ID

16273

Beskrivning

NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Nyckelord

Versioner (1)
  1. 2016-07-08 2016-07-08 -
Uppladdad den

8 juli 2016

DOI

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Licens

Creative Commons BY-NC-ND 3.0
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Adverse Event: Heparin RICH study NCT02669589

Engelsk

Adverse Event: Heparin RICH study NCT02669589

1 Formulär  
Patient Information
Beskrivning

Patient Information

Alias
UMLS CUI-1
C1955348
ID of Center
Beskrivning

Center ID

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
ID of Patient
Beskrivning

Patient ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Adverse Event Description
Beskrivning

Adverse Event Description

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0678257
Number of current Adverse Event:
Beskrivning

Adverse Event Number

Datatyp

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Adverse Event Diagnosis specify diagnosis if known, otherwise symptoms:
Beskrivning

Adverse Event Diagnosis

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
Duration
Beskrivning

Duration

Alias
UMLS CUI-1
C0449238
Onset: Date
Beskrivning

Onset: Date

Datatyp

date

Alias
UMLS CUI [1]
C0574845
End: Date
Beskrivning

End: Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Therapy
Beskrivning

Therapy

Alias
UMLS CUI-1
C0087111
Max. intensity:
Beskrivning

Intensity

Datatyp

text

Alias
UMLS CUI [1]
C0522510
Therapy of adverse event
Beskrivning

Therapy of adverse event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0877248
Therapy of adverse event: If "yes", please comment:
Beskrivning

Therapy of adverse event: specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2348235
Outcome of event:
Beskrivning

Outcome of event

Datatyp

text

Alias
UMLS CUI [1]
C1705586
Serious adverse event?
Beskrivning

Serious adverse event

Datatyp

boolean

Alias
UMLS CUI [1]
C2985919
Why was this event serious?
Beskrivning

Serious adverse event specification

Datatyp

text

Alias
UMLS CUI [1,1]
C2985919
UMLS CUI [1,2]
C2348235
Serious adverse event? If "yes", please verify immedietly, if SAE reporting is necessary according to protocol.
Beskrivning

Serious adverse event: specification

Datatyp

text

Alias
UMLS CUI [1,1]
C2985919
UMLS CUI [1,2]
C2348235
If serious, SAE report necessary according to protocol?
Beskrivning

SAE report

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
Causal relationship with systemic heparin anticoagulation
Beskrivning

Systemic heparin

Datatyp

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0205373
Action taken with trial drug due to event
Beskrivning

Action heparin anticoagulation

Datatyp

text

Alias
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C0019134
UMLS CUI [1,3]
C0205373
Causal relationship with medical procedure
Beskrivning

Medical procedure

Datatyp

text

Alias
UMLS CUI [1]
C0199171
Comments
Beskrivning

Comments

Alias
UMLS CUI-1
C0947611
Comment (please refer to AE No.):
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Case report form data
Beskrivning

Case report form data

Alias
UMLS CUI-1
C1516308
Date of confirmation of CRF:
Beskrivning

Case report form date

Datatyp

date

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0011008
Name of authorized trial physician:
Beskrivning

Doctor's Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0031831
Signature of authorized trial physician:
Beskrivning

Doctor's signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Adverse Event: Heparin RICH study NCT02669589

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Center ID
Item
ID of Center
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient ID
Item
ID of Patient
text
C2348585 (UMLS CUI [1])
Item Group
Adverse Event Description
C0877248 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
Adverse Event Number
Item
Number of current Adverse Event:
float
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse Event Diagnosis
Item
Adverse Event Diagnosis specify diagnosis if known, otherwise symptoms:
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item Group
Duration
C0449238 (UMLS CUI-1)
Onset: Date
Item
Onset: Date
date
C0574845 (UMLS CUI [1])
End: Date
Item
End: Date
date
C0806020 (UMLS CUI [1])
Item Group
Therapy
C0087111 (UMLS CUI-1)
Item
Max. intensity:
text
C0522510 (UMLS CUI [1])
Intensity
Code List
Max. intensity:
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
life-threatening (4)
CL Item
death realted to AE (5)
Therapy of adverse event
Item
Therapy of adverse event
boolean
C0087111 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Therapy of adverse event: specification
Item
Therapy of adverse event: If "yes", please comment:
text
C0087111 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Outcome of event:
text
C1705586 (UMLS CUI [1])
Outcome of event
Code List
Outcome of event:
CL Item
recovered (1)
CL Item
recovering (2)
CL Item
not recovered (3)
CL Item
recovered with sequel (4)
CL Item
fatal (5)
CL Item
unknown (6)
Serious adverse event
Item
Serious adverse event?
boolean
C2985919 (UMLS CUI [1])
Item
Why was this event serious?
text
C2985919 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Serious adverse event specification
Code List
Why was this event serious?
CL Item
death (1)
CL Item
liferisk (2)
CL Item
hospitalisation (3)
CL Item
disability (4)
CL Item
birth defect (5)
CL Item
medically important condition (6)
Serious adverse event: specification
Item
Serious adverse event? If "yes", please verify immedietly, if SAE reporting is necessary according to protocol.
text
C2985919 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
SAE report
Item
If serious, SAE report necessary according to protocol?
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Item
Causal relationship with systemic heparin anticoagulation
text
C0019134 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Medical device
Code List
Causal relationship with systemic heparin anticoagulation
CL Item
no reasonable possibility (2)
CL Item
reasonable possibility (1)
Item
Action taken with trial drug due to event
text
C0441472 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Action medical device
Code List
Action taken with trial drug due to event
CL Item
does not changed (1)
CL Item
dose reduced (2)
CL Item
dose increased (3)
CL Item
drug withdrawal (4)
CL Item
unknown (5)
CL Item
not applicable (6)
Item
Causal relationship with medical procedure
text
C0199171 (UMLS CUI [1])
Medical procedure
Code List
Causal relationship with medical procedure
CL Item
no (0)
CL Item
possible (2)
CL Item
yes (3)
Item Group
Comments
C0947611 (UMLS CUI-1)
Comment
Item
Comment (please refer to AE No.):
text
C0947611 (UMLS CUI [1])
Item Group
Case report form data
C1516308 (UMLS CUI-1)
Case report form date
Item
Date of confirmation of CRF:
date
C1516308 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Doctor's Name
Item
Name of authorized trial physician:
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Doctor's signature
Item
Signature of authorized trial physician:
text
C1519316 (UMLS CUI [1])
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