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) |