Summary of Safety Profile [n (%)]
| CT-P10 | US-RTX | EU-RTX | Reference Products (US-RTX + EU-RTX) | |
|---|---|---|---|---|
| (N=161) | (N=151) | (N=60) | (N=211) | |
| AE | 122 (75.8) | 96 (63.6) | 37 (61.7) | 133 (63.0) |
| Serious Adverse Event | 13 (8.1) | 14 (9.3) | 2 (3.3) | 16 (7.6) |
| Infection | 61 (37.9) | 53 (35.1) | 17 (28.3) | 70 (33.2) |
| Serious infection | 2 (1.2) | 3 (2.0) | 0 | 3 (1.4) |
| Infusion related reaction (IRR)* | 33 (20.5) | 12 (7.9) | 13 (21.7) | 25 (11.8) |
| Malignancy | 0 | 2 (1.3) | 1 (1.7) | 3 (1.4) |
| Progressive multifocal leukoencephalopathy | 0 | 0 | 0 | 0 |
*None of IRR were serious or led to study drug discontinuation.