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