Table 3.
Summary of AEs and TEAEs
| B. clausii (n = 129) | Placebo (n = 130) | |||
|---|---|---|---|---|
| n (%) | AEs/TEAEs | n (%) | AEs/TEAEs | |
| Any AE | 68 (52.7) | 137 | 66 (50.8) | 144 |
| Any TEAE | 57 (44.2) | 97 | 46 (35.4) | 91 |
| Any TEAE of special interest | 0 | 0 | 0 | 0 |
| Any SAE | 1 (0.8)a | 1 | 0 | 0 |
| Any serious TEAE | 0 | 0 | 0 | 0 |
| Any TEAE related to the study medication | 7 (5.4) | 9 | 5 (3.8) | 6 |
| Any serious TEAE related to the study medication | 0 | 0 | 0 | 0 |
| Any TEAE leading to discontinuation of study medication | 2 (1.6) | 2 | 0 | 0 |
| Any serious TEAE leading to discontinuation of study medication | 0 | 0 | 0 | 0 |
| AE leading to death | 0 | 0 | 0 | 0 |
| TEAE leading to death | 0 | 0 | 0 | 0 |
| TEAEs by SOC and PT (≥3% of patients in either group) | ||||
| Infections and infestations | 26 (20.2) | 31 | 24 (18.5) | 29 |
| Nasopharyngitis | 4 (3.1) | 4 | 4 (3.1) | 4 |
| Pharyngitis | 4 (3.1) | 5 | 4 (3.1) | 4 |
| Influenza | 7 (5.4) | 7 | 8 (6.2) | 8 |
| Nervous system disorders | 11 (8.5) | 15 | 17 (13.1) | 19 |
| Headache | 11 (8.5) | 15 | 15 (11.5) | 17 |
| Gastrointestinal disorders | 9 (7.0) | 11 | 11 (8.5) | 12 |
| Injury, poisoning and procedural complications | 10 (7.8) | 12 | 5 (3.8) | 6 |
| Overdose | 5 (3.9) | 7 | 3 (2.3) | 4 |
| Respiratory, thoracic and mediastinal disorders | 8 (6.2) | 9 | 7 (5.4) | 8 |
| Musculoskeletal and connective tissue disorders | 4 (3.1) | 4 | 2 (1.5) | 2 |
| Reproductive system and breast disorders | 2 (1.6) | 4 | 4 (3.1) | 6 |
AE adverse event, B. clausii Bacillus clausii, PT preferred term, SAE serious adverse event, SOC system organ class, TEAE treatment-emergent adverse event
aThis SAE was a case of febrile multisystem inflammatory syndrome of moderate severity lasting 2 days, which was not related to B. clausii and no medical intervention was required