Table 2 Overall safety and TEAEs of interest (n = 466)*
Variable | Number of patients, n (%) |
|---|---|
Overall summary of TEAEs | |
Any adverse event | 297 (63.7) |
Any grade ≥ 3 adverse event | 42 (9.0) |
Any adverse event with the outcome of death | 0 (0.0) |
Any serious adverse event | 46 (9.9) |
Treatment-related serious adverse event | 3 (0.6) |
Any adverse event leading to discontinuation of IP | 17 (3.6) |
Any adverse event leading to discontinuation from study | 8 (1.7) |
Most frequent TEAEs by preferred term | |
Nasopharyngitis | 43 (9.2) |
Upper respiratory tract infection | 40 (8.6) |
Bronchitis | 30 (6.4) |
Rheumatoid arthritis | 29 (6.2) |
Hypertension | 22 (4.7) |
Pharyngitis | 19 (4.1) |
Serious TEAEs | |
Musculoskeletal and connective tissue disorders | 12 (2.6) |
Infections and infestations | 6 (1.3) |
Cardiac disorders | 5 (1.1) |
Eye disorders | 4 (0.9) |
Gastrointestinal disorders | 4 (0.9) |
Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 4 (0.9) |
Reproductive system and breast disorders | 3 (0.6) |
Vascular disorders | 3 (0.6) |
Injury, poisoning, and procedural complications | 2 (0.4) |
Nervous system disorders | 2 (0.4) |
Surgical and medical procedures | 2 (0.4) |
General disorders and administration site conditions | 1 (0.2) |
Hepatobiliary disorders | 1 (0.2) |
Pregnancy, puerperium, and perinatal conditions | 1 (0.2) |
Psychiatric disorders | 1 (0.2) |
Respiratory, thoracic, and mediastinal disorders | 1 (0.2) |
TEAEs of interest | |
Infections | 190 (40.8) |
Malignancies | 8 (1.7) |
Hypersensitivity | 20 (4.3) |
Demyelinating diseases | 0 (0.0) |
Hematological reactions | 5 (1.1) |
Heart failure | 0 (0.0) |
Lupus-like syndrome | 0 (0.0) |
Liver enzyme elevations | 25 (5.4) |
Injection site reactions | 0 (0.0) |