Table 2.
Patients with AEs and SAEs Leading to Discontinuation of the Study Drug
| n (%) | Overall Patient Cohort N=297 |
|---|---|
| AEs | 226 (76.1) |
| SAEs | 48 (16.2) |
| AE related to the study drug | 72 (24.2) |
| AE leading to study drug discontinuation | 17 (5.7) |
| Stomatitis | 1 (0.3) |
| Large intestine polyp | 1 (0.3) |
| Colitis ulcerative | 1 (0.3) |
| Rash pustular | 2 (0.7) |
| Upper respiratory tract infection | 1 (0.3) |
| Respiratory tract infection | 1 (0.3) |
| Infusion-related reaction | 1 (0.3) |
| Psoriatic arthropathy | 1 (0.3) |
| Lung neoplasm malignant | 1 (0.3) |
| Breast cancer | 1 (0.3) |
| Major depression | 1 (0.3) |
| Pulmonary mass | 1 (0.3) |
| Psoriasis | 2 (0.7) |
| Papule | 1 (0.3) |
| Dermatitis exfoliative | 1 (0.3) |
| Dermatitis atopic | 1 (0.3) |
| Skin exfoliation | 1 (0.3) |
| Hypertension | 1 (0.3) |
| SAE leading to study drug discontinuation | 5 (1.7) |
| Colitis ulcerative | 1 (0.3) |
| Lung cancer | 1 (0.3) |
| Breast cancer | 1 (0.3) |
| Major depression | 1 (0.3) |
| Pulmonary mass | 1 (0.3) |
Abbreviations: AE, adverse event; N, number of patients in the study cohort; n, number of patients with at least one AE in the category; SAE, serious AE.