Table 4.
Event-Level Summary of Injection Site Reactions Through Week 256
| Outcome | ITT, Maintenance-Exposed, Randomized Population | Extension-Switch Population | ||
|---|---|---|---|---|
| Q8W IM (n = 115) |
Q4W IM (n = 115) |
Q8W IM (n = 34) |
Q4W IM (n = 10) |
|
| Injection, No. | 7673 | 13 506 | 1503 | 816 |
| ISR event, No. | 3373 | 4702 | 429 | 182 |
| Grade, No. (% of ISR events) | ||||
| 1 | 2772 (82) | 4151 (88) | 358 (83) | 143 (79) |
| 2 | 571 (17) | 527 (11) | 64 (15) | 36 (20) |
| 3 | 24 (<1) | 22 (<1) | 7 (2) | 3 (2) |
| 4 | 0 | 0 | 0 | 0 |
| Most common ISR event, No. (% of ISR events) | ||||
| Pain | 2265 (67) | 2936 (62) | 368 (86) | 166 (91) |
| Nodule | 238 (7) | 557 (12) | 26 (6) | 13 (7) |
| Pruritis | 230 (7) | 222 (5) | 8 (2) | 0 |
| Swelling | 200 (6) | 248 (5) | 9 (2) | 2 (1) |
| Duration, d | ||||
| ≤7 | 2964 (88) | 3992 (85) | 399 (93) | 167 (92) |
| 8–14 | 263 (8) | 300 (6) | 12 (3) | 9 (5) |
| ≥15 | 137 (4) | 398 (8) | 17 (4) | 5 (3) |
| Median, d | 3.0 | 3.0 | 3.0 | 2.0 |
| Participants with ISR leading to withdrawal, No. (% of participants)a | 2 (2)b | 2 (2)c | 0 | 1 (10)d |
Abbreviations: IM, intramuscular; ISR, injection site reaction; ITT, intention to treat; Q4W, every 4 weeks; Q8W, every 8 weeks.
aParticipants could have >1 ISR event leading to withdrawal.
bInjection site pain (n = 2), injection site induration (n = 1), injection site pruritis (n = 1), and injection site swelling (n = 1).
cInjection site nodule (n = 1) and injection site pain (n = 1).
dInjection site pain.