“…The included studies used various approaches to retrieve or generate ADE labels and could broadly be categorized into 3 categories: 5 category I studies using ADEs that were registered by healthcare providers (20%), 30 , 33 , 51–53 3 category II studies using adverse event signals followed by a(n) (formal) ADE causality assessment (12%), 43 , 44 , 46 and 15 category III studies using adverse event signals without a(n) (formal) ADE causality assessment (60%). 31 , 34–39 , 41 , 42 , 45 , 46 , 48–50 , 54 Studies in the first category retrieved International Classification of Diseases version 9 or 10 codes (ICD-9 or ICD-10) 55 , 56 that explicitly describe a causal relation between a drug and an adverse symptom (eg, ICD-10 code I95.1: Hypotension due to drugs ).…”