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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, three patients (1 woman and 2 men), which included an elderly man [exact age at the time of reaction onset not stated] and two patients aged 53 years and 72 years, respectively were described, who developed various immune-related adverse events (irAEs) during treatment with ipilimumab or nivolumab. Two of the 3 patients additionally developed tremor (1 patient) or nephrotoxicity (1 patient) due to off-label use of tacrolimus, indicated for irAEs; one of these two patients exhibited docetaxel related intolerable peripheral neuropathy [not all dosages, routes, durations of treatments to reactions onsets and outcomes stated].
Case 1: The 53-year-old woman had been diagnosed with Stage IV melanoma in 2014 following a resection of a T1a primary melanoma in...
- Beardslee T, et al. Tacrolimus for the treatment of immune-related adverse effects refractory to systemic steroids and anti-tumor necrosis factor a therapy. Journal of Oncology Pharmacy Practice 25: 1275-1281, No. 5, Jul 2019. Available from: URL: http://doi.org/10.1177/1078155218793709 - USA