Table 2.
Treatment-emergent adverse events (TEAEs).
| System organ class Preferred term |
Treatment | |
|---|---|---|
| SB-121 (N = 15) n (%) |
Placebo (N = 15) n (%) |
|
| Number of Subjects with at least one TEAE | 7 (46.7) | 9 (60.0) |
| Blood and lymphatic system disorders | 1 (6.7) | 0 |
| Leukocytosis | 1 (6.7) | 0 |
| Gastrointestinal disorders | 3 (20.0) | 4 (26.7) |
| Diarrhea | 2 (13.3) | 3 (20.0) |
| Abdominal pain | 0 | 1 (6.7) |
| Abdominal pain upper | 1 (6.7) | 0 |
| Nausea | 1 (6.7) | 0 |
| Vomiting | 0 | 2 (13.3) |
| General disorders and administration site conditions | 1 (6.7) | 1 (6.7) |
| Fatigue | 1 (6.7) | 0 |
| Pain | 0 | 1 (6.7) |
| Infections and infestations | 2 (13.3) | 3 (20.0) |
| Sinusitis | 2 (13.3) | 0 |
| COVID-19 | 0 | 1 (6.7) |
| Tinea infection | 0 | 1 (6.7) |
| Upper respiratory tract infection | 0 | 1 (6.7) |
| Investigations | 0 | 1 (6.7) |
| Alanine aminotransferase increased | 0 | 1 (6.7) |
| Nervous system disorders | 1 (6.7) | 2 (13.3) |
| Headache | 1 (6.7) | 2 (13.3) |
| Psychiatric disorders | 0 | 1 (6.7) |
| Anxiety | 0 | 1 (6.7) |
| Depression | 0 | 1 (6.7) |
| Insomnia | 0 | 1 (6.7) |
| Renal and urinary disorders | 0 | 1 (6.7) |
| Bilirubinuria | 0 | 1 (6.7) |
| Respiratory, thoracic and mediastinal disorders | 2 (13.3) | 2 (13.3) |
| Cough | 2 (13.3) | 0 |
| Nasal congestion | 0 | 1 (6.7) |
| Oropharyngeal pain | 0 | 1 (6.7) |