Tables

TABLE · STUDY POPULATION

Demographics Summary

Continuous + categorical statistics by treatment arm with Total column. Age, age group, sex, race, ethnicity. Group headers, blank-after, decimal alignment.

decimal cards

TABLE · STUDY POPULATION

Medical History

Medical history by SOC and preferred term. Hierarchical layout with indentation.

hierarchy cards

TABLE · STUDY POPULATION

Prior Medication

Prior medications by medication class and preferred name. Hierarchical layout.

hierarchy cards

TABLE · STUDY POPULATION

Subject Disposition

Screening, randomization, treatment completion, and reasons for discontinuation.

decimal cards

TABLE · STUDY POPULATION

Disposition - Screening

Screened, screen failures, and enrolled subject counts.

decimal

TABLE · STUDY POPULATION

Disposition - End of Study

End of study status — completed, discontinued, ongoing.

decimal

TABLE · STUDY CONDUCT

Enrollment by Country and Site

Enrollment counts by country with site-level detail. Hierarchical layout.

hierarchy decimal

TABLE · STUDY POPULATION

Analysis Populations

Summary of analysis populations — enrolled, safety, ITT/FAS.

decimal

TABLE · SAFETY

Death Summary

Deaths by treatment arm with cause-of-death breakdown.

decimal

TABLE · SAFETY

AE by SOC and Preferred Term

Hierarchical SOC/PT structure. Bold SOC rows, indented PTs, frequency sorting.

hierarchy decimal cards

TABLE · SAFETY

TABLE · SAFETY

Common Adverse Events

Preferred terms occurring at ≥5% in any treatment arm. Sorted by frequency.

decimal cards

TABLE · SAFETY

AE by Grade/Intensity

Adverse events by maximum CTCAE grade per treatment arm.

hierarchy decimal

TABLE · SAFETY

Overall Safety Summary

Any TEAE, SAEs, deaths, discontinuations due to AE.

decimal

TABLE · SAFETY

AE with Event Counts

SOC/PT table showing both subject counts and event counts per term.

hierarchy decimal cards

TABLE · SAFETY

Exposure-Adjusted Adverse Events

AE incidence rates per 100 patient-years by SOC and preferred term.

hierarchy decimal

TABLE · SAFETY

Adverse Events by Subgroup

Treatment-emergent AE summary stratified by treatment arm and age subgroup.

decimal split

TABLE · SAFETY

Serious AEs by SOC and PT

Serious adverse events by system organ class and preferred term. Hierarchical with bold SOC rows.

hierarchy cards

TABLE · SAFETY

AEs Leading to Discontinuation

Treatment-emergent AEs leading to study drug discontinuation by SOC and PT.

hierarchy cards

TABLE · SAFETY

Vital Signs

One row per treatment group at each visit, Value and Change from Baseline statistics as columns. Page-by parameter with spanning headers.

page_by decimal split

TABLE · EXTENT OF EXPOSURE

Concomitant Medications

Medications by ATC class and preferred name. Hierarchical with bold category rows.

hierarchy decimal

TABLE · EXTENT OF EXPOSURE

Extent of Exposure

Study drug exposure: total duration, total dose, average daily dose with duration categories.

decimal cards

TABLE · SAFETY

Laboratory Results - Chemistry

Chemistry panel summary by visit. Per-variable decimal precision showcase with fr_wide_ard().

decimal page_by cards

TABLE · SAFETY

Laboratory Marked Abnormalities

Subjects with notable high/low laboratory values by chemistry parameter and treatment arm.

decimal cards

TABLE · SAFETY

Electrocardiogram Summary

Worst post-baseline QTc categories and maximum increase from baseline by treatment arm.

decimal cards

TABLE · EFFICACY

Time to Event Summary

Overall survival with KM median, quartiles, hazard ratio, and log-rank p-value.

decimal

TABLE · EFFICACY

Best Overall Response

BOR categories with derived ORR and DCR rates. Oncology efficacy endpoint summary.

decimal cards

Figures

FIGURE · EFFICACY

Kaplan-Meier Plot

Progression-free survival curves by treatment arm with number-at-risk table.

FIGURE · EFFICACY

Swimmer Plot

Subject treatment duration with response markers over time.

FIGURE · EFFICACY

Waterfall Plot

Best percentage change from baseline in target lesion size per subject.

Listings

LISTING · SAFETY

Adverse Event Listing

Subject-level AE listing with SOC, PT, severity, onset, duration, outcome, relationship.

listing

LISTING · STUDY POPULATION

Demographic Characteristics

Subject-level demographics — age, sex, race, ethnicity, weight, height.

listing

LISTING · SAFETY

Medical History Listing

Subject-level medical history with SOC, preferred term, reported term, category, and severity.

listing page_by

LISTING · SAFETY

Vital Signs Listing

Subject-level vital signs by visit with baseline and change values.

listing page_by

LISTING · SAFETY

Laboratory Test Results Listing

Subject-level chemistry lab results with value, baseline, change, and normal range flag.

listing decimal page_by

LISTING · EXTENT OF EXPOSURE

Concomitant Medications Listing

Subject-level concomitant medications with ATC class, dose, route, and dates.

listing page_by