Cui 2013.
Study characteristics | ||
Methods | Phase II parallel‐group RCT. Double‐blind study. |
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Participants | Untreated metastatic melanoma harbouring no mutations in KRAS, NRAS, BRAF, or c‐kit genes. Participants randomised: 114. |
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Interventions | Two‐arm trial:
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Outcomes | Overall survival. Progression‐free survival. Tumour response. Toxicity. |
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Notes | Cross‐over: not reported. Quality of life: not reported. Participants with brain metastasis: excluded. Median follow‐up: not available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Simple stratified randomization with permuted blocks of size 2 was used to create a prospective randomization schedule". Comment: Randomisation method was adequate. |
Allocation concealment (selection bias) | Low risk | Quote: "Random assignment of patients was performed by designated personnel at each participating site in a double‐blind fashion such that the investigator and patient did not know the treatment assignment" Comment: Allocation was likely concealed. |
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. |