Table 3 Adverse Events with an Incidence of 5% in at Least One Treatment Arm

From: Effect of the mGluR5-NAM Basimglurant on Behavior in Adolescents and Adults with Fragile X Syndrome in a Randomized, Double-Blind, Placebo-Controlled Trial: FragXis Phase 2 Results

 

Placebo ( n =63)

Basimglurant 0.5 mg ( n =58)

Basimglurant 1.5 mg ( n =62)

Overall total number of AEs

112

96

155

Total patients with at least one AE, n (%)

40 (63.5%)

37 (63.8%)

45 (72.6%)

Nasopharyngitis

11 (17.5%)

9 (15.5%)

6 (9.7%)

Headache

10 (15.9%)

4 (6.9%)

10 (16.1%)

Vomiting

5 (7.9%)

3 (5.2%)

7 (11.3%)

Upper respiratory tract infection

4 (6.3%)

1 (1.7%)

6 (9.7%)

Anxiety

1 (1.6%)

2 (3.4%)

6 (9.7%)

Aggression

1 (1.6%)

5 (8.6%)

5 (8.1%)

Insomnia

1 (1.6%)

0

5 (8.1%)

Diarrhea

3 (4.8%)

4 (6.9%)

2 (3.2%)

Upper abdominal pain

4 (6.3%)

2 (3.4%)

0

Agitation

2 (3.2%)

0

4 (6.5%)

Dizziness

1 (1.6%)

1 (1.7%)

4 (6.5%)

Irritability

1 (1.6%)

3 (5.2%)

3 (4.8%)

  1. All adverse events (MedDRA preferred term) were reported by the safety population during the study treatment and follow-up periods. Multiple occurrences of the same AE in an individual were counted only once. For frequency counts in the ‘Total number of AEs’ row, multiple occurrences of the same AE in an individual are counted separately. The safety population consisted of all patients who had received at least one dose of study medication.