Table 3. Relevant nonhaematologic and haematologic treatment-emergent adverse events occurring with an incidence of 10% or more.
|
Aflibercept, 4 mg kg−1, n=6 |
Aflibercept, 5 mg kg−1, n=7 |
Aflibercept, 6 mg kg−1, n=17 |
||||
|---|---|---|---|---|---|---|
| AE, n (%) | Grade 3/4 | All grade | Grade 3/4 | All grade | Grade 3/4 | All grade |
| Any AE | 6 (100.0) | 6 (100.0) | 5 (71.4) | 7 (100.0) | 16 (94.1) | 17 (100.0) |
| Nonhaematologic | ||||||
| Asthenia/fatigue | 1 | 6 (100) | 0 | 7 (100) | 5 (29.4) | 17 (100.0) |
| Epistaxis | 0 | 6 (100.0) | 0 | 7 (100.0) | 0 | 12 (70.6) |
| Stomatitis | 0 | 5 (83.3) | 2 (28.6) | 6 (85.7) | 4 (23.5) | 12 (70.6) |
| Nausea | 1 (16.7) | 5 (83.3) | 0 | 6 (85.7) | 1 (5.9) | 11 (64.7) |
| Dysphonia | 0 | 4 (66.7) | 0 | 6 (85.7) | 0 | 11 (64.7) |
| Diarrhoea | 1 (16.7) | 5 (83.3) | 0 | 5 (71.4) | 0 | 8 (47.1) |
| Vomiting | 1 (16.7) | 6 (100.0) | 0 | 5 (71.4) | 0 | 7 (41.2) |
| Headache | 0 | 3 (50.0) | 0 | 5 (71.4) | 1 (5.9) | 9 (52.9) |
| Hypertension | 1 (16.7) | 4 (66.7) | 2 (28.6) | 6 (85.7) | 2 (11.8) | 5 (29.4) |
| Alopecia | 0 | 1 (16.7) | 0 | 4 (57.1) | 0 | 7 (41.2) |
| Abdominal pain | 0 | 3 (50.0) | 0 | 2 (28.6) | 1 (5.9) | 5 (29.4) |
| Nail disorder | 0 | 1 (16.7) | 1 (14.3) | 4 (57.1) | 0 | 5 (29.4) |
| Haematologic | ||||||
| Lymphopenia | 4 (66.7) | 6 (100.0) | 3 (42.9) | 7 (100.0) | 5 (29.4) | 14 (82.4) |
| Anaemia | 1 (16.7) | 6 (100.0) | 0 | 7 (100.0) | 0 | 14 (82.4) |
| Thrombocytopenia | 1 (16.7) | 5 (83.3) | 1 (14.3) | 6 (85.7) | 2 (11.8) | 12 (70.6) |
| Neutropenia | 6 (100.0) | 6 (100.0) | 3 (42.9) | 4 (57.1) | 4 (23.5) | 8 (47.1) |
| Leucopenia | 5 (83.3) | 6 (100.0) | 2 (28.6) | 3 (42.9) | 3 (17.6) | 7 (41.2) |
| Urinalysis | ||||||
| Proteinuria | 0 | 3 (50.0) | 0 | 3 (42.9) | 1 (5.9) | 10 (58.8) |
Abbreviation: AE=adverse event.