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. 2022 Nov 15;39(3):435–441. doi: 10.1007/s12288-022-01602-5

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