TABLE 3.
Treatment-emergent adverse events occurring more than once in a given system organ class in the two AVI studies
| TEAEa | No. (%) of subjects |
|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AVI-6002 study |
AVI-6003 study |
|||||||||||||||
| Placebo (n = 6) | Dose (mg/kg) |
AVI-6002 (n = 24) | Placebo (n = 6) | Dose (mg/kg) |
AVI-6003 (n = 24) | |||||||||||
| 0.01 (n = 4) | 0.1 (n = 4) | 1 (n = 4) | 3 (n = 4) | 6 (n = 4) | 9 (n = 4) | 0.01 (n = 4) | 0.1 (n = 4) | 1 (n = 4) | 3 (n = 4) | 6 (n = 4) | 9 (n = 4) | |||||
| Total | 5 (83) | 3 (75) | 0 | 2 (50) | 3 (75) | 3 (75) | 1 (25) | 12 (50) | 1 (17) | 2 (50) | 4 (100) | 1 (25) | 2 (50) | 2 (50) | 2 (50) | 13 (54) |
| Gastrointestinal disordersb | 1 (17) | 2 (50) | 0 | 0 | 2 (50) | 1 (25) | 0 | 5 (21) | 0 | 0 | 2 (50) | 0 | 1 (25) | 1 (25) | 1 (25) | 5 (21) |
| Nervous system disordersc | 0 | 3 (75) | 0 | 0 | 0 | 1 (25) | 0 | 4 (17) | 0 | 1 (25) | 2 (50) | 0 | 1 (25) | 1 (25) | 1 (25) | 6 (25) |
| Respiratory, thoracic, and mediastinal disordersd | 1 (17) | 1 (25) | 0 | 0 | 0 | 1 (25) | 0 | 2 (8) | 0 | 0 | 1 (25) | 0 | 0 | 0 | 1 (25) | 2 (8) |
| General disorders and administrative site conditionse | 3 (50) | 2 (50) | 0 | 0 | 0 | 0 | 0 | 2 (8) | 0 | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (4) |
| Musculoskeletal and connective tissue disordersf | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (4) |
TEAE, treatment-emergent adverse event.
Gastrointestinal disorders included nausea in three subjects and abdominal discomfort, upper abdominal pain, diarrhea, and vomiting in one subject each in the AVI-6002 study and abdominal distension, abdominal pain, gastroesophageal reflux disease, anorectal discomfort, aphthous stomatitis, nausea, and vomiting in one subject each in the AVI-6003 study.
Nervous system disorders included headache in four subjects and somnolence in one subject in the AVI-6002 study and headache in three subjects, dizziness in two subjects, and cataplexy, dysgeusia, and tremor in one subject each in the AVI-6003 study.
Respiratory, thoracic, and mediastinal disorders included sinus congestion in three subjects in the AVI-6002 study and nasal congestion and rhinorrhea in one subject each in the AVI-6003 study.
General disorders and administrative site conditions included chest discomfort, fatigue, feeling cold, and infusion site erythema in one one subject each in the AVI-6002 study and fatigue in one subject in the AVI-6003 study.
Musculoskeletal and connective tissue disorders included arthralgia and muscle tightness in one subject each in the AVI-6003 study.