Upload the source documents for all data requested in this eCRF (e.g., labs, study results) as well as the admission History and Physical Examination findings and the Discharge Summary. PRESENTATION When was valvulopathy noted as an event? : Day Month Year Hr:Min(00:00-23:59) Did subject require hospitalization as [Y] Yes [N] No [NK] Not known a result of the valvulopathy? If Yes, admission date and time Day Month Year HR: History Did the subject have [Y] Yes [N] No [NK] Not known valvulopathy prior to the reported event? Did subject have any prior/concomitant medical condition [Y] Yes [N] No [NK] Not known or medication known to cause or contribute to valvulopathy? If Yes and this event is reported as an SAE, record details in ___________________Section of SAE. If Yes and this event has not been reported as an SAE, record details: ___________________________________________________________________________ MEDICATIONS USED IN THE PAST KNOWN TO CAUSE/CONTRIBUTE TO VALVULOPATHY Fenfluramine [Y] Yes [N] No [NK]Not known Selective serotonin reuptake inhibitor [Y] Yes [N] No [NK]Not known Amphetamine [Y] Yes [N] No [NK]Not known Ergot derivatives [Y] Yes [N] No [NK]Not known Other, specify [Y] Yes [N] No [NK]Not known If Yes, specify: _________________________________________________________
Upload the source documents for all data requested in this eCRF (e.g., labs, study results) as well as the admission History and Physical Examination findings and the Discharge Summary. PRESENTATION When was valvulopathy noted as an event? : Day Month Year Hr:Min(00:00-23:59) Did subject require hospitalization as a result of the valvulopathy? [Y] Yes [N] No [NK] Not known If Yes, admission date and time Day Month Year HR: History Did the subject have valvulopathy prior to the reported event? [Y] Yes [N] No [NK] Not known Did subject have any prior/concomitant medical condition or medication known to cause or contribute to valvulopathy? [Y] Yes [N] No [NK] Not known If Yes and this event is reported as an SAE, record details in ___________________Section of SAE. If Yes and this event has not been reported as an SAE, record details: ___________________________________________________________________________ MEDICATIONS USED IN THE PAST KNOWN TO CAUSE/CONTRIBUTE TO VALVULOPATHY Fenfluramine [Y] Yes [N] No [NK]Not known Selective serotonin reuptake inhibitor [Y] Yes [N] No [NK]Not known Amphetamine [Y] Yes [N] No [NK]Not known Ergot derivatives [Y] Yes [N] No [NK]Not known Other, specify [Y] Yes [N] No [NK]Not known If Yes, specify: _________________________________________________________
ValvulopathyDoc_FINAL_2-Dec-2013.docx