Table 2.
Incidences of the most commonly reported adverse events, serious adverse events, important adverse drug reactions, and death
| Event | n (%) |
|---|---|
| Patients with at least 1 AE,a total | 4336 (31.2) |
| Injection site reaction | 610 (4.4) |
| Rash | 339 (2.4) |
| Abnormal hepatic function | 328 (2.4) |
| Nasopharyngitis | 288 (2.1) |
| Pyrexia | 261 (1.9) |
| Upper respiratory tract infection | 224 (1.6) |
| Pruritus | 202 (1.5) |
| Total pneumoniab | 189 (1.0) |
| Herpes zoster | 115 (0.8) |
| Erythema | 114 (0.8) |
| Patients with at least 1 SAE,a total | 857 (6.2) |
| Total pneumoniab | 116 (0.8) |
| Interstitial lung disease | 77 (0.6) |
| Pyrexia | 40 (0.3) |
| Sepsis | 27 (0.2) |
| Herpes zoster | 23 (0.2) |
| Pneumocystis jiroveci pneumonia | 24 (0.2) |
| Urinary tract infection | 16 (0.1) |
| Abnormal hepatic function | 15 (0.1) |
| Bacterial arthritis | 13 (0.1) |
| Bronchitis | 13 (0.1) |
| Patients with at least 1 important ADRa | 968 (7.0)c |
| Total pneumoniab | 174 (1.3) |
| Interstitial lung disease | 81 (0.6) |
| Pneumocystis jiroveci pneumonia | 25 (0.2) |
| Malignancy | 30 (0.2) |
| Tuberculosisd | 12 (0.1) |
| Pulmonary | 10 (0.1) |
| Extrapulmonary | 3 (<0.1) |
| Congestive heart failure | 7 (0.1) |
| Lupus-like syndrome | 5 (<0.1) |
| Demyelinating disease | 0 (0) |
| Deaths | 76 (0.6) |
ADR adverse drug reaction, AE adverse event, SAE serious adverse event
aPatients who had at least 1 AE, SAE, or specifically important ADR, respectively. The 10 most frequently reported AEs, SAEs, and ADRs are listed
bTotal pneumonia = pneumonia + bacterial pneumonia + bronchopneumonia + Chlamydia pneumonia + staphylococcal pneumonia + Candida pneumonia + fungal pneumonia; 1 patient developed both pneumonia and bronchopneumonia
c609 patients who had injection site reactions were included
d1 patient had both pulmonary and extrapulmonary tuberculosis