Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Serious Adverse Experience
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
No significant worsening since screening (2)
CL Item
Worsening since screening -> Please record in the Adverse Experience section (3)
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 (2)
CL Item
Worsening since screening -> Please record in the Adverse Experience section (3)
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 screening (2)
CL Item
Worsening since screening -> Please record in the Adverse Experience section (3)
Supportive Therapy (Including Erythropoietin)
Item
Has the patient received any transfusions during this course?
boolean
C0344211 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
Type of transfusions
Item
Specify the type of transfusions
text
C1879316 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Transfusions (Number of Units)
Item
Transfusions (Number of Units)
text
C1879316 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Erythropoietin Dose
Item
Erythropoietin Dose
float
C0014822 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Date
Item
Date of transfusion
date
C0011008 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
Supportive Anti-Infective Therapy
Item
Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during this course?
boolean
C1141958 (UMLS CUI [1,1])
C0344211 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,3])
Drug name
Item
Drug name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose (e.g. 500mg)
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medical Condition
Item
Medical Condition
text
C3843040 (UMLS CUI [1])
Item
Other
text
C1141958 (UMLS CUI [1])
CL Item
anti-infectives administered prophylactically (PM)
CL Item
anti-infectives used for symptomatic treatment (EM)
CL Item
anti-infectives administered for a confirmed infection in the column provided (TX)
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
If Continuing to Medication
Item
If Continuing to Medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Drug name
Item
Drug name (Trade name Preferred)
text
C2360065 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Total Daily Dose
Item
Total Daily Dose (e.g. 500mg)
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Medical Condition
Item
Medical Condition
text
C3843040 (UMLS CUI [1])
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
If Continung to Medication
Item
If Continung to Medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])