Table 3.

Adverse events (≥10% incidence) related to BIBF 1120 in all treatment courses

BIBF 1120 dose150 bid (N = 3)200 bid (N = 12)250 bid (N = 6)Total (N = 21)
CTCAE grade1/23/41/23/41/23/4All
NNNNNNN(%)
ALT increased0044321361.9
AST increased0062311257.1
γ-GT increased0044221257.1
Vomiting1090201257.1
Anorexia1080201152.4
Fatigue2060211152.4
ALP increased005130942.9
Nausea105020838.1
Diarrhea005020733.3
Hemoptysis103000419.0
Upper abdominal pain101020419.0
Weight decreased004000419.0
Abdominal pain102000314.3
Hypertension111000314.3
Rash002010314.3
Proteinuria102000314.3
LDH increased002010314.3

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.