Oncology Registrational Study – Simulated Figures (English)
Subject Disposition Flow Diagram
Figure 1. Overall Survival (OS) Kaplan–Meier Curve
Figure 2. Progression-Free Survival (PFS) Kaplan–Meier Curve
Figure 3. Waterfall Plot – Best Tumor Burden Change
RECIST (Response Evaluation Criteria in Solid Tumors) –
Summary Table
|
Term |
Definition (RECIST 1.1) |
|
Target Lesions |
Selected measurable lesions (maximum 5 total, up to 2 per organ) used for quantitative assessment of tumor burden |
|
Non-Target Lesions |
All other lesions, including non-measurable disease (e.g., ascites, bone lesions) |
|
CR (Complete Response) |
Disappearance of all target lesions; all pathological lymph nodes must be <10 mm in short axis |
|
PR (Partial Response) |
At least a 30% decrease in the sum of diameters of target lesions, relative to baseline |
|
SD (Stable Disease) |
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD |
|
PD (Progressive Disease) |
At least a 20% increase in the sum of diameters of target lesions (minimum absolute increase of 5 mm) or appearance of new lesions |
|
Best Overall Response (BOR) |
The best response recorded from start of treatment until disease progression or start of new anti-cancer therapy |
|
ORR (Objective Response Rate) |
Proportion of patients with BOR of CR or PR |
|
DCR (Disease Control Rate) |
Proportion of patients with BOR of CR, PR, or SD |
|
PFS (Progression-Free Survival) |
Time from randomization or treatment start to disease progression or death |
|
DoR (Duration of Response) |
Time from first documented CR or PR to disease progression or death |
Figure 4. Swimmer Plot – Time on Treatment and Response
This swimmer plot depicts individual subject treatment duration and
response dynamics. Colored bars represent time on treatment across different
study stages. Triangles indicate the start of response, circles indicate the
end of response, squares denote durable responders, and stars indicate ongoing
responses at data cutoff. The plot demonstrates that responses occurred across
multiple subjects and stages, with several durable and ongoing responses,
supporting the consistency and durability of clinical benefit.
|
Status
Transition |
Considered
End of Response |
|
PR → SD |
❌ No |
|
PR → PR |
❌ No |
|
PR → PD |
✅ Yes |
|
PR → Death |
✅ Yes |
|
PR → SD → PD |
✅ Yes
(at the time of PD) |
Figure 5. Forest Plot – PFS by Subgroup
Figure 6. Summary of Treatment-Emergent Adverse Events
Figure → ADaM → Variable → SDTM
Audit Traceability Matrix (6 Core Figures)
Figure 1. Overall Survival (OS) Kaplan–Meier Curve
|
Figure |
ADaM Dataset |
ADaM Variable(s) |
SDTM
Source |
|
OS KM |
ADTTE |
PARAMCD="OS", PARAM |
Assigned (ADTTE
parameterization) |
|
ADTTE |
STARTDT (e.g., RANDDT or TRTSDT) |
DM.RFSTDTC and/or EX.EXSTDTC |
|
|
ADTTE |
ADT (event/censor date) |
Derived from DTHDT / LSTALVDT |
|
|
ADTTE |
CNSR (0=event,1=censored) |
Derived |
|
|
ADTTE |
AVAL (time-to-event, days) |
Derived (ADT − STARTDT +
1) |
|
|
ADTTE |
DTHDT (if stored), LSTALVDT (if stored) |
DM.DTHDTC and/or DS (survival/follow-up) |
|
|
ADSL |
TRT01A (treatment group) |
EX (actual treatment
derivation) |
Figure 2. Progression-Free Survival (PFS)
Kaplan–Meier Curve
|
Figure |
ADaM Dataset |
ADaM Variable(s) |
SDTM
Source |
|
PFS KM |
ADTTE |
PARAMCD="PFS", PARAM |
Assigned (ADTTE
parameterization) |
|
ADTTE |
STARTDT (e.g., RANDDT or TRTSDT) |
DM.RFSTDTC and/or EX.EXSTDTC |
|
|
ADTTE |
PDADT (if stored) |
RS.RSDTC (progression assessment date) |
|
|
ADTTE |
DTHDT (if stored) |
DM.DTHDTC and/or DS |
|
|
ADTTE |
ADT = min(PDADT,
DTHDT) |
Derived |
|
|
ADTTE |
CNSR, AVAL |
Derived |
|
|
ADTTE |
EVNTDESC (Progression/Death/Censored) |
Derived |
|
|
ADSL |
TRT01A |
EX |
Figure 3. Waterfall Plot – Best Tumor Burden Change
|
Figure |
ADaM Dataset |
ADaM Variable(s) |
SDTM
Source |
|
Waterfall |
ADTR (or equivalent Tumor
Burden BDS) |
TRT01A, USUBJID |
EX (TRT01A derivation), DM.USUBJID |
|
ADTR |
PARAMCD (e.g., SLD), PARAM |
Derived/assigned |
|
|
ADTR |
BASE (baseline tumor burden) |
TR (baseline tumor measurement)
(sometimes derived using TU+TR) |
|
|
ADTR |
AVAL (postbaseline tumor burden) |
TR (tumor measurement results) |
|
|
ADTR |
PCHG (percent change from baseline) |
Derived from BASE and AVAL |
|
|
ADTR |
BESTPCHG (if stored) or ANLxxFL to select best change |
Derived |
|
|
ADTR |
ADT / ADY / AVISIT (timing/visit for best change) |
TR/TRDTC (and visit variables) |
|
|
ADRS (optional) |
AVALC (CR/PR/SD/PD/NE) for labeling |
RS (RECIST responses) |
Typical
SDTM note:
Waterfall is usually anchored on tumor measurement results (often SDTM TR,
sometimes TU+TR depending on sponsor implementation) rather than categorical
response alone.
Figure 4. Swimmer Plot – Time on Treatment and
Response
|
Figure |
ADaM Dataset |
ADaM Variable(s) |
SDTM
Source |
|
Swimmer |
ADSL |
TRTSDT, TRTEDT, TRT01A, USUBJID |
EX.EXSTDTC, EX.EXENDTC,
EX; DM.USUBJID |
|
ADRS |
PARAMCD (OVR/BOR), AVALC (CR/PR/SD/PD/NE) |
RS (RECIST responses) |
|
|
ADRS |
FRSTDRESPDT (first CR/PR date) |
Derived from RS.RSDTC |
|
|
ADTTE |
PARAMCD="DOR" and/or PARAMCD="PFS" |
Assigned |
|
|
ADTTE |
STARTDT (DoR
start), ADT (end/censor), CNSR, AVAL |
STARTDT derived from ADRS/RS;
end from RS (PD) and/or DM/DS (death); derived CNSR/AVAL |
|
|
ADTTE/ADRS (optional) |
Flags for Durable / Ongoing
(e.g., DURFL, ONGOFL if created) |
Derived per SAP |
Interpretation
note: In registrational settings, Swimmer plots usually
emphasize CR/PR timing and durability; SD is typically not
highlighted as “response” (but can be reflected via time on treatment / PFS).
Figure 5. Forest Plot – PFS by Subgroup
|
Figure |
ADaM Dataset |
ADaM Variable(s) |
SDTM
Source |
|
Forest (PFS HR by subgroup) |
ADTTE |
PARAMCD="PFS", AVAL, CNSR, TRT01A |
AVAL/CNSR derived from
RS+DM/DS; TRT01A from EX |
|
ADSL |
Subgroup variables (e.g., AGEGR1, SEX, ECOG, STAGE, METASTFL, region) |
DM (AGE/SEX), SC/QS (ECOG,
stage), MH/SC (metastasis), DM (region/country) |
|
|
ADTTE/ADSL |
Analysis flags (e.g., ANL01FL, population flags ITTFL) |
Derived from DM/EX/DS rules |
Stat
note: The
HR/CI itself is computed in the statistical procedure; the figure is driven by ADaM inputs (ADTTE + ADSL
subgroups).
Figure 6. Summary of Treatment-Emergent Adverse
Events
|
Figure |
ADaM Dataset |
ADaM Variable(s) |
SDTM
Source |
|
TEAE Summary |
ADAE |
TRTEMFL/TEAEFL (treatment-emergent flag) |
Derived using AE dates vs EX
exposure window |
|
ADAE |
AESEV/AETOXGR (severity/grade) |
AE.AESEV and/or supplemental grading |
|
|
ADAE |
AESER (SAE), AEACN (action taken), AEOUT (outcome) |
AE.AESER, AE.AEACN,
AE.AEOUT |
|
|
ADAE |
Derivation flags (e.g., G3PFL, DISCONFL, DEATHFL) |
Derived from AE + DS (and
protocol rules) |
|
|
ADSL |
TRT01A, SAFFL |
EX (TRT01A), EX-derived (SAFFL) |