TABLE 5.
Safety events during mobocertinib treatment.
| All patients | Asian | Non‐Asian | |
|---|---|---|---|
| N | 105 | 41 | 64 |
| Patients with any AE, N (%) | 73 (69.5%) | 27 (65.9%) | 46 (71.9%) |
| Patients with any SAE, N (%) | 15 (14.3%) | 2 (4.9%) | 13 (20.3%) |
| Patients with any AE causing a dose or drug modification a , N (%) | 50 (47.6%) | 15 (36.6%) | 35 (54.7%) |
| Patients with any AE leading to death, N (%) | 4 (3.8%) | 0 | 4 (6.3%) |
| GI AEs, N (%) | |||
| Any GI AE | 60 (57.1%) | 24 (58.5%) | 36 (56.3%) |
| Any GI AE related to mobocertinib | 59 (56.2%) | 23 (56.1%) | 36 (56.3%) |
| Diarrhea AEs, N (%) | |||
| Any diarrhea AE | 52 (49.5%) | 20 (48.8%) | 32 (50.0%) |
| Any diarrhea AE related to mobocertinib | 51 (48.6%) | 19 (46.3%) | 32 (50.0%) |
| Nausea/vomiting AEs, N (%) | |||
| Any nausea/vomiting AE | 22 (21.0%) | 9 (22.0%) | 13 (20.3%) |
| Any nausea/vomiting AE related to mobocertinib | 22 (21.0%) | 9 (22.0%) | 13 (20.3%) |
Abbreviations: AE = adverse event; GI = gastrointestinal; N = number.
a
Dose or drug modification = dose reduced, dose rate reduced, drug interrupted, drug withdrawn, dose delayed, drug infusion interrupted, all drugs withdrawn, dose increased.