Table 2.
Overview of AEs, overall and by age group (safety analysis set).
| N (%) | Participants receiving burosumab | |||
|---|---|---|---|---|
| Overall population, n = 67 | (1 to <5 years), n = 22 | (5 to <12 years), n = 34 | (12 to <18 years), n = 11 | |
| Any AE | 25 (37.3) | 7 (31.8) | 13 (38.2) | 5 (45.5) |
| Any AE possibly/probably related to XLH treatment a | 13 (19.4) | 4 (18.2) | 7 (20.6) | 2 (18.2) |
| Any AE leading to death | 0 | 0 | 0 | 0 |
| Any AE leading to death and possibly/probably related to XLH treatment a | 0 | 0 | 0 | 0 |
| Any AE leading to XLH treatment withdrawn | 0 | 0 | 0 | 0 |
| Any AE leading to XLH treatment withdrawn and possibly/probably related to XLH treatment a | 0 | 0 | 0 | 0 |
| Any severe AE | 4 (6.0) | 0 | 3 (8.8) | 1 (9.1) |
| Any SAE | 2 (3.0) | 0 | 2 (5.9) | 0 |
| Any SAE possibly/probably related to XLH treatment a | 0 | 0 | 0 | 0 |
Percentages are calculated using the number of participants in the safety analysis set as denominator.
a
The relationship of the AE with XLH treatment as reported by the investigator.
AE, adverse event; SAE, serious adverse event; XLH, X-linked hypophosphatemia.