Table 3. Grade ≥ 3 (CTCAE) TEAEs in > 1 patient.
Onapristone Dose | |||||||
---|---|---|---|---|---|---|---|
Preferred Term | Overall (N = 52) n (%) |
10 mg BID (N = 12 a) n (%) |
20 mg BID (N = 12 a) n (%) |
30 mg BID (N = 6) n (%) |
40 mg BID (N = 10) n (%) |
50 mg BID (N = 6) n (%) |
100 mg QD (N = 6) n (%) |
Any Grade ≥ 3 TEAE | 30 (58) | 8 (67) | 7 (58) | 3 (50) | 6 (60) | 3 (50) | 3 (50) |
GGT increase | 13 (25) | 5 (42) | 2 (17) | 2 (33) | 3 (30) | 1 (17) | 0 |
Asthenia | 4 (8) | 0 | 2 (17) | 0 | 1 (10) | 0 | 1 (17) |
ALP increase | 4 (8) | 1 (8) | 1 (8) | 0 | 2 (20) | 0 | 0 |
AST increase | 3 (6) | 2 (17) | 1 (8) | 0 | 0 | 0 | 0 |
ALT increase | 2 (4) | 1 (8) | 1 (8) | 0 | 0 | 0 | 0 |
Bilirubin increase | 2 (4) | 1 (8) | 0 | 0 | 1 (10) | 0 | 0 |
Disease progression | 2 (4) | 0 | 1 (8) | 0 | 1 (10) | 0 | 0 |
Peripheral edema | 2 (4) | 1(8) | 0 | 0 | 1 (10) | 0 | 0 |
Pyrexia | 2 (4) | 0 | 2 (17) | 0 | 0 | 0 | 0 |
a. 1 patient randomized to 20mg was treated at 10mg BID and is included in all data tables as being at the 10mg dose level