Date of onset of CHF
Item
1. Date of onset of CHF (dd mon yy)
date
Study Medication
Item
2. Was the patient on study medication within the 7 days prior to the event?
boolean
Item
If NO, which medication was the patient was not taking (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
Code List
If NO, which medication was the patient was not taking (please indicate all that apply):
CL Item
Blister card C (3)
CL Item
Blister card D (4)
Characteristic Symptoms
Item
3. Did the patient experience characteristic symptoms or signs of CHF?
boolean
Item
If Yes, indicate which
integer
Code List
If Yes, indicate which
CL Item
Peripheral edema (2)
CL Item
Elevation of JVP (3)
CL Item
Shortness of breath at rest (4)
CL Item
Shortness of breath during exertion (5)
CL Item
Paraoxysmal nocturnal dyspnea (6)
pulmonary congestion
Item
4. Was evidence of pulmonary congestion confirmed by X-ray?
boolean
C0242073 (UMLS CUI [1])
ejection fraction
Item
5. Was ejection fraction <40% or other evidence of systolic dysfunction?
boolean
If yes
Item
If ejection fraction <40% please provide ejection fraction
float
diastolic dysfunction
Item
6. Was there evidence of diastolic dysfunction?
boolean
C0520863 (UMLS CUI [1])
Item
If evidence of diastolic or systolic dysfunction please indicate which method was used
integer
Code List
If evidence of diastolic or systolic dysfunction please indicate which method was used
CL Item
Radionuclide angiography (1)
Item
7. Please indicate which of the following events accompanied the CHF: (Indicate all that apply)
integer
Code List
7. Please indicate which of the following events accompanied the CHF: (Indicate all that apply)
CL Item
Other infections (2)
CL Item
Atrial fibrillation (3)
CL Item
Pneumonia/Respiratory Infection (4)
CL Item
Acute Ischemic event (5)
CL Item
Other Precipitating Cause (6)
Item
8. Please indicate which of the following treatments were given for the CHF: (Indicate all that apply)
integer
Code List
8. Please indicate which of the following treatments were given for the CHF: (Indicate all that apply)
CL Item
Oral diuretics (1)
CL Item
Open Label ACE inhibitors (5)
CL Item
Open Label ARBs (6)
Events Leading to Hospitalization
Item
9. Did the event lead to hospitalization? If Yes please complete the Hospitalization Report Form.
boolean
Item
If No, please indicate where patient attended:
integer
Code List
If No, please indicate where patient attended:
CL Item
Emergency Room (1)
CL Item
Physician Office (2)
Specification
Item
Specify "Other":
text
C2348235 (UMLS CUI [1])
Fatal Event
Item
10. Was the event fatal (death within 28 days). If Yes please complete Death Report Form.
boolean
Invenstigator´s Declaration
Item
8. Invenstigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
text
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])