AEs occurring in >1 patient (safety analysis set)
| MedDRA preferred term . | Prior on-demand group n (%)/events . | Switch group n (%)/events . |
|---|---|---|
| Headache | 4 (30.8)/4 | 0 |
| Arthralgia | 1 (7.7)/1 | 2 (20.0)/2 |
| ALT increased | 1 (7.7)/1 | 1 (10.0)/1 |
| Ear infection | 2 (15.4)/2 | 0 |
| Gastroenteritis | 0 | 2 (20.0)/2 |
| Joint injury | 2 (15.4)/2 | 0 |
| Urinary tract infection | 1 (7.7)/1 | 1 (10.0)/1 |
| MedDRA preferred term . | Prior on-demand group n (%)/events . | Switch group n (%)/events . |
|---|---|---|
| Headache | 4 (30.8)/4 | 0 |
| Arthralgia | 1 (7.7)/1 | 2 (20.0)/2 |
| ALT increased | 1 (7.7)/1 | 1 (10.0)/1 |
| Ear infection | 2 (15.4)/2 | 0 |
| Gastroenteritis | 0 | 2 (20.0)/2 |
| Joint injury | 2 (15.4)/2 | 0 |
| Urinary tract infection | 1 (7.7)/1 | 1 (10.0)/1 |
ALT, alanine aminotransferase.
Table displays the number and percentage of patients who had AEs that occurred in >1 patient across the 2 groups (prior on-demand and switch) and the number of events with the same preferred term. Only 1 AE (nonserious headache) out of 41 treatment-emergent AEs was considered related to study treatment.