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Table 4 Most frequently occurring Treatment Emergent Adverse Events (TEAEs) in the study for ITT-S subjects

From: Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial

  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%) 0.393
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
  1. 1The p-value for comparing Treatment groups uses Chi-square test method.
  2. 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.
  3. At each level of summarization (SOC/preferred term), subjects reporting more than one AE will only be counted once.