Category | A | B | A + B | |||
---|---|---|---|---|---|---|
(N = 5) | (N = 5) | (N = 10) | ||||
Patients n (%) | Events n | Patients n (%) | Events n | Patients n (%) | Events n | |
Any TEAE | 5 (100) | 54 | 5 (100) | 32 | 10 (100) | 86 |
Death | 1 (20) | 2 (40) | 3 (30) | |||
Any Serious TEAE | 2 (40) | 5 | 4 (40) | 4 | 6 (60) | 9 |
Any Severe TEAE | 1 (20) | 2 | 2 (40) | 2 | 3 (10) | 4 |
Any TEAE related to the study drug AstroRx® | 0 | 0 | 0 | 0 | 0 | 0 |
Any TEAE related to IT Procedure | 3 (60) | 6 | 4 (80) | 6 | 7 (70) | 12 |
Any TEAE related to immunosuppression | 1 (20) | 2 | 2 (40) | 2 | 3 (30) | 4 |
TEAEs Severity | ||||||
Mild | 5 (100) | 41 | 5 (100) | 22 | 10 (100) | 63 |
Moderate | 4 (80) | 11 | 4 (80) | 8 | 8 (80) | 19 |
Severe | 1 (20) | 2 | 2 (40) | 2 | 3 (10) | 4 |