Table 2.
Summary of Adverse Events
| Adverse events, number of participants (%)* | Part A, single ascending dose cohorts | Part B, multiple ascending dose cohorts | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=12) | 10 mg (n=6) | 30 mg (n=6) | 90 mg (n=6) | 250 mg (n=6) | 500 mg (n=6) | 500 mg Japanese (n=6) | Total (n=48) | Placebo (n=10) | 90 mg (n=10) | 150 mg (n=10) | 250 mg (n=10) | Total (n=40) | |
| Any | 6 (50.0) | 2 (33.3) | 5 (83.3) | 3 (50.0) | 3 (50.0) | 4 (66.7) | 5 (83.3) | 28 (58.3) | 7 (70.0) | 7 (70.0) | 6 (60.0) | 9 (90.0) | 29 (72.5) |
| Any treatment‐related | 2 (16.7) | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 4 (8.3) | 2 (20.0) | 2 (20.0) | 0 | 0 | 4 (10.0) |
| ≥Grade 3 severity | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (12.5) | 1 (10.0) | 0 | 0 | 1 (10.0) | 2 (5.0) |
| Leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (12.5) | 1 (10.0) | 0 | 1 (10.0) | 1 (10.0) | 3 (7.5) |
| Serious and ≥ grade 3 severity | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (12.5) | 1 (10.0) | 0 | 1 (10.0) | 1 (10.0) | 3 (7.5) |
| Serious and related to MEDI6570 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Leading to study discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
*
Patients are counted once per category regardless of the number of events.