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) |
