Testori 2008.

Study characteristics
Methods	Phase III parallel‐group RCT. Open label study. Multicentre trial.
Participants	Untreated metastatic melanoma. Participants randomised: 322.
Interventions	Two‐arm trial: Vitespen: first 4 injections were administered weekly, and subsequent injections were administered every other week (N = 215); Physician's choice of treatment including at least one of the following: IL‐2 (60 million U/m²), DTIC (1000 mg/m²), temozolomide (600 mg/m²), tumour resection with or without additional therapy, any therapy licensed for the treatment of cancer (N = 107).
Outcomes	Progression‐free survival. Overall survival. Tumour response. Toxicity.
Notes	Cross‐over: not allowed. Quality of life: not reported. Participants with brain metastasis: excluded. Median follow‐up: 9 months.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomly assigned". Comment: Risk was likely low because this was a multicentre trial with centralised randomisation
Allocation concealment (selection bias)	Low risk	Risk was likely low because this was a multicentre trial with centralised randomisation.
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	There was insufficient information to permit judgment.
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)	Low risk	No differences between protocol and published report.
Other bias	Low risk	The study appeared to be free of other sources of bias.