AEs, n (%) [number of events] | Placebo (n = 10) | IMCY-0098 dose A (n = 6) | IMCY-0098 dose B (n = 9) | IMCY-0098 dose C (n = 16) | Total (N = 41) |
---|---|---|---|---|---|
All AEs | 9 (90.0) [51] | 6 (100) [38] | 9 (100) [85] | 16 (100) [141] | 40 (97.6) [315] |
Solicited AEs | 7 (70.0) [24] | 3 (50.0) [19] | 7 (77.8) [40] | 12 (75.0) [72] | 29 (70.7) [156] |
Unsolicited AEs | 8 (80.0) [27] | 6 (100) [19] | 9 (100) [43] | 16 (100) [69] | 39 (95.1) [159] |
AEs by grade | |||||
Grade 1 | 5 (50.0) | 5 (83.3) | 4 (44.4) | 6 (37.5) | 20 (48.8) |
Grade 2 | 3 (30.0) | 1 (16.7) | 5 (55.6) | 10 (62.5) | 19 (46.3) |
Grade 3 | 1 (10.0) | 0 | 0 | 0 | 1 (2.4) |
Grade 4 | 0 | 0 | 0 | 0 | 0 |
Treatment-related AEs | 6 (60.0) [25] | 4 (66.7) [18] | 7 (77.8) [41] | 11 (68.8) [65] | 28 (68.3) [150] |
Injection site reactions | 5 (50.0) [18] | 3 (50.0) [12] | 4 (44.4) [26] | 8 (50.0) [50] | 20 (48.8) [106] |
Injection site pain | 3 (30.0) [3] | 3 (50.0) [9] | 3 (33.3) [8] | 6 (37.5) [28] | 15 (36.6) [47] |
Injection site erythema | 3 (30.0) [11] | 1 (16.7) [1] | 2 (22.2) [9] | 4 (25.0) [6] | 10 (24.4) [27] |
Injection site induration | 1 (10.0) [1] | 0 | 1 (11.1) [4] | 3 (18.8) [5] | 5 (12.2) [10] |
Injection site pruritus | 1 (10.0) [1] | 1 (16.7) [1] | 1 (11.1) [3] | 2 (12.5) [4] | 5 (12.2) [9] |
Injection site swelling | 0 | 1 (16.7) [1] | 1 (11.1) [1] | 2 (12.5) [3] | 4 (9.8) [5] |
Injection site bruising | 0 | 0 | 1 (11.1) [1] | 3 (18.8) [3] | 4 (9.8) [4] |
Injection site reaction | 1 (10.0) [2] | 0 | 0 | 0 | 1 (2.4) [2] |
Injection site irritation | 0 | 0 | 0 | 1 (6.3) [1] | 1 (2.4) [1] |
SAEs | 0 | 0 | 1 (11.1) [2]a | 1 (6.3) [1] | 2 (4.9) [3] |
Phimosis | 0 | 0 | 1 (11.1) [1] | 0 | 1 (2.4) [1] |
Varicocele | 0 | 0 | 1 (11.1) [1] | 0 | 1 (2.4) [1] |
Vestibular neuronitis | 0 | 0 | 0 | 1 (6.3) [1] | 1 (2.4) [1] |
AEs leading to drug withdrawal | 0 | 0 | 0 | 0 | 0 |
AEs leading to death | 0 | 0 | 0 | 0 | 0 |