Moore 2004.
| Methods | Randomised Phase III trial | |
| Participants | 280 women with squamous cell Stage IVb, recurrent or persistent cervical cancer. No previous chemotherapy allowed | |
| Interventions | Arm 1: cisplatin 50 mg/m2 iv d1 q21 Arm 2: cisplatin 50 mg/m2 iv d1 and paclitaxel 135 mg/m2 iv d1 q21 |
|
| Outcomes | Response rates OS PFS Toxicity (WHO) |
|
| Notes | 16 ineligible patients (7 non‐squamous histology, 1 incorrect stage, 8 inadequate pathology). A further 5 patients did not receive chemotherapy, but were included in the ITT analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | With equal probability block design balancing sequences of assigned arms within institutions |
| Allocation concealment (selection bias) | Low risk | Not documented |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Not documented but OS unlikely to be affected by blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 16 ineligible patients A further 5 patients did not receive chemotherapy, but were included in the ITT analysis |
| Selective reporting (reporting bias) | Low risk | Published report included all pre‐specified outcomes |
| Other bias | Low risk | No hint at any other possible biases |