Table 1.
Summary of the most common AEs and SAEs associated with the treatment with Opdualag compared to Nivolumab alone in the RELATIVITY-047 clinical trial (NCT03470922).
| Opdualag (n = 355) | Nivolumab (n = 359) | ||
|---|---|---|---|
| AEs | Musculoskeletal pain | 54.6% | 33.1% |
| Fatigue | 29.3% | 20.6% | |
| Asthenia | 13.5% | 9.2% | |
| Pyrexia | 12.4% | 9.2% | |
| Headache | 18.0% | 13.1% | |
| Cough | 14.1% | 10.6% | |
| Rash | 17.4% | 13.6% | |
| Pruritus | 24.8% | 17.3% | |
| Diarrhea | 23.1% | 17.3% | |
| Nausea | 17.7% | 16.4% | |
| Constipation | 11.0% | 7.0% | |
| Decreased appetite | 15.5% | 7.5% | |
| Anaemia | 14.1% | 10.3% | |
| Increased AST | 9.9% | 4.7% | |
| Increased ALT | 10.1% | 5.85% | |
| Hypothyroidism | 16.3% | 13.1% | |
| SAEs | Anaemia | 1.4% | 1.1% |
| Acute myocardial infarction | 1.1% | 0.6% | |
| Myocarditis | 1.1% | 0.3% | |
| Adrenal insufficiency | 1.4% | 0.0% | |
| Colitis | 1.4% | 0.3% | |
| Diarrhea | 1.1% | 0.8% | |
| General health deterioration | 0.6% | 1.7% | |
| Pyrexia | 0.9% | 1.4 % | |
| Pneumonia | 1.4% | 0.8% | |
| Urinary tract infection | 0.9% | 1.7% | |
| Back pain | 1.1% | 0.6% | |
| Malignant neoplasm progression | 11.0% | 13.1% | |
| Metastases to central nervous system | 1.1% | 0.8% | |
| Pneumonitis | 1.1% | 0.3% |