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Table 5 Treatment Emergent Adverse Events (TEAEs) with respect to relationship to study drug- related vs. unrelated 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
  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%)
  1. Related category includes Possible, Probable, and Definite relationships. Unrelated category includes unlikely and not related.
  2. At each level of summarization (SOC/preferred term), subjects reporting more than on AE will only be counted once under the strongest relationship.