Visit 6 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062 - Portaal voor medische datamodellen (MDM-portaal)

Visit 6 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

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StudyEvent: ODM
1. Visit 6 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Month 15 Phone Check Of Patient

Item Group

Month 15 Phone Check Of Patient

C0039457 (UMLS CUI-1)
C1283174 (UMLS CUI-2)

Telephone check

Item

1. Was telephone check done?

boolean

C0039457 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])

if Yes

Item

2. If Yes, date of phone call (dd-mon-yy)

date

C0011008 (UMLS CUI [1])

Visit

Item Group

Visit

C0545082 (UMLS CUI-1)

Visit done

Item

3. Was visit 6 done?

boolean

C0545082 (UMLS CUI [1])

If No,reason

Item

4. If No, indicate reason:

integer

C0681841 (UMLS CUI [1])

If No,reason

Code List

4. If No, indicate reason:

CL Item

Died (complete respective outcome event form and End of Trial visit) (1)

CL Item

Patients refuses further participation (2)

CL Item

Unable to contact patient or other source (3)

If Yes date of visit 3

Item

5. If Yes date of visit 6 (dd-mon-yy)

date

C1320303 (UMLS CUI [1])

Type of visit

Item

6. Type of visit

integer

C3641100 (UMLS CUI [1])

Type of visit

Code List

6. Type of visit

CL Item

Clinic (in-person) (1)

CL Item

Telephone (2)

CL Item

Information obtained from source other than patient (3)

If not patient, indicate source

Item

7. If not patient, indicate source (try to re-establish direct contact with patient)

integer

C0449416 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])

If not patient, indicate source

Code List

7. If not patient, indicate source (try to re-establish direct contact with patient)

CL Item

Physician (1)

CL Item

Relative or friend (2)

CL Item

Other (3)

Vital Signs

Item Group

Vital Signs

C0518766 (UMLS CUI-1)

Systolic blood pressure

Item

8. Systolic blood pressure after 5 minutes sitting/supine

float

C0871470 (UMLS CUI [1])

Diastolic Blood Pressure

Item

8. Diastolic Blood Pressure after 5 minutes sitting/supine

float

C0428883 (UMLS CUI [1])

Blood Pressure Position

Item

9. Blood Pressure Position

integer

C1828063 (UMLS CUI [1])

Blood Pressure Position

Code List

9. Blood Pressure Position

CL Item

Sitting (1 )

CL Item

Supine (2 )

Neurological Status

Item Group

Neurological Status

C0746866 (UMLS CUI-1)

Clinical Neurological Status is different

Item

10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit

integer

C0038454 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])

Clinical Neurological Status is different

Code List

10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit

CL Item

Unchanged (1)

CL Item

Improved (2)

CL Item

Worsened (3)

Events

Item Group

Events

C0877248 (UMLS CUI-1)

Outcome Events or Serious Adverse Events

Item

11. Have any Outcome Events or Serious Adverse Events been experienced, or has patient been hospitalised? (See instructions on facing page)

boolean

C1705586 (UMLS CUI [1])
C0877248 (UMLS CUI [2])

If Yes

Item

12. If "YES" please indicate all that apply:

integer

C1521902 (UMLS CUI [1])

If Yes

Code List

12. If "YES" please indicate all that apply:

CL Item

Stroke (1)

CL Item

Myocardial Infarction (2)

CL Item

Death (3)

CL Item

New or worsening congestive heart failure (CHF) (4)

CL Item

Other designated vascular event (5)

CL Item

Hemorrhagic Event (6)

CL Item

Thrombotic Thrombocytopenic purpura (7)

CL Item

Neutropenia (8)

CL Item

Other Hospitalization (9)

CL Item

Newly diagnosed diabetes (10)

New Or Worsening Disease States

Item Group

New Or Worsening Disease States

C0012634 (UMLS CUI-1)
C1442792 (UMLS CUI-2)

PAOD

Item

1. New peripheral arterial occlusive disease (PAOD)

boolean

C1306889 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])

PAOD Worsening

Item

2. Worsening peripheral arterial occlusive disease (PAOD)

boolean

C1306889 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])

Foot ulcers/foot infection

Item

3. Foot ulcers/foot infection requiring antibiotics

boolean

C0085119 (UMLS CUI [1])
C0016504 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0003232 (UMLS CUI [3])

Renal Dialysis

Item

4. Renal Dialysis

boolean

C0011946 (UMLS CUI [1])

diabetic nephropathy

Item

5. Diabetic Nephropathy

boolean

C0011881 (UMLS CUI [1])

Other Nephropathy

Item

6. Other Nephropathy

boolean

C0022658 (UMLS CUI [1])

Laser therapy for retinopathy

Item

7. Laser therapy for retinopathy

boolean

C0035309 (UMLS CUI [1,1])
C1955835 (UMLS CUI [1,2])

Cataract extraction

Item

8. Cataract extraction

boolean

C0086543 (UMLS CUI [1,1])
C0185115 (UMLS CUI [1,2])

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Visit 6 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062