Palo 1976.
Methods | Randomised Phase II trial | |
Participants | 48 women with cervical cancer | |
Interventions | Arm 1: adriamycin 75 mg/m2 d1 + bleomycin 15 mg/m2 d1, 8 q21 Arm 2: cyclophosphamide 1.2 g/m2 d1 + vincristine 1.4 mg/m2 d1, 8 q21 |
|
Outcomes | Response rates OS PFS Toxicity |
|
Notes | 14 patients excluded from analysis (3 lack of measurable disease, 11 lost to follow‐up). 18 patients also allowed to cross‐over between arms | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not documented |
Allocation concealment (selection bias) | Unclear risk | Not documented |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not documented but OS unlikely to be affected by blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | 14 patients excluded from analysis balanced across group |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | Low risk | No hint at any other possible biases |