This dataset integrates response assessments from SP.RS (Response) and subject‑level treatment and status information from ADS.ADSL (Subject‑Level Analysis Dataset). The response data provide the timing and categorical outcome of each assessment, while the ADSL data supply treatment assignment, start date, and intent‑to‑treat and safety flags needed to define the analysis population.
The ADRESP (Response Analysis Dataset) dataset contains one record per subject per response parameter per analysis visit, keyed by USUBJID, PARAMCD, and AVISITN. Identifiers include STUDYID (Study Identifier), USUBJID (Unique Subject Identifier), and ASEQ (Analysis Sequence Number), providing unique identification and ordering of each analysis record. Parameter identifiers include PARAMCD (Parameter Code), PARAM (Parameter), PARCAT1 (Parameter Category 1), and PARCAT2 (Parameter Category 1), defining the response variable and its classification. Treatment information includes TRT01P (Planned Treatment 1), TRT01PN (Planned Treatment 1 (N)), TRT01A (Actual Treatment 1), TRT01AN (Actual Treatment 1 (N)), and TRTSDT (Treatment Start Date), describing the assigned and received therapy and its initiation date. Analysis flags include ITTFL (Intent to Treat Flag), SAFFL (Safety Flag), and ANL01FL (Analysis Flag), indicating subject inclusion criteria and data quality status for the analysis. Timing variables include ADT (Analysis Date) and ADY (Analysis Day), denoting when the response assessment occurred relative to study start. Analysis values include AVALC (Analysis Value (C)), capturing the categorical result of the response assessment. Taken together, this dataset enables evaluation of subject‑level response outcomes by linking each subject and visit to specific response parameters, treatment exposure, and relevant flags, supporting efficacy and safety analyses.
Upstream datasets
Downstream datasets
TLFs
The ADSL dataset combines subject demographic and baseline characteristics from SP.DM (Demographics), treatment exposure end dates from SP.EX (Exposure), vital sign measurements from SP.VS (Vital Signs), tumor assessment data from SP.TU (Tumor), and scheduled visit information from SP.SV (Subject Visits) to provide a comprehensive subject‑level analysis dataset.
The ADSL (Subject‑Level Analysis Dataset) dataset contains one row per subject, keyed by USUBJID. Baseline anthropometric measures include WEIGHTBL (Weight (kg) at Baseline), HEIGHTBL (Height (cm) at Baseline), and BMIBL (Body Mass Index (kg/m2) at Baseline), providing the subject's physical characteristics at study start. Treatment exposure includes TRT01AN (Actual Treatment 1(N)), indicating the numeric identifier of the treatment actually received by the subject. Demographic grouping includes AGEGR1 (Age Group), categorizing subjects into predefined age strata for subgroup analyses. Baseline lesion assessment includes NUMLESBL (Number of Lesion at baseline), representing the count of lesions observed at baseline for efficacy evaluation. Taken together, this dataset enables linking each subject's baseline physical characteristics, treatment assignment, age stratification, and baseline lesion burden to support efficacy and safety analyses across treatment groups.
The dataset supports tables and listings describing demographics and baseline characteristics for the safety population, and Kaplan‑Meier estimates of Progression‑Free Survival (PFS) for the intent‑to‑treat population. It also feeds into ADS.ADTTE (Time‑to‑Event Analysis Dataset), ADS.ADRESP (Response Analysis Dataset), and ADS.ADVS (Vital Signs Analysis Dataset).
Upstream datasets
Downstream datasets
TLFs
This ADTTE dataset combines the event dates from SP.RS (Response Date) with subject‑level treatment and outcome information from ADS.ADSL (Subject‑Level Analysis Dataset), providing randomization dates, planned and actual treatment assignments, and key dates such as death, end of treatment, and end of study for time‑to‑event analyses.
The ADTTE (Time‑to‑Event Analysis Dataset) dataset contains one row per subject per analysis parameter, with domain keys USUBJID and PARAMCD. Identifiers include STUDYID (Study Identifier), USUBJID (Unique Subject Identifier), ASEQ (Analysis Sequence Number), PARAM (Parameter), and PARAMCD (Parameter Code), providing unique identification and classification of each record. Treatment variables include TRT01P (Planned Treatment 1), TRT01PN (Planned Treatment 1 (N)), TRT01A (Actual Treatment 1), and TRT01AN (Actual Treatment 1 (N)), indicating the assigned and received treatment arms for each subject. Timing variables include ADT (Analysis Date) and STARTDT (Time‑to‑Event Origin Date for Subject), establishing the reference dates for time‑to‑event calculations. Outcome variable includes AVAL (Analysis Value), representing the calculated time‑to‑event duration or other numeric result for the parameter. Censoring information includes CNSR (Censor), EVNTDESC (Event or Censoring Description), and CNSDTDSC (Censor Date Description), describing whether the observation is censored and providing textual details of the event or censoring. Taken together, this dataset enables analysis of time‑to‑event endpoints by linking subject and treatment identifiers to event dates, calculated durations, and censoring status, supporting survival analyses such as Kaplan‑Meier estimates and Cox proportional hazards modeling.
Kaplan‑Meier estimates of progression‑free survival are presented for the intent‑to‑treat population. This analysis evaluates the time to disease progression or death, providing insight into the efficacy of the investigational treatment.
Upstream datasets
Downstream datasets
TLFs
The ADVS dataset merges vital sign observations from SP.VS (Vital Signs) with baseline demographics and treatment details from ADS.ADSL (Subject‑Level Analysis Dataset) to support analysis of safety and efficacy endpoints.
The ADVS (Vital Signs Analysis Dataset) dataset contains one row per subject per parameter per analysis timepoint, with domain keys USUBJID, PARAMCD, AVISITN. Identifiers include STUDYID (Study Identifier), USUBJID (Unique Subject Identifier), ASEQ (Analysis Sequence), PARAMCD (Parameter Code), AVALCAT1 (Category of Analysis Parameter), AVISITN (Analysis Visit (N)), TRTPN (Planned Treatment (N)), TRTAN (Actual Treatment (N)), TRTP (Planned Treatment), TRTA (Actual Actual), and AVISIT (Analysis Visit), these variables uniquely identify each record and define the treatment and visit context. Demographics include AGE (Age), SEX (Sex), RACE (Race), providing baseline subject characteristics for subgroup analyses. Visit and timing information include VISIT (Visit Name), VISITNUM (Visit Number), ADT (Analysis Study Date), ADY (Analysis Study Day), VSDTC (Date/Time of Collection), TRTSDT (Treatment Start Date), capturing when and where vital sign measurements were taken relative to the study timeline. Measurement variables include AVAL (Analysis Value), VSORRESU (Orginal Units), BASE (Baseline Value), CHG (Change from Baseline), and PCHG (Percent Change from Baseline), containing the vital sign values, their units, categorization, and derived changes from baseline for efficacy and safety assessment. Flag variables include ABLFL (Analysis Baseline Flag), POSTBL (Post‑Baseline Record Flag), CRIT1FL (Criterion Flag), indicating baseline status, post‑baseline records, and any predefined criteria met for the observation. Taken together, this dataset enables longitudinal analysis of vital sign measurements across subjects, visits, and treatment arms, supporting safety and efficacy evaluations by linking identifiers, demographics, timing, values, and flags.
Upstream datasets
Downstream datasets
TLFs