Adverse events: | Camicinal | |||
---|---|---|---|---|
Placebo | 50 mg | 75 mg | Total | |
n = 12 | n = 15 | n = 6 | n = 33 | |
n (%) | n (%) | n (%) | n (%) | |
No. subjects with any AE | 9 (75) | 12 (80) | 5 (83) | 26 (79) |
Most frequent AEs (≥2 subjects in any single group) | ||||
Gamma-glutamyltransferase increased | 4 (33) | 0 | 2 (33) | 6 (18) |
Oral candidiasis | 0 | 2 (13) | 1 (17) | 3 (9) |
Blood alkaline phosphatase increased | 2 (17) | 0 | 1 (17) | 3 (9) |
Decubitus ulcer | 1 (8) | 0 | 2 (33.) | 3 (9) |
Constipation | 1 (8) | 2 (13) | 0 | 3 (9) |
Vomiting | 2 (17) | 1 (7) | 0 | 3 (9) |
Diarrhea | 2 (17) | 0 | 0 | 2 (6) |
Liver function test abnormal | 0 | 2 (13) | 0 | 2 (6) |
Supraventricular tachycardia | 0 | 2 (13) | 0 | 2 (6) |