Additional file 1: of A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines

Dose modification. (XLSX 14 kb) (XLSX 14 kb

Treatment effectiveness analysis results – comparison of data sets.

*<p>HR >1 indicates a benefit to experimental treatment.</p>1<p>Discrepancy in number of deaths between SDV and original data is due to the identification of 29 additional dates of death (all dates occurred before the censoring date used in this comparison) following source data verification. These patients were censored in the ‘original’ analysis using date of last follow-up.</p>2<p>Date of progression missing for one patient (id 113).</p>3<p>Date of progression is before date of randomisation for one patient (id 468).</p

RECIST response classification for each CT scan comparing SDV and original data (numbers relate to CT scans not patients).

*<p>No scan result available in the respective data set.</p

Response analysis comparing SDV and original data (numbers relate to patients).

*<p>OR >1 indicates a benefit to experimental treatment.</p

Date of death discrepancies between SDV and original data.

<p>Date of death discrepancies between SDV and original data.</p

Patients with discrepancy in number of Serious Adverse Events.

<p>Patients with discrepancy in number of Serious Adverse Events.</p

Baseline discrepancies between SDV and original data.

*<p>Four ineligible patients were not identified as ineligible by SDV.</p

Kaplan Meier curves comparing SDV and original data: Progression Free Survival.

<p>Kaplan Meier curves comparing SDV and original data: Progression Free Survival.</p

Additional file 1: of Adjuvant trastuzumab duration trials in HER2 positive breast cancer – what results would be practice-changing? Persephone investigator questionnaire prior to primary endpoint results

Trastuzumab Duration questionnaire. The questionnaire that was completed by the oncologists. (PDF 476 kb

Additional file 1: Table S1. of A nested cohort study of 6,248 early breast cancer patients treated in neoadjuvant and adjuvant chemotherapy trials investigating the prognostic value of chemotherapy-related toxicities

Patient characteristics of the 6,248 patients shown by trial. Table S2. National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2. Table S3. Case-control classification method for the 13 CRTs investigated. Table S4. Neutropenia and fatigue in relation to outcome, split by different treatment components. Figure S1. Trial objectives, outcomes and treatment regimens of the contributing clinical trials. (DOCX 82 kb