ID

21014

Description

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Keywords

  1. 22/02/2017 22/02/2017 -
  2. 03/04/2017 03/04/2017 -
Uploaded on

3 de abril de 2017

DOI

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License

Creative Commons BY 4.0

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Death Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Death Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Death Report Form
Description

Death Report Form

Alias
UMLS CUI-1
C0011065
UMLS CUI-2
C1516308
1. Date of death (dd mon yy)
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
2. Was the patient on study medication within the 7 days prior to the event?
Description

Study Medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
If NO, which medication was the patient was not taking (please indicate all that apply):
Description

if NO

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0457432
3. What was the cause of death (please indicate one)?
Description

Cause of death

Data type

integer

Alias
UMLS CUI [1]
C0007465
Cancer Specification
Description

Cancer Specification

Data type

integer

Alias
UMLS CUI [1]
C0178759
Specify "Other Non Vascular Causes"
Description

Other Non Vascular Causes

Data type

text

Alias
UMLS CUI [1,1]
C3262234
UMLS CUI [1,2]
C2348235
4. Did the patient die in hospital? If yes, complete Hospitalization Report Form
Description

Death in Hospital

Data type

boolean

Alias
UMLS CUI [1]
C0277608
Please remember to fax Supporting Documentation clearly identified with the patient number
Description

Please remember to fax Supporting Documentation clearly identified with the patient number

5. Please indicate which supporting documentation has been supplied:
Description

Supporting Documentation

Data type

integer

Alias
UMLS CUI [1]
C0678257
Invenstigator´s Declaration
Description

Invenstigator´s Declaration

Alias
UMLS CUI-1
C0008961
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.
Description

Invenstigator´s Declaration

Data type

text

Investigator´s signature
Description

Investigator´s signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Description

Date of Signature

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519316

Similar models

Death Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Death Report Form
C0011065 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
Date of death
Item
1. Date of death (dd mon yy)
date
C1148348 (UMLS CUI [1])
Study Medication
Item
2. Was the patient on study medication within the 7 days prior to the event?
boolean
C0013227 (UMLS CUI [1])
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
Bottle A (1)
CL Item
Bottle B (2)
CL Item
Blister card C (3)
CL Item
Blister card D (4)
Item
3. What was the cause of death (please indicate one)?
integer
C0007465 (UMLS CUI [1])
Code List
3. What was the cause of death (please indicate one)?
CL Item
Ischemic Stroke (Complete Stroke report form) (1)
CL Item
Hemorrhagic Stroke (Complete Stroke report form and Hemorrhagic Events Report Form) (2)
CL Item
Stroke of Uncertain Cause (Complete Stroke report form) (3)
CL Item
Myocardial Infarction (Complete MI report form) (4)
CL Item
Hemorrhage (excluding intracranial bleeding) (Complete Hemorrhagic Events report form) (5)
CL Item
Other Vascular Causes (Complete Other Designated Vascular Events Report form) (6)
CL Item
Asystole (7)
CL Item
Congestive Heart failure (8)
CL Item
Ventricular Tachycardia (9)
CL Item
Ventricular fibrillation (10)
CL Item
Pneumonia (11)
CL Item
Other Infection (12)
CL Item
Cancer (please specify site below) (13)
CL Item
Trauma (14)
CL Item
Other Non Vascular Causes (15)
Item
Cancer Specification
integer
C0178759 (UMLS CUI [1])
Code List
Cancer Specification
CL Item
Lung (1)
CL Item
Breast (2)
CL Item
Gastrointestinal (3)
CL Item
Prostate (4)
CL Item
Brain (5)
CL Item
Skin (6)
CL Item
Multi site (7)
CL Item
Genito-urinary (8)
CL Item
Other Sites (9)
Other Non Vascular Causes
Item
Specify "Other Non Vascular Causes"
text
C3262234 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Death in Hospital
Item
4. Did the patient die in hospital? If yes, complete Hospitalization Report Form
boolean
C0277608 (UMLS CUI [1])
Item Group
Please remember to fax Supporting Documentation clearly identified with the patient number
Item
5. Please indicate which supporting documentation has been supplied:
integer
C0678257 (UMLS CUI [1])
Code List
5. Please indicate which supporting documentation has been supplied:
CL Item
Death certificate (1)
CL Item
Emergency Room report (2)
CL Item
Autopsy report (3)
CL Item
Other (4)
Item Group
Invenstigator´s Declaration
C0008961 (UMLS CUI-1)
Invenstigator´s Declaration
Item
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])

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