Attachment: Extract from Clinical Evaluation Report ...

A 62-year-old female in the placebo/placebo/ew group (that is, received placebo throughout Study M11-810 and then received adalimumab ew in the OLE study) with a history of Hashimoto's thyroiditis experienced a fatal AE of autoimmune pancreatitis on Day 214 and cardiac arrest/respiratory failure on Day 241 (30 days after the last dose of ... ................
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