Table 2.
Adverse Events
| Adverse event, n (%) | Icosapent ethyl (N=1737) |
Placebo (N=1671) |
P value |
|---|---|---|---|
| Atrial fibrillation/flutter requiring emergency treatment* | 115 (6.6) | 75 (4.5) | 0.007 |
| Atrial fibrillation/flutter requiring hospitalization ≥24 hours † | 59 (3.4) | 36 (2.2) | 0.04 |
| Bleeding events+hemorrhagic stroke ‡ | 226 (13.0) | 205 (12.3) | 0.54 |
| Total bleeding events | 221 (12.7) | 202 (12.1) | 0.60 |
| Gastrointestinal bleeding | 60 (3.5) | 56 (3.4) | 0.92 |
| Central nervous system bleeding | 13 (0.8) | 7 (0.4) | 0.26 |
| Other bleeding | 171 (9.8) | 155 (9.3) | 0.60 |
| Hemorrhagic stroke | 5 (0.3) | 5 (0.3) | 1.00 |
| Severe TEAE | 378 (21.8) | 365 (21.8) | 0.97 |
| Serious TEAE | 593 (34.1) | 584 (34.9) | 0.64 |
TEAE indicates treatment emergent adverse event.
*
Includes atrial fibrillation/flutter TEAEs and excludes positively adjudicated events. P value is based on Fisher's Exact test.
†
Includes positively adjudicated atrial fibrillation/flutter requiring ≥24 hours of hospitalization clinical events by the Clinical Endpoint Committee. P value is based on stratified log‐rank test.
‡
Multiple bleeding TEAEs of the same preferred term are counted only once within each preferred term. Events that were positively adjudicated as clinical end points are not included in bleeding TEAEs. P values are based on Fisher's Exact test.