AE | Number of patients who had an AE, n (%) | ||
---|---|---|---|
Period 1 (Oral; 24 h), N = 20 | Period 2 (IV; 36 h), N = 20 | Period 3 + follow-up (Oral; up to 37 days), N = 20 | |
Patients with at least 1 AE across all periods | 15 (75) | ||
Patients with at least 1 AE | 2 (10) | 10 (50) | 8 (40) |
Headache | 0 | 4 (20) | 1 (5) |
Flushing | 0 | 1 (5) | 1 (5) |
Nausea | 0 | 1 (5) | 1 (5) |
Infusion site erythema | 0 | 2 (10) | 0 |
Sleep disorder | 1 (5) | 0 | 0 |
Swelling face | 1 (5) | 0 | 0 |
Diarrhea | 0 | 1 (5) | 0 |
Dysgeusia | 0 | 1 (5) | 0 |
Epistaxis | 0 | 1 (5) | 0 |
Flatulence | 0 | 1 (5) | 0 |
Incorrect drug administration rate | 0 | 1 (5) | 0 |
Infusion site swelling | 0 | 1 (5) | 0 |
Lymphadenopathy | 0 | 1 (5) | 0 |
Myalgia | 0 | 1 (5) | 0 |
Nasal congestion | 0 | 1 (5) | 0 |
Pain in jaw | 0 | 1 (5) | 0 |
Tachycardia | 0 | 1 (5) | 0 |
Tension headache | 0 | 1 (5) | 0 |
Vascular access complication | 0 | 1 (5) | 0 |
Vomiting | 0 | 1 (5) | 0 |
Edema peripheral | 0 | 0 | 2 (10) |
Blindness unilateral | 0 | 0 | 1 (5) |
Cough | 0 | 0 | 1 (5) |
Chromaturia | 0 | 0 | 1 (5) |
Dyspnea | 0 | 0 | 1 (5) |
Hypokalemia | 0 | 0 | 1 (5) |
Nasopharyngitis | 0 | 0 | 1 (5) |
Rhegmatogenous retinal detachment | 0 | 0 | 1 (5) |
Right ventricular failure | 0 | 0 | 1 (5) |
Upper respiratory tract infection | 0 | 0 | 1 (5) |