Table 3.
Adverse events of special interest (AESI) detected in the safety analysis set (n = 4067)
| System | Preferred term | N (%) | EAIR per year (95% CI) |
|---|---|---|---|
| Cardiac events | Hypertension | 255 (6.27%) | 0.021 [0.018, 0.023] |
| Infections | Herpes zoster | 122 (3.0%) | 0.010 [0.008, 0.011] |
| Progressive multifocal leukoencephalopathy | 2 (0.05%) | 0.000 [0.000, 0.001] | |
| Meningitis, cryptococcal | 1 (0.02%) | 0.000 [0.000, 0.000] | |
| Leukopenia | Lymphopenia | 477 (11.73%) | 0.040 [0.037, 0.044] |
| Leukopenia | 291 (7.16%) | 0.024 [0.021, 0.027] | |
| White blood cell count decreased | 115 (2.83%) | 0.009 [0.007, 0.011] | |
| Diseases of the nervous system | Posterior reversible encephalopathy syndrome | 0 | 0.000 [0.000, 0.000] |
| Acute disseminated encephalomyelitis | 0 | 0.000 [0.000, 0.000] | |
| Hepatic enzymes | Hepatic enzyme level increased | 230 (5.66%) | 0.018 [0.016, 0.021] |
| Alanine aminotransferase level increased | 187 (4.60%) | 0.015 [0.013, 0.017] | |
| Eye disorder | Macular edema | 20 (0.49%) | 0.002 [0.001, 0.002] |
| Neoplasms | Thyroid cancer | 1 (0.02%) | 0.000 [0.000, 0.000] |
| Benign breast neoplasm | 1 (0.02%) | 0.000 [0.000, 0.000] | |
| Benign neoplasm | 1 (0.02%) | 0.000 [0.000, 0.000] | |
| Lymphoma | Diffuse large B-cell lymphoma stage I | 1 (0.02%) | 0.000 [0.000, 0.000] |
| Follicle center lymphoma, follicular grade I, II, III stage IV | 1 (0.02%) | 0.000 [0.000, 0.000] | |
| Non-Hodgkin’s lymphoma | 1 (0.02%) | 0.000 [0.000, 0.000] | |
| Pregnancy | Abortion spontaneous | 7 (0.17%) | 0.001 [0.000, 0.001] |
| Abortion | 3 (0.07%) | 0.000 [0.000, 0.001] | |
| Abortion incomplete | 1 (0.02%) | 0.000 [0.000, 0.000] |
EAIR exposure adjusted incidence rate