Table 2 Primary outcome of treatment-related, treatment-emergent adverse events by system organ class and preferred term at 2 years
System organ class preferred term | Cohort 1 (dose, 1.85 × 1013 vg kg−1)a (n = 3) | Cohort 2 (dose, 7.41 × 1013 vg kg−1)b (n = 3) | Total (n = 6) |
|---|---|---|---|
Subjects with any treatment-related, treatment-emergent adverse event | 2 (66.7%) | 3 (100.0%) | 5 (83.3%) |
Gastrointestinal disorders | 1 (33.3%) | 3 (100.0%) | 4 (66.7%) |
Abdominal pain | 0 | 2 (66.7%) | 2 (33.3%) |
Abdominal pain, upper | 1 (33.3%) | 1 (33.3%) | 2 (33.3%) |
Nausea | 0 | 2 (66.7%) | 2 (33.3%) |
Vomiting | 1 (33.3%) | 3 (100.0%) | 4 (66.7%) |
General disorders and administration site conditions | 0 | 1 (33.3%) | 1 (16.7%) |
Pyrexia | 0 | 1 (33.3%) | 1 (16.7%) |
Hepatobiliary disorders | 1 (33.3%) | 0 | 1 (16.7%) |
Hepatitis | 1 (33.3%)c | 0 | 1 (16.7%) |
Hyperbilirubinemia | 1 (33.3%) | 0 | 1 (16.7%) |
Investigations | 2 (66.7%) | 3 (100.0%) | 5 (83.3%) |
GGT increased | 2 (66.7%) | 1 (33.3%) | 3 (50.0%) |
Neutrophil count decreased | 0 | 1 (33.3%) | 1 (16.7%) |
White blood cell count decreased | 0 | 2 (66.7%) | 2 (33.3%) |
Metabolism and nutrition disorders | 1 (33.3%) | 1 (33.3%) | 2 (33.3%) |
Decreased appetite | 1 (33.3%) | 0 | 1 (16.7%) |
Dehydration | 0 | 1 (33.3%)c | 1 (16.7%) |
Nervous system disorders | 1 (33.3%) | 0 | 1 (16.7%) |
Dizziness | 1 (33.3%) | 0 | 1 (16.7%) |
