Data and code for: Toxicity-related treatment discontinuation and treatment-related mortality with intensive versus gemcitabine-based first-line chemotherapy in advanced/metastatic PDAC — a systematic review and meta-analysis

Data and code for: Toxicity-related treatment discontinuation and treatment-related mortality with intensive versus gemcitabine-based first-line chemotherapy in advanced and metastatic pancreatic ductal adenocarcinoma — a systematic review and meta-analysis of randomized controlled trials This repository contains the full extraction dataset, analysis code, and risk-of-bias assessments underlying the meta-analysis. It is provided to support reproducibility and in fulfilment of the journal Data Availability requirement. PROSPERO registration: CRD420261408001 Search date: inception to 25 February 2026 Included studies: 36 randomized controlled trials (14,839 randomized patients) License: CC BY 4.0 Contents File Description PDAC_MA_dataset_full.xlsx Master extraction workbook (all sheets): trial characteristics, per-arm safety extraction, analysis-ready 2×2 tables, risk-of-bias, R code, verbatim source quotes, and version/verification logs. This is the primary, authoritative data file. PDAC_MA_primary_outcomes_2x2.csv Analysis-ready 2×2 data for the co-primary outcomes: AE-related treatment discontinuation and treatment-related mortality (long format for metafor/meta). PDAC_MA_grade34_AEs_2x2.csv Analysis-ready 2×2 data for grade 3–4 adverse events and dose modifications. PDAC_trial_characteristics.csv One row per trial: design, phase, regimen class, N randomized, % metastatic, sponsorship, blinding. PDAC_RoB2_assessments.csv Cochrane RoB 2.0 judgments per trial × domain (D1–D5 + overall). PDAC_verbatim_extraction_quotes.csv Verbatim source-text quotes supporting each extracted discontinuation and mortality value. PDAC_MA_analysis.R R script reproducing all pooled estimates, subgroup analyses, sensitivity analyses, funnel plots, and forest plots. How to reproduce the analysis Install R (≥ 4.0) and the packages: meta, metafor, readxl, dplyr, ggplot2. Place PDAC_MA_dataset_full.xlsx in your working directory. Run PDAC_MA_analysis.R. Methods summary Pooled risk ratios were estimated with inverse-variance random-effects meta-analysis (DerSimonian–Laird τ² with the Knapp–Hartung–Sidik–Jonkman adjustment), a 0.5 continuity correction for single-zero studies, and exclusion of double-zero studies. Multi-arm trials sharing one gemcitabine control arm (GEST, GAMMA, ECOG E6201, GENERATE) had the shared control divided across comparisons. AViTA is excluded from the AE-related discontinuation pool because the source reports events, not patients, which is invalid for a patient-level risk ratio. Key results (for orientation) AE-related discontinuation: 24 comparisons, RR 1.34 (95% CI 1.16–1.55); Egger t=2.19, P=0.039. Treatment-related mortality: 21 comparisons, RR 1.16 (95% CI 0.95–1.41); Egger t=2.97, P=0.008. Citation If you use these data or code, please cite the associated article and this dataset. Authors: Ramy Yassa; Steven Danial Azmy Habib (contributed equally).