Pharmachild N = 2022 | BiKeR N = 1697 | |
---|---|---|
Infections: | 1523 (75.3%) | 1509 (89%) |
Serious/targeted infections (Epstein–Barr virus, cytomegalovirus, papilloma virus, herpes zoster primary and reactivation, and opportunistic infections) | 674 (33.3%) | 171 (10.1%) |
Tuberculosis | 27 (1,3%) | 0 |
Other infections | 822 (40.6%) | 1338 (78.8%) |
Infusion/injection related reactions: | 218 (10.8%) | 24 (1.4%) |
Infusion related reaction | 144 (7.1%) | 11 (0.6%) |
Injection related reaction | 74 (3.7%) | 13 (0.8%) |
Blood cell–related events of special interest (ESI): | 188 (9.3%) | 90 (5.3%) |
Pancytopenia | 6 (0.3%) | 65 (3.8%) |
Neutropenia | 107 (5.3%) | 14 (0.8%) |
Macrophage activation syndrome | 75 (3.7%) | 11 (0.6%) |
Aplastic anemia | 0 | 0 |
Autoimmune ESI: | 50 (2.5%) | 50 (2.9%) |
Inflammatory bowel disease (IBD) | 21 (1.1%) | 23 (1.3) |
Other autoimmune diseases excluding IBD, uveitis, and demyelinisation disorders | 18 (0.9%) | 24 (1.4%) |
Lupus erythematosus systemic/lupus-like syndrome | 4 (0.2%) | 1 (0.1%) |
Optic neuritis | 4 (0.2%) | 0 |
Multiple sclerosis | 2 (0.1%) | 0 |
Demyelination | 1 (0.05%) | 2 (0.2%) |
Malignancies: | 16 (0.8%) | 13 (0.8%) |
Leukemias | 3 (0.1%) | 2 (0.2%) |
Lymphomas | 2 (0.1%) | 5 (0.3%) |
Hematopoietic neoplasms (excluding leukemias and lymphomas) | 1 (0.05%) | 2 (0.2%) |
Neoplasm (other) | 10 (0.5%) | 4 (0.2%) |
Others ESI: | 27 (1.3%) | 11 (0.6%) |
Gastrointestinal (GI) ulcer/GI bleed/GI perforation | 17 (0.8%) | 4 (0.2%) |
Pregnancy | 9 (0.4%) | 7 (0.4%) |
Congestive heart failure | 1 (0.05%) | 0 |