Table 3.
Summary of adverse events (full analysis set)
| Event | VITAL (N = 9), n (%) |
CL08 (N = 10), n (%) |
|---|---|---|
| Any TEAE | 9 (100) | 10 (100) |
| Mild or moderate TEAEs | 0 (0) | 3 (30) |
| Any treatment-related or possibly related TEAE | 6 (67) | 8 (80) |
| Any SAE | 9 (100) | 10 (100) |
| Any treatment-related or possibly related SAE | 1 (11) | 5 (50) |
| Any IAR | 5 (56) | 8 (80) |
| Mild or moderate IARs | 5 (56) | 6 (60) |
| Dose modification due to a TEAEa | 7 (78) | 7 (70) |
| Discontinuation due to a TEAE | 0 (0) | 0 (0) |
| Death | 4 (44) | 2 (20) |
IAR infusion-associated reaction, SAE serious adverse event, TEAE treatment-emergent adverse event
aIncludes dose increases, dose decreases, drug interruptions, and study drug withdrawal