Table 5.
TEAEs (safety population)
| Category | Total (N = 21) |
|
|---|---|---|
| Participants n (%) |
Events n |
|
| TEAEs | ||
| All TEAEs | 20 (95.2) | 126 |
| Study drug-related TEAEs | 1 (4.8) | 1 |
| TEAEs by maximum severitya | ||
| All TEAEs | ||
| Mild (CTCAE Grade 1) | 4 (19.0) | 4 |
| Moderate (CTCAE Grade 2) | 3 (14.3) | 8 |
| Severe (CTCAE Grade 3) | 5 (23.8) | 8 |
| Life-threatening (CTCAE Grade 4) | 3 (14.3) | 3 |
| Death (CTCAE Grade 5) | 5 (23.8) | 5 |
| Study drug-related TEAEs | ||
| Moderate (CTCAE Grade 2) | 1 (4.8) | 1 |
| SAEs | ||
| All SAEs | 9 (42.9) | 19 |
| Study drug-related SAEs | 0 (0.0) | 0 |
| TEAEs leading to discontinuation of drug | ||
| All TEAEs | 3 (14.3) | 3 |
| Study drug-related TEAEs | 0 | 0 |
| AEs leading to discontinuation of study | ||
| All AEs | 5 (23.8) | 5 |
| Study drug-related TEAEs | 0 | 0 |
Percentages were calculated using the number of participants in the column heading as the denominator. TEAEs were defined as AEs occurring on or after the first dose of study drug. AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; SAE, serious adverse event; TEAE, treatment-emergent adverse event.
Both participants and events are listed by maximum severity.