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. 2016 Mar 10;2016(3):MR000043. doi: 10.1002/14651858.MR000043.pub2

CHARM 2003.

Methods RCT comparing candesartan versus placebo in patients with chronic heart failure and preserved left‐ventricular ejection fraction.
Data 3025 patients were randomised (1514/1509, respectively in each treatment group), including two patients who mistakenly received randomisation numbers but had no other data recorded and never received study medication.
Comparisons Onsite assessment (local investigator blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcome selected was admission to hospital for chronic heart disease or cardiovascular death. The study's primary outcome was cardiovascular death or admission to hospital for chronic heart failure.
Notes The study was identified because it was include in a review of six RCTs (Granger 2008). Data related to the number of events in each treatment group resulting from onsite‐assessor and AC assessments were extracted from this review .
Risk of bias
Item Authors' judgement Description
Method for selecting cases to adjudicate? No All suspect events adjudicated were identified by onsite assessor who was blinded to allocated treatment.