TRAEs classified as possibly/probably related to treatment by the reporting investigator
| TRAE . | Number of events (number of participants) . | Number of events (number of participants) . |
|---|---|---|
| Cohort 1 (n = 5) . | Cohort 2 (n = 5) . | |
| Any TRAEs | 4 (3) | 10 (3) |
| Liver enzymes increased | 1 (1) | 3 (2) |
| Pyrexia | 1 (1) | 2 (2) |
| Anxiety | 1 (1) | 1 (1) |
| Drug ineffective* | 1 (1) | 0 |
| Palpitations | 0 | 1 (1) |
| Headache | 0 | 1 (1) |
| Prostatitis | 0 | 1 (1) |
| Rash | 0 | 1 (1) |
| TRAE . | Number of events (number of participants) . | Number of events (number of participants) . |
|---|---|---|
| Cohort 1 (n = 5) . | Cohort 2 (n = 5) . | |
| Any TRAEs | 4 (3) | 10 (3) |
| Liver enzymes increased | 1 (1) | 3 (2) |
| Pyrexia | 1 (1) | 2 (2) |
| Anxiety | 1 (1) | 1 (1) |
| Drug ineffective* | 1 (1) | 0 |
| Palpitations | 0 | 1 (1) |
| Headache | 0 | 1 (1) |
| Prostatitis | 0 | 1 (1) |
| Rash | 0 | 1 (1) |
TRAEs were defined as adverse events that were assessed by the investigator as possibly or probably related to AMT-060 administration.
Because this was an early trial of gene therapy, lack of efficacy was included as an adverse event of special notification and therefore was automatically reported. Participant 6 in cohort 2 experienced 7 TRAEs (2 instances of increases in liver enzymes, pyrexia, anxiety, palpitations, headache, and rash).