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PharmaCo STDY1234
Guide to SDTM Tabulations Data
Guide to SDTM Tabulations Data
PharmaCo Study STDY1234 is titled “A Phase II, Multicenter, Randomized, Double-Blind,
Placebo-Controlled Trial Evaluating the Efficacy and Safety of PHC-9876 as Maintenance
Therapy in Patients with Ovarian Cancer in a Second or Third Complete Remission.”
This document provides an introduction to SDTM domain datasets that benefit from additional
explanation beyond what is available in the Data Definitions (define.xml) document.
Contents
Guide to SDTM Tabulations Data............................................................................................... 1
Contents ..................................................................................................................................... 1
Where to Find Key Data........................................................................................................... 2
Demographics and Compliance .............................................................................................. 2
Exposure to Study Treatment.................................................................................................. 2
Subject Disposition ................................................................................................................. 2
Safety ...................................................................................................................................... 2
Efficacy ................................................................................................................................... 3
Trial Design Model Datasets .................................................................................................. 3
Domains not Submitted ............................................................................................................ 3
IE – Inclusion/Exclusion Criteria Not Met ............................................................................. 3
Overview of Custom Domains ................................................................................................. 3
XR
Radiotherapy ............................................................................................................... 3
YK
Study Drug Identification ........................................................................................... 4
YP
Procedures and Surgeries ............................................................................................ 4
TU
Tumor Identification ................................................................................................... 4
ZB
Biomarkers and Diagnostic Results ............................................................................ 4
ZH
Disease History ........................................................................................................... 4
ZS
Survival Follow-Up .................................................................................................... 4
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Where to Find Key Data
Demographics and Compliance
Basic data on subject demographics and reproductive potential are in the DM (Demographics)
and SC (Subject Characteristics) domains, respectively. Screen failures are excluded from DM
and the rest of the database but accounted for separately in the Clinical Study Report.
Overall eligibility is recorded in SUPPDS as a supplemental qualifier to the Informed Consent
record in DS (Disposition Events; DSCAT=PROTOCOL MILESTONE). There were no
eligibility exceptions.
DV (Protocol Deviations) records irregularities that occurred during the study.
The special-purpose datasets SE (Subject Elements) and SV (Subject Visits) provide the start and
end dates and rules for subjects entering into each study element and visit described in the Trial
Design Model datasets.
Exposure to Study Treatment
EX (Exposure) contains derived total daily dose over each constant dosing interval for a subject.
Total daily dose was derived from the number of capsules taken and this is stored in DA (Drug
Accountability). Bottle information is stored in YK (Study Drug Identification) for
administrative purposes.
Subject Disposition
The DS (Subject Disposition) domain presents protocol milestones, including Informed Consent
and Randomization, disposition events, including study drug and study completion or
discontinuation, and Other Events, including initial investigator assignment and investigator
changes by subject. Up to three disposition events are recorded for each subject, one for end of
treatment, one for study exit, and another for the end of the survival follow-up period.
Safety
Key safety data are found in the domains named AE (Adverse Events), EG (ECG Results), LB
(Laboratory Test Results), CM (Concomitant Medications), MH (Medical History), QS
(Questionnaires: ECOG Performance Status), ZH (Disease History), and VS (Vital Signs).
Cancer therapies received prior to study enrollment are in XR (Radiotherapy), YP (Procedures
and Surgeries), and CM (CMCAT=PRIOR CANCER THERAPY). YP also contains on-study
surgeries and procedures, including biopsies.
The definitive source for all deaths is DS (Disposition Events), where DSDECOD=DEATH and
DSCAT=OTHER EVENT. The date of death is stored in DSSTDTC for these records. Note that
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PharmaCo STDY1234
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there can be other records in DS with DSDECOD=DEATH if it was the reason for discontinuing
study drug, the study period, or survival follow-up.
Deaths are also stored in AE for cases where the outcome of an AE was death (AESDTH=Y).
The date of death for these cases is stored in SUPPAE.
Efficacy
The TU (Tumor Identification) domain contains identification of new tumors to support the
evaluation of progression-free survival, the primary efficacy endpoint.
Data that describe other secondary efficacy endpoints are in DS (Disposition Events) and ZS
(Survival Follow-Up) for progression-free survival and overall survival, AE (Adverse Events),
and ZB (Biomarkers and Diagnostic Results).
Trial Design Model Datasets
Trial-level information is found in the SDTM special-purpose datasets TI (Trial
Inclusion/Exclusion Criteria), TS (Trial Summary), TA (Trial Arms), TE (Trial Elements), and
TV (Trial Visits).
TI contains a complete list of the study Inclusion and Exclusion criteria.
TS contains a list of CDISC standard data elements used to describe the population, intervention,
and design of the study.
TA, TE, and TV all contain information about data elements used to describe the planned time
periods of the study, including Arm, Element, and Visit.
Domains not Submitted
IE – Inclusion/Exclusion Criteria Not Met
The IE domain is used to record exceptions to inclusion or exclusion criteria for subjects who
were enrolled into the study. This study had no inclusion/exclusion criteria exceptions, which
resulted in no records being added to the IE dataset. SDTM rules stipulate that empty datasets
are not submitted, hence there is no IE domain for this study.
Overview of Custom Domains
XR
Radiotherapy
Observation class: Interventions
This domain contains information about whether radiotherapy was received prior to enrollment
and, when it was, the date and dose of the last treatment.
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YK
Guide to SDTM Tabulations Data
Study Drug Identification
Observation class: Events
This domain contains information about bottles dispensed by IVRS and received by subjects
during study drug administration and the manufacturing lots they came from.
YP
Procedures and Surgeries
Observation class: Events
This domain contains records for surgery and procedures performed for diagnostic or therapeutic
reasons. Data in this domain are captured on the following forms: Surgery and Procedures
History Log, Prior Cancer Surgery, and Cancer-Related Medical/Surgical Procedures.
TU
Tumor Identification
Observation class: Findings
TU is used to identify new tumors identified during the study.
ZB
Biomarkers and Diagnostic Results
Observation class: Findings
ZB is used to record biomarker results captured as Hh ligand expression findings for archival
tissue.
ZH
Disease History
Observation class: Findings
ZH is used to record findings at Screening about ovarian cancer, the indication for study
treatment.
ZS
Survival Follow-Up
Observation class: Findings
Subjects who discontinue the study are followed every three months for survival. ZS is used to
record the status of these subjects as Alive, Yes or No (Y/N).
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