Symptomatic Reportable as a Reportable as a As for LVSD (that is, SAE, using the SAE using the TRYPHAENA Grade 3 or greater term congestive term ‘left LVD) heart failure ventricular (CHF) systolic dysfunction’ (LVSD) Reportable as a As for As for single diagnosis NEOSPHERE NEOSPHERE rather than symptoms or signs and graded according to and NYHA classification CHF occurring As for Symptomatic during the study NEOSPHERE LVSD occurring and up to 24 (except using the during study and months after the term symptomatic up to 36 months last dose of study LVSD rather than after last dose of medications was CHF) study medications to be reported was to be regardless of reported , causality graded regardless of according to causality, and and NYHA graded according classification to NCI-CTCAE and NYHA classification Specific and A cardiac Cardiac symptoms symptoms of questionnaire was and signs were LVSD were completed by reported on a entered into the investigators ‘Symptomatic comments section prior to each LVSD’ eCRF page of the AE eForm treatment cycle. for patients with Cardiac symptom LVSD and physical findings of symptomatic LVSD were entered into the cardiac questionnaire eForm
Symptomatic LVSD (that is, Grade 3 or greater LVD) Reportable as a SAE, using the term congestive heart failure (CHF) Reportable as a SAE using the term ‘left ventricular systolic dysfunction’ (LVSD) As for TRYPHAENA Reportable as a single diagnosis rather than symptoms or signs and graded according to and NYHA classification As for NEOSPHERE As for NEOSPHERE CHF occurring during the study and up to 24 months after the last dose of study medications was to be reported regardless of causality graded according to and NYHA classification As for NEOSPHERE (except using the term symptomatic LVSD rather than CHF) Symptomatic LVSD occurring during study and up to 36 months after last dose of study medications was to be reported , regardless of causality, and graded according to NCI-CTCAE and NYHA classification Specific and symptoms of LVSD were entered into the comments section of the AE eForm A cardiac questionnaire was completed by investigators prior to each treatment cycle. Cardiac symptom and physical findings of symptomatic LVSD were entered into the cardiac questionnaire eForm Cardiac symptoms and signs were reported on a ‘Symptomatic LVSD’ eCRF page for patients with LVSD
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