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 done
Item
3. Was visit 7 done?
boolean
C0545082 (UMLS CUI [1])
Item
4. If No, indicate reason:
integer
C0681841 (UMLS CUI [1])
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 7 (dd-mon-yy)
date
C1320303 (UMLS CUI [1])
Item
6. Type of visit
integer
C3641100 (UMLS CUI [1])
Code List
6. Type of visit
CL Item
Clinic (in-person) (1)
CL Item
Information obtained from source other than patient (3)
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])
Code List
7. If not patient, indicate source (try to re-establish direct contact with patient)
CL Item
Relative or friend (2)
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])
Item
9. Blood Pressure Position
integer
C1828063 (UMLS CUI [1])
Code List
9. Blood Pressure Position
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])
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
Item
11. Please fill in the current Modified Rankin Scale below. (Indicate only one)
integer
C2984908 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
Code List
11. Please fill in the current Modified Rankin Scale below. (Indicate only one)
CL Item
Grade 6(fatal) (7)
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])
Item
13. If "YES" please indicate all that apply:
integer
C1521902 (UMLS CUI [1])
Code List
13. If "YES" please indicate all that apply:
CL Item
Myocardial Infarction (2)
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
Other Hospitalization (9)
CL Item
Newly diagnosed diabetes (10)
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 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])
Item
if Yes, in which leads (indicate all that apply)
integer
C0179504 (UMLS CUI [1])
Code List
if Yes, in which leads (indicate all that apply)
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])
Smoked last week
Item
13. Has the patient smoked in the last week?
boolean
C0543414 (UMLS CUI [1,1])
C2987125 (UMLS CUI [1,2])
Number of cigarettes per day
Item
If the patient smoked cigarettes number of cigarettes per day
float
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Urine sample
Item
14. Has urine sample (preferably first morning) been collected for central analysis?
boolean
C0200354 (UMLS CUI [1])