Information coming directly from patients or subjects through interviews or self-completed questionnaires or other data capture tools such as diaries about their life, health condition(s), and treatment. NOTE: PROs are used to assess outcomes involving the patients’/ subjects’ perceptions, symptoms, satisfaction with treatment, adherence to prescribed regimens. PROs include outcomes recorded by interviewers transcribing the views expressed by the patient, but the term does not apply to outcomes recorded by observers who rely on their own judgment. A PRO is usually a subjective assessment of feeling or function distinguished from a self-reported objective measurement such as body weight. (CDISC v 9.0)