A16 FLCSG 1.
Methods | RCT: 1982 to 1987 | |
Participants | 110 patients Stage I‐III |
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Interventions | surgery vs surgery + chemotherapy 6 cycles of chemotherapy cisplatin 40 mg/m2 doxorubicin 40 mg/m2 cyclophosphamide 400 mg/m2 |
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Outcomes | Overall survival | |
Notes | ||
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 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 |