Mutch 2007.

Methods	Phase III open‐label multicentre RCT; accrual from July 2002 to May 2004 at 44 sites in the USA.
Participants	195 women with PR ROC who had received 1‐2 prior platinum‐based chemotherapy regimens with measurable (RECIST) or assessable disease (Zubrod performance status of 0 to 2 and adequate bone marrow, hepatic and neurological function.
Interventions	Arm 1: GEM (1000 mg/m²) IV day 1, 8 q3wk Arm 2: PLD (50 mg/m²) IV q4wk
Outcomes	Primary: PFS Secondary: OS, SAE (NCI‐CTCAE v 2.0) QoL (FACT‐O)
Notes	If participants experienced disease progression, unacceptable toxicity or if cumulative PLD dose exceeded 500 mg/m², they crossed over to the alternative drug. Median follow‐up was 29.2 months. 99% of women had received prior taxane. Median TTP was 15.4 weeks versus 13.3 weeks in favour of the GEM arm. Median time to death was 54.4 versus 57.9 weeks in favour of the PLD arm. PFS and OS were not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central randomisation.
Allocation concealment (selection bias)	Low risk	Central allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Independent assessment/blinding not described.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Number of events/(total number evaluated) and censoring was not described for the primary outcome (PFS) or OS. Attrition for QoL outcomes not reported. Additional data requested from authors 4/12/12.
Selective reporting (reporting bias)	High risk	HRs, number of events, and censoring was not described for the primary outcome (PFS) or OS. Limited (non‐comparative) QoL data reported. Additional data requested from authors 4/12/12.
Other bias	Low risk	Baseline characteristics were similar.