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Table 3 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%) 0.39
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
  1. 1The p-value for comparing Treatment groups uses Chi-square test method.
  2. 2P-value is calculated using Fisher’s exact test method.
  3. At each level of summarization (SOC/preferred term), subjects reporting more than one AE will only be counted once.