Table 3.
Adverse events up to week 24 (safety population).
| Number of patients (%) | CT-P10 (n = 161) |
US-RTX (n = 151) |
EU-RTX (n = 60) |
RTXa (n = 211) |
|---|---|---|---|---|
| AE | 96 (59.6%) | 76 (50.3%) | 33 (55.0%) | 109 (51.7%) |
| Treatment-related | 50 (31.1%) | 38 (25.2%) | 22 (36.7%) | 60 (28.4%) |
| SAE | 9 (5.6%) | 9 (6.0%) | 0 | 9 (4.3%) |
| Treatment-related | 0 | 5 (3.3%) | 0 | 5 (2.4%) |
| IRR | 25 (15.5%) | 8 (5.3%) | 12 (20.0%) | 20 (9.5%) |
| Pruritus | 9 (5.6%) | 3 (2.0%) | 4 (6.7%) | 7 (3.3%) |
| Rash | 8 (5.0%) | 4 (2.6%) | 3 (5.0%) | 7 (3.3%) |
| Throat irritation | 5 (3.1%) | 1 (0.7%) | 3 (5.0%) | 4 (1.9%) |
| Infection | 40 (24.8%) | 36 (23.8%) | 11 (18.3%) | 47 (22.3%) |
| Upper respiratory tract infection | 17 (10.6%) | 18 (11.9%) | 4 (6.7%) | 22 (10.4%) |
| Urinary tract infection | 9 (5.6%) | 5 (3.3%) | 1 (1.7%) | 6 (2.8%) |
| Lower respiratory tract infection | 4 (2.5%) | 7 (4.6%) | 2 (3.3%) | 9 (4.3%) |
| Influenza | 1 (0.6%) | 0 | 2 (3.3%) | 2 (0.9%) |
| Malignancy | 0 | 0 | 0 | 0 |
| Death | 1 (0.6%)b | 0 | 0 | 0 |
| Discontinuation due to AEs | 3 (1.9%) | 4 (2.6%) | 1 (1.7%) | 5 (2.4%) |
AE = adverse event. EU = European Union. IRR = infusion-related reaction. RTX = rituximab. SAE = serious adverse event. US = United States.
Note: The total number of AEs included all patient events. At each level of summarization, a patient was counted only once if they reported one or more events. Only the most severe event was counted.
aThe RTX group consists of data from the combined US-RTX and EU-RTX treatment groups.
bOne patient, who had an ongoing medical history of hypertension, thrombocytosis, and anaemia of chronic disease, initially experienced cellulitis and thrombosis of the right brachial vein and was hospitalized approximately two months after receiving the first dose of study drug. The condition of the patient worsened and the patient died due to acute respiratory distress syndrome approximately three weeks after hospitalization. The death was considered unrelated to the study drug.