2.3 Definition of clinical outcomes
Clinical outcomes of respective adverse events are categorized into recovery, remission, non-recovery, sequelae, unknown, and death in the REAC table. We defined the clinical outcomes of the PAH patients with at least one adverse event that resulted in death or without adverse events that resulted in death as death from any cause or non-death, respectively. Preferred terms (PTs), high level group terms (HLGTs), and high level terms (HLTs) in the Medical Dictionary for Regulatory Activities/Japanese version 25.1 (www.pmrj.jp/jmo/php/indexj.php) were used for coding of adverse events. Death from adverse events reported as the following PTs was defined as PAH-related death: ”pulmonary arterial hypertension (PT code: 10064911)”, ”sudden death (PT code: 10042434)”, ”condition aggravated (PT code: 10010264)”, PTs included in ”heart failures (HLGT code: 10019280)”, and PTs included in ”respiratory failures (excl neonatal) (HLT code: 10052549)”.