Treatment group | ||||
---|---|---|---|---|
Diclegis (N = 131) | Placebo (N = 127) | |||
System Organ Class (SOC) preferred term | Related | Unrelated | Related | Unrelated |
# of Subjects with at least one | 40 (30.5%) | 34 (26.0%) | 32 (25.2%) | 33 (26.0%) |
TEAE in the study | ||||
Cardiac disorders | 1 (0.8%) | 0 | 0 | 1 (0.8%) |
Palpitations | 1 (0.8%) | 0 | 0 | 1 (0.8%) |
Eye disorders | 0 | 1 (0.8%) | 0 | 0 |
Dry eye | 0 | 1 (0.8%) | 0 | 0 |
Gastrointestinal disorders | 8 (6.1%) | 15 (11.5%) | 8 (6.3%) | 14 (11.0%) |
Abdominal pain | 1 (0.8%) | 4 (3.1%) | 3 (2.4%) | 5 (3.9%) |
Abdominal pain upper | 0 | 3 (2.3%) | 2 (1.6%) | 3 (2.4%) |
Constipation | 1 (0.8%) | 1 (0.8%) | 1 (0.8%) | 1 (0.8%) |
Diarrhea | 2 (1.5%) | 2 (1.5%) | 1 (0.8%) | 1 (0.8%) |
Dry mouth | 4 (3.1%) | 0 | 1 (0.8%) | 0 |
Dyspepsia | 1 (0.8%) | 4 (3.1%) | 1 (0.8%) | 1 (0.8%) |
Flatulence | 0 | 0 | 0 | 1 (0.8%) |
Salivary hypersecretion | 0 | 0 | 0 | 1 (0.8%) |
General disorders and administration | 7 (5.3%) | 6 (4.6%) | 6 (4.7%) | 6 (4.7%) |
Feeling jittery | 1 (0.8%) | 0 | 0 | 0 |
Nervous system disorders | 33 (25.2%) | 9 (6.9%) | 24 (18.9%) | 13 (10.2%) |
Dizziness | 6 (4.6%) | 2 (1.5%) | 5 (3.9%) | 3 (2.4%) |
Headache | 8 (6.1%) | 9 (6.9%) | 8 (6.3%) | 12 (9.4%) |
Loss of consciousness | 0 | 0 | 0 | 1 (0.8%) |
Poor quality sleep | 0 | 1 (0.8%) | 0 | 0 |
Somnolence | 19 (14.5%) | 0 | 15 (11.8%) | 0 |
Syncope | 1 (0.8%) | 0 | 0 | 1 (0.8%) |
Fatigue | 6 (4.6%) | 3 (2.3%) | 5 (3.9%) | 3 (2.4%) |