Table 4.
Liver-related onapristone extended-release treatment-emergent adverse events (TEAEs) [all grades] in the safety dataset (n = 88)
| Overall (AR18-CT-101 + AR18-CT-102) | Without abiraterone/prednisone | With abiraterone/prednisone | Without liver metastases | With liver metastases | Without bone metastases | With bone metastases | |
|---|---|---|---|---|---|---|---|
| TEAE | (N = 88) n (%) |
(N = 73) n (%) |
(N = 15) n (%) |
(N = 63) n (%) |
(N = 25) n (%) |
(N = 46) n (%) |
(N = 42) n (%) |
| Hepatobiliary disorders | 1 (1.1) | 1 (1.4) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 1 (2.4) |
| Hepatocellular injury | 1 (1.1) | 1 (1.4) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 1 (2.4) |
| ALT increased | 9 (10.2) | 8 (11.0) | 1 (6.7) | 4 (6.3) | 5 (20.0) | 3 (6.5) | 6 (14.3) |
| AST increased | 11 (12.5) | 11 (15.1) | 0 (0.0) | 6 (9.5) | 5 (20.0) | 3 (6.5) | 8 (19.0) |
| Blood bilirubin increased | 3 (3.4) | 3 (4.1) | 0 (0.0) | 1 (1.6) | 2 (8.0) | 1 (2.2) | 2 (4.8) |
| Conjugated bilirubin increased | 2 (2.3) | 1 (1.4) | 1 (6.7) | 2 (3.2) | 0 (0.0) | 2 (4.3) | 0 (0.0) |
| Blood ALP increased | 6 (6.8) | 5 (6.8) | 1 (6.7) | 1 (1.6) | 5 (20.0) | 1 (2.2) | 5 (11.9) |
| GGT increased | 14 (15.9) | 13 (17.8) | 1 (6.7) | 6 (9.5) | 8 (32.0) | 4 (8.7) | 10 (23.8) |
Safety population = all subjects who receive at least one dose of onapristone. N = number of subjects in the safety population and subgroup. n = number of subjects with an event. Related adverse events = related to onapristone for AR18-CT-101 and AR18-CT-102 or abiraterone/prednisone for AR18-CT-102. Studies: AR18-CT-101 and AR18-CT-102
ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, GGT gamma-glutamyl transpeptidase