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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.