| B. clausii (n = 227) | Placebo (n = 227) |
---|---|---|
Patients with any TEAE | 22 (9.7) | 28 (12.3) |
Patients with any treatment-emergent serious AE | 0 | 0 |
Patients with any treatment-emergent AESI | 0 | 0 |
Patients with any TEAE leading to death | 0 | 0 |
Patients with any TEAE leading to definitive | ||
treatment discontinuation | 2 (0.9) | 3 (1.3) |
Infections and infestations | 6 (2.6) | 7 (3.1) |
 Nasopharyngitis | 5 (2.2) | 3 (1.3) |
 Upper respiratory tract infection | 1 (0.4) | 3 (1.3) |
 Dysentery | 0 | 1 (0.4) |
Blood and lymphatic system disorders | 1 (0.4) | 0 |
 Anemia | 1 (0.4) | 0 |
Metabolism and nutrition disorders | 3 (1.3) | 3 (1.3) |
 Dehydration | 2 (0.9) | 2 (0.9) |
 Hypokalemia | 2 (0.9) | 0 |
 Lactose intolerance | 0 | 1 (0.4) |
Eye disorders | 0 | 1 (0.4) |
 Periorbital swelling | 0 | 1. (0.4) |
Respiratory, thoracic and mediastinal disorders | 1 (0.4) | 4 (1.8) |
 Rhinorrhea | 1 (0.4) | 2 (0.9) |
 Cough | 0 | 2 (0.9) |
Gastrointestinal disorders | 6 (2.6) | 8 (3.5) |
 Vomiting | 6 (2.6) | 6 (2.6) |
 Upper abdominal pain | 0 | 1 (0.4) |
 Diarrhea | 0 | 1 (0.4) |
Skin and subcutaneous tissue disorders | 2 (0.9) | 0 |
 Rash | 1 (0.4) | 0 |
 Erythematous rash | 1 (0.4) | 0 |
General disorders and administration site conditions | 5 (2.2) | 6 (2.6) |
 Pyrexia | 5 (2.2) | 6 (2.6) |