data-sdtm.RdA sample study dataset following SDTM guidelines. This generally follows a controlled terminolgy (NCI 2020) .
ae dm eg lb mh pe vs
SDTM
ae: 18 Variables, 16 Observations.
dm: 16 Variables, 5 Observations.
eg: 21 Variables, 56 Observations.
lb: 29 Variables, 83 Observations.
mh: 12 Variables, 18 Observations.
pe: 13 Variables, 65 Observations.
vs: 18 Variables, 72 Observations.
Emam and CDISC (2019) .
ae: Adverse Events data.
dm: Subject demographics data.
eg: Electrogardiogram data.
lb: Laboratory findings data.
mh: Medical History data.
pe: Physical examination data.
vs: Vital Signs data..
Emam I, CDISC (2019).
“CDISC-SDTM sample study.”
doi: 10.7910/DVN/51B6NK
, Data.
NCI (2020).
“NCI Term Browser.”
Version 2.18 - Last accessed 2020-12-18, https://thesaurus.cancer.gov/ncitbrowser/pages/multiple_search.jsf?nav_type=terminologies.
#> STUDYID DOMAIN USUBJID AESEQ AESPID AETERM AEMODIFY #> 1 S-CDSK-01 AE CDISC01.100008 1 1 AGITATED AGITATION #> 2 S-CDSK-01 AE CDISC01.100008 2 2 ANXIETY #> 3 S-CDSK-01 AE CDISC01.100008 3 3 DECREASED APPETITE #> 4 S-CDSK-01 AE CDISC01.100014 1 1 DIARRHEA #> 5 S-CDSK-01 AE CDISC01.100014 2 2 HEMORRHOIDS #> 6 S-CDSK-01 AE CDISC01.100014 3 3 HEADACHE #> AEDECOD AEBODSYS AESEV AESER #> 1 Agitation Psychiatric disorders MILD N #> 2 Anxiety Psychiatric disorders MODERATE N #> 3 Decreased appetite Metabolism and nutrition disorders MILD N #> 4 Diarrhoea Gastrointestinal disorders MILD N #> 5 Haemorrhoids Gastrointestinal disorders MODERATE N #> 6 Headache Nervous system disorders MILD N #> AEACN AEREL AESTDTC AEENDTC AESTDY AEENDY AEENRF #> 1 DOSE NOT CHANGED POSSIBLY RELATED 2003-05 3 NA AFTER #> 2 DOSE NOT CHANGED POSSIBLY RELATED 2003-05-13 15 NA AFTER #> 3 DOSE NOT CHANGED POSSIBLY RELATED 2003-08-19 2003-09-15 113 140 #> 4 DOSE NOT CHANGED NOT RELATED 2004-01-06 84 NA AFTER #> 5 DOSE NOT CHANGED NOT RELATED 2004-01-06 84 NA AFTER #> 6 DOSE NOT CHANGED NOT RELATED 2004-01-27 105 NA AFTERdm#> STUDYID DOMAIN USUBJID SUBJID RFSTDTC RFENDTC SITEID #> 1 S-CDSK-01 DM CDISC01.100008 100008 2003-04-29 2003-10-12 Site-100 #> 2 S-CDSK-01 DM CDISC01.100014 100014 2003-10-15 2004-03-29 Site-100 #> 3 S-CDSK-01 DM CDISC01.200001 200001 2003-09-30 2004-02-02 Site-200 #> 4 S-CDSK-01 DM CDISC01.200002 200002 2003-10-10 2004-03-28 Site-200 #> 5 S-CDSK-01 DM CDISC01.200005 200005 2003-10-10 2004-03-28 Site-200 #> BRTHDTC AGE AGEU SEX RACE ETHNIC #> 1 1930-08-05 72 YEARS M OTHER NOT HISPANIC OR LATINO #> 2 1936-11-01 66 YEARS F WHITE NOT HISPANIC OR LATINO #> 3 1923-09-03 80 YEARS F MULTIPLE NOT HISPANIC OR LATINO #> 4 1933-07-22 70 YEARS F BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO #> 5 1937-02-22 66 YEARS F WHITE NOT HISPANIC OR LATINO #> ARMCD ARM COUNTRY #> 1 WONDER10 Miracle Drug 10 mg USA #> 2 WONDER20 Miracle Drug 20 mg USA #> 3 PLACEBO Placebo USA #> 4 WONDER10 Miracle Drug 10 mg USA #> 5 SCRNFAIL Screen Failure USA#> STUDYID DOMAIN USUBJID EGSEQ EGSPID EGTESTCD #> 1 S-CDSK-01 EG CDISC01.100008 1 ECG-06 INTP #> 2 S-CDSK-01 EG CDISC01.100008 2 ECG-06 INTP #> 3 S-CDSK-01 EG CDISC01.100008 3 ECG-03 PRMEAN #> 4 S-CDSK-01 EG CDISC01.100008 4 ECG-03 PRMEAN #> 5 S-CDSK-01 EG CDISC01.100008 5 ECG-02 QRSDUR #> 6 S-CDSK-01 EG CDISC01.100008 6 ECG-02 QRSDUR #> EGTEST EGPOS EGORRES EGORRESU EGSTRESC EGSTRESN #> 1 Interpretation SUPINE ABNORMAL ABNORMAL NA #> 2 Interpretation SUPINE ABNORMAL ABNORMAL NA #> 3 Summary (Mean) PR Duration SUPINE 200 msec 200 200 #> 4 Summary (Mean) PR Duration SUPINE 182 msec 182 182 #> 5 Summary (Mean) QRS Duration SUPINE 92 msec 92 92 #> 6 Summary (Mean) QRS Duration SUPINE 92 msec 92 92 #> EGSTRESU EGBLFL EGDRVFL EGEVAL VISITNUM VISIT VISITDY EGDTC EGDY #> 1 Y INVESTIGATOR 1 SCREEN -13 2003-04-15 -14 #> 2 INVESTIGATOR 10 WEEK 24 169 2003-10-13 168 #> 3 msec Y 1 SCREEN -13 2003-04-15 -14 #> 4 msec 10 WEEK 24 169 2003-10-13 168 #> 5 msec Y 1 SCREEN -13 2003-04-15 -14 #> 6 msec 10 WEEK 24 169 2003-10-13 168#> STUDYID DOMAIN USUBJID LBSEQ LBREFID LBTESTCD LBTEST #> 1 S-CDSK-01 LB CDISC01.100008 1 B232115 BILI Bilirubin #> 2 S-CDSK-01 LB CDISC01.100008 2 B290028 BILI Bilirubin #> 3 S-CDSK-01 LB CDISC01.100008 3 B232115 BUN Blood Urea Nitrogen #> 4 S-CDSK-01 LB CDISC01.100008 4 B290028 BUN Blood Urea Nitrogen #> 5 S-CDSK-01 LB CDISC01.100008 5 B232115 GLUC Glucose #> 6 S-CDSK-01 LB CDISC01.100008 6 B290028 GLUC Glucose #> LBCAT LBSCAT LBORRES LBORRESU LBORNRLO LBORNRHI LBSTRESC LBSTRESN #> 1 CHEMISTRY CHEMISTRY 0.4 mg/dL 0 1.1 6.8 6.80 #> 2 CHEMISTRY CHEMISTRY 0.3 mg/dL 0 1.1 5.1 5.10 #> 3 CHEMISTRY CHEMISTRY 26 mg/dL 9 24.0 9.28 9.28 #> 4 CHEMISTRY CHEMISTRY 18 mg/dL 9 24.0 6.43 6.43 #> 5 CHEMISTRY CHEMISTRY 100 mg/dL 68 110.0 5.5 5.50 #> 6 CHEMISTRY CHEMISTRY 87 mg/dL 68 110.0 4.8 4.80 #> LBSTRESU LBSTNRLO LBSTNRHI LBSTNRC LBNRIND LBSPEC LBMETHOD LBBLFL LBFAST #> 1 umol/L 0.00 18.80 NORMAL BLOOD Y Y #> 2 umol/L 0.00 18.80 NORMAL BLOOD N #> 3 mmol/L 3.21 8.57 HIGH BLOOD Y Y #> 4 mmol/L 3.21 8.57 NORMAL BLOOD N #> 5 mmol/L 3.80 6.10 NORMAL BLOOD Y Y #> 6 mmol/L 3.80 6.10 NORMAL BLOOD Y #> VISITNUM VISIT VISITDY LBDTC LBDY #> 1 1 SCREEN -13 2003-04-15T11:20 -14 #> 2 10 WEEK 24 169 2003-10-13T11:55 168 #> 3 1 SCREEN -13 2003-04-15T11:20 -14 #> 4 10 WEEK 24 169 2003-10-13T11:55 168 #> 5 1 SCREEN -13 2003-04-15T11:20 -14 #> 6 10 WEEK 24 169 2003-10-13T11:55 168#> STUDYID DOMAIN USUBJID MHSEQ #> 1 S-CDSK-01 MH CDISC01.100008 1 #> 2 S-CDSK-01 MH CDISC01.100008 2 #> 3 S-CDSK-01 MH CDISC01.100008 3 #> 4 S-CDSK-01 MH CDISC01.100014 1 #> 5 S-CDSK-01 MH CDISC01.100014 2 #> 6 S-CDSK-01 MH CDISC01.200001 1 #> MHTERM #> 1 ARTHRITIS #> 2 HEARING AIDS #> 3 DEPRESSION OF ALZHEIMERS DISEASE,PSYCHIATRIC HISTORY,Y,Y,,2003-04-15,2003-04-11,\nS-CDSK-01,MH,CDISC01.100008,4,PROBABLE ALZHEIMERS DISEASE #> 4 SLOW GAIT #> 5 DEPRESSION OF ALZHEIMERS DISEASE,PSYCHIATRIC HISTORY,Y,Y,,2003-10-06,2003-10-01,\nS-CDSK-01,MH,CDISC01.100014,3,PROBABLE ALZHEIMERS DISEASE #> 6 HEARING AIDS BOTH EARS #> MHCAT MHPRESP MHOCCUR MHBODSYS MHDTC #> 1 MEDICAL AND SURGICAL HISTORY Musculoskeletal 2003-04-15 #> 2 MEDICAL AND SURGICAL HISTORY Eyes-Ears-Nose-Throat 2003-04-15 #> 3 PSYCHIATRIC HISTORY Y Y 2003-04-15 #> 4 MEDICAL AND SURGICAL HISTORY Neurological 2003-10-06 #> 5 PSYCHIATRIC HISTORY Y Y 2003-10-06 #> 6 MEDICAL AND SURGICAL HISTORY Eyes-Ears-Nose-Throat 2003-09-09 #> MHSTDTC MHENRF #> 1 1996 DURING/AFTER #> 2 1998 DURING/AFTER #> 3 2003-04-04 #> 4 2001 DURING/AFTER #> 5 2001 #> 6 1962 DURING/AFTER#> STUDYID DOMAIN USUBJID PESEQ PETESTCD PETEST #> 1 S-CDSK-01 PE CDISC01.100008 1 PE01 Appearance/Skin #> 2 S-CDSK-01 PE CDISC01.100008 2 PE01 Appearance/Skin #> 3 S-CDSK-01 PE CDISC01.100008 3 PE02 Head/Neck (Including Thyroid) #> 4 S-CDSK-01 PE CDISC01.100008 4 PE02 Head/Neck (Including Thyroid) #> 5 S-CDSK-01 PE CDISC01.100008 5 PE03 Eyes-Ears-Nose-Throat #> 6 S-CDSK-01 PE CDISC01.100008 6 PE03 Eyes-Ears-Nose-Throat #> PEORRES PESTRESC VISITNUM VISIT VISITDY PEDTC PEDY #> 1 NORMAL NORMAL 1 SCREEN -13 2003-04-15 -14 #> 2 NORMAL NORMAL 10 WEEK 24 169 2003-10-13 168 #> 3 NORMAL NORMAL 1 SCREEN -13 2003-04-15 -14 #> 4 NORMAL NORMAL 10 WEEK 24 169 2003-10-13 168 #> 5 NORMAL NORMAL 1 SCREEN -13 2003-04-15 -14 #> 6 NORMAL NORMAL 10 WEEK 24 169 2003-10-13 168#> STUDYID DOMAIN USUBJID VSSEQ VSTESTCD VSTEST #> 1 S-CDSK-01 VS CDISC01.100008 1 DIABP Diastolic Blood Pressure #> 2 S-CDSK-01 VS CDISC01.100008 2 DIABP Diastolic Blood Pressure #> 3 S-CDSK-01 VS CDISC01.100008 3 DIABP Diastolic Blood Pressure #> 4 S-CDSK-01 VS CDISC01.100008 4 DIABP Diastolic Blood Pressure #> 5 S-CDSK-01 VS CDISC01.100008 5 FRMSIZE Body Frame Size #> 6 S-CDSK-01 VS CDISC01.100008 6 HEIGHT Height #> VSPOS VSORRES VSORRESU VSSTRESC VSSTRESN VSSTRESU VSBLFL VISITNUM VISIT #> 1 SITTING 74 mmHg 74 74.0 mmHg 1 SCREEN #> 2 SITTING 88 mmHg 88 88.0 mmHg Y 2 BASELINE #> 3 SITTING 78 mmHg 78 78.0 mmHg 3 WEEK 2 #> 4 SITTING 90 mmHg 90 90.0 mmHg 10 WEEK 24 #> 5 LARGE LARGE NA 1 SCREEN #> 6 66 IN 167.6 167.6 cm Y 1 SCREEN #> VISITDY VSDTC VSDY #> 1 -13 2003-04-15 -14 #> 2 1 2003-04-29 1 #> 3 15 2003-05-13 15 #> 4 169 2003-10-13 168 #> 5 -13 2003-04-15 -14 #> 6 -13 2003-04-15 -14