Table 5.
Patients, treated with PPI combined with Esoxx or placebo, with at least one TEAEs classified for system organ class (SOC) – safety analysis
| SOC | Esoxx (n = 76) | Placebo (n = 71) |
|---|---|---|
| Patients with at least one TEAE | 18 (23.7) | 11 (15.5) |
| Gastrointestinal disorders | 13 (17.1) | 7 (9.9) |
| Respiratory, thoracic, mediastinal disorders (cough, rhinitis, throat irritation, pharyngeal disorders) | 4 (5.3) | 1 (1.4) |
| Nervous system disorders (dysgeusia, headache, migraine) | 3 (3.9) | – |
| Cardiac disorders (palpitations, tachycardia) | 1 (1.3) | 1 (1.4) |
| Ear and labyrinth (vertigo) | 1 (1.3) | – |
| General disorders (hypertension) | 1 (1.3) | – |
| Infections and infestations | 1 (1.3) | 3 (4.2) |
Values within parenthesis are expressed as percentage.