Table 4.
Summary of treatment-emergent AEs (safety analysis population)
| Part 1 | Part 2 | |||||||
|---|---|---|---|---|---|---|---|---|
| DRL_RI N = 91 |
RTX-US N = 92 |
RTX-EU N = 93 |
Total N = 276 |
DRL_RI N = 91 |
RTX-US N = 92 |
RTX-EU N = 93 |
Total N = 276 |
|
| Patients with at least 1 AE, n (%) | 33 (36.3) | 30 (32.6) | 37 (39.8) | 100 (36.2) | 27 (29.7) | 28 (30.4) | 29 (31.2) | 84 (30.4) |
| Patients with at least 1 treatment-related AE, n (%) | 10 (11.0) | 10 (10.9) | 12 (12.9) | 32 (11.6) | 8 (8.8) | 9 (9.8) | 12 (12.9) | 29 (10.5) |
| Patients with at least 1 SAE, n (%) | 2 (2.2) | 4 (4.3) | 6 (6.5) | 12 (4.3) | 1 (1.1) | 1 (1.1) | 4 (4.3) | 6 (2.2) |
| Patients with at least 1 treatment-related SAE, n (%) | 1 (1.1) | 3 (3.3) | 4 (4.3) | 8 (2.9) | 0 | 0 | 3 (3.2) | 3 (1.1) |
| Patients died from AE, n (%) | 1 (1.1) | 0 | 0 | 1 (0.4) | 1 (1.1) | 0 | 0 | 1 (0.4) |
| Patients discontinued study due to AE, n (%) | 1 (1.1) | 3 (3.3) | 6 (6.5) | 10 (3.6) | 1 (1.1) | 1 (1.1) | 0 | 2 (0.7) |
Part 1: All treatment-emergent AEs occurring up to week 24 of the study
Part 2: Treatment-emergent AEs ongoing at the week 24 and AEs occurring after week 24 up to week 52
Patients experiencing multiple events were counted only once within the treatment group
Percentages were based on number of patients within each treatment group under safety analysis population (N)
AE adverse event, RTX-EU MabThera®, RTX-US Rituxan®, SAE serious adverse event