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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case report, a 23-year-old man developed chronic renal failure during treatment with zoledronic-acid [zoledronate] for bone metastasis cancer and with cabozantinib for metastatic medullary thyroid cancer (MTC), and a 67-year-old man developed aggravation of known mild chronic renal insufficiency leading to chronic renal failure during treatment with lenvatinib for metastatic papillary thyroid carcinoma and with iomeprol [Imeron] and iopromide [Ultravist-370] used an an contrast media.
Patient 1: A 23-year-old man was diagnosed with metastatic MTC. He was enrolled in the phase III study comparing cabozantinib to placebo. He received blinded treatment for 3 weeks. On day 1 of study treatment, he had a normal renal function. He received cabozantinib for metastatic MTC. He had...
- Paschke L, et al. Anti VEGF-TKI Treatment and New Renal Adverse Events Not Reported in Phase III Trials. European Thyroid Journal 7: 308-312, No. 6, Nov 2018. Available from: URL: http://doi.org/10.1159/000491387 - Germany