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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 case review series, three men and two women aged between 57−77 years were described, who developed haemolysis and showed falsely low HbA1c levels during treatment with dapsone or sulfasalazine [routes and durations of treatments to reactions onsets not stated; not all dosages and outcomes stated].
Patient 1: A 57-year-old man was diagnosed with type 1 diabetes at 22 years of age in 1982 and was regularly reviewed for glycaemic control. His regular medication included insulin glargine, insulin aspart and metformin. He also had a history of coeliac disease, obesity and dermatitis herpetiformis. During March 2011-May 2015, his HbA1c levels were <6.0%. Although his blood glucose levels were between 145−270 mg/dL during self-monitoring, his HbA1c level was...