Table 2.
Common treatment-emergent AEs
| AE | Momelotinib (N = 725), n (%) |
|
|---|---|---|
| Any-grade AE | Grade ≥3 AE | |
| Most common nonhematologic AEs (occurring in ≥10% of patients) by PT | ||
| Diarrhea | 194 (26.8) | 19 (2.6) |
| Nausea | 141 (19.4) | 8 (1.1) |
| Fatigue | 127 (17.5) | 18 (2.5) |
| Cough | 126 (17.4) | 5 (0.7) |
| Dizziness | 112 (15.4) | 4 (0.6) |
| Abdominal pain | 102 (14.1) | 13 (1.8) |
| Pyrexia | 102 (14.1) | 9 (1.2) |
| Headache | 101 (13.9) | 6 (0.8) |
| Asthenia | 96 (13.2) | 8 (1.1) |
| Pruritus | 90 (12.4) | 5 (0.7) |
| Dyspnea | 89 (12.3) | 15 (2.1) |
| Peripheral sensory neuropathy | 89 (12.3) | 5 (0.7) |
| Urinary tract infection | 88 (12.1) | 18 (2.5) |
| Pneumonia | 83 (11.4) | 61 (8.4) |
| Constipation | 81 (11.2) | 1 (0.1) |
| Peripheral edema | 75 (10.3) | 5 (0.7) |
| Arthralgia | 73 (10.1) | 2 (0.3) |
| Upper respiratory tract infection | 73 (10.1) | 3 (0.4) |
| AEs of clinical importance∗ | ||
| Infections (SOC) | 402 (55.4) | 154 (21.2) |
| Opportunistic infections (similar PTs) | 40 (5.5) | 11 (1.5) |
| Malignancies (similar PTs) | 97 (13.4) | 53 (7.3) |
| AML/malignant transformation (similar PTs) | 22 (3.0) | 22 (3.0) |
| Nonmelanoma skin cancer (similar PTs) | 35 (4.8) | 4 (0.6) |
| MACE (similar PTs) | 57 (7.9) | 48 (6.6) |
| Thrombocytopenia (similar PTs) | 181 (25.0) | 119 (16.4) |
| Neutropenia (similar PTs) | 49 (6.8) | 38 (5.2) |
| Anemia (similar PTs) | 170 (23.4) | 107 (14.8) |
| Thromboembolism (SMQ) | 64 (8.8) | 39 (5.4) |
| Hemorrhage (SMQ) | 207 (28.6) | 49 (6.8) |
| Peripheral neuropathy (SMQ) | 107 (14.8) | 9 (1.2) |
Data cutoff: 3 December 2021.
Includes AEs reported between the first momelotinib dose date and 30 days after the last momelotinib dose date.
PT, preferred term; SMQ, standardized MedDRA query.
∗
Detailed search criteria for the categories of AEs of clinical importance are listed in the supplemental Methods.