Table 4.
All participants (n = 8) | |
---|---|
TEAE summary, n (%) | |
Any TEAE | 6 (75) |
Any serious TEAE | 0 |
Any TEAE leading to discontinuation | 0 |
Any TEAE resulting in death | 0 |
All TEAEs by MedDRA preferred term, n (%) | |
Headachea | 2 (25) |
Arthropod sting | 1 (13) |
Blepharospasm | 1 (13) |
Dermatitis contact | 1 (13) |
Dizzinessa | 1 (13) |
Frequent bowel movements | 1 (13) |
Gastritis | 1 (13) |
Myalgia | 1 (13) |
Nasopharyngitis | 1 (13) |
Pyrexia | 1 (13) |
Vomiting | 1 (13) |
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.
Mild headache and mild dizziness (each in 1 participant) were judged by the investigator as “possibly” related to study drug.