Summary of AEs
| MedDRA system organ class, n (%)* . | Phase 1 . | Phase 2 . | ||
|---|---|---|---|---|
| Andexanet alfa (n = 24) . | Placebo (n = 8) . | Andexanet alfa (n = 36) . | Placebo (n = 18) . | |
| Any AE | 13 (54) | 4 (50) | 27 (75) | 15 (83) |
| Gastrointestinal disorders | 3 (13) | 0 | 1 (3) | 2 (11) |
| General disorders and administration site conditions | 6 (25) | 2 (25) | 5 (14) | 4 (22) |
| Infections and infestations | 1 (4) | 1 (13) | 1 (3) | 0 |
| Injury, poisoning, and procedural complications | 3 (13) | 1 (13) | 7 (19) | 8 (44) |
| Musculoskeletal and connective tissue disorders | 2 (8) | 0 | 5 (14) | 2 (11) |
| Nervous system disorders | 5 (21) | 0 | 7 (19) | 3 (17) |
| Pregnancy, puerperium, and perinatal conditions | 1 (4) | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | 0 | 0 | 2 (6) | 5 (28) |
| Respiratory, thoracic, and mediastinal disorders | 0 | 0 | 3 (8) | 0 |
| Eye disorders | 0 | 0 | 1 (3) | 0 |
| Cardiac disorders | 0 | 0 | 0 | 1 (6) |
| MedDRA system organ class, n (%)* . | Phase 1 . | Phase 2 . | ||
|---|---|---|---|---|
| Andexanet alfa (n = 24) . | Placebo (n = 8) . | Andexanet alfa (n = 36) . | Placebo (n = 18) . | |
| Any AE | 13 (54) | 4 (50) | 27 (75) | 15 (83) |
| Gastrointestinal disorders | 3 (13) | 0 | 1 (3) | 2 (11) |
| General disorders and administration site conditions | 6 (25) | 2 (25) | 5 (14) | 4 (22) |
| Infections and infestations | 1 (4) | 1 (13) | 1 (3) | 0 |
| Injury, poisoning, and procedural complications | 3 (13) | 1 (13) | 7 (19) | 8 (44) |
| Musculoskeletal and connective tissue disorders | 2 (8) | 0 | 5 (14) | 2 (11) |
| Nervous system disorders | 5 (21) | 0 | 7 (19) | 3 (17) |
| Pregnancy, puerperium, and perinatal conditions | 1 (4) | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | 0 | 0 | 2 (6) | 5 (28) |
| Respiratory, thoracic, and mediastinal disorders | 0 | 0 | 3 (8) | 0 |
| Eye disorders | 0 | 0 | 1 (3) | 0 |
| Cardiac disorders | 0 | 0 | 0 | 1 (6) |
Classified according to Version 15.0.