Table 4.
Incidence of SAEs (>1 patient) by cohort type (combined primary and extension studies)
| Idela + R (n = 32) | Idela + B (n = 33) | Idela + BR (n = 14) | Total (n = 79) | |
|---|---|---|---|---|
| SAE, n (%) | 14 (44) | 23 (70) | 11 (79) | 48 (61) |
| Pneumonia | 3 (9) | 9 (27) | 1 (7) | 13 (16) |
| Pyrexia | 0 | 7 (21) | 4 (29) | 11 (14) |
| Diarrhea/colitis | 2 (6) | 3 (9) | 2 (14) | 7 (9) |
| Febrile neutropenia | 0 | 5 (15) | 0 | 5 (6) |
| Rash | 1 (3) | 1 (3) | 4 (29) | 6 (8) |
| Renal failure, acute | 2 (6) | 1 (3) | 0 | 3 (4) |
| Sepsis | 0 | 4 (12) | 1 (7) | 5 (6) |
| Atrial fibrillation | 0 | 0 | 2 (14) | 2 (2.5) |
| Cardiac arrest | 2 (6) | 0 | 0 | 2 (2.5) |
| Herpes zoster | 1 (3) | 1 (3) | 0 | 2 (2.5) |
| Pneumonitis | 0 | 2 (6) | 0 | 2 (2.5) |
| Vomiting | 0 | 1 (3) | 1 (7) | 2 (2.5) |
SAEs classified by PT using MedDRA, version 15.1. Patients who experienced multiple events within the same PT were counted once per PT.