Table 4 Summary of ADRs by treatment, SOC, and PT: MAD study
SOC and PT | Dose group | Total (N = 32) n (%) [F] | ||
|---|---|---|---|---|
480 mg (N = 6) n (%) [F] | 960 mg (N = 6) n (%) [F] | Placebo (N = 8) n (%) [F] | ||
Subjects with AEs | 5 (83.3) [6] | 1 (16.7) [2] | 6 (37.5) [8] | |
Investigations | 4 (66.7) [4] | 4 (25.0) [4] | ||
Blood triglycerides increased | 1 (16.7) [1] | 1 (6.3) [1] | ||
Blood creatine phosphokinase increased | 3 (50.0) [3] | 3 (18.8) [3] | ||
Gastrointestinal disorders | 1 (16.7) [2] | 1 (6.3) [2] | ||
Diarrhea | 1 (16.7) [1] | 1 (6.3) [1] | ||
Abdominal pain | 1 (16.7) [1] | 1 (6.3) [1] | ||
Skin and subcutaneous tissue disorder | 1 (16.7) [2] | 1 (6.3) [2] | ||
Hyperhidrosis | 1 (16.7) [1] | 1 (6.3) [1] | ||
Pruritus | 1 (16.7) [1] | 1 (6.3) [1] | ||