Table 4 Summary of TEAEs in the safety set
PDA10 (N = 150) | Eprex® (N = 146) | P-value | |
|---|---|---|---|
Subjects with TEAEs | 98(65.33) [273] | 88(60.27) [231] | 0.3678 (c) |
Infection | 34(22.67) [49] | 35(23.97) [51] | 0.7905 (c) |
Infection with corresponding category | 29(19.33) [35] | 28(19.18) [39] | 0.9730 (c) |
a. Respiratory tract infections | 21(14.00) [26] | 24(16.44) [33] | 0.5591 (c) |
b. Gastrointestinal infections | 6(4.00) [6] | 4(2.74) [4] | 0.7499 (f) |
c. Urinary tract infections | 0 | 0 | – |
d. Vascular access infections | 3(2.00) [3] | 2(1.37) [2] | 1.0000 (f) |
No corresponding category | 10(6.67) [14] | 11(7.53) [12] | 0.7713 (c) |
Non-Infection | 89(59.33) [224] | 78(53.42) [180] | 0.3054 (c) |
Non-Infection with corresponding category | 39(26.00) [60] | 35(23.97) [46] | 0.6871 (c) |
a. Poorly controlled BP | 26(17.33) [41] | 20(13.70) [26] | 0.3882 (c) |
b. Ischemic coronary artery disease | 3(2.00) [3] | 3(2.05) [3] | 1.0000 (f) |
c. Heart failure | 13(8.67) [16] | 8(5.48) [8] | 0.2856 (c) |
d. Ischemic stroke | 0 | 0 | – |
e. Haemorrhagic stroke | 0 | 0 | – |
f. AVF thrombosis | 0 | 7(4.79) [7] | 0.0066 (f) |
g. Death | 0 | 2(1.37) [2] | 0.2424 (f) |
No corresponding category | 76(50.67) [164] | 61(41.78) [134] | 0.1253 (c) |