Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Summary of the clinical safety data in Study 002 and Study 001
| Adverse event type | Study 002 (n = 21), n (%) | Study 001 (n = 9), n (%) |
|---|---|---|
| All adverse events | 21 (100) | 9 (100) |
| Adverse events of grade 3 or higher | 18 (85.7) | 3 (33.3) |
| Adverse events leading to death | 0 | 0 |
| Serious adverse events | 1 (4.8) | 1 (11.1) |
| Adverse events leading to treatment discontinuation | 0 | 0 |
