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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.