Nicoletto 2004.
Study characteristics | ||
Methods | RCT | |
Participants | 122 women with epithelial ovarian cancer achieved PCR Stage 1c, 2b, 2c, 3 and 4 Mean age was 55 years old Median follow‐up time was not reported |
|
Interventions | 5‐Fu + cisplatin versus observation | |
Outcomes | 3‐year OS and 3‐year PFS; toxic events | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "…at time of randomization" Comment: Probably done |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding (performance bias and detection bias) All outcomes | Low risk | No blinding, but the outcome and the outcome measurement are not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "one patient refused treatment entirely after randomization and is therefore not evaluable" Comment: For OS and PFS, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate. |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
Other bias | Low risk | The study appears to be free of other sources of bias |