TABLE 3.
TEAE, n (%) | Trazpiroben 25 mg (n = 12) | Trazpiroben 25 mg + rifampin 600 mg (n = 12) | Overall (n = 12) |
---|---|---|---|
Number of participants with TEAEs | 6 (50) | 2 (17) | 6 (50) |
Gastrointestinal disorders | 1 (8) | 0 (0) | 1 (8) |
Abdominal pain, upper | 1 (8) | 0 (0) | 1 (8) |
Nervous system disorders | 3 (25) | 1 (8) | 3 (25) |
Headache | 2 (17) | 1 (8) | 2 (17) |
Sensory disturbance | 1 (8) | 0 (0) | 1 (8) |
Respiratory, thoracic, and mediastinal disorders | 1 (8) | 1 (8) | 2 (17) |
Cough | 0 (0) | 1 (8) | 1 (8) |
Nasal congestion | 0 (0) | 1 (8) | 1 (8) |
Sinus congestion | 1 (8) | 0 (0) | 1 (8) |
Sneezing | 1 (8) | 0 (0) | 1 (8) |
Skin and subcutaneous tissue disorders | 1 (8) | 0 (0) | 1 (8) |
Dermatitis contact | 1 (8) | 0 (0) | 1 (8) |
Note: Adverse events are classified according to the Medical Dictionary for Regulatory activities (MedDRA) version 22.1. If a participant had two or more clinical adverse events within a category, the participant is counted only once within the category.
Abbreviation: TEAE, treatment‐emergency adverse event.