Table 2.
Summary of TEAEs
ENZ110 | Nplate | Overall | |
---|---|---|---|
(N = 39) | (N = 13) | (N = 52) | |
All TEAEs, n (%) E | 26 (66.7) 111 | 8 (61.5) 18 | 34 (65.4) 129 |
p-value for difference in the incidence of AEs between treatment | 0.8679 | ||
TEAEs related to investigational product, n (%) E | |||
Possible | 15 (38.5) 71 | 5 (38.5) 12 | 20 (38.5) 83 |
Probable/Likely | 2 (5.1) 3 | 1 (7.7) 1 | 3 (5.8) 4 |
Unlikely | 20 (51.3) 37 | 3 (23.1) 5 | 23 (44.2) 42 |
Severity of TEAEs, n (%) E | |||
Mild | 21 (53.8) 76 | 8 (61.5) 16 | 29 (55.8) 92 |
Moderate | 12 (30.8) 29 | 1 (7.7) 2 | 13 (25.0) 31 |
Severe | 6 (15.4) 6 | 0 (0.0) 0 | 6 (11.5) 6 |
Seriousness of TEAEs, n (%) E | |||
Hospitalization or prolongation of hospitalization | 4 (10.3) 4 | 0 (0.0) 0 | 4 (7.7) 4 |
Death | 1 (2.6) 1 | 0 (0.0) 0 | 1 (1.9) 1 |
TEAEs leading to discontinuation of IMP | 3 (7.7) 3 | 0 (0.0) 0 | 3 (5.8) 3 |
E number of events, N number of subjects dosed with each treatment, n number of subjects with adverse event with particular category, % calculated using the number of subjects treated with each treatment as the denominator (n/N)*100, TEAEs treatment-emergent adverse events, ENZ110 biosimilar romiplostim, Nplate innovator romiplostim, IMP investigational medicinal product