An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective chart review of 8 patients conducted from January 2016 to December 2017 at National Cancer Institute, Malaysia, 3 patients (2 women and 1 man) aged 32−60 years were described, who developed respiratory depression, transient somnolence or nausea and vomiting during treatment with oxycodone or following an off-label treatment with methadone for refractory cancer related pain [not all durations of treatment to reactions onsets stated].
Patient F: The 57-year-old woman developed respiratory depression during treatment with oxycodone and following an off-label treatment with methadone. The woman, who had metastatic breast cancer and brachial plexoplathy, had mixed nociceptive-neuropathic type pain in the chest and axilla rotating to arm. She had received oxycodone...