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

Eisen 2010.

Study characteristics
Methods Phase II/III parallel‐group RCT.
Double‐blind study.
Multicentre trial.
Participants Previously treated metastatic melanoma.
Participants randomised: 306.
Interventions Two‐arm trial:
  • Lenalidomide 25 mg orally days 1 to 21 of a 28‐day cycle (N = 152);

  • Placebo (N = 154).

Outcomes Progression‐free survival.
Overall survival.
Tumour response.
Toxicity.
Notes Cross‐over: not reported.
Quality of life: not investigated.
Participants with brain metastasis: excluded.
Median follow‐up: not available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomized using an interactive voice response system".
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 Quote: "Double‐blind".
Comment: This method makes low the risk of performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Double‐blind".
Comment: This method makes low the 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.