Table 3 Treatment Emergent Adverse Events (TEAEs) in the study for ITT-S subjects
Treatment group | |||
|---|---|---|---|
System Organ Class (SOC) preferred term | Diclegis (N = 131) | Placebo (N = 127) | P-value1 |
# of Subjects with at least one TEAE | 74 (56.5%) | 65 (51.2%) | 0.39 |
Cardiac disorders | 1 (0.8%) | 1 (0.8%) | 1.0002 |
Palpitations | 1 (0.8%) | 1 (0.8%) | 1.0002 |
Eye disorders | 1 (0.8%) | 0 | 1.0002 |
Dry eye | 1 (0.8%) | 0 | 1.0002 |
Gastrointestinal disorders | 23 (17.6%) | 22 (17.3%) | 0.960 |
Constipation | 2 (1.5%) | 2 (1.6%) | 1.0002 |
Dry mouth | 4 (3.1%) | 1 (0.8%) | 0.3702 |
Haematemesis | 0 | 1 (0.8%) | 0.4922 |
Feeling jittery | 1 (0.8%) | 0 | 1.0002 |
Laboratory Investigations | 7 (5.3%) | 6 (4.7%) | 0.820 |
Alanine aminotransferase increased | 0 | 1 (0.8%) | 0.4922 |
Aspartate aminotransferase increased | 0 | ||
Blood albumin decreased | 1 (0.8%) | 0 | 1.0002 |
Blood amylase increased | 2 (1.5%) | 2 (1.6%) | 1.0002 |
Blood chloride decreased | 0 | 1 (0.8%) | 0.4922 |
Blood creatinine increased | 1 (0.8%) | 1 (0.8%) | 1.0002 |
Blood lactate dehydrogenase increased | 1 (0.8%) | 0 | 1.0002 |
Blood sodium decreased | 0 | 1 (0.8%) | 0.4922 |
Blood triglycerides increased | 1 (0.8%) | 0 | |
Gamma-glutamyltransferase increased | 1 (0.8%) | 1 (0.8%) | 1.0002 |
Heart rate increased | 0 | 1 (0.8%) | 0.4922 |
Platelet count decreased | 1 (0.8%) | 0 | 1.0002 |
Nervous system disorders | 42 (32.1%) | 37 (29.1%) | 0.610 |
Dizziness | 8 (6.1%) | 8 (6.3%) | 0.949 |
Headache | 17 (13.0%) | 20 (15.7%) | 0.526 |
Loss of consciousness | 0 | 1 (0.8%) | 0.4922 |
Poor quality sleep | 1 (0.8%) | 0 | 1.0002 |
Somnolence | 19 (14.5%) | 15 (11.8%) | 0.523 |
Syncope | 1 (0.8%) | 1 (0.8%) | 1.0002 |
Fatigue | 9 (6.9%) | 8 (6.3%) | 0.853 |