Table 2.
Incidence of adverse events reported by more than 5% in the DON-DON10 group over time (SAS)
| DON-DON10 group (DON5-DON10 a and DON10-DON10) | ||||||
|---|---|---|---|---|---|---|
| AE | Treatment-related AE b | |||||
| AE | Week 1–12 | >Week 12–24 | >Week 24–36 | >Week 36 | 52 weeks | 52 weeks |
| ( n = 96) | ( n = 75) | ( n = 72) | ( n = 69) | ( n = 96) | ( n = 96) | |
| n (%) | n (%) | |||||
| Total number of incidents | 65 | 15 | 7 | 3 | 90 (93.8) | 46 (47.9) |
| Constipation | 0 | 2 | 0 | 3 | 5 (5.2) | 2 (2.1) |
| Diarrhea | 2 | 1 | 1 | 2 | 6 (6.3) | 1 (1.0) |
| Nausea | 4 | 1 | 0 | 0 | 5 (5.2) | 3 (3.1) |
| Nasopharyngitis | 6 | 4 | 4 | 3 | 17 (17.7) | 0 |
| Contusion | 1 | 2 | 1 | 3 | 7 (7.3) | 0 |
| Blood creatine phosphokinase increased | 2 | 1 | 0 | 2 | 5 (5.2) | 0 |
| Glucose urine present | 2 | 2 | 1 | 0 | 5 (5.2) | 0 |
| Decreased appetite | 5 | 1 | 0 | 0 | 6 (6.3) | 4 (4.2) |
| Muscle spasms | 3 | 2 | 0 | 0 | 5 (5.2) | 1 (1.0) |
| Parkinsonism | 6 | 1 | 3 | 2 | 12 (12.5) | 10 (10.4) |
| Insomnia | 2 | 2 | 2 | 0 | 6 (6.3) | 4 (4.2) |
SAS, safety analysis set; AE, adverse event.
aTreatment with 10 mg started from Week 24.
bAEs for which a causal relation with the study drug was considered possible or probable.