Table 3.
Injection-Site Reactions
| Q8W (n = 522) | Q4W (n = 523) | |
|---|---|---|
| Number of injections | 20 563 | 39 478 |
| Number of ISR eventsa | 4168 | 5494 |
| Grade or intensityb | ||
| Grade 1c | 3343 (80) | 4571 (83) |
| Grade 2c | 771 (18) | 873 (16) |
| Grade 3c | 54 (1) | 50 (<1) |
| Type of ISR adverse events (≥1% of injections as reported) | ||
| Injection-site paind,e | 3189 (16) | 4180 (11) |
| Injection-site noduled,f | 259 (1) | 457 (1) |
| Duration (days) | ||
| 1–7c | 3477 (83) | 4594 (84) |
| 8–14c | 368 (9) | 435 (8) |
| >14c | 292 (7) | 425 (8) |
| Median (IQR), days | 3 (2–5) | 3 (2–5) |
| Participants withdrawing for injection-related reasonsg | 8 (2) | 14 (3) |
Data are presented as n (%) unless otherwise indicated.
Abbreviations: IQR, interquartile range; ISR, injection-site reaction; Q4W, every 4 weeks; Q8W, every 8 weeks.
Each ISR event was counted separately. A participant may have had multiple ISR events following a single injection.
There were no grade 4 or grade 5 ISRs.
Percentages are calculated from the total number of ISR events.
Percentages are calculated from the total number of injections.
Q8W: 3189 injection-site pain events occurred in 398/522 (76%) participants; Q4W: 4180 injection-site pain events occurred in 387/523 (74%) participants.
Q8W: 259 injection-site nodule events occurred in 91/522 (17%) participants; Q4W: 457 injection-site nodule events occurred in 141/523 (27%) participants.
Percentages are calculated from the total number of participants with injections (Q8W, n = 516/522 [99%]; Q4W, n = 517/523 [99%]).