Table 3 Abnormal renal and liver function and serious adverse events
R+ ≤ 100 mg (n = 38) | R+ 101–200 mg (n = 46) | R+ > 200 mg (n = 48) | P value | |
Liver and renal function adverse events | ||||
GGT | 10 (26.3) | 12 (26.1) | 8 (16.7) | 0.45 |
ALP | 3 (7.9) | 1 (2.2) | 4 (8.3) | 0.39 |
AST | 4 (10.5) | 3 (6.5) | 0 (0) | 0.09 |
ALT | 3 (7.9) | 4 (8.7) | 8 (16.7) | 0.35 |
CrCL increase > 20% | 6 (15.8) | 5 (10.9) | 8 (16.7) | 0.70 |
CrCL decrease > 20% | 11 (28.9) | 9 (19.6) | 14 (29.2) | 0.49 |
Serious adverse events | ||||
R+ ≤ 100 mg (n = 38) | R+ 101–200 mg (n = 46) | R+ > 200 mg (n = 48) | Total | |
Cardiac disorders | 1 | 4 (4) | 4 (3) | 9 |
Gastrointestinal disorders | 1 | 2 (2) | 3 (3) | 6 |
General disorders | 1 | 2 (2) | 3 | |
Hepatobiliary disorders | 1 | 1 | ||
Infections and infestations | 3 (3) | 3 (3) | 6 | |
Injury, poisoning and procedural complications | 1 | 1 | 2 (2) | 4 |
Investigations | 1 | 1 | ||
Metabolism and nutrition | 1 | 1 | ||
Musculoskeletal | 3 (2) | 3 | ||
Nervous system disorders | 3 (2) | 3 | ||
Psychiatric disorders | 1 | 1 | ||
Renal and urinary disorders | 2 (2) | 2 | ||
Respiratory | 1 | 1 | ||
Skin | 1 | 1 | ||
Total number of events (number of participants (% of participants)) | 8 (4 (10.5%)) | 18 (8 (17.4%)) | 16 (10 (20.8%)) | 42 |