Adverse events by group
| ADD-ON (N=115) | SWITCH (N=111) | |||
|---|---|---|---|---|
| AE | SAE | AE | SAE | |
| Total patients with ≥1 AE or ≥1 SAE | 69, 60.0% | 16, 13.9% | 50, 45.0% | 9, 8.1% |
| Infections and infestations | 47, 40.9% | 6, 5.2% | 25, 22.5% | 7, 6.3% |
| Bacterial pneumonia | 2, 1.7% | 2, 1.7% | 3, 2.7% | 1, 0.9% |
| Nasopharyngitis | 10, 8.7% | 0 | 3, 2.7% | 1, 0.9% |
| Gastrointestinal disorders | 29, 25.2% | 1, 0.9% | 14, 12.6% | 2, 1.8% |
| Hepatobiliary disorders | 22, 19.1% | 1, 0.9% | 5, 4.5% | 1, 0.9% |
| Liver function disorders | 15, 13.0% | 1, 0.9% | 3, 2.7% | 0 |
| Respiratory, thoracic and mediastinal disorders | 14, 12.2% | 1, 0.9% | 5, 4.5% | 0 |
| Laboratory test abnormalities | 18, 15.7% | 0 | 9, 8.1% | 0 |
| Metabolism and nutrition disorders | 9, 7.8% | 0 | 7, 6.3% | 0 |
| Skin and subcutaneous tissue disorders | 7, 6.1% | 0 | 7, 6.3% | 2, 1.8% |
| Injury, poisoning, and procedural complications | 7, 6.1% | 4, 3.5% | 2, 1.8% | 1, 0.9% |
| General disorders and administration site conditions | 4, 3.5% | 0 | 1, 0.9% | 0 |
| Neoplasms benign, malignant, unspecified | 2, 1.7% | 2, 1.7% | 1, 0.9% | 0 |
| Eye disorders | 3, 2.6% | 0 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 2, 1.7% | 1, 0.9% | 1, 0.9% | 0 |
| Blood and lymphatic system disorders | 2, 1.7% | 1, 0.9% | 1, 0.9% | 0 |
AE, adverse event; SAE, serious adverse event