Table 3 Summary of adverse events related to injection-site reaction (≥2%) in pooled EVOLVE-1, EVOLVE-2 and REGAIN (placebo-controlled analysis set)
IS pain | Unspecified ISR | IS erythema | IS pruritus | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo (N = 1451) | GMB 120 mg (N = 705) | GMB 240 mg (N = 730) | Placebo (N = 1451) | GMB 120 mg (N = 705) | GMB 240 mg (N = 730) | Placebo (N = 1451) | GMB 120 mg (N = 705) | GMB 240 mg (N = 730) | Placebo (N = 1451) | GMB 120 mg (N = 705) | GMB 240 mg (N = 730) | |
Participants with ≥2% TEAE, n (%) | 138 (9.5) | 71 (10.1) | 85 (11.6) | 14 (1.0) | 22 (3.1) | 45 (6.2) | 20 (1.4) | 20 (2.8) | 29 (4.0) | 2 (0.1) | 15 (2.1) | 24 (3.3) |
Maximum severity of ISRs n (%) | ||||||||||||
Mild | 79 (5.4) | 41 (5.8) | 50 (6.9) | 8 (0.6) | 8 (1.1) | 23 (3.2) | 11 (0.8) | 13 (1.8) | 21 (2.9) | 2 (0.14) | 10 (1.4) | 12 (1.6) |
Moderate | 41 (2.8) | 21 (3.0) | 29 (4.0) | 6 (0.4) | 14 (2.0) | 20 (2.7) | 9 (0.6) | 5 (0.7) | 5 (0.7) | 0 | 2 (0.3) | 6 (0.8) |
Severe | 18 (1.2) | 9 (1.3) | 6 (0.8) | 0 | 0 | 2 (0.3) | 0 | 2 (0.3) | 3 (0.4) | 0 | 3 (0.4) | 6 (0.8) |
SAE of ISR, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
aDiscontinued due to ISR, n (%) | 0 | 0 | 1 (0.1) | 0 | 1 (0.1) | 3 (0.4) | 0 | 1 (0.1) | 0 | 0 | 0 | 0 |
Median duration of ISR event, days (SD) | 1.6 (8.4) | 1.2 (1.0) | 1.5 (2.7) | 1.2 (0.8) | 5.3 (9.3) | 3.7 (3.9) | 3.8 (16.0) | 6.5 (9.4) | 4.6 (5.6) | 1.0 (0.00) | 6.1 (7.5) | 6.2 (7.2) |