Table 5. Key Adverse Events in the Safety Populationa.
| No. (%) | ||
|---|---|---|
| Omega-3 CA (n = 6532) | Corn oil (n = 6535) | |
| Drug-related adverse event | 1451 (22.2) | 843 (12.9) |
| Adverse event leading to drug discontinuation | 708 (10.8) | 525 (8.0) |
| Gastrointestinal disordersb | 1616 (24.7) | 959 (14.7) |
| Diarrhea | 780 (11.9) | 323 (4.9) |
| Nausea | 207 (3.2) | 113 (1.7) |
| Dyspepsia | 90 (1.4) | 42 (0.6) |
| Abdominal discomfort | 87 (1.3) | 36 (0.6) |
| New onset of diabetesc | 286/1929 (14.8) | 280/1975 (14.2) |
| Syncope | 35 (0.5) | 17 (0.3) |
| Any bleeding event | 322 (4.9) | 322 (4.9) |
| TIMI criteria major bleeding event | 52 (0.8) | 46 (0.7) |
Abbreviations: CA, carboxylic acid formulation; TIMI, Thrombolysis in Myocardial Infarction.
a
The safety population includes all randomized patients who received at least one dose of study drug.
b
Gastrointestinal disorders reported by the patient.
c
In those without diabetes on or before first dose of study medication.