Table 1.
Seriousness Criteria of Clinical Events
| Clinical Event | Overall, n | Serious, n (% of Overall) | Hospitalization/Prolongation, n (% of Serious Events) | Death, n (% of Serious Events) | Life Threatening, n (% of Serious Events) | Important Medical Event, n (% of Serious Events) | Disability, n (% of Serious Events) |
|---|---|---|---|---|---|---|---|
| Overall | 13 909 | 3250 (23.4) | 2594 (79.9) | 321 (9.9) | 173 (5.3) | 93 (2.9) | 38 (1.2) |
| AEsa | 12 743 | 2276 (17.9) | 1839 (80.9) | 221 (9.7) | 89 (3.9) | 78 (3.4) | 19 (0.8) |
| Suspected clinical end points | 1166 | 974 (83.6) | 755 (77.6) | 100 (10.3) | 84 (8.6) | 15 (1.5) | 19 (2.0) |
| CEC‐confirmed | 769 | 723 (94.0) | 563 (78.0) | 69 (9.6) | 70 (9.7) | 5 (0.7) | 15 (2.1) |
| MI | 416 | 407 (97.8) | 309 (76.1) | 46 (11.3) | 42 (10.3) | 1 (0.2) | 8 (2.0) |
| UA | 184 | 175 (95.1) | 160 (91.4) | 2 (1.1) | 9 (5.1) | 1 (0.6) | 3 (1.7) |
| Stroke | 83 | 78 (94.0) | 49 (62.8) | 16 (20.5) | 8 (10.3) | 1 (1.3) | 4 (5.1) |
| TIMI bleeding, major or minor | 86 | 63 (73.3) | 45 (71.4) | 5 (7.9) | 11 (17.5) | 2 (3.2) | 0 (0) |
| CEC‐negated | 397 | 251 (63.2) | 192 (76.5) | 31 (12.4) | 14 (5.6) | 10 (4.0) | 4 (1.6) |
| MI or UA | 251 | 181 (72.4) | 143 (79.0) | 25 (13.8) | 7 (3.9) | 4 (2.2) | 2 (1.1) |
| Stroke | 38 | 31 (81.6) | 18 (58.1) | 4 (12.9) | 4 (12.9) | 3 (9.7) | 2 (6.5) |
| TIMI bleeding, major or minor | 108 | 39 (36.1) | 31 (79.5) | 2 (5.1) | 3 (7.7) | 3 (7.7) | 0 (0) |
AE indicates adverse event; CEC, clinical events classification committee; MI, myocardial infarction; TIMI, Thrombolysis in Myocardial Infarction; UA, unstable angina.
a
Includes the bleeds that were sent only for coordinator‐level review. Three serious AEs and 1 serious end point did not provide a cause. Twenty‐two serious AEs were cancer.