Treatment-emergent adverse event (TEAE) summary
| Number of TEAEs . | Patients in part A, (N = 12) . | Patients in part B, (N = 7) . |
|---|---|---|
| 74 . | 70 . | |
| Patients with ≥1 TEAE, n (%) | 10 (83.3) | 6 (85.7) |
| Number of treatment-related TEAEs∗ | 21† | 10‡ |
| Patients with ≥1 related TEAE∗, n (%) | 6 (50.0) | 3 (42.9) |
| Number of serious TEAEs | 4§ | 1‖ |
| Patients with ≥1 serious TEAE, n (%) | 3 (25.0) | 1 (14.3) |
| Patients with ≥1 treatment-related serious TEAE∗, n (%) | 1 (8.3)¶ | 0 (0.0) |
| Patients with ≥1 serious TEAE of infection#, n (%) | 0 (0.0) | 1 (14.3) |
| Thromboembolic events, n | 0 | 0 |
| Discontinuation due to TEAE, n | 0 | 0 |
| Deaths, n | 0 | 0 |
| Number of TEAEs . | Patients in part A, (N = 12) . | Patients in part B, (N = 7) . |
|---|---|---|
| 74 . | 70 . | |
| Patients with ≥1 TEAE, n (%) | 10 (83.3) | 6 (85.7) |
| Number of treatment-related TEAEs∗ | 21† | 10‡ |
| Patients with ≥1 related TEAE∗, n (%) | 6 (50.0) | 3 (42.9) |
| Number of serious TEAEs | 4§ | 1‖ |
| Patients with ≥1 serious TEAE, n (%) | 3 (25.0) | 1 (14.3) |
| Patients with ≥1 treatment-related serious TEAE∗, n (%) | 1 (8.3)¶ | 0 (0.0) |
| Patients with ≥1 serious TEAE of infection#, n (%) | 0 (0.0) | 1 (14.3) |
| Thromboembolic events, n | 0 | 0 |
| Discontinuation due to TEAE, n | 0 | 0 |
| Deaths, n | 0 | 0 |
TEAEs with an investigator’s causality assessment of “possible” or “probable” are considered “related.”
Infusion-related reaction (n = 2), thrombocytosis, nausea, feeling cold, pain, alanine aminotransferase increased, antinuclear antibody positive, migraine, insomnia, nightmare, and pruritus (n = 1).
Infusion site pain, bronchitis bacterial, viral upper respiratory tract infection, infusion-related reaction, arthralgia, headache, and erythema nodosum.
Thrombocytopenia, dural arteriovenous fistula, migraine, and petechiae (n = 1).
Diverticulitis in patient with a history of diverticulum.
Migraine.
Infections are defined as all events within the system organ class of infections and infestations.