Adverse events (≥10% incidence) related to BIBF 1120 in all treatment courses
| BIBF 1120 dose | 150 bid (N = 3) | 200 bid (N = 12) | 250 bid (N = 6) | Total (N = 21) | ||||
|---|---|---|---|---|---|---|---|---|
| CTCAE grade | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | All | |
| N | N | N | N | N | N | N | (%) | |
| ALT increased | 0 | 0 | 4 | 4 | 3 | 2 | 13 | 61.9 |
| AST increased | 0 | 0 | 6 | 2 | 3 | 1 | 12 | 57.1 |
| γ-GT increased | 0 | 0 | 4 | 4 | 2 | 2 | 12 | 57.1 |
| Vomiting | 1 | 0 | 9 | 0 | 2 | 0 | 12 | 57.1 |
| Anorexia | 1 | 0 | 8 | 0 | 2 | 0 | 11 | 52.4 |
| Fatigue | 2 | 0 | 6 | 0 | 2 | 1 | 11 | 52.4 |
| ALP increased | 0 | 0 | 5 | 1 | 3 | 0 | 9 | 42.9 |
| Nausea | 1 | 0 | 5 | 0 | 2 | 0 | 8 | 38.1 |
| Diarrhea | 0 | 0 | 5 | 0 | 2 | 0 | 7 | 33.3 |
| Hemoptysis | 1 | 0 | 3 | 0 | 0 | 0 | 4 | 19.0 |
| Upper abdominal pain | 1 | 0 | 1 | 0 | 2 | 0 | 4 | 19.0 |
| Weight decreased | 0 | 0 | 4 | 0 | 0 | 0 | 4 | 19.0 |
| Abdominal pain | 1 | 0 | 2 | 0 | 0 | 0 | 3 | 14.3 |
| Hypertension | 1 | 1 | 1 | 0 | 0 | 0 | 3 | 14.3 |
| Rash | 0 | 0 | 2 | 0 | 1 | 0 | 3 | 14.3 |
| Proteinuria | 1 | 0 | 2 | 0 | 0 | 0 | 3 | 14.3 |
| LDH increased | 0 | 0 | 2 | 0 | 1 | 0 | 3 | 14.3 |
NOTE: Presented is the highest ever reached CTCAE grade. One patient may have experienced >1 event.
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; bid, twice daily; γ-GT, γ–glutamyl transferase; ALP, alkaline phosphatase; LDH, lactate dehydrogenase.