A10 ANITA1.
| Methods | RCT: 1994 to 2000 | |
| Participants | 463 patients Stage IB‐IIIA |
|
| Interventions | surgery vs surgery + chemotherapy 4 cycles of chemotherapy cisplatin 100 mg/m2 vinorelbine 180 mg/m2 Complete resection |
|
| Outcomes | Overall survival | |
| Notes | 840 patients randomised in trial, 436 patients relevant to this trial comparison | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Data checks on IPD provided suggest adequate sequence generation |
| Allocation concealment (selection bias) | Low risk | Central computer randomisation |
| Selective reporting (reporting bias) | Low risk | IPD supplied for outcomes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Trial not blinded due to nature of intervention, outcome not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Trial not blinded due to nature of intervention, primary outcome not likely to be influenced by lack of blinding |