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.
Adverse events observed during follow-up.
| Category | Overall number of AEs (number of individuals) | Rate of AEs: AEs/number of cycles |
|---|---|---|
| All toxicities | ||
| SAEs | 104 (46) | 0.29 |
| Grade | ||
| 5 | 5 (5) | 0.014 |
| 4 | 4 (45) | 0.011 |
| 3 | 436 (64) | 1.20 |
| 2 | 876 (70) | 2.42 |
| 1 | 1732 (71) | 4.78 |
| Toxicities related to study medicationa | ||
| SAEs | 18 (8) | 0.05 |
| Grade | ||
| 5 | 0 | 0 |
| 4 | 0 | 0 |
| 3 | 42 (19) | 0.12 |
| 2 | 91 (32) | 0.25 |
| 1 | 166 (47) | 0.46 |
aDesignated as definitely, probably or possibly related to any of the study medications
