Table 3 Summary of Immunotherapy- related Adverse Events (Patients who received at least one dose of study drug)
Parameter | BEXIDEM® (N = 64) | BCG (N = 73) | P |
|---|---|---|---|
No. of patients with AE | 29 (45.3%) | 62 (84.9%) | < 0.001 |
16 (25.0%) | 39 (53.4%) | < 0.001 | |
Grade Moderate | |||
Grade Severe | 7 (10.9%) | 12 (16.4%) | 0.4593 |
Relationship Probable | 7 (10.9%) | 31 (42.5%) | < 0.001 |
Relationship Definite | 3 (4.7%) | 26 (35.6%) | < 0.001 |
No. of patients who discontinued due to an AE | 1 (1.6%) | 6 (8.2%) | 0.121 |