Table 2.
ADRs, Serious ADRs, and ADRs of Special Interest
| Type of ADR | Safety analysis population (n = 1,523) |
|
|---|---|---|
| ADR | Serious ADR | |
| All | 276 (18.1) | 74 (4.9) |
| Infections and infestations | 92 (6.0) | 27 (1.8) |
| Nasopharyngitis | 24 (1.6) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 37 (2.4) | 7 (0.5) |
| Interstitial lung disease | 6 (0.4) | 4 (0.3) |
| Upper respiratory tract inflammation | 13 (0.9) | 0 |
| Gastrointestinal disorders | 45 (3.0) | 15 (1.0) |
| Colitis ulcerative | 20 (1.3) | 10 (0.7) |
| Hepatobiliary disorders | 1 (0.1) | 0 |
| Liver disorder | 1 (0.1) | 0 |
| Skin and subcutaneous tissue disorders | 61 (4.0) | 4 (0.3) |
| Rash | 21 (1.4) | 1 (0.1) |
| Musculoskeletal and connective tissue disorders | 21 (1.4) | 5 (0.3) |
| Arthralgia | 10 (0.7) | 0 |
| Lupus-like syndrome | 4 (0.3) | 4 (0.3) |
| General disorders and administration site conditions | 31 (2.0) | 5 (0.3) |
| Pyrexia | 13 (0.9) | 5 (0.3) |
| Investigations | 28 (1.8) | 3 (0.2) |
| C-reactive protein increased | 11 (0.7) | 1 (0.1) |
| ADRs of special interest | ||
| Infection | 92 (6.0) | 27 (1.8) |
| Tuberculosisa | 3 (0.2) | 3 (0.2) |
| Malignancy | 7 (0.5) | 7 (0.5) |
| Injection site reaction | 10 (0.7) | 0 |
| Interstitial pneumonia | 6 (0.4) | 4 (0.3) |
| Autoimmune disease | 5 (0.3) | 5 (0.3) |
| Pancytopenia | 0 | 0 |
Values are presented as number (%).
a
Also included in the system organ class infections and infestations.
ADR, adverse drug reaction.