Table 4.
Injection Site Assessments
| Single-Dose Study | Multiple-Dose Study | ||
|---|---|---|---|
| Deltoid (n = 17) | Gluteal (n = 18) | Total (n = 138) |
|
| Investigator-rated injection site reactions, n (%) of patientsa | |||
| Pain, 1 h after first injection | 4 (23.5) | 1 (5.6) | 12 (8.7) |
| Pain, last visit/injectionb | 2 (11.8) | 0 | 9 (6.5) |
| Swelling, 1 h after first injection | 0 | 0 | 2 (1.4) |
| Swelling, last visit/injectionb | 0 | 0 | 0 |
| Redness, 1 h after first injection | 0 | 0 | 1 (0.7) |
| Redness, last visit/injectionb | 0 | 0 | 0 |
| Induration, 1 h after first injection | 0 | 1 (5.6) | 2 (1.4) |
| Induration, last visit/injectionb | 0 | 0 | 0 |
| Patient-reported pain (VAS scale score),a,c mean (SD) | |||
| 1 h after first injection | 3.1 (7.3) | 1.7 (2.7) | - |
| Deltoid/deltoid (n = 71) | - | - | 2.3 (4.1) |
| Gluteal/deltoid (n = 67) | - | - | 1.8 (4.7) |
| Last visit/5th injectionb | 2.2 (7.2) | 0.5 (1.3) | 1.2 (3.4) |
Abbreviation: VAS, visual analog scale.
a Investigator or patient ratings for the first injection.
b Last visit for the single-dose study; fifth injection (1 h postdose) for the multiple-dose study (n = 100).
c Assessed using a VAS ranging from 0 mm (no pain) to 100 mm (unbearable pain).