Table 2.
Subjects Experiencing Treatment Emergent Serious Adverse Events and Adverse Events Occuring in >1 Subject In Any Cohort by MedRA System Organ Class
| Cohort 1 7·5 × 1011vg (N = 5) | Cohort 2 1·5 × 1012vg (N = 5) | Cohort 3 4·7 × 1012vg (N = 5) | Total (N = 15) | |
|---|---|---|---|---|
| Any adverse event | 5 | 5 | 5 | 15 |
| Any serious averse event | 0 | 1a | 0 | 1 |
| Gastrointestinal disorders | ||||
| Constipation | 1 | 2 | 0 | 3 |
| Vomiting | 1 | 1 | 0 | 2 |
| Infections and infestations | ||||
| Tooth abcess | 2 | 0 | 0 | 2 |
| Upper respiratory tract infection | 2 | 0 | 1 | 3 |
| Metabolism and nutrition disorders | ||||
| Vitamin B12 deficiency | 0 | 2 | 0 | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2 | 2 | 0 | 4 |
| Musculoskeletal pain | 3 | 0 | 1 | 4 |
| Nervous system disorders | ||||
| Dizziness | 2 | 0 | 0 | 2 |
| Dyskinesia | 2 | 1 | 1 | 4 |
| Headache | 5 | 3 | 3 | 11 |
| Hypoaesthesia | 3 | 1 | 3 | 7 |
| Memory impairment | 2 | 0 | 0 | 2 |
| Neuralgia | 2 | 0 | 0 | 2 |
| Psychiatric disorders | ||||
| Depression | 2 | 1 | 0 | 3 |
| Vascular disorders | ||||
| Orthostatic hypotension | 2 | 0 | 0 | 2 |
a
One participant experienced a deep venous thrombosis, pulmonary embolus, and subsequent atrial fibrillation, likely attributed to immobility during the surgery.
MedRA = Medical Dictionary for Regulatory Activities; vg = vector genomes.