Urinary electrolyte wasting is one of the adverse events mentioned on the chemotherapy form. What does it refer to?
Urinary electrolyte wasting (see EURAMOS 1 protocol: Appendix A.4, page 41) refers to the inability of the kidneys to excrete acid into the urine. This condition is called renal tubular acidosis and can be triggered by several drugs, including chemotherapy drugs. It may also be hereditary (i.e. Fanconi’s syndrome), triggered by an autoimmune disease, or caused by heavy metal poisoning diabetes, sickle cell disease or an obstruction in the urinary tract. Resulting symptoms and metabolic abnormalities include: a) high blood acidity, e.g. low bicarbonate b) mild dehydration c) low or high potassium blood levels (depending of the type of renal tubular acidosis) d) fragile bones and bone pain e) kidney stones due to calcium deposits in the kidneys The grading of this AE is as follows: grade 1: asymptomatic, intervention not indicated grade 2: mild, reversible and manageable with replacement grade 3: irreversible, requiring continued replacement grade 4: not applicable grade 5: not applicabl
- If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
- Urinary electrolyte wasting is one of the adverse events mentioned on the chemotherapy form. What does it refer to?
- Are surgical complications, chemotherapy toxicities, and radiation effects all considered types of Adverse Events?