Table 2.
Adverse Events | AVT001 (N=16) | Placebo (N=9) |
---|---|---|
TEAEs by preferred term | ||
Participants with any TEAE | 9 (56.3) | 6 (66.7) |
Neutrophil count decreased | 4 (25.0) | 1 (11.1) |
Hyponatremia | 3 (18.8) | 1 (11.1) |
Cough | 3 (18.8) | 0 (0.0) |
White blood-cell count decreased | 2 (12.5) | 1 (11.1) |
Ear pain | 2 (12.5) | 0 (0.0) |
Lymphocyte count decreased | 2 (12.5) | 0 (0.0) |
Dizziness | 1 (6.3) | 2 (22.2) |
Headache | 0 (0.0) | 2 (22.2) |
PTAEs by preferred term | ||
Participants with any PTAE | 16 (100.0) | 8 (88.9) |
White blood-cell count decreased | 5 (31.3) | 4 (44.4) |
Neutrophil count decreased | 4 (25.0) | 1 (11.1) |
Blood alkaline phosphatase increased | 3 (18.8) | 1 (11.1) |
Blood bicarbonate decreased | 3 (18.8) | 0 (0.0) |
Lymphocyte count decreased | 3 (18.8) | 0 (0.0) |
Corona virus infection | 2 (12.5) | 1 (11.1) |
Anemia | 2 (12.5) | 0 (0.0) |
Hypocalcemia | 2 (12.5) | 0 (0.0) |
Blood bilirubin increased | 1 (6.3) | 2 (22.2) |
Treatment-emergent adverse events (TEAEs) are defined as adverse events that started on or after the first dose of study medication through 30 days following the last dose. Posttreatment adverse events (PTAEs) are defined as adverse events that started more than 30 days following the last dose through day 360.