Edmonson 1988.
Methods | Randomised Phase II trial 1980 to 1985 |
|
Participants | 91 women with advanced cervical carcinoma | |
Interventions | Arm 1: bleomycin 20 U/m2 iv 3‐d infusion, cisplatin 60 mg/m2 d1 iv, doxorubicin 40 mg/m2 iv D1, cyclophosphamide 400 mg/m2 iv d1 q28 Arm 2: bleomycin 20 U/m2 iv 3‐d infusion, cisplatin 60 mg/m2 d1 iv q21 Bleomycin omitted after 4 cycles in both arms |
|
Outcomes | Response rates OS |
|
Notes | 1 patient excluded as ineligible owing to second primary cancer. No ITT analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Dynamic allocation system |
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 | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
Other bias | Low risk | No hint at any other possible biases |