Table 5 Treatment-emergent adverse events (AEs) from baseline to week 8, by treatment (safety population)
From: Arbaclofen in fragile X syndrome: results of phase 3 trials
| Â | Adolescent/adult study | Child study | ||||
|---|---|---|---|---|---|---|
Event | Placebo | Arbaclofen | Placebo | Arbaclofen 5Â mg BID | Arbaclofen 10Â mg BID | Arbaclofen 10Â mg TID |
| Â | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) |
|  | N = 63 | N = 62 | N = 45 | N = 42 | N = 42 | N = 43 |
Any adverse event | 40 (63.5) | 45 (72.6) | 34 (75.6) | 35 (83.3) | 39 (92.9) | 35 (81.4) |
Vomiting | 3 (4.8) | 9 (14.5) | 8 (17.8) | 5 (11.9) | 7 (16.7) | 13 (30.2) |
Aggression | 1 (1.6) | 2 (3.2) | 8 (17.8) | 0 (0.0) | 5 (11.9) | 7 (16.3) |
Headache | 6 (9.5) | 9 (14.5) | 3 (6.7) | 1 (2.4) | 2 (4.8) | 5 (11.6) |
Nausea | 1 (1.6) | 6 (9.7) | 0 (0.0) | 1 (2.4) | 2 (4.8) | 0 (0.0) |
Diarrhea | 3 (4.8) | 5 (8.1) | 3 (6.7) | 5 (11.9) | 5 (11.9) | 5 (11.6) |
URI | 8 (12.7) | 5 (8.1) | 6 (13.3) | 4 (9.5) | 2 (4.8) | 5 (11.6) |
Rhinorrhea | 2 (3.2) | 1 (1.6) | 2 (4.4) | 2 (4.8) | 2 (4.8) | 4 (9.3) |
Nasal congestion | 0 (0.0) | 2 (3.2) | 2 (4.4) | 3 (7.1) | 2 (4.8) | 3 (7.0) |
Irritability | 4 (6.3) | 6 (9.7) | 2 (4.4) | 3 (7.1) | 3 (7.1) | 2 (4.7) |
Agitation | 2 (3.2) | 5 (8.1) | 3 (6.7) | 3 (7.1) | 3 (7.1) | 2 (4.7) |
Anxiety | 1 (1.6) | 5 (8.1) | 1 (2.2) | 4 (9.5) | 6 (14.3) | 3 (7.0) |
Terminal insomnia | 0 (0.0) | 0 (0.0) | 1 (2.2) | 2 (4.8) | 2 (4.8) | 3 (7.0) |
Middle insomnia | 0 (0.0) | 0 (0.0) | 1 (2.2) | 1 (2.4) | 2 (4.8) | 3 (7.0) |
Decreased appetite | 0 (0.0) | 4 (6.5) | 1 (2.2) | 3 (7.1) | 1 (2.4) | 2 (4.7) |
Ear infection | 1 (1.6) | 0 (0.0) | 0 (0.0) | 2 (4.8) | 2 (4.8) | 3 (7.0) |
Gastroenteritis | 0 (0.0) | 2 (3.2) | 0 (0.0) | 2 (4.8) | 1 (2.4) | 3 (7.0) |
Convulsion | 1 (1.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |