Table 2 Treatment-emergent adverse events occurring in > 1% of patients (safety analysis set)
Adverse event, n (%) | Placebo (n = 102) | ZYN002 (n = 109) |
|---|---|---|
Patients with at least 1 TEAE | 51 (50) | 63 (57.8) |
Upper respiratory tract infection | 7 (6.9) | 15 (13.8) |
Nasopharyngitis | 9 (8.8) | 10 (9.2) |
Vomiting | 6 (5.9) | 8 (7.3) |
Pyrexia | 7 (6.9) | 5 (4.6) |
Application site pain | 1 (1.0) | 7 (6.4) |
Diarrhea | 0 (0) | 5 (4.6) |
Gastroenteritis | 1 (1.0) | 7 (6.4) |
Pharyngitis streptococcal | 2 (2.0) | 3 (2.8) |
Rhinorrhea | 2 (2.0) | 2 (1.8) |
Cough | 0 (0) | 3 (2.8) |
Rash | 1 (1.0) | 2 (1.8) |
Skin abrasion | 1 (1.0) | 2 (1.8) |
Viral upper respiratory tract infection | 2 (2.0) | 1 (0.9) |