Table 2.

Number of patients with BIBF 1120–related adverse events occurring in >5% of patients

Adverse event*Maximum grade (CTC)BIBF 1120
Once dailyTwice daily
First, n (%)All courses, n (%)First, n (%)All courses, n (%)
All patients25253636
Patients with adverse event21 (84)24 (96)30 (83.3)33 (91.7)
Nausea113 (52)13 (52)17 (47.2)19 (52.8)
24 (16)5 (20)2 (5.6)3 (8.3)
3002 (5.6)2 (5.6)
Vomiting17 (28)9 (36)10 (27.8)15 (41.7)
23 (12)3 (12)00
3001 (2.8)1 (2.8)
Diarrhea16 (24)6 (24)9 (25)13 (36.1)
25 (20)6 (24)1 (2.8)1 (2.8)
30001 (2.8)
Dyspepsia12 (8)2 (8)02 (5.6)
Anorexia102 (8)00
Abdominal pain22 (8)2 (8)00
Fatigue12 (8)3 (12)4 (11.1)4 (11.1)
2004 (11.1)5 (13.9)
Dizziness1004 (11.1)5 (13.9)
Pruritus104 (16)00
Urticaria10002 (5.6)
Hepatic enzyme elevation21 (4)1 (4)00
33 (12)3 (12)00
41 (4)1 (4)1 (2.8)1 (2.8)
ALT increase2001 (2.8)1 (2.8)
3001 (2.8)2 (5.6)
AST increase2001 (2.8)0
31 (4)2 (8)1 (2.8)1 (2.8)
γ-GT increase2001 (2.8)1 (2.8)
31 (4)1 (4)1 (2.8)2 (5.6)
CD4 lymphocytes decreased31 (4)4 (16)2 (5.6)2 (5.6)
Hypertension10002 (5.6)
21 (4)1 (4)00
301 (4)00
Headache102 (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.