Table 4.
Most frequently occurring 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-value 1 |
| # of Subjects with at least one TEAE | 74 (56.5%) | 65 (51.2%) | 0.393 |
| Gastrointestinal disorders | 23 (17.6%) | 22 (17.3%) | 0.960 |
| Abdominal pain | 5 (3.8%) | 8 (6.3%) | 0.362 |
| General disorders and administration site | 13 (9.9%) | 12 (9.4%) | 0.897 |
| Conditions | |||
| Fatigue | 9 (6.9%) | 8 (6.3%) | 0.949 |
| Musculoskeletal and connective tissue | 11 (8.4%) | 4 (3.1%) | 0.072 |
| Disorders | |||
| Back pain | 7 (5.3%) | 4 (3.1%) | 0.383 |
| 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 |
| Somnolence | 19 (14.5%) | 15 (11.8%) | 0.523 |
1The p-value for comparing Treatment groups uses Chi-square test method.
TEAEs that are considered most frequently occurring include the events (in preferred terms) reported by at least 5% of subjects in any of the treatment groups.
At each level of summarization (SOC/preferred term), subjects reporting more than one AE will only be counted once.