| Methods | RCT (Randomised Controlled Trial); multicentre (Japan) | |
| Participants | Patients with Dukes A, B and C (TNM stage I, II, III) rectal cancer undergoing radical surgery of the primary tumor (n=713) | |
| Interventions | 2‐arm trial: patients were randomly assigned to: A) surgery alone (n=356), or B) surgery + adjuvant chemotherapy (n=357) with HCFU (oral) + MMC (mitomycin‐C, intravenously) | |
| Outcomes | Disease‐free survival (DFS) and overall survival (OS) | |
| Notes | The original article is in Japanese: data were retrieved from an individual patient data (IPD) meta‐analysis conducted in 2004 by the Meta‐analysis Group in Cancer (see Sakamoto 2004) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | |
| Selective reporting (reporting bias) | High risk | Data from an IPD meta‐analysis, not the original article |
| Other bias | Low risk | |
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