Number of patients with BIBF 1120–related adverse events occurring in >5% of patients
| Adverse event* | Maximum grade (CTC) | BIBF 1120 | |||
|---|---|---|---|---|---|
| Once daily | Twice daily | ||||
| First, n (%) | All courses, n (%) | First, n (%) | All courses, n (%) | ||
| All patients | 25 | 25 | 36 | 36 | |
| Patients with adverse event | 21 (84) | 24 (96) | 30 (83.3) | 33 (91.7) | |
| Nausea | 1 | 13 (52) | 13 (52) | 17 (47.2) | 19 (52.8) |
| 2 | 4 (16) | 5 (20) | 2 (5.6) | 3 (8.3) | |
| 3 | 0 | 0 | 2 (5.6) | 2 (5.6) | |
| Vomiting | 1 | 7 (28) | 9 (36) | 10 (27.8) | 15 (41.7) |
| 2 | 3 (12) | 3 (12) | 0 | 0 | |
| 3 | 0 | 0 | 1 (2.8) | 1 (2.8) | |
| Diarrhea | 1 | 6 (24) | 6 (24) | 9 (25) | 13 (36.1) |
| 2 | 5 (20) | 6 (24) | 1 (2.8) | 1 (2.8) | |
| 3 | 0 | 0 | 0 | 1 (2.8) | |
| Dyspepsia | 1 | 2 (8) | 2 (8) | 0 | 2 (5.6) |
| Anorexia | 1 | 0 | 2 (8) | 0 | 0 |
| Abdominal pain | 2 | 2 (8) | 2 (8) | 0 | 0 |
| Fatigue | 1 | 2 (8) | 3 (12) | 4 (11.1) | 4 (11.1) |
| 2 | 0 | 0 | 4 (11.1) | 5 (13.9) | |
| Dizziness | 1 | 0 | 0 | 4 (11.1) | 5 (13.9) |
| Pruritus | 1 | 0 | 4 (16) | 0 | 0 |
| Urticaria | 1 | 0 | 0 | 0 | 2 (5.6) |
| Hepatic enzyme elevation†‡ | 2 | 1 (4) | 1 (4) | 0 | 0 |
| 3 | 3 (12) | 3 (12) | 0 | 0 | |
| 4 | 1 (4) | 1 (4) | 1 (2.8) | 1 (2.8) | |
| ALT increase† | 2 | 0 | 0 | 1 (2.8) | 1 (2.8) |
| 3 | 0 | 0 | 1 (2.8) | 2 (5.6) | |
| AST increase† | 2 | 0 | 0 | 1 (2.8) | 0 |
| 3 | 1 (4) | 2 (8) | 1 (2.8) | 1 (2.8) | |
| γ-GT increase† | 2 | 0 | 0 | 1 (2.8) | 1 (2.8) |
| 3 | 1 (4) | 1 (4) | 1 (2.8) | 2 (5.6) | |
| CD4 lymphocytes decreased† | 3 | 1 (4) | 4 (16) | 2 (5.6) | 2 (5.6) |
| Hypertension† | 1 | 0 | 0 | 0 | 2 (5.6) |
| 2 | 1 (4) | 1 (4) | 0 | 0 | |
| 3 | 0 | 1 (4) | 0 | 0 | |
| Headache | 1 | 0 | 2 (8) | 2 (5.6) | 2 (5.6) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; γ-GT, γ glutamyl transpeptidase.
↵*Preferred terms.
↵†Number of patients with adverse events occurring in >1% of patients. Presented is the highest ever reached CTC grade. The same patient may have experienced more than one event.
↵‡Hepatic enzyme elevation describes the following cases that were presented under the respective highest CTC grade. Twice daily cohort: one patient had AST of grade 4 and ALT + γGT grade 3. Once daily cohort: one patient had ALT+AST of grade 4 +γGT grade 3, one patient had ALT+γGT of grade 3, one patient had AST+γGT of grade 3, one patient had ALT+AST of grade 3 and one patient had ALT of grade 2.