Table 3.
Adverse events occurring in more than one subject in studies I and II by treatment
| Adverse event | Study I
|
Study II
|
|||||
|---|---|---|---|---|---|---|---|
| Treatment A (N=19) |
Treatment B (N=20) |
Treatment C (N=20) |
Treatment D (N=20) |
Treatment A (N=22) |
Treatment B (N=24) |
Treatment C (N=23) |
|
| Fatigue | 18 (94.7) 19 | 16 (80.0) 17 | 18 (90.0) 19 | 12 (60.0) 14 | 19 (86.4) 29 | 14 (58.3) 17 | 18 (78.3) 23 |
| Somnolence | 15 (78.9) 41 | 17 (85.0) 37 | 13 (65.0) 32 | 16 (80.0) 38 | 17 (77.3) 17 | 9 (37.5) 9 | 20 (83.3) 39 |
| Headache | 6 (31.6) 8 | 9 (45.0) 11 | 9 (45.0) 10 | 8 (40.0) 10 | 4 (18.2) 5 | 5 (20.8) 6 | 6 (26.1) 10 |
| Vertigo | 1 (5.3) 1 | 0 (0.0) 0 | 1 (5.0) 1 | 2 (10.0) 2 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 |
| Abnormal dreams | 0 (0.0) 0 | 1 (5.0) 1 | 0 (0.0) 0 | 1 (5.0) 1 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 |
| Nausea | 1 (5.3) 1 | 0 (0.0) 0 | 1 (5.0) 1 | 1 (5.0) 1 | 1 (4.5) 1 | 1 (4.2) 1 | 1 (4.3) 2 |
Notes: Numbers indicate in order: number of subjects, (%), and event count; study I treatments: (A) a single 200 mg dose of a tablet formulation with increased crystal size administered as 2×100 mg, (B) a single 200 mg dose of a tablet formulation with increased crystal size and excipients in the extra-granular phase administered as 2×100 mg, (C) a single 200 mg dose of the old formulation used in previous studies administered as 2×100 mg, and (D) a single 200 mg dose of a tablet formulation with increased crystal size and excipients in the extra-granular phase administered as one 200 mg tablet. Study II treatments: (A) a single 200 mg dose of a tablet formulation with increased crystal size and excipients in the extra-granular phase administered as 2×100 mg (same as treatment B in study I); (B) 25 mg of a liquid-filled hard gelatin capsule; (C) 50 mg of a liquid-filled hard gelatin capsule administered as 2×25 mg capsules.