Table 4.
Treatment-Related Adverse Events for Which at Least One Patient Experienced a Grade 3 or Higher Event
| Adverse event | No. of Grade ≥ 3 Events by Treatment Arm |
|||||
|---|---|---|---|---|---|---|
| Arm A: Ziv-Aflibercept + Topotecan (n = 93) |
Arm B: Topotecan (n = 87) |
|||||
| 3 | 4 | 5 | 3 | 4 | 5 | |
| Hematologic | ||||||
| Hemoglobin | 8 | 1 | 0 | 6 | 0 | 0 |
| Hemolysis | 1 | 0 | 0 | 1 | 0 | 0 |
| Leukocytes | 15 | 2 | 0 | 18 | 3 | 0 |
| Lymphopenia | 4 | 1 | 0 | 12 | 0 | 0 |
| Neutrophils | 27 | 3 | 0 | 17 | 5 | 0 |
| Platelets | 20 | 10 | 0 | 14 | 3 | 0 |
| Maximum grade any hematologic adverse event | 38 | 14 | 0 | 37 | 8 | 0 |
| Nonhematologic | ||||||
| Cardiac, general | 2 | 1 | 0 | 0 | 0 | 0 |
| Coagulation | 1 | 0 | 0 | 0 | 0 | 0 |
| Constitutional symptoms | 14 | 1 | 0 | 3 | 0 | 0 |
| Gastrointestinal | 9 | 1 | 0 | 2 | 1 | 0 |
| Hemorrhage/bleeding | 5 | 0 | 1 | 0 | 0 | 0 |
| Infection | 3 | 1 | 0 | 1 | 1 | 2 |
| Metabolic/laboratory | 9 | 2 | 0 | 5 | 0 | 0 |
| Musculoskeletal/soft tissue | 3 | 0 | 0 | 1 | 0 | 0 |
| Neurology | 4 | 1 | 0 | 2 | 0 | 0 |
| Pain | 6 | 0 | 0 | 0 | 0 | 0 |
| Pulmonary/upper respiratory | 8 | 0 | 0 | 2 | 1 | 0 |
| Renal/genitourinary | 0 | 0 | 0 | 1 | 0 | 1 |
| Syndromes | 0 | 1 | 0 | 0 | 0 | 0 |
| Vascular | 1 | 1 | 0 | 0 | 0 | 0 |
| Maximum grade any nonhematologic adverse event | 32 | 7 | 1 | 7 | 2 | 3 |
| Maximum grade any adverse event | 45 | 19 | 1 | 37 | 10 | 3 |