All (N=301) | Serious (N=301) | |||
---|---|---|---|---|
ADR | ||||
Total | 80 | 26.6% | 21 | 7.0% |
ADRs by SOC | ||||
Infections and infestations | 29 | 9.6% | 9 | 3.0% |
Investigations | 16 | 5.3% | 1 | 0.3% |
Respiratory, thoracic and mediastinal disorders | 13 | 4.3% | 3 | 1.0% |
Hepatobiliary disorders | 9 | 3.0% | 0 | |
ADRs of particular interest | ||||
Tuberculosis | 0 | 0 | ||
Pneumocystis jirovecii pneumonia | 4 | 1.3% | 4 | 1.3% |
Pneumonia bacterial* | 6 | 2.0% | 4 | 1.3% |
Herpes zoster | 4 | 1.3% | 0 | |
Malignancy (1) | 4 | 1.3% | 4 | 1.3% |
Interstitial lung disease | 2 | 0.7% | 2 | 0.7% |
Sepsis | 0 | 0 | ||
Pancytopenia | 0 | 0 | ||
Reactivation of hepatitis B | 0 | 0 |
*Pneumonia, Pneumonia bacterial, Pneumonia pneumococcal, Pneumonia legionella, Pneumonia streptococcal. (1) Colon cancer, diffuse large B-cell lymphoma, ovarian cancer metastatic, lung neoplasm malignant.