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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 study, three patients [two women and one man] aged 30−68 years were described, who developed various toxicities during treatment with etoposide, doxorubicin, cisplatin and mitotane [time to reactions onsets not stated; not all routes stated].
Case 1: A 45-year-old woman developed neutropenia, thrombocytopenia, anaemia, febrile neutropenia and fatigue during treatment with etoposide, doxorubicin, cisplatin and mitotane. The woman, who had metastatic adrenocortical carcinoma (inferior vena cava, massive liver metastases and multiple pulmonary metastases), received treatment with etoposide 100 mg/m2 on days 5−7 every four weeks, doxorubicin 20 mg/m2 on days 1 and 8 every four weeks, cisplatin 40 mg/m2on days 2 and 9 every four weeks and oral mitotane 1 g/day (days 1−7),...
- Sasaki S. Three Cases of Advanced or Recurrent Adrenocortical Carcinoma Patients Treated with Etoposide, Doxorubicin and Cisplatin plus Mitotane. Gan to Kagaku Ryoho 45: 67-70, No. 1, Jan 2018. Available from: URL: https://www.ncbi.nlm.nih.gov/pubmed/29362311 [Japanese; summarised from a translation] - JapanPubMedGoogle Scholar