ID

20918

Beschrijving

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. For Serious and Significant Adverse Events, this form is to be completed by the investigator and forwarded immediately to the sponsor (preferably additionally by Fax). Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

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

Trefwoorden

Versies (1)
  1. 27-03-17 27-03-17 -
Geüploaded op

27 maart 2017

DOI

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Licentie

Creative Commons BY 4.0
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Serious Adverse Event Report in Clinical Trials PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Engels

Serious Adverse Event Report in Clinical Trials PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulieren  
Patient data
Beschrijving

Patient data

Alias
UMLS CUI-1
C2707520
Sex
Beschrijving

Gender

Datatype

integer

Alias
UMLS CUI [1]
C0079399
Date of birth (dd mon yy)
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Height
Beschrijving

Height

Datatype

float

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Race
Beschrijving

Race

Datatype

text

Alias
UMLS CUI [1]
C0034510
Pregnant
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
if yes, week
Beschrijving

weeks pregnant

Datatype

text

Alias
UMLS CUI [1]
C1135241
Events
Beschrijving

Events

Alias
UMLS CUI-1
C0877248
Event
Beschrijving

Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Date of event: Onset (dd mon yy)
Beschrijving

Date of Onset

Datatype

date

Alias
UMLS CUI [1]
C0574845
Date of event: End (dd mon yy), if ongoing, record "cont" in the end column
Beschrijving

End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Onset how long (hh:mm) after first admin. of trial drug. If tretm duration at onset is <24 hours
Beschrijving

Onset

Datatype

time

Alias
UMLS CUI [1]
C0332162
Intensity of event
Beschrijving

Intensity

Datatype

integer

Alias
UMLS CUI [1]
C0522510
Therapy for event
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
If yes, specify in description below
Beschrijving

Specification

Datatype

boolean

Alias
UMLS CUI [1]
C2348235
Action taken with trial drug due to event
Beschrijving

Action(s) taken

Datatype

integer

Alias
UMLS CUI [1]
C2826626
Outcome of event
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C0085565
*Autopsy (if yes, attach report)
Beschrijving

Autopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0004398
Was event serious?
Beschrijving

Seriousness

Datatype

integer

Alias
UMLS CUI [1]
C1710056
if yes, enter appropriate code(s): 1=results in death, 2=immediately life-threatening, 3=persistent or significant disability/incapacity, 4=requires or prolongs patient hospitalization, 5=congenital anomaly/birth defect, 6=other comparable medical criteria (specify under description)
Beschrijving

code

Datatype

text

Alias
UMLS CUI [1]
C0008902
Causal relationship, Indicate which test drug(s) is causally related to the event? (Medical judgement including kind and pattern of reaction, reasonableness of time relationship, patient´s clinical status, co-medication etc.)
Beschrijving

Causal relationship

Datatype

text

Alias
UMLS CUI [1]
C0013227
Investigator
Beschrijving

Investigator

Datatype

integer

Alias
UMLS CUI [1]
C2826892
Clin. Monitor
Beschrijving

Clinical Monitor

Datatype

integer

Alias
UMLS CUI [1]
C1521743
Was the event unlisted? (please see instruction) Clin. Monitor :
Beschrijving

Clinical Monitor

Datatype

boolean

Alias
UMLS CUI [1]
C1521743
Description of the above recorded event(s) if necessary (make reference to event by above line number):
Beschrijving

Description

Datatype

text

Alias
UMLS CUI [1]
C0678257
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Similar models

Serious Adverse Event Report in Clinical Trials PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Patient data
C2707520 (UMLS CUI-1)
Item
Sex
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
male (1)
CL Item
female (2)
Date of birth
Item
Date of birth (dd mon yy)
date
C0421451 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
Pregnancy
Item
Pregnant
boolean
C0032961 (UMLS CUI [1])
weeks pregnant
Item
if yes, week
text
C1135241 (UMLS CUI [1])
Item Group
Events
C0877248 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Date of Onset
Item
Date of event: Onset (dd mon yy)
date
C0574845 (UMLS CUI [1])
End Date
Item
Date of event: End (dd mon yy), if ongoing, record "cont" in the end column
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Onset
Item
Onset how long (hh:mm) after first admin. of trial drug. If tretm duration at onset is <24 hours
time
C0332162 (UMLS CUI [1])
Item
Intensity of event
integer
C0522510 (UMLS CUI [1])
Intensity
Code List
Intensity of event
CL Item
mild (1)
CL Item
mod. (2)
CL Item
severe (3)
Therapeutic procedure
Item
Therapy for event
boolean
C0087111 (UMLS CUI [1])
Specification
Item
If yes, specify in description below
boolean
C2348235 (UMLS CUI [1])
Item
Action taken with trial drug due to event
integer
C2826626 (UMLS CUI [1])
Action(s) taken
Code List
Action taken with trial drug due to event
CL Item
continued (1)
CL Item
reduced (2)
CL Item
discontinued (3)
CL Item
increased (4)
CL Item
completed acc. protocol (5)
CL Item
discont. & reintroduced (6)
CL Item
not applicable (7)
Item
Outcome of event
integer
C0085565 (UMLS CUI [1])
Outcome
Code List
Outcome of event
CL Item
recovered (0)
CL Item
not yet recovered (1)
CL Item
sequelae (2)
CL Item
fatal* (3)
CL Item
unknown (4)
Autopsy
Item
*Autopsy (if yes, attach report)
boolean
C0004398 (UMLS CUI [1])
Item
Was event serious?
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Was event serious?
CL Item
no (1)
CL Item
yes (2)
CL Item
no, but sign. (3)
code
Item
if yes, enter appropriate code(s): 1=results in death, 2=immediately life-threatening, 3=persistent or significant disability/incapacity, 4=requires or prolongs patient hospitalization, 5=congenital anomaly/birth defect, 6=other comparable medical criteria (specify under description)
text
C0008902 (UMLS CUI [1])
Causal relationship
Item
Causal relationship, Indicate which test drug(s) is causally related to the event? (Medical judgement including kind and pattern of reaction, reasonableness of time relationship, patient´s clinical status, co-medication etc.)
text
C0013227 (UMLS CUI [1])
Item
Investigator
integer
C2826892 (UMLS CUI [1])
Investigator
Code List
Investigator
CL Item
No (0)
CL Item
Aggrenox (1)
CL Item
Clopidogrel (2)
CL Item
Aspirin (3)
CL Item
Micardis (4)
Item
Clin. Monitor
integer
C1521743 (UMLS CUI [1])
Investigator
Code List
Clin. Monitor
CL Item
No (0)
CL Item
Aggrenox (1)
CL Item
Clopidogrel (2)
CL Item
Aspirin (3)
CL Item
Micardis (4)
Clinical Monitor
Item
Was the event unlisted? (please see instruction) Clin. Monitor :
boolean
C1521743 (UMLS CUI [1])
Description
Item
Description of the above recorded event(s) if necessary (make reference to event by above line number):
text
C0678257 (UMLS CUI [1])
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