adrs_onco

adrs_onco

Tumor Response Analysis

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

from pharmadata import pharmaverseadam

meta = pharmaverseadam.meta('adrs_onco')
print(f"Rows: {meta.number_rows:,}  Columns: {meta.number_columns}")
Rows: 3,694  Columns: 79

Variables

Show variable specs
shape: (79, 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
"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"
"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"
"ADTF""Analysis Date Imputation Flag""String""No""Timing Variables for BDS Datasets"
"AVISIT""Analysis Visit""String""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"
"PARCAT1""Parameter Category 1""String""No"null
"PARCAT2""Parameter Category 2""String""No"null
"PARCAT3""Parameter Category 3""String""No"null
"AVAL""Analysis Value""Float64""No""Analysis Parameter Variables for BDS Datasets"
"AVALC""Analysis Value (C)""String""No""Analysis Parameter Variables for BDS Datasets"
"ANL01FL""Analysis Flag 01""String""No"null
"ANL02FL""Analysis Flag 02""String""No"null
"VISITNUM""Visit Number""Float64""No"null
"VISIT""Visit Name""String""No"null
"RSTESTCD""Assessment Short Name""String""No"null
"RSTEST""Assessment Name""String""No"null
"RSORRES""Result or Finding in Original Units""String""No"null
"RSSTRESC""Character Result/Finding in Std Format""String""No"null
"RSEVAL""Evaluator""String""No"null
"RSEVALID""Evaluator Identifier""String""No"null
"RSACPTFL""Accepted Record Flag""String""No"null
"RSDTC""Date/Time of Assessment""String""No"null
"RSSEQ""Sequence Number""Int32""No"null
"DTHDTF""Date of Death Imputation Flag""String"nullnull

Examples

from great_docs import tbl_explorer
from pharmadata import pharmaverseadam

tbl_explorer(pharmaverseadam.adrs_onco.head(10))
PolarsRows10Columns79
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
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
DTHCAUS
str
DTHCGR1
str
ADT
date
ADTF
str
AVISIT
str
PARAM
str
PARAMCD
str
PARCAT1
str
PARCAT2
str
PARCAT3
str
AVAL
f64
AVALC
str
ANL01FL
str
ANL02FL
str
VISITNUM
f64
VISIT
str
RSTESTCD
str
RSTEST
str
RSORRES
str
RSSTRESC
str
RSEVAL
str
RSEVALID
str
RSACPTFL
str
RSDTC
str
RSSEQ
i32
DTHDTF
str
0 CDISCPILOT01 01-701-1015 1015 701 USA RS 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 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 2014-03-06 None WEEK 9 Best Overall Response of CR/PR by Investigator (confirmation not required) BCP Tumor Response Investigator RECIST 1.1 1 Y Y Y 4 WEEK 9 OVRLRESP Overall Response CR CR INVESTIGATOR None None 2014-03-06 9 None
1 CDISCPILOT01 01-701-1015 1015 701 USA RS 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 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 2014-03-06 None WEEK 9 Best Overall Response by Investigator (confirmation not required) BOR Tumor Response Investigator RECIST 1.1 1 CR Y Y 4 WEEK 9 OVRLRESP Overall Response CR CR INVESTIGATOR None None 2014-03-06 9 None
2 CDISCPILOT01 01-701-1015 1015 701 USA RS 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 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 2014-03-06 None WEEK 9 Clinical Benefit by Investigator (confirmation for response not required) CB Tumor Response Investigator RECIST 1.1 1 Y Y Y 4 WEEK 9 OVRLRESP Overall Response CR CR INVESTIGATOR None None 2014-03-06 9 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 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 None None Best Confirmed Overall Response of CR/PR by Investigator CBCP Tumor Response Investigator RECIST 1.1 0 N Y None None None None None None None None None None None None None
4 CDISCPILOT01 01-701-1015 1015 701 USA RS 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 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 2014-03-06 None WEEK 9 Best Confirmed Overall Response by Investigator CBOR Tumor Response Investigator RECIST 1.1 3 SD Y Y 4 WEEK 9 OVRLRESP Overall Response CR CR INVESTIGATOR None None 2014-03-06 9 None
5 CDISCPILOT01 01-701-1015 1015 701 USA RS 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 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 2014-03-06 None WEEK 9 Confirmed Clinical Benefit by Investigator CCB Tumor Response Investigator RECIST 1.1 1 Y Y Y 4 WEEK 9 OVRLRESP Overall Response CR CR INVESTIGATOR None None 2014-03-06 9 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 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 None None Confirmed Response by Investigator CRSP Tumor Response Investigator RECIST 1.1 0 N Y None None None None None None 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 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 None None Death DEATH Reference Event None None 0 N Y None None None None None None None None None None None None None
8 CDISCPILOT01 01-701-1015 1015 701 USA RS 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 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 2014-03-06 None WEEK 9 Last Disease Assessment by Investigator LSTA Tumor Response Investigator RECIST 1.1 1 CR Y Y 4 WEEK 9 OVRLRESP Overall Response CR CR INVESTIGATOR None None 2014-03-06 9 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 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 None 2014-07-02 182 None None None None None None Measurable Disease at Baseline by Investigator MDIS None Investigator RECIST 1.1 1 Y Y None None None None None None None None None None None None None