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To determine the incidence and risk factors of adverse events (AE) in a Tunisian university hospital. We carried out a longitudinal observational study in 2016 over a period of 3months in the Sahloul university hospital of Sousse, Tunisia. Data were collected using a pretested form filled by doctors previously trained in the collection methodology, upon each visit to all hospitalized patients. Overall, 1,357patients were eligible. We identified 168AEs in 131patients with AEs incidence of 12.4% (95% CI [7.41 – 17.