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. 2018 Feb 6;2018(2):CD011123. doi: 10.1002/14651858.CD011123.pub2

Kim 2012.

Study characteristics
Methods Phase II parallel‐group RCT.
Double‐blinded study.
Participants Untreated metastatic melanoma.
Randomised participants: 214.
Interventions Two‐arm trial:
  • Bevacizumab 15 mg/kg IV, carboplatin area under the curve, 5, and paclitaxel 175 mg/m² IV (N = 143);

  • Carboplatin area under the curve, 5, and paclitaxel 175 mg/m² IV (N = 71).

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: 13 months.
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.