Table 5.
Summary of AEs in patients with TS and in the overall PATRO Children study population
| Patients with TS (n = 348) |
All patients (n = 7,042) |
|||
|---|---|---|---|---|
| n | % | n | % | |
| Any AE | 170 | 48.9 | 3,583 | 50.9 |
| Relationship to study drug | ||||
| Not suspected | 167 | 48.0 | 3,470 | 49.3 |
| Suspected | 25 | 7.2 | 527 | 7.5 |
| Intensity | ||||
| Mild | 139 | 39.9 | 2,797 | 39.7 |
| Moderate | 85 | 24.4 | 1,556 | 22.1 |
| Severe | 14 | 4.0 | 334 | 4.7 |
| Missing | 32 | 9.2 | 690 | 9.8 |
| Changes to rhGH treatment | ||||
| Not changed | 163 | 46.8 | 3,406 | 48.4 |
| Increased | 9 | 2.6 | 138 | 2.0 |
| Reduced | 5 | 1.4 | 87 | 1.2 |
| Interrupted | 8 | 2.3 | 191 | 2.7 |
| Permanently discontinued | 10 | 2.9 | 122 | 1.7 |
| Missing | 9 | 2.6 | 156 | 2.2 |
| SAEs | ||||
| No | 160 | 46.0 | 3,423 | 48.6 |
| Yes | 49 | 14.1 | 915 | 13.0 |
| SAE relationship to study drug | ||||
| Not suspected | 48 | 13.8 | 877 | 12.5 |
| Suspected | 1 | 0.3 | 59 | 0.8 |
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; rhGH, recombinant human growth hormone; TS, Turner syndrome.