Serious adverse experiences
Item
Has the patient had any serious adverse experiences during this course?
boolean
C1519255 (UMLS CUI [1])
Date Performed
Item
Date Performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of 12-Lead ECG
text
C1274040 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Code List
Result of 12-Lead ECG
CL Item
Normal/no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (If 'Yes' please record details on the Significant Medical/ Surgical History and Physical Examination page.) (2)
Perform Status
Item
Is this not done?
boolean
C1623258 (UMLS CUI [1])
Ejection Fraction
Item
Was an Ejection Fraction obtained?
boolean
C0232174 (UMLS CUI [1])
Date Performed
Item
Date Performed
date
C0011008 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
LV Ejection Fraction (2-dimensional mode) (%)
Item
LV Ejection Fraction (2-dimensional mode) (%)
float
C0428772 (UMLS CUI [1])
Item
Which procedure was performed?
text
C0013516 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
Code List
Which procedure was performed?
CL Item
Echocardiogram (1)
Item
Result of Echocardiography/MUGA
text
C1274040 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
Code List
Result of Echocardiography/MUGA
CL Item
No significant worsening since screening (1)
CL Item
Worsening since screening (Please record in the Adverse Experience section) (2)
Date Performed
Item
Date Performed
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Item
Result of Chest X-Ray
text
C1274040 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Code List
Result of Chest X-Ray
CL Item
No significant worsening since screenin (1)
CL Item
Worsening since screening (Please record in the Adverse Experience section) (2)