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)”.