Table 2.
Summary of TEAEs by age and in the overall population
| Paediatric n = 19 |
Adult n = 14 |
Overall N = 33 |
||||
|---|---|---|---|---|---|---|
| Number of events | Number of patients (%) | Number of events | Number of patients (%) | Number of events | Number of patients (%) | |
| Any TEAEs | 423 | 17 (89.5) | 123 | 12 (85.7) | 546 | 29 (87.9) |
| ADRs | 69 | 12 (63.2) | 15 | 5 (35.7) | 84 | 17 (51.5) |
| Serious TEAEs | 9 | 7 (36.8) | 5 | 5 (35.7) | 14 | 12 (36.4) |
| Serious treatment-related TEAEs | 1 | 1 (5.3) | 1 | 1 (7.1) | 2 | 2 (6.1) |
| Severe TEAEs | 3 | 2 (10.5) | 1 | 1 (7.1) | 4 | 3 (9.1) |
| TEAEs with a fatal outcome | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
| TEAEs leading to discontinuation | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
ADR adverse drug reaction, TEAEs treatment-emergent adverse events