Aernoud Fiolet

131 Colchicine in Patients with Chronic Coronary Disease Table 2. Adverse Events in the Intention-to-Treat Population.* Event Colchicine Placebo Hazard Ratio or Cumulative Incidence Ratio (95% CI) no. of patients/ total no. (%) no. of events/100 person-yrs no. of patients/ total no. (%) no. of events/100 person-yrs Noncardiovascular death 53/2762 (1.9) 0.7 35/2760 (1.3) 0.5 1.51 (0.99–2.31) Diagnosis of cancer 120/2762 (4.3) 1.6 122/2760 (4.4) 1.6 0.98 (0.76–1.26) Hospitalization for infection 137/2762 (5.0) 1.8 144/2760 (5.2) 1.9 0.95 (0.75–1.20) Hospitalization for pneumonia 46/2762 (1.7) 0.6 55/2760 (2.0) 0.7 0.84 (0.56–1.24) Hospitalization for gastrointestinal reason 53/2762 (1.9) 0.7 50/2760 (1.8) 0.7 1.06 (0.72–1.56) Gout 38/2762 (1.4) — 95/2760 (3.4) — 0.40 (0.28–0.58) Neutropenia 4/2762 (0.1) — 3/2760 (0.1) — NR Myotoxic effects† 3/2762 (0.1) — 3/2760 (0.1) — NR Myalgia‡ 384/1811 (21.2) — 334/1807 (18.5) — 1.15 (1.01–1.31) Dysesthesia: numbness or tingling‡ 143/1811 (7.9) — 150/1807 (8.3) — 0.95 (0.76–1.18) * Hazard ratios are reported for noncardiovascular death, diagnosis of cancer, hospitalization for infection, hospitalization for pneumonia, and hospitalization for gastrointestinal reason; cumulative incidence ratios are reported for gout, myalgia, and dysesthesia because time-to-event data were not collected for these end points. Cumulative incidence ratios are not reported (NR) for neutropenia and myotoxic effects because of the low numbers of events. † Rhabdomyolysis occurred in one patient in the colchicine group, who had a full recovery. ‡ Data were collected for the Netherlands cohort only. Reporting of these adverse events was requested by the Medicines Evaluation Board in the Netherlands when the trial was expanded to include patients from that country.