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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 retrospective analysis of data of patients who met the ACR 2010 criteria of diagnosis, cases of 10 patients aged 64−75 years [sexes not stated] were described, who developed pancytopenia during toxicity with low-dose (<25−35 mg/week) methotrexate for rheumatoid arthritis; out of them 3 patients took incorrect dose of methotrexate and 1 patient died of sepsis.
Case 1: An 81-year-old patient, who had a 15-year-long medical history of rheumatoid arthritis, presented with fever, oral ulcer, mucositis and weakness. Concurrent conditions included deep vein thrombosis and pulmonary thromboembolism. The patient had a disease activity score (DAS-28) of 1.49 for rheumatoid arthritis. The patient was prescribed methotrexate 10 mg/week [route not stated] for rheumatoid arthritis. The...
- Cansu DU, et al. How should we manage low-dose methotrexate-induced pancytopenia in patients with rheumatoid arthritis?. Clinical Rheumatology 37: 3419-3425, No. 12, Dec 2018. Available from: URL: http://doi.org/10.1007/s10067-018-4242-8 - Turkey