Balch 1984.

Study characteristics
Methods	Phase III parallel‐group RCT. Open label study.
Participants	Resected advanced regional and distant metastasis from cutaneous melanoma. Number of participants: 136.
Interventions	Two‐arm trial: Chemo‐immunotherapy: Dacarbazine and cyclophosphamide 600 mg/m² IV every 3 weeks for 9 cycles plus C parvum 4 mg/m² in 1 to 2 week cycle (N = 78); Immunotherapy: C parvum 4 mg/m² weekly for 13 weeks (N = 78).
Outcomes	Progression‐free survival. Overall survival. Toxicity.
Notes	Cross‐over: not allowed. Quality of life: not reported. Participants with brain metastasis: included. Median follow‐up: 10 months.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	There was insufficient information 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	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)	Unclear risk	There was insufficient information to permit judgment.
Other bias	Low risk	The study appeared to be free of other sources of bias.