Kim 2012.
Study characteristics | ||
Methods | Phase II parallel‐group RCT. Double‐blinded study. |
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Participants | Untreated metastatic melanoma. Randomised participants: 214. |
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Interventions | Two‐arm trial:
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Outcomes | Progression‐free survival. Overall survival. Tumour response. Toxicity. |
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Notes | Cross‐over: not allowed. Quality of life: not reported. Participants with brain metastasis: excluded. Median follow‐up: 13 months. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Random assignment was performed using an interactive voice response system". Comment: There was insufficient information about the sequence generation process to permit judgment. |
Allocation concealment (selection bias) | Unclear risk | No sufficient information to judge |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double‐blind". Comment: This method ensured low risk of performance bias. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Double‐blind". Comment: This method ensured 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) | Low risk | No differences between protocol and published report. |
Other bias | Low risk | The study appeared to be free of other sources of bias. |