TABLE 5.
Same ADRs among Enfortumab vedotin and Erdafitinib.
| System organ classes | ADRs | Signal N |
|---|---|---|
| Blood and lymphatic system disorders | Thrombocytopenia and anaemia | 2 |
| Cardiac disorders | Cardiac disorder | 1 |
| Eye disorders | Eye disorder, ocular toxicity, keratitis, visual impairment, vision blurred, lacrimation increased, and dry eye | 7 |
| Gastrointestinal disorders | Nausea, gastrointestinal disorder, dry mouth, abdominal pain upper, abdominal pain, diarrhoea, vomiting, dysphagia, constipation, colitis, and stomatitis | 11 |
| General disorders and administration site conditions | Condition aggravated, feeling abnormal, mucosal inflammation, pain, disease progression, asthenia, fatigue, general physical health deterioration, drug ineffective, death, and malaise | 11 |
| Hepatobiliary disorders | Liver disorder, hepatitis, cholestasis, hepatotoxicity, and hepatic failure | 5 |
| Immune system disorders | Hypersensitivity | 1 |
| Infections and infestations | COVID-19, infection, nasopharyngitis, staphylococcal infection, conjunctivitis, pneumonia, herpes zoster, urinary tract infection, and sepsis | 9 |
| Injury, poisoning and procedural complications | Product use in unapproved indication, off label use, toxicity to various agents, fall, incorrect dose administered, product use issue, and inappropriate schedule of product administration | 7 |
| Investigations | Blood alkaline phosphatase increased, weight decreased, alanine aminotransferase increased, blood creatinine increased, aspartate aminotransferase increased, transaminases increased, liver function test increased, blood bilirubin increased, hepatic enzyme increased, and gamma-glutamyltransferase increased | 10 |
| Metabolism and nutrition disorders | Dehydration, hyponatraemia, decreased appetite, hypercalcaemia, hypophosphataemia, and electrolyte imbalance | 6 |
| Musculoskeletal and connective tissue disorders | Arthralgia, myalgia,and pain in extremity | 3 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Malignant neoplasm progression, neoplasm progression, metastases to liver, and bladder cancer | 4 |
| Nervous system disorders | Somnolence, dizziness, neuropathy peripheral, burning sensation, paraesthesia, taste disorder, dysgeusia, balance disorder, headache, and ageusia | 10 |
| Psychiatric disorders | Insomnia and confusional state | 2 |
| Renal and urinary disorders | Renal failure, renal impairment, and acute kidney injury | 3 |
| Respiratory, thoracic and mediastinal disorders | Interstitial lung disease, oropharyngeal pain, respiratory distress, pneumonitis, cough, dyspnoea, pulmonary embolism, hypoxia, and dysphonia | 9 |
| Skin and subcutaneous tissue disorders | Blister, pruritus, erythema, dry skin, alopecia, skin exfoliation, skin toxicity, and rash | 8 |
| Vascular disorders | Hypotension | 1 |