adoe_ophtha

adoe_ophtha

Exam Analysis for Ophthalmology

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

from pharmadata import pharmaverseadam

meta = pharmaverseadam.meta('adoe_ophtha')
print(f"Rows: {meta.number_rows:,}  Columns: {meta.number_columns}")
Rows: 19,136  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""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)""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"null
"AVAL""Analysis Value""Float64""No""Analysis Parameter Variables for BDS Datasets"
"AVALC""Analysis Value (C)""String""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"
"BASEC""Baseline Value (C)""String""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"
"ABLFL""Baseline Record Flag""String""No""Flag Variables for BDS Datasets"
"ANL01FL""Analysis Flag 01""String""No"null
"ANL02FL""Analysis Flag 02""String""No"null
"ONTRTFL""On Treatment Record Flag""String""No""Flag Variables for BDS Datasets"
"OESEQ""Sequence Number""Int32""No"null
"OECAT""Category for Ophthalmic Test or Exam""String""No"null
"OESCAT""Subcategory for Ophthalmic Test or Exam""String""No"null
"OEDTC""Date/Time of Collection""String""No"null
"VISIT""Visit Name""String""No"null
"VISITNUM""Visit Number""Float64""No"null
"VISITDY""Planned Study Day of Visit""Float64""No"null
"OESTRESN""Numeric Result/Finding in Standard Units""Float64""No"null
"OESTRESC""Character Result/Finding in Std Format""String""No"null
"OEORRES""Result or Finding in Original Units""String""No"null
"OETEST""Name of Ophthalmic Test or Exam""String""No"null
"OETESTCD""Short Name of Ophthalmic Test or Exam""String""No"null
"OETSTDTL""Ophthalmic Test or Exam Detail""String""No"null
"OELAT""Laterality""String""No"null
"OELOC""Location Used for the Measurement""String""No"null
"OEDY""Study Day of Visit/Collection/Exam""Float64""No"null
"OEMETHOD""Method of Test or Examination""String""No"null
"OEORRESU""Original Units""String""No"null
"OESTRESU""Standard Units""String""No"null
"OESTAT""Completion Status""String""No"null
"OETPT""Planned Time Point Name""String""No"null
"OETPTNUM""Planned Time Point Number""Float64""No"null
"STUDYEYE""Study Eye Location""String""No"null
"AFEYE""Affected Eye""String""No"null
"WORS01FL""Worst Post Baseline Obs""String""No"null

Examples

from great_docs import tbl_explorer
from pharmadata import pharmaverseadam

tbl_explorer(pharmaverseadam.adoe_ophtha.head(10))
PolarsRows10Columns103
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
f64
ATPT
str
ATPTN
f64
PARAM
str
PARAMCD
str
PARAMN
f64
AVAL
f64
AVALC
str
AVALU
str
BASE
f64
BASEC
str
BASETYPE
str
CHG
f64
PCHG
f64
DTYPE
str
ABLFL
str
ANL01FL
str
ANL02FL
str
ONTRTFL
str
OESEQ
i32
OECAT
str
OESCAT
str
OEDTC
str
VISIT
str
VISITNUM
f64
VISITDY
f64
OESTRESN
f64
OESTRESC
str
OEORRES
str
OETEST
str
OETESTCD
str
OETSTDTL
str
OELAT
str
OELOC
str
OEDY
f64
OEMETHOD
str
OEORRESU
str
OESTRESU
str
OESTAT
str
OETPT
str
OETPTNUM
f64
STUDYEYE
str
AFEYE
str
WORS01FL
str
0 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 Screening 1 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 211 211 um 71 71 LAST 140 197.183098592 None None None None None 2 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2013-12-26 SCREENING 1 1 -7 211 211 211 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA -7 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
1 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 3 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 71 71 um 71 71 LAST 0 0 None Y Y Y None 10 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-01-02 BASELINE 3 1 71 71 71 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 1 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
2 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2014-01-30 29 Week 4 5 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 304 304 um 71 71 LAST 233 328.169014085 None None Y None Y 18 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-01-30 WEEK 4 5 28 304 304 304 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 29 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
3 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2014-02-12 42 Week 6 7 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 357 357 um 71 71 LAST 286 402.816901408 None None Y None Y 26 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-02-12 WEEK 6 7 42 357 357 357 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 42 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
4 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2014-03-05 63 Week 8 8 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 164 164 um 71 71 LAST 93 130.985915493 None None Y None Y 34 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-03-05 WEEK 8 8 56 164 164 164 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 63 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
5 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2014-03-26 84 Week 12 9 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 398 398 um 71 71 LAST 327 460.563380282 None None Y None Y 42 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-03-26 WEEK 12 9 84 398 398 398 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 84 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
6 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2014-05-07 126 Week 16 10 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 325 325 um 71 71 LAST 254 357.746478873 None None Y None Y 50 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-05-07 WEEK 16 10 112 325 325 325 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 126 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
7 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2014-05-21 140 Week 20 11 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 175 175 um 71 71 LAST 104 146.478873239 None None Y None Y 58 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-05-21 WEEK 20 11 140 175 175 175 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 140 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
8 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2014-06-18 168 Week 24 12 PRE-DOSE -0.5 Fellow Eye Center Subfield Thickness (um) FCSUBTH None 25 25 um 71 71 LAST -46 -64.7887323944 None None Y Y Y 66 OPHTHALMIC ASSESSMENTS SD-OCT CST SINGLE FORM 2014-06-18 WEEK 24 12 168 25 25 25 Center Subfield Thickness CSUBTH CENTER SUBFIELD THICKNESS RIGHT RETINA 168 SD-OCT um um None PRE-DOSE -0.5 LEFT Fellow Eye None
9 CDISCPILOT01 01-701-1015 1015 701 USA OE 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 2013-12-26 -7 Screening 1 PRE-DOSE -0.5 Fellow Eye Diabetic Retinopathy Severity FDRSSR None 8 8 None 6 6 LAST 2 33.3333333333 None None None None None 4 OPHTHALMIC ASSESSMENTS FORM FOR CFP EVALUATION FOR 7M/4W 2013-12-26 SCREENING 1 1 -7 8 8 8 Diabetic Retinopathy Sev Recode Value DRSSR DIABETIC RETINOPATHY SEVERITY LEVEL RECODE VALUE (ETDRS SCALE) RIGHT RETINA -7 COLOR FUNDUS PHOTOGRAPH None None None PRE-DOSE -0.5 LEFT Fellow Eye None