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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 series of 10 patients, three patients (1 man and 2 women) were described, of whom a 65-year-old woman developed focal phlebitis during treatment with polidocanol for saphenous vein (SSV) reflux (off label indication) and great saphenous vein (GSV) reflux, a 46-year-old woman developed focal phlebitis during treatment with polidocanol for superficial venous reflux and a 65-year-old man developed deep vein thrombosis during treatment with polidocanol [Varithena] for fibrosis of the GSV.
The 65-year-old woman woman, who had bilateral thigh GSV, severe venous eczema and lipodermatosclerosis (LDS) presented with venous reflux in the right SSV, right calf area GSV, and two perforators surrounding the area of LDS. Therefore, polidocanol 1% endovenous microfoam [Varithena]...
- Davis PE, et al. Use of Polidocanol Endovenous Microfoam to Improve Hemodynamics and Symptomology in Patients with Challenging Clinical Presentations: A Case Series. Annals of Vascular Surgery 52: 176-182, Oct 2018. Available from: URL: http://doi.org/10.1016/j.avsg.2018.02.034 - USA