Flaherty 2001.

Study characteristics
Methods	Phase II parallel‐group RCT. Open label study.
Participants	Untreated metastatic melanoma. Number of randomised participants: 81.
Interventions	Two‐arm trial: Inpatient biochemotherapy: dacarbazine 250 mg/m² IV and cisplatin 25 mg/m² IV daily on days 1 to 3, IFN‐α‐2b 5 mU/m² SC on days 6, 8, 10, 13, and 15, and IL‐2 18.0 mU/m² IV daily on days 6 to 10 and 13 to 15 given every 4 weeks (N = 44); Outpatient biochemotherapy: dacarbazine 250 mg/m² IV and cisplatin 25 mg/m² IV daily on days 1 to 3, IFN‐α‐2b 5 mU/m² SC on days 6, 8, 10, 13, and 15, and IL‐2 5.0 mU/m² SC daily on days 6 to 10 and 13 to 15 given every 4 weeks (N = 37).
Outcomes	Overall survival. Tumour response. Toxicity.
Notes	Cross‐over: not reported. Quality of life: not reported. Participants with brain metastasis: excluded. Median follow‐up: not available.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomized". Comment: There was insufficient information about the sequence generation process to permit judgment.
Allocation concealment (selection bias)	Unclear risk	There was insufficient information to permit judgment.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	As an open label study, no blinding of participants or personnel was possible. However, we believe that in this setting (metastatic melanoma), with the treatments tested and outcomes assessed, the knowledge of which intervention was received or administered (rather than the intervention itself), could not affect the outcomes under investigation. Therefore, we judged the risk of performance bias as low.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "All measurements for response were confirmed by one of the coauthors (C.A.), who also was responsible for collection of data from individual centers." Comment: It was unclear if this method was sufficient to ensure low risk of detection bias.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data were balanced across intervention groups, with similar reasons for missing data across groups.
Selective reporting (reporting bias)	Unclear risk	Published report include all expected outcomes. However, no protocol is available and thus it is unclear if all planned outcomes are reported.
Other bias	Low risk	The study appeared to be free of other sources of bias.