Table 2 Most frequent adverse events* in adolescent patients during the extension period, by last dose before event onset (safety population). *Incidence ≥10% in any group.
Preferred term | Total n (%) | Mavoglurant 25 mg bid n (%) | Mavoglurant 50 mg bid n (%) | Mavoglurant 75 mg bid n (%) | Mavoglurant 100 mg bid n (%) |
|---|---|---|---|---|---|
Adolescent study | N = 119 | N = 119 | N = 118 | N = 116 | N = 108 |
Patients with any adverse event | 110 (92.4) | 36 (30.3) | 41 (34.7) | 44 (37.9) | 90 (83.3) |
Nasopharyngitis | 35 (29.4) | 7 (5.9) | 3 (2.5) | 8 (6.9) | 25 (23.1) |
Insomnia | 25 (21.0) | 4 (3.4) | 10 (8.5) | 5 (4.3) | 12 (11.1) |
Aggression | 19 (16.0) | 3 (2.5) | 3 (2.5) | 4 (3.4) | 12 (11.1) |
Initial insomnia | 18 (15.1) | 3 (2.5) | 2 (1.7) | 4 (3.4) | 9 (8.3) |
Upper respiratory tract infection | 17 (14.3) | 3 (2.5) | 5 (4.2) | 3 (2.6) | 9 (8.3) |
Anxiety | 15 (12.6) | 3 (2.5) | 1 (0.8) | 0 | 11 (10.2) |
Headache | 15 (12.6) | 4 (3.4) | 1 (0.8) | 4 (3.4) | 8 (7.4) |
Irritability | 15 (12.6) | 3 (2.5) | 1 (0.8) | 3 (2.6) | 9 (8.3) |
Vomiting | 13 (10.9) | 2 (1.7) | 5 (4.2) | 0 | 8 (7.4) |
Cough | 12 (10.1) | 1 (0.8) | 1 (0.8) | 4 (3.4) | 7 (6.5) |
Diarrhea | 12 (10.1) | 2 (1.7) | 4 (3.4) | 0 | 5 (4.6) |
Patients with any serious adverse event | 4 (3.4) | 0 | 1 (0.8) | 0 | 3 (2.8) |
Patients with any adverse event leading to study drug discontinuation | 6 (5.0) | 2 (1.7) | 2 (1.7) | 0 | 3 (2.8) |
