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A variable naming convention for breast cancer study data
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variableName | labelDescription | type | RClass | controlledTermsOrFormat | reference | comment | |
---|---|---|---|---|---|---|---|
studyid | Study Identifier | Char | character | SDTM 2.2.4 | |||
siteid | Study Site Identifier | Char | character | ||||
usubjid | Unique Subject Identifier | Char | character | SDTM 2.2.4 | |||
subjid | Subject Identifier for the Study | Char | character | ||||
brthdtc | Date of Birth - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | ||
brthdtm | Date of Birth | Num | Date | R's Date class | SDSIG 4.1.4.3 | ||
age | Age at Reference Date | Num | integer | SDSIG 5.1.1 | |||
ageu | Age Units | Char | character | decades, years, months, days | SDSIG 5.1.1 | ||
agerfdt | Reference Date for Age | Char | character | ISO 8601, vaiable name, or free text (e.g. 'Diagnosis') | 'rf' from CDISC naming fragments; 'dt' see SDSIG 4.1.4.2 | ||
sex | Sex | Char | factor | M, F, U | SDSIG 5.1.1 | ||
diagdtc | Date of Diagnosis - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | 'dtc' from CDISC naming fragments | |
diagdtm | Date of Diagnosis | Num | Date | R's Date class | SDSIG 4.1.4.3 | ||
surgdtc | Date of Surgery - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | 'dtc' from CDISC naming fragments | |
surgdtm | Date of Surgery | Num | Date | R's Date class | SDSIG 4.1.4.3 | ||
tumsize | Tumour Size | Num | numeric | ||||
tumsizeu | Tumour Size Units | Char | character | cm, mm | 'u' from CDISC naming fragments | ||
lnstat | Lymph Node Status | Char | factor | LN-, LN+ | 'stat' from CDISC naming fragments | ||
histgrn | Histological Grade, Elston-Ellis Score, Numeric Total Grade | Num | integer | 1, 2, 3 | 'gr' and 'n' from CDISC naming fragments | ||
histgr | Histological Grade, Elston-Ellis Score, Total Grade | Char | factor | G1, G2, G3 | 'gr' from CDISC naming fragments | ||
erstat | Oestrogen Receptor Status | Char | factor | ER-, ER+ | 'stat' from CDISC naming fragments | ||
erval | Oestrogen Receptor Value | Num | numeric | 'val' from CDISC naming fragments | |||
ervalu | Oestrogen Receptor Value Units | Char | character | 'val' and 'u' from CDISC naming fragments | |||
prstat | Progesterone Receptor Status | Char | factor | PR-, PR+ | 'stat' from CDISC naming fragments | ||
prval | Progesterone Receptor Value | Num | numeric | 'val' from CDISC naming fragments | |||
prvalu | Progesterone Value Units | Char | character | 'val' and 'u' from CDISC naming fragments | |||
her2stat | HER2/neu Status | Char | factor | HER2-, HER2+ | 'stat' from CDISC naming fragments | ||
her2val | HER2/neu Value | Num | numeric | 'val' from CDISC naming fragments | |||
her2mth | HER2/neu Method | Char | character | 'mth' from CDISC naming fragments | |||
subtype | Molecular Intrinsic Subtype | Char | factor | Luminal A, Luminal B, HER2-enriched, Claudin-low, Basal-like, Normal Breast-like, No subtype | Terms inspired by PMID 21147047, Fig 1 | ||
subtypecd | Molecular Intrinsic Subtype Code | Char | factor | LA, LB, H2, CL, BL, NBL, none | Terms inspired by PMID 21147047, Fig 1 | ||
visitnum | Visit Number | Num | integer | SDSIG 7.8; SDSIG 4.1.4.5 | |||
visit | Visit Name | Char | character | SDSIG 7.8; SDSIG 4.1.4.5 | |||
visitdy | Planned Study Day of Visit | Num | integer | SDSIG 7.8; SDSIG 4.1.4.5 | |||
tptnum | Planned Time Point Number | Num | integer | ||||
tpt | Planned Time Point Name | Char | character | ||||
armcd | Planned Arm Code | Char | character | SDSIG 5.1.1 | |||
arm | Description of Planned Arm | Char | factor | SDSIG 5.1.1 | |||
trtcd | Treatment Code | Char | character | See SDSIG 5.1.1 | |||
trt | Treatment Name | Char | factor | inspired by cmtrt and extrt in CDISC SDTM | |||
trtgrp | Treatment Group | Char | character | See SDSIG 5.1.1 | |||
sustdtc | Start Date of Substance Use - Character | Char | character | ISO 8601 | SDSIG 6.1.3; SDSIG 4.1.4.3 | ||
sustdtm | Start Date of Substance Use | Num | Date | R's Date class | |||
bioploc | Location of Biopsy | Char | character | 'loc' from CDISC naming fragments | |||
biopdtc | Date of Biopsy - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | 'dtc' from CDISC naming fragments | |
biopdtm | Date of Biopsy | Num | Date | R's Date class | SDSIG 4.1.4.3 | ||
assaynum | Assay Number | Num | integer | 'num' from CDISC naming fragments | |||
assayid | Assay Identifier | Char | character | 'id' from CDISC naming fragments | |||
reldtc | Date of Relapse or Censoring - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | 'dtc' from CDISC naming fragments | |
reldtm | Date of Relapse or Censoring | Num | Date | R's Date class | SDSIG 4.1.4.3 | ||
survreltm | Elapsed Time until Relapse or Censoring | Num | numeric | ||||
survreltmu | Units of Elapsed Time until Relapse or Censoring | Char | character | decades, years, months, days | |||
survrelrfdt | Reference Date for Elapsed Time until Relapse or Censoring | Char | character | ISO 8601, vaiable name, or free text (e.g. 'Diagnosis') | 'rf' from CDISC naming fragments; 'dt' see SDSIG 4.1.4.2 | ||
relstat | Breast Cancer Relapse Status Indicator | Num | integer | 0, 1 | 'stat' from CDISC naming fragments; status indicator values, 0 and 1, as in the function Surv in the R package survival | ||
dmdtc | Date of Distant Metastasis - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | 'dtc' from CDISC naming fragments | |
dmdtm | Date of Distant Metastasis | Num | Date | R's Date class | SDSIG 4.1.4.3 | ||
survdmtm | Elapsed Time until Distant Metastasis or Cencoring | Num | numeric | ||||
survdmtmu | Units of Elapsed Time until Distant Metastasis or Cencoring | Char | character | decades, years, months, days | |||
survdmrfdt | Reference Date for Elapsed Time until Distant Metastasis or Censoring | Char | character | ISO 8601, vaiable name, or free text (e.g. 'Diagnosis') | 'ref' from CDISC naming fragments; 'dt' see SDSIG 4.1.4.2 | ||
dmstat | Distant Metastasis Status Indicator | Num | integer | 0, 1 | 'stat' from CDISC naming fragments; status indicator values, 0 and 1, as in the function Surv in the R package survival | ||
progdtc | Date of Progression - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | 'dtc' from CDISC naming fragments | |
progdtm | Date of Progression | Num | Date | R's Date class | SDSIG 4.1.4.3 | ||
survprogtm | Elapsed Time until Progression or Cencoring | Num | numeric | ||||
survprogtmu | Units of Elapsed Time until Progression or Cencoring | Char | character | decades, years, months, days | |||
survprogrfdt | Reference Date for Elapsed Time until Progression or Censoring | Char | character | ISO 8601, vaiable name, or free text (e.g. 'Diagnosis') | 'ref' from CDISC naming fragments; 'dt' see SDSIG 4.1.4.2 | ||
progstat | Progression Status Indicator | Num | integer | 0, 1 | 'stat' from CDISC naming fragments; status indicator values, 0 and 1, as in the function Surv in the R package survival | ||
dthdtc | Date of Death or Censoring - Character | Char | character | ISO 8601 | SDSIG 4.1.4.1 | 'dth' and 'dtc' from CDISC naming fragments | |
dthdtm | Date of Death or Censoring | Num | Date | R's Date class | SDSIG 4.1.4.3 | 'dth' from CDISC naming fragments | |
survdthtm | Elapsed Time until Death or Censoring | Num | numeric | 'dth' and 'dtc' from CDISC naming fragments | |||
survdthtmu | Units of Elapsed Time until Death or Censoring | Char | character | decades, years, months, days | 'dth' and 'dtc' from CDISC naming fragments | ||
survdthrfdt | Reference Date for Elapsed Time until Death or Censoring | Char | character | ISO 8601, vaiable name, or free text (e.g. 'Diagnosis') | 'dth', 'rf' from CDISC naming fragments; 'dt' see SDSIG 4.1.4.2 | ||
dthcd | Death Code | Char | character | ||||
dthstat | Death from Any Reason | Num | integer | 0, 1 | 'dth', 'stat' from CDISC naming fragments; status indicator values, 0 and 1, as in the function Surv in the R package survival | ||
dthbcstat | Death due to Breast Cancer | Num | integer | 0, 1 | 'dth', 'stat' from CDISC naming fragments; status indicator values, 0 and 1, as in the function Surv in the R package survival | ||
com | Comment | Char | character | 'com' from CDISC naming fragments |
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