TABLE 3.
Adverse AEs per Patient Reported During Treatment in Phase 1 Trials
| Characteristic | Women With Gynecologic Cancer (n = 685) |
Women With Nongynecologic Cancer (n = 1698) |
Men With Cancer (n = 1886) |
|---|---|---|---|
| No. of AEs | |||
| Average AEs at baseline | 7.0 | 7.4 | 7.0 |
| Average AEs on treatment | 17.1 | 14.7 | 13.5 |
| AEs (on treatment only) | |||
| Attributable to drug | 8.31 | 6.86 | 6.20 |
| Not attributable to drug | 8.76 | 7.79 | 7.32 |
| Grade of AEs (on treatment only) | |||
| 1 | 10.13 | 8.41 | 7.89 |
| 2 | 4.64 | 3.95 | 3.51 |
| 3-5 | 2.30 | 2.30 | 2.10 |
| Grade of AEs (on treatment only and attributable to drug) | |||
| 1 | 4.76 | 3.94 | 3.65 |
| 2 | 2.36 | 1.82 | 1.61 |
| 3-5 | 1.19 | 1.10 | 0.94 |
| Categories of AEs (on treatment only) | |||
| Abdominal-related AEsa | 5.54 | 4.49 | 4.26 |
| Myelosuppression | 2.06 | 1.76 | 1.50 |
| Electrolyte derangement (Na, K, Mg) | 0.86 | 0.71 | 0.62 |
| Liver enzyme derangement | 0.83 | 0.95 | 1.00 |
| Genitourinary AEs | 0.54 | 0.32 | 0.39 |
| Infection | 0.52 | 0.38 | 0.34 |
Abbreviation: AE, adverse event.
a
These AEs include nausea, vomiting, constipation, diarrhea, abdominal pain, and so forth.