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. 2020 Jun 27;43(10):1045–1055. doi: 10.1007/s40264-020-00964-x

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