Table 2.
Drug-related adverse events reported by investigator
| AEs (N = 21a,b) | N (%) |
|---|---|
| Any drug-related AEc | 19 (90) |
| Proteinuria | 10 (48) |
| Diarrhea | 8 (38) |
| Nausea | 6 (29) |
| Vomiting | 4 (19) |
| Decreased appetite | 2 (10) |
| Dupuytren’s contracture | 2 (10) |
| Rash, maculo-papular | 2 (10) |
| Abdominal pain upper | 1 (5) |
| Anemia | 1 (5) |
| AST increased | 1 (5) |
| Back pain | 1 (5) |
| Blood bilirubin increased | 1 (5) |
| Blood creatinine increased | 1 (5) |
| Dehydration | 1 (5) |
| Erectile dysfunction | 1 (5) |
| Fatigue | 1 (5) |
| Inguinal hernia | 1 (5) |
AE adverse event, AST aspartate aminotransferase
aSafety was evaluated in all patients who had received at least one dose of BI 853520
bIncludes patients in the BI 853520 200 mg expansion cohort
cDrug-related AEs were all of grade 1 or 2 severity, except for one case of grade 3 proteinuria in a patient in the 200 mg expansion cohort