Table 3.
Treatment-related serious adverse events (SAEs) that were reported in patients in the GB242 and INF group, # (%)
Treatment-related SAEs | GB242 (N = 283) n (%) |
INF (N = 283) n (%) |
Total (N = 566) n (%) |
---|---|---|---|
Any treatment-related SAEs, patients (%) | 10 (3.5%) | 12 (4.2%) | 22 (3.9%) |
Lung infection | 2 (0.7%) | 1 (0.4%) | 3 (0.5%) |
Shingles | 1 (0.4%) | 0 | 1 (0.2%) |
Cryptococcal pneumonia | 1 (0.4%) | 0 | 1 (0.2%) |
Drug-induced hypersensitivity | 1 (0.4%) | 0 | 1 (0.2%) |
Immediate anaphylactic shock | 1 (0.4%) | 0 | 1 (0.2%) |
Decreased oral sensation | 1 (0.4%) | 0 | 1 (0.2%) |
gastritis | 1 (0.4%) | 0 | 1 (0.2%) |
Lung inflammation | 1 (0.4%) | 1 (0.4%) | 2 (0.4%) |
Liver damage | 1 (0.4%) | 0 | 1 (0.2%) |
Upper respiratory tract infection | 0 | 1 (0.4%) | 1 (0.2%) |
Lymph node tuberculosis | 0 | 1 (0.4%) | 1 (0.2%) |
Gastroenteritis | 0 | 1 (0.4%) | 1 (0.2%) |
Hematopoietic lymphohistiocytosis | 0 | 1 (0.4%) | 1 (0.2%) |
Cough | 0 | 1 (0.4%) | 1 (0.2%) |
Expectoration | 0 | 1 (0.4%) | 1 (0.2%) |
Interstitial lung disease | 0 | 1 (0.4%) | 1 (0.2%) |
Fever | 0 | 1 (0.4%) | 1 (0.2%) |
Polyserositis | 0 | 1 (0.4%) | 1 (0.2%) |
Lupus-like syndrome | 0 | 1 (0.4%) | 1 (0.2%) |
Sinus bradycardia | 0 | 1 (0.4%) | 1 (0.2%) |
Erythema nodosa | 0 | 1 (0.4%) | 1 (0.2%) |
Anemia | 0 | 1 (0.4%) | 1 (0.2%) |