Table 3.
The most common (≥ 10%) treatment-emergent adverse events by treatment arm
| Adverse event | Etirinotecan pegol (n = 42) | Irinotecan (n = 41) | ||
|---|---|---|---|---|
| No. | % | No. | % | |
| Patients with ≥ 1 TEAE | 42 | 100 | 41 | 100 |
| Diarrhea | 26 | 62 | 31 | 76 |
| Nausea | 23 | 55 | 24 | 59 |
| Vomiting | 18 | 43 | 21 | 51 |
| Fatigue | 20 | 48 | 18 | 44 |
| Abdominal pain | 18 | 43 | 14 | 34 |
| Alopecia | 7 | 17 | 24 | 59 |
| Anorexia | 13 | 31 | 10 | 24 |
| Constipation | 12 | 29 | 10 | 24 |
| Weight decreased | 13 | 31 | 6 | 15 |
| Dehydration | 6 | 14 | 8 | 20 |
| Dizziness | 7 | 17 | 7 | 17 |
| Neutropeniaa | 11 | 26 | 12 | 29 |
| Hypokalemia | 9 | 21 | 4 | 10 |
| Anemia | 6 | 14 | 6 | 15 |
| Pyrexia | 4 | 10 | 7 | 17 |
| Asthenia | 7 | 17 | 3 | 7 |
| Upper abdominal pain | 5 | 12 | 4 | 10 |
| Decreased hemoglobin | 2 | 5 | 6 | 15 |
| Hyponatremia | 5 | 12 | 3 | 7 |
| Lethargy | 3 | 7 | 5 | 12 |
| Leukopenia | 5 | 12 | 2 | 5 |
| Abdominal distention | 1 | 2 | 5 | 12 |
| Headache | 5 | 12 | 1 | 2 |
| Blurred vision | 5 | 12 | 1 | 2 |
| Anxiety | 5 | 12 | 0 | 0 |
TEAE treatment-emergent adverse events
Includes neutropenia, decreased neutrophils, and febrile neutropenia