Oncology Clinical Trial – Comprehensive Mandatory Table Shells

Table 1. Subject Disposition

Category	Treatment A	Treatment B	Total
Screened
Randomized
Safety Population (SAF)
Intent-to-Treat Population (ITT)
Per-Protocol Population (PP)
Completed Study Treatment
Discontinued Study Treatment
- Adverse Event
- Progressive Disease
- Death
- Withdrawal of Consent
- Other

Table 2. Demographics and Baseline Characteristics

Characteristic	Treatment A (N=)	Treatment B (N=)	Total (N=)
Age (years), Mean (SD)
Age (years), Median (Min–Max)
Sex: Male, n (%)
Sex: Female, n (%)
Race: Asian, n (%)
Race: White, n (%)
ECOG Performance Status 0, n (%)
ECOG Performance Status 1, n (%)
Disease Stage IV, n (%)
Visceral Metastasis, Yes, n (%)

The ECOG Performance Status is a scale that measures a patient's overall functional capacity and tolerance, directly impacting eligibility for clinical trials, continuation of treatment, and prognosis.

Table 3. Treatment Exposure Summary

Parameter	Treatment A	Treatment B
Number of Subjects Treated
Duration of Treatment (days), Median (Range)
Cumulative Dose, Median (Range)
Relative Dose Intensity (%), Mean (SD)
Dose Reduction, n (%)
Dose Interruption, n (%)

Table 4. Best Overall Response (RECIST v1.1)

Response Category	Treatment A n (%)	Treatment B n (%)
Complete Response (CR)
Partial Response (PR)
Stable Disease (SD)
Progressive Disease (PD)
Not Evaluable (NE)
Objective Response Rate ORR (CR+PR)
Disease Control Rate DCR (CR+PR+SD)

RECIST stands for Response Evaluation Criteria in Solid Tumors, a set of standardized rules used to assess the effectiveness of cancer treatment using imaging techniques (CT/MRI).

Table 5. Objective Response Rate (ORR) with 95% Confidence Interval

Statistic	Treatment A	Treatment B
Responders (CR+PR), n/N (%)
Exact 95% CI

Table 6. Progression-Free Survival (PFS)

Statistic	Treatment A	Treatment B
Events / Total Subjects
Median PFS (months)
95% CI for Median
Hazard Ratio (A vs B)
95% CI for HR
Log-rank P-value

Table 7. Overall Survival (OS)

Statistic	Treatment A	Treatment B
Deaths / Total Subjects
Median OS (months)
95% CI for Median
Hazard Ratio (A vs B)
95% CI for HR
Log-rank P-value

Table 8. Duration of Response (DoR) – Responders Only

Statistic	Treatment A	Treatment B
Number of Responders
Events / Responders
Median DoR (months)
95% CI

DoR = Duration of Response, the time from the date of first achieving objective response (CR or PR) to the time of first disease progression (RECIST-PD) or death.

Endpoint	ADaM Dataset	PARAMCD	CNSR = 0 (Event)	CNSR = 1 (Censoring)	STARTDT
OS	ADTTE	OS	Death (ADT = DTHDT)	Last known alive (ADT = LSTALVDT)	RANDDT or TRTSDT
PFS	ADTTE	PFS	Progressive disease or death, whichever occurs first (ADT = MIN(PDADT, DTHDT))	Last evaluable tumor assessment (ADT = LSTASSDT)	RANDDT or TRTSDT
DoR	ADTTE	DOR	Progressive disease or death occurring after response, whichever occurs first	Last evaluable tumor assessment after response	FRSTDRESPDT (or date of confirmed response)
BOR	ADRS	BOR	Not applicable (categorical endpoint)	Not applicable	Not applicable

Adtte

USUBJID	PARAMCD	PARAM	STARTDT	ADT	CNSR	AVAL
01-001	OS	Overall Survival	2022-01-10	2023-03-01	0	416
01-001	PFS	Progression-Free Survival	2022-01-10	2022-09-15	0	249
01-001	DOR	Duration of Response	2022-03-20	2022-11-10	1	236

Table 9. Summary of Treatment-Emergent Adverse Events

Category	Treatment A n (%)	Treatment B n (%)
≥1, TEAE
≥1, Grade ≥3 TEAE, severity
≥1, Serious AE (SAE)
AE Leading to Treatment Discontinuation
AE Leading to Death
Treatment-Related AE

TEAE assesses "whether or not it occurred";

Grade ≥3 assesses "how severe it is";

TRAE assesses "whether or not it was caused by the drug";

SAE assesses "whether or not it triggers the regulatory definition".

Table 10. Treatment-Emergent Adverse Events by SOC and Preferred Term (≥5%)

SOC / Preferred Term	Treatment A n (%)	Treatment B n (%)
Gastrointestinal Disorders
- Nausea
- Diarrhea
Hematologic Disorders
- Neutropenia

Table 11. Laboratory Abnormalities – Shift from Baseline

Laboratory Parameter	Treatment Group A	Treatment Group B	Treatment Group A	Treatment Group B
	Normal→Abnormal n (%)	Abnormal→Worse n (%)	Normal→Abnormal n (%)	Abnormal→Worse n (%)
ALT
AST
Hemoglobin

Others
14-6.06	Hy’s Law Shifts
14-7.02	Vital Signs Change from Baseline
14-7.03	Weight Change from Baseline
14-7.04	Summary of Concomitant Medications
14-3.01	Change from Baseline to Week 24 (LOCF)
14-3.07	Change from Baseline to Week 24 (Completers)
14-3.08	Change from Baseline to Week 24 (Males)

https://github.com/Daniel-355/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/53-clin-stud-rep/535-rep-effic-safety-stud/5351-stud-rep-contr/cdiscpilot01/cdiscpilot01.pdf

Table → ADaM → Variable → SDTM

Oncology Traceability Matrix

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Table 1. Subject Disposition

Table	ADaM Dataset	ADaM Variable	SDTM Source
Subject Disposition	ADSL	USUBJID	DM.USUBJID
	ADSL	TRT01P	DM / Trial Design
	ADSL	TRT01A	EX
	ADSL	SAFFL	EX (≥1 dose)
	ADSL	ITTFL	DM
	ADSL	PPFL	Derived (Protocol rules)
	ADSL	COMPLFL	DS
	ADSL	DCSREAS	DS.DSDECOD
	ADSL	TRTEDT	EX.EXENDTC

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Table 2. Demographics and Baseline Characteristics

Table	ADaM Dataset	ADaM Variable	SDTM Source
Demographics & Baseline	ADSL	AGE	DM.AGE
	ADSL	SEX	DM.SEX
	ADSL	RACE	DM.RACE
	ADSL	HEIGHT	VS
	ADSL	WEIGHT	VS
	ADSL	BMI	Derived (VS)
	ADSL	ECOG	SC or QS
	ADSL	STAGE	SC
	ADSL	METASTFL	SC / MH
	ADSL	TRT01A	EX

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Table 3. Treatment Exposure Summary

Table	ADaM Dataset	ADaM Variable	SDTM Source
Treatment Exposure	ADEX	EXDOSE	EX.EXDOSE
	ADEX	CUMDOSE	Derived from EX
	ADEX	TRTDUR	EX.EXSTDTC / EX.EXENDTC
	ADEX	RDI	Derived (EX + Protocol)
	ADEX	DOSEADJFL	EX
	ADEX	DOSEINTFL	EX
	ADSL	TRT01A	EX

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Table 4. Best Overall Response (RECIST)

Table	ADaM Dataset	ADaM Variable	SDTM Source
BOR	ADRS	PARAMCD = BOR	Assigned
	ADRS	AVALC	RS.RSTESTCD / RS.RSORRES
	ADRS	BOR	Derived from RS
	ADRS	ORRFL	Derived
	ADRS	DCRFL	Derived
	ADRS	ADT	RS.RSDTC
	ADSL	TRT01A	EX

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Table 5. Objective Response Rate (ORR)

Table	ADaM Dataset	ADaM Variable	SDTM Source
ORR	ADRS	ORRFL	Derived from BOR
	ADRS	BOR	Derived from RS
	ADSL	ITTFL	DM
	ADSL	TRT01A	EX

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Table 6. Progression-Free Survival (PFS)

Table	ADaM Dataset	ADaM Variable	SDTM Source
PFS	ADTTE	PARAMCD = PFS	Assigned
	ADTTE	STARTDT	DM.RFSTDTC or EX.EXSTDTC
	ADTTE	PDADT	RS.RSDTC
	ADTTE	DTHDT	DM.DTHDTC / DS
	ADTTE	ADT	MIN(PDADT, DTHDT)
	ADTTE	CNSR	Derived
	ADTTE	AVAL	Derived
	ADSL	TRT01A	EX

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Table 7. Overall Survival (OS)

Table	ADaM Dataset	ADaM Variable	SDTM Source
OS	ADTTE	PARAMCD = OS	Assigned
	ADTTE	STARTDT	DM.RFSTDTC or EX.EXSTDTC
	ADTTE	DTHDT	DM.DTHDTC / DS
	ADTTE	LSTALVDT	DS / Follow-up
	ADTTE	ADT	Derived
	ADTTE	CNSR	Derived
	ADTTE	AVAL	Derived

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Table 8. Duration of Response (DoR)

Table	ADaM Dataset	ADaM Variable	SDTM Source
DoR	ADTTE	PARAMCD = DOR	Assigned
	ADTTE	STARTDT (FRSTDRESPDT)	RS
	ADTTE	PDADT	RS
	ADTTE	DTHDT	DM / DS
	ADTTE	ADT	Derived
	ADTTE	CNSR	Derived
	ADTTE	AVAL	Derived
	ADRS	BOR	Derived
	ADSL	TRT01A	EX

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Table 9. Summary of TEAE

Table	ADaM Dataset	ADaM Variable	SDTM Source
TEAE Summary	ADAE	TRTEMFL	AE (date comparison with EX)
	ADAE	AESEV / AETOXGR	AE
	ADAE	AESER	AE
	ADAE	AEREL	AE
	ADAE	AEACN	AE
	ADAE	AEOUT	AE
	ADSL	TRT01A	EX

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Table 10. TEAE by SOC / PT

Table	ADaM Dataset	ADaM Variable	SDTM Source
TEAE by SOC/PT	ADAE	AEBODSYS	AE
	ADAE	AEDECOD	AE
	ADAE	TRTEMFL	AE
	ADAE	TRT01A	EX

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Table 11. Laboratory Abnormalities – Shift

Table	ADaM Dataset	ADaM Variable	SDTM Source
Lab Shift	ADLB	PARAMCD / PARAM	LB
	ADLB	BASE	LB
	ADLB	AVAL	LB
	ADLB	ANRIND	LB
	ADLB	SHIFT1	Derived
	ADLB	ATOXGR	LB
	ADSL	TRT01A	EX

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✅

Each CSR table is fully traceable from SDTM to ADaM at the variable level, with all oncology efficacy endpoints (OS, PFS, DoR, BOR) pre-derived in ADaM (ADTTE / ADRS), ensuring reproducibility, auditability, and regulatory compliance.