Critical appraisal:Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, et al 2015 3
From Cancer Guidelines Wiki
Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)
Random sequence generation
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
- minimisation technique
Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of or during, enrolment.
- local pharmacist that did the randomisation was unmasked for allocated treatment
Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
- no details reported
Incomplete outcome data
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
- intention to treat population as well as safety analysis for treated pts.
Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
- No response
What was the risk of bias from selective outcome reporting? Assessments should be made for each main outcome (or class of outcomes).
Other sources of bias
Overall risk of bias
|Unclear risk of bias||Additional comments:|
- Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol 2015 May;16(5):522-30 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25840693.
- Assigned to
- Topic area
- Clinical question
Section below only relevant for Cancer Council Project Officer