ID

20382

Beschreibung

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. Visit 9 (Month 36) Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

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

Stichworte

Versionen (1)
  1. 21.02.17 21.02.17 -
Hochgeladen am

21. Februar 2017

DOI

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Trial Medication Compliance Discontinuation Dispense Visit 9 PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Englisch

Trial Medication Compliance Discontinuation Dispense Visit 9 PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare  
Trial Medication Compliance
Beschreibung

Trial Medication Compliance

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C0013227
1. Did the patient take at least 75% of each trial medication
Beschreibung

Patient take

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
2. If NO, which medication was the patient non compliant with (please indicate all that apply):
Beschreibung

In case of non-compliance to study medication, please remind the patient about medication intake requirements.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0457432
Discontinuation Of Trial Medication
Beschreibung

Discontinuation Of Trial Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0457454
3. Since the last visit did the patient discontinue trial medication?
Beschreibung

Discontinuation Of Trial Medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0457454
4. If YES, was this a permanent discontinuation?
Beschreibung

If the patient permanently discontinued one or more of the trial medications since the previous visit, please record detailed information on the Permanent Termination of Trial Medication page 48. Even if the patient has stopped all trial medication he/she should be encouraged to return for all remaining visits.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0205355
5. Discontinuation Of Trial Medication
Beschreibung

5. Discontinuation Of Trial Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0457454
5. If the patient had either an adverse event which led to temporary discontinuation of trial medication, or the patient temporarily discontinued study medication for any reason for > 28days, please record details below.
Beschreibung

Adverse Event Led to Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0457454
Drug (1-ABC, 2-D, 3-ABCD)
Beschreibung

Drug

Datentyp

integer

Alias
UMLS CUI [1]
C0013227
Date Stopped (dd mon yy)
Beschreibung

Date Stopped

Datentyp

date

Alias
UMLS CUI [1]
C1531784
Date Restarted (mon dd yy)
Beschreibung

Date Restarted

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Was trial medication temporarily stopped due to an Adverse Event?
Beschreibung

Trial Medication due to an Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1531784
If YES enter Adverse Event Name
Beschreibung

if Yes

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Dispense Trail Medication
Beschreibung

Dispense Trail Medication

Alias
UMLS CUI-1
C0947323
6. Was trial medication dispensed
Beschreibung

Trial Medication Dispensed

Datentyp

boolean

Alias
UMLS CUI [1]
C0947323
7. If yes, provide patient with trial medication kit assigned by IVRS. Stick the label from trial medication kits below. If labels are lost, please enter assigned numbers below:
Beschreibung

if Yes

Datentyp

text

Preparation for next visit
Beschreibung

Preparation for next visit

Alias
UMLS CUI-1
C1521827
UMLS CUI-2
C0545082
8. Signature of Investigator or Sub-Investigator By signing and dating this page, I declare that I have reviewed for accuracy all the case report form pages for this patient visit; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed on the specified dates.
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Date of Signature (dd mon yy)
Beschreibung

Date

Datentyp

date

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

Trial Medication Compliance Discontinuation Dispense Visit 9 PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Trial Medication Compliance
C1321605 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Patient take
Item
1. Did the patient take at least 75% of each trial medication
boolean
C0013227 (UMLS CUI [1])
Item
2. If NO, which medication was the patient non compliant with (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
if NO
Code List
2. If NO, which medication was the patient non compliant with (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 Group
Discontinuation Of Trial Medication
C0013227 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Discontinuation Of Trial Medication
Item
3. Since the last visit did the patient discontinue trial medication?
boolean
C0013227 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
If YES
Item
4. If YES, was this a permanent discontinuation?
boolean
C0457454 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
Item Group
5. Discontinuation Of Trial Medication
C0013227 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Adverse Event Led to Discontinuation
Item
5. If the patient had either an adverse event which led to temporary discontinuation of trial medication, or the patient temporarily discontinued study medication for any reason for > 28days, please record details below.
text
C0877248 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Item
Drug (1-ABC, 2-D, 3-ABCD)
integer
C0013227 (UMLS CUI [1])
Drug
Code List
Drug (1-ABC, 2-D, 3-ABCD)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date Stopped
Item
Date Stopped (dd mon yy)
date
C1531784 (UMLS CUI [1])
Date Restarted
Item
Date Restarted (mon dd yy)
date
C3173309 (UMLS CUI [1])
Trial Medication due to an Adverse Event
Item
Was trial medication temporarily stopped due to an Adverse Event?
boolean
C0877248 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
if Yes
Item
If YES enter Adverse Event Name
text
C0877248 (UMLS CUI [1])
Item Group
Dispense Trail Medication
C0947323 (UMLS CUI-1)
Trial Medication Dispensed
Item
6. Was trial medication dispensed
boolean
C0947323 (UMLS CUI [1])
if Yes
Item
7. If yes, provide patient with trial medication kit assigned by IVRS. Stick the label from trial medication kits below. If labels are lost, please enter assigned numbers below:
text
Item Group
Preparation for next visit
C1521827 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Signature
Item
8. Signature of Investigator or Sub-Investigator By signing and dating this page, I declare that I have reviewed for accuracy all the case report form pages for this patient visit; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed on the specified dates.
text
C1519316 (UMLS CUI [1])
Date
Item
Date of Signature (dd mon yy)
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
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