Table VI.
Early (0–30 days) and late (31–365 days) serious adverse events (SAE) by body system
| Category | 0–30 days (early) | 31–365 days (late) | 0–365 days |
|---|---|---|---|
|
|
|
|
|
| % (n/N) | % (n/N) | % (n/N) | |
| Patients with ≥ SAE | 26.3 (64/243) | 15.3 (36/236) | 35.8 (87/243) |
| Bleeding | 3.3 (8/243) | 0.4 (1/236) | 3.7 (9/243) |
| Cardiac | 7.8 (19/243) | 3.4 (8/236) | 11.1 (27/243) |
| Cancer | 1.6 (4/243) | 1.3 (3/236) | 2.9 (7/243) |
| Edema | 0.0 (0/243) | 0.0 (0/236) | 0.0 (0/243) |
| Gastrointestinal | 8.2 (20/243) | 2.5 (6/236) | 10.3 (25/243) |
| Genitourinary | 1.2 (3/243) | 1.7 (4/236) | 2.9 (7/243) |
| Infection | 1.2 (3/243) | 0.4 (1/236) | 1.6 (4/243) |
| Neurologic | 1.6 (4/243) | 1.7 (4/236) | 3.3 (8/243) |
| Orthopedic | 0.4 (1/243) | 0.4 (1/236) | 0.8 (2/243) |
| Pulmonary | 10.7 (26/243) | 2.5 (6/236) | 12.3 (30/243) |
| Renal | 3.7 (9/243) | 0.0 (0/236) | 3.7 (9/243) |
| Vascular | 4.9 (12/243) | 0.8 (2/236) | 9.9 (24/243) |
| Wound | 2.1 (5/243) | 0.0 (0/236) | 2.1 (5/243) |
| Othera | 1.2 (3/243) | 1.3 (3/236) | 2.5 (6/243) |
| Unknown | 2.1 (5/243) | 3.4 (8/236) | 5.3 (13/243) |
| Deaths | 2.9 (7/243) | 4.7 (11/236) | 7.4 (18/243) |
a
See Table V footnote for explanation.