Incidence of TEAEs (≥15% of patients) and SAEs (≥2 patients), combined primary and extension studies (N = 64)
| Preferred term . | Grade . | |
|---|---|---|
| Any . | ≥3 . | |
| TEAEs, n (%) | 64 (100) | 49 (77) |
| Diarrhea and/or colitis | 41 (64) | 27 (42) |
| Only diarrhea | 25 (39) | 11 (17) |
| Only colitis | 3 (5) | 9 (14) |
| Pyrexia | 27 (42) | 2 (3) |
| Nausea | 24 (38) | 1 (2) |
| Rash* | 37 (58) | 8 (13) |
| Chills | 23 (36) | 0 (0) |
| Cough | 21 (33) | 1 (2) |
| Fatigue | 20 (31) | 0 (0) |
| Pneumonia | 18 (28) | 12 (19) |
| Dyspnea | 16 (25) | 4 (6) |
| Headache | 15 (23) | 0 (0) |
| Vomiting | 14 (22) | 2 (3) |
| Insomnia | 13 (20) | 0 (0) |
| Arthralgia | 11 (17) | 1 (2) |
| Constipation | 11 (17) | 0 (0) |
| Pruritus | 11 (17) | 1 (2) |
| Night sweats | 10 (16) | 0 (0) |
| Back pain | 10 (16) | 1 (2) |
| Urinary tract infection | 10 (16) | 4 (6) |
| SAEs, n (%) | 39 (61) | 38 (59) |
| Diarrhea and/or colitis | 24 (37) | 23 (36) |
| Pneumonia | 11 (17) | 11 (17) |
| Dehydration | 2 (3) | 2 (3) |
| Dyspnea | 2 (3) | 2 (3) |
| Febrile neutropenia | 3 (5) | 3 (5) |
| Hypoxia | 2 (3) | 2 (3) |
| Pneumonitis | 2 (3) | 2 (3) |
| Pulmonary fibrosis | 2 (3) | 2 (3) |
| Pyrexia | 2 (3) | 1 (2) |
| Respiratory failure | 2 (3) | 2 (3) |
| Cellulitis | 2 (3) | 2 (3) |
| Urinary tract infection | 2 (3) | 2 (3) |
| Preferred term . | Grade . | |
|---|---|---|
| Any . | ≥3 . | |
| TEAEs, n (%) | 64 (100) | 49 (77) |
| Diarrhea and/or colitis | 41 (64) | 27 (42) |
| Only diarrhea | 25 (39) | 11 (17) |
| Only colitis | 3 (5) | 9 (14) |
| Pyrexia | 27 (42) | 2 (3) |
| Nausea | 24 (38) | 1 (2) |
| Rash* | 37 (58) | 8 (13) |
| Chills | 23 (36) | 0 (0) |
| Cough | 21 (33) | 1 (2) |
| Fatigue | 20 (31) | 0 (0) |
| Pneumonia | 18 (28) | 12 (19) |
| Dyspnea | 16 (25) | 4 (6) |
| Headache | 15 (23) | 0 (0) |
| Vomiting | 14 (22) | 2 (3) |
| Insomnia | 13 (20) | 0 (0) |
| Arthralgia | 11 (17) | 1 (2) |
| Constipation | 11 (17) | 0 (0) |
| Pruritus | 11 (17) | 1 (2) |
| Night sweats | 10 (16) | 0 (0) |
| Back pain | 10 (16) | 1 (2) |
| Urinary tract infection | 10 (16) | 4 (6) |
| SAEs, n (%) | 39 (61) | 38 (59) |
| Diarrhea and/or colitis | 24 (37) | 23 (36) |
| Pneumonia | 11 (17) | 11 (17) |
| Dehydration | 2 (3) | 2 (3) |
| Dyspnea | 2 (3) | 2 (3) |
| Febrile neutropenia | 3 (5) | 3 (5) |
| Hypoxia | 2 (3) | 2 (3) |
| Pneumonitis | 2 (3) | 2 (3) |
| Pulmonary fibrosis | 2 (3) | 2 (3) |
| Pyrexia | 2 (3) | 1 (2) |
| Respiratory failure | 2 (3) | 2 (3) |
| Cellulitis | 2 (3) | 2 (3) |
| Urinary tract infection | 2 (3) | 2 (3) |
SAE, serious adverse event; TEAE, treatment-emergent adverse event.
TEAEs were classified by preferred term using Medical Dictionary for Regulatory Activities, version 15.1. Patients who experienced multiple events within the same preferred term were counted once per preferred term.
Includes multiple preferred terms related to rash.