advfq_ophtha

advfq_ophtha

Visual Function Questionnaire Analysis

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

from pharmadata import pharmaverseadam

meta = pharmaverseadam.meta('advfq_ophtha')
print(f"Rows: {meta.number_rows:,}  Columns: {meta.number_columns}")
Rows: 28,798  Columns: 89

Variables

Show variable specs
shape: (89, 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"
"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)""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
"AVAL""Analysis Value""Float64""No""Analysis Parameter Variables for BDS Datasets"
"AVALC""Analysis Value (C)""String""No""Analysis Parameter Variables for BDS Datasets"
"BASE""Baseline Value""Float64""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"
"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"
"QSSEQ""Sequence Number""Int32""No"null
"QSTESTCD""Question Short Name""String""No"null
"QSTEST""Question Name""String""No"null
"QSCAT""Category of Question""String""No"null
"QSSCAT""Subcategory for Question""String""No"null
"QSORRES""Finding in Original Units""String""No"null
"QSORRESU""Original Units""String""No"null
"QSSTRESC""Character Result/Finding in Std Format""String""No"null
"QSSTRESN""Numeric Finding in Standard Units""Float64""No"null
"QSSTRESU""Standard Units""String""No"null
"QSBLFL""Baseline Flag""String""No"null
"QSDRVFL""Derived 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
"QSDTC""Date/Time of Finding""String""No"null
"QSDY""Study Day of Finding""Float64""No"null

Examples

from great_docs import tbl_explorer
from pharmadata import pharmaverseadam

tbl_explorer(pharmaverseadam.advfq_ophtha.head(10))
PolarsRows10Columns89
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
DTHDTF
str
DTHCAUS
str
DTHCGR1
str
ADT
date
ADY
f64
AVISIT
str
AVISITN
str
PARAM
str
PARAMCD
str
PARCAT1
str
PARCAT2
str
AVAL
f64
AVALC
str
BASE
f64
CHG
f64
PCHG
f64
ABLFL
str
ANL01FL
str
ONTRTFL
str
QSSEQ
i32
QSTESTCD
str
QSTEST
str
QSCAT
str
QSSCAT
str
QSORRES
str
QSORRESU
str
QSSTRESC
str
QSSTRESN
f64
QSSTRESU
str
QSBLFL
str
QSDRVFL
str
VISITNUM
f64
VISIT
str
VISITDY
f64
QSDTC
str
QSDY
f64
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 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 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 85 None 75 10 13.3333333333 None None None None None None None None None None None None None None None 1 SCREENING 1 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 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 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 75 None 75 0 0 Y None None None None None None None None None None None None None None 3 BASELINE 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 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 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 65 None 75 -10 -13.3333333333 None Y Y None None None None None None None None None None None None 4 WEEK 2 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 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 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 100 None 75 25 33.3333333333 None Y Y None None None None None None None None None None None None 5 WEEK 4 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 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 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 122.5 None 75 47.5 63.3333333333 None Y Y None None None None None None None None None None None None 7 WEEK 6 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 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 2014-03-05 63 Week 8 8 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 140 None 75 65 86.6666666667 None Y Y None None None None None None None None None None None None 8 WEEK 8 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 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 2014-03-26 84 Week 12 12 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 117.5 None 75 42.5 56.6666666667 None Y Y None None None None None None None None None None None None 9 WEEK 12 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 2014-04-09 98 Week 14 (T) 14 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 30 None 75 -45 -60 None Y Y None None None None None None None None None None None None 9.1 WEEK 14 (T) 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 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 2014-05-07 126 Week 16 16 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 130 None 75 55 73.3333333333 None Y Y None None None None None None None None None None None None 10 WEEK 16 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 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 2014-05-21 140 Week 20 20 Composite Score QBCSCORE NEI VFQ-25 Averaged Result 105 None 75 30 40 None Y Y None None None None None None None None None None None None 11 WEEK 20 None None None