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Table 3 Incidence rates and exposure-adjusted incidence rates for primary MACE and secondary CV endpoints

From: Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

  Primary MACE Endpoint Secondary MACE Endpoint
  Exenatide (N = 2,316) Pooled Comparator (N = 1,629) Exenatide (N = 2,316) Pooled Comparator (N = 1,629)
Primary Analyses     
Incidence (n) 20 18 46 42
Incidence (n/N) 0.009 0.011 0.020 0.026
   RR (95% CI) 0.70 (0.38, 1.31) 0.69 (0.46, 1.03)
Secondary Analysis     
EAIR (per 1,000 years) 18.73 23.17 43.37 54.37
   RR (95% CI) 0.81 (0.43, 1.53) 0.80 (0.53, 1.21)
Event Rate (per 1,000 years) 22.40 28.21 54.13 66.67
   RR (95% CI) 0.79 (0.45, 1.42) 0.81 (0.56, 1.18)
  1. CI = confidence interval; CV = cardiovascular; EAIR = exposure-adjusted incidence rate; MACE = major adverse cardiovascular events; RR = risk ratio
  2. RR for the incidence was calculated using the Mantel-Haenszel estimate with study as a stratification factor
  3. EAIR and event rate were calculated based on the Exact method, with corresponding RR calculated using the log-normal approximation