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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

  Adolescent/adult study Child study
Event Placebo Arbaclofen Placebo Arbaclofen 5 mg BID Arbaclofen 10 mg BID Arbaclofen 10 mg TID
  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)
  1. BID twice daily, TID three times daily, URI upper respiratory infection