End of Trial Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062 - Portal de Modelos de Datos Médicos (MDM-Portal)

End of Trial 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. End of Trial Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Phone Check Of Patient

Item Group

Phone Check Of Patient

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

Telephone check

Item

1. Has a phone check been done since last visit?

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 done?

boolean

C0545082 (UMLS CUI [1])

If No,reason

Item

4. If No, please indicate reason:

integer

C0681841 (UMLS CUI [1])

If No,reason

Code List

4. If No, please 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 end of trial visit

Item

5. If Yes date of end of trial visit (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)

Abdominal girth

Item

8. Abdominal girth (Waist Circumference)

float

C0232501 (UMLS CUI [1])

Systolic blood pressure

Item

9. Systolic blood pressure after 5 minutes sitting/supine

float

C0871470 (UMLS CUI [1])

Diastolic Blood Pressure

Item

9. Diastolic Blood Pressure after 5 minutes sitting/supine

float

C0428883 (UMLS CUI [1])

Blood Pressure Position

Item

10. Blood Pressure Position

integer

C1828063 (UMLS CUI [1])

Blood Pressure Position

Code List

10. 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

11. 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

11. 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

12. 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

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

integer

C1521902 (UMLS CUI [1])

If Yes

Code List

13. 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])

ECG

Item Group

ECG

C1623258 (UMLS CUI-1)

ECG perfomance

Item

9. Has an ECG been performed?

boolean

C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])

If Yes

Item

If Yes, record patient number, visit number, and date of tracing on the ECG printout and fax to the Trial Data Centre.

text

C1830427 (UMLS CUI [1])
C1549755 (UMLS CUI [2])
C0013798 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])

Pathological Q waves

Item

10. Are there any new pathological Q waves since visit 1?

boolean

C1305738 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])

if Yes, in which leads

Item

if Yes, in which leads (indicate all that apply)

integer

C0179504 (UMLS CUI [1])

if Yes, in which leads

Code List

if Yes, in which leads (indicate all that apply)

CL Item

I (1)

CL Item

V6 (10)

CL Item

II (2)

CL Item

III (3)

CL Item

aVF (4)

CL Item

V1 (5)

CL Item

V2 (6)

CL Item

V3 (7)

CL Item

V4 (8)

CL Item

V5 (9)

ECG shows LVH

Item

11. Does the ECG show left ventricular hypertrophy (LVH)?

boolean

C0149721 (UMLS CUI [1])

Modified Cornell Criteria

Item

12. If Yes, was this confirmed by the Modified Cornell Criteria (see facing page)?

boolean

C0521093 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])

Urinalysis

Item Group

Urinalysis

C0042014 (UMLS CUI-1)

Urine sample

Item

14. Has urine sample (preferably first morning) been collected for central analysis?

boolean

C0200354 (UMLS CUI [1])

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End of Trial Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062