Table 2 Summary of injection-site reactions in pooled EVOLVE-1, EVOLVE-2, and REGAIN (placebo-controlled analysis set)
Placebo (N = 1451) | GMB 120 mg (N = 705) | GMB 240 mg (N = 730) | |
|---|---|---|---|
Any/all ISRs, n (%) | 183 (12.6) | 128 (18.2) | 166 (22.7) |
ISRs excluding pain, n (%) | 60 (4.1) | 70 (9.9) | 106 (14.5) |
ISRs, n (%) | |||
IS pain | 138 (9.5) | 71 (10.1) | 85 (11.6) |
Unspecified ISR | 14 (1.0) | 22 (3.1) | 45 (6.2) |
IS erythema | 20 (1.4) | 20 (2.8) | 29 (4.0) |
IS pruritus | 2 (0.1) | 15 (2.1) | 24 (3.3) |
IS bruising | 9 (0.6) | 4 (0.6) | 10 (1.4) |
IS swelling | 1 (0.1) | 8 (1.1) | 4 (0.6) |
IS rash | 2 (0.1) | 6 (0.9) | 4 (0.6) |
IS induration | 1 (0.1) | 3 (0.4) | 3 (0.4) |
IS discomfort | 3 (0.2) | 3 (0.4) | 2 (0.3) |
IS hematoma | 7 (0.5) | 1 (0.1) | 3 (0.4) |
IS hypersensitivity | 0 | 1 (0.1) | 3 (0.4) |
IS mass | 0 | 3 (0.4) | 0 |
IS haemorrhage | 2 (0.1) | 1 (0.1) | 1 (0.1) |
IS inflammation | 0 | 1 (0.1) | 1 (0.1) |
IS irritation | 3 (0.2) | 1 (0.1) | 1 (0.1) |
IS urticarial | 1 (0.1) | 1 (0.1) | 1 (0.1) |
IS discoloration | 0 | 0 | 1 (0.1) |
IS oedema | 1 (0.1) | 1 (0.1) | 0 |
IS papules | 0 | 1 (0.1) | 0 |
IS vesicles | 0 | 0 | 1 (0.1) |
IS warmth | 1 (0.1) | 0 | 0 |