Trial Experience Variables"
"EOSDT""End of Study Date""Date""No""ADSL Subject-Level Trial Experience Variables"
"RFICDTC""Date/Time of Informed Consent""String""No"null
"RANDDT""Date of Randomization""Date""No""ADSL Subject-Level Trial Experience Variables"
"LSTALVDT""Date Last Known Alive""Date""No""ADSL Subject-Level Trial Experience Variables"
"TRTDURD""Total Treatment Duration (Days)""Float64""No""ADSL Subject-Level Trial Experience Variables"
"DTHDT""Date of Death""Date""No""ADSL Subject-Level Trial Experience Variables"
"DTHDTF""Date of Death Imputation Flag""String""No""ADSL Subject-Level Trial Experience Variables"
"DTHCAUS""Cause of Death""String""No"null
"DTHCGR1""Cause of Death Reason 1""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"
"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"
"AVAL""Analysis Value""Float64""No""Analysis Parameter Variables for BDS Datasets"
"AVALCAT1""Analysis Value Category 1""String""No"null
"AVALCA1N""Analysis Value Category 1 (N)""Float64""No"null
"BASE""Baseline Value""Float64""No""Analysis Parameter Variables for BDS Datasets"
"BASETYPE""Baseline Type""String""No""Analysis Parameter Variables for BDS Datasets"
"CHG""Change from Baseline""Float64""No""Analysis Parameter Variables for BDS Datasets"
"PCHG""Percent Change from Baseline""Float64""No""Analysis Parameter Variables for BDS Datasets"
"DTYPE""Derivation Type""String""No""Analysis Descriptor Variables for BDS Datasets"
"ANRIND""Analysis Reference Range Indicator""String""No""Toxicity and Range Variables for BDS Datasets"
"BNRIND""Baseline Reference Range Indicator""String""No""Toxicity and Range Variables for BDS Datasets"
"ANRLO""Analysis Normal Range Lower Limit""Float64""No""Toxicity and Range Variables for BDS Datasets"
"ANRHI""Analysis Normal Range Upper Limit""Float64""No""Toxicity and Range Variables for BDS Datasets"
"A1LO""Analysis Range 1 Lower Limit""Float64""No"null
"A1HI""Analysis Range 1 Upper Limit""Float64""No"null
"ABLFL""Baseline Record Flag""String""No""Flag Variables for BDS Datasets"
"ANL01FL""Analysis Flag 01""String""No"null
"ONTRTFL""On Treatment Record Flag""String""No""Flag Variables for BDS Datasets"
"VSSEQ""Sequence Number""Float64""No"null
"VSTESTCD""Vital Signs Test Short Name""String""No"null
"VSTEST""Vital Signs Test Name""String""No"null
"VSPOS""Vital Signs Position of Subject""String""No"null
"VSORRES""Result or Finding in Original Units""String""No"null
"VSORRESU""Original Units""String""No"null
"VSSTRESC""Character Result/Finding in Std Format""String""No"null
"VSSTRESN""Numeric Result/Finding in Standard Units""Float64""No"null
"VSSTRESU""Standard Units""String""No"null
"VSSTAT""Completion Status""String""No"null
"VSLOC""Location of Vital Signs Measurement""String""No"null
"VSBLFL""Baseline Flag""String""No"null
"VISITNUM""Visit Number""Float64""No"null
"VISIT""Visit Name""String""No"null
"VISITDY""Planned Study Day of Visit""Float64""No"null
"VSDTC""Date/Time of Measurements""String""No"null
"VSDY""Study Day of Vital Signs""Float64""No"null
"VSTPT""Planned Time Point Name""String""No"null
"VSTPTNUM""Planned Time Point Number""Float64""No"null
"VSELTM""Planned Elapsed Time from Time Point Ref""String""No"null
"VSTPTREF""Time Point Reference""String""No"null

Examples

from great_docs import tbl_explorer
from pharmadata import pharmaverseadam

tbl_explorer(pharmaverseadam.advs.head(10))
PolarsRows10Columns105
STUDYID
str
USUBJID
str
SUBJID
str
SITEID
str
COUNTRY
str
DOMAIN
str
RFSTDTC
str
RFENDTC
str
RFXSTDTC
str
RFXENDTC
str
RFPENDTC
str
SCRFDT
date
FRVDT
date
DTHDTC
str
DTHADY
f64
DTHFL
str
LDDTHELD
f64
LDDTHGR1
str
DTH30FL
str
DTHA30FL
str
DTHDOM
str
DTHB30FL
str
ASEQ
i32
REGION1
str
DMDTC
str
DMDY
f64
AGE
f64
AGEU
str
AGEGR1
str
SEX
str
RACE
str
RACEGR1
str
ETHNIC
str
SAFFL
str
ARM
str
ARMCD
str
ACTARM
str
ACTARMCD
str
TRTP
str
TRTA
str
TRT01P
str
TRT01A
str
TRTSDT
date
TRTSDTM
dtime
TRTSTMF
str
TRTEDT
date
TRTEDTM
dtime
TRTETMF
str
EOSSTT
str
EOSDT
date
RFICDTC
str
RANDDT
date
LSTALVDT
date
TRTDURD
f64
DTHDT
date
DTHDTF
str
DTHCAUS
str
DTHCGR1
str
ADT
date
ADY
f64
AVISIT
str
AVISITN
f64
ATPT
str
ATPTN
f64
PARAM
str
PARAMCD
str
PARAMN
f64
AVAL
f64
AVALCAT1
str
AVALCA1N
f64
BASE
f64
BASETYPE
str
CHG
f64
PCHG
f64
DTYPE
str
ANRIND
str
BNRIND
str
ANRLO
f64
ANRHI
f64
A1LO
f64
A1HI
f64
ABLFL
str
ANL01FL
str
ONTRTFL
str
VSSEQ
f64
VSTESTCD
str
VSTEST
str
VSPOS
str
VSORRES
str
VSORRESU
str
VSSTRESC
str
VSSTRESN
f64
VSSTRESU
str
VSSTAT
str
VSLOC
str
VSBLFL
str
VISITNUM
f64
VISIT
str
VISITDY
f64
VSDTC
str
VSDY
f64
VSTPT
str
VSTPTNUM
f64
VSELTM
str
VSTPTREF
str
0 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 1 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2013-12-26 -7 None None None None Body Mass Index(kg/m^2) BMI 8 24.8719284597 None None 25.0792713238 LAST None None None None None None None None None None None None None None None None None None None None None None None None 1 SCREENING 1 None None None None None None None
1 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 2 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2013-12-26 -7 None None None None Body Mass Index(kg/m^2) BMI 8 24.8719284597 None None 25.0792713238 LAST None None AVERAGE None None None None None None None None None None None None None None None None None None None None None None None None None None None None None None
2 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 3 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-01-02 1 Baseline 0 None None Body Mass Index(kg/m^2) BMI 8 25.0792713238 None None 25.0792713238 LAST None None None None None None None None None Y None None None None None None None None None None None None None None 3 BASELINE None None None None None None None
3 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 4 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-01-02 1 Baseline 0 None None Body Mass Index(kg/m^2) BMI 8 25.0792713238 None None 25.0792713238 LAST None None AVERAGE None None None None None None None None None None None None None None None None None None None None None None None None None None None None None None
4 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 5 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-01-16 15 Week 2 2 None None Body Mass Index(kg/m^2) BMI 8 24.4526351122 None None 25.0792713238 LAST -0.626636211655 -2.49862208341 None None None None None None None None Y Y None None None None None None None None None None None None 4 WEEK 2 None None None None None None None
5 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 6 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-01-16 15 Week 2 2 None None Body Mass Index(kg/m^2) BMI 8 24.4526351122 None None 25.0792713238 LAST -0.626636211655 -2.49862208341 AVERAGE None None None None None None None Y Y None None None None None None None None None None None None None None None None None None None None None
6 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 7 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-01-30 29 Week 4 4 None None Body Mass Index(kg/m^2) BMI 8 24.8719284597 None None 25.0792713238 LAST -0.207342864151 -0.826749954069 None None None None None None None None Y Y None None None None None None None None None None None None 5 WEEK 4 None None None None None None None
7 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 8 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-01-30 29 Week 4 4 None None Body Mass Index(kg/m^2) BMI 8 24.8719284597 None None 25.0792713238 LAST -0.207342864151 -0.826749954069 AVERAGE None None None None None None None Y Y None None None None None None None None None None None None None None None None None None None None None
8 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 9 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-02-12 42 Week 6 6 None None Body Mass Index(kg/m^2) BMI 8 24.4526351122 None None 25.0792713238 LAST -0.626636211655 -2.49862208341 None None None None None None None None Y Y None None None None None None None None None None None None 7 WEEK 6 None None None None None None None
9 CDISCPILOT01 01-701-1015 1015 701 USA None 2014-01-02 2014-07-02 2014-01-02 2014-07-02 2014-07-02T11:45 None None None None None None None None None None None 10 NA 2013-12-26 -7 63 YEARS 18-64 F WHITE White HISPANIC OR LATINO Y Placebo Pbo Placebo Pbo Placebo Placebo Placebo Placebo 2014-01-02 2014-01-02 00:00:00+00:00 H 2014-07-02 2014-07-02 23:59:59+00:00 H COMPLETED 2014-07-02 None 2014-01-02 2014-07-02 182 None None None None 2014-02-12 42 Week 6 6 None None Body Mass Index(kg/m^2) BMI 8 24.4526351122 None None 25.0792713238 LAST -0.626636211655 -2.49862208341 AVERAGE None None None None None None None Y Y None None None None None None None None None None None None None None None None None None None None None