ID

15691

Descripción

Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

Palabras clave

Versiones (1)
  1. 8/6/16 8/6/16 -
Subido en

8 de junio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Nerventra Study Liver enzyme evaluation

Inglés

Nerventra Study Liver enzyme evaluation

1 formularios  
Demographic Information
Descripción

Demographic Information

Protocol Number
Descripción

Protocol Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Visit Type
Descripción

i.e "Screening"

Tipo de datos

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Descripción

Visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Study site number
Descripción

Study site

Tipo de datos

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1709561
No data to report
Descripción

Blank

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0750479
Evaluation of liver enzymes
Descripción

Evaluation of liver enzymes

Date of sample in which elevation of ALT/AST >3XULN was first noted
Descripción

Date of diagnosis

Tipo de datos

date

Alias
UMLS CUI [1]
C2316983
Were any signs and symptoms compatible with liver disease reported/observed from subjects complaints/physical examination?
Descripción

If yes, and considered clinically significant record in the appropriate eCRF e.g AE,MH

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037088
History of liver enzyme elevations or any liver disease prior to entering the study
Descripción

If yes, please update the appropriate eCRF e.g MH,Comments

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0235996
Checking with the subject that all medical history conditions and adverse events of the subject were reported and captured in the appropriate eCRF e.g. AE,MH
Descripción

Risk factor medical history

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0262926
Alcohol use (chronic or acute)
Descripción

Risk factor alcohol use

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0085762
If alcohol is being used, specify when the subject started using
Descripción

Substance use disorder start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0808070
If alcohol has been used, specify when the subject stopped using
Descripción

Substance use disorder end date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0806020
ongoing alcohol abuse
Descripción

Substance use disorder ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0549178
Type and amount of alcohol consumption
Descripción

Alcohol consumption

Tipo de datos

text

Alias
UMLS CUI [1]
C0001948
Use of prescribed and/or over the counter drugs,including herbs, dietary supplements,recreational drugs
Descripción

If yes, update medication log

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Exposure to environmental chemical agents? If yes, specify
Descripción

Environmental exposure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014412
Exposure to environmental chemical agents,please specify type
Descripción

Environmental exposure

Tipo de datos

text

Alias
UMLS CUI [1]
C0014412
Start date of environmental exposure
Descripción

Start date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
End date of environmental exposure
Descripción

End date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Ongoing environmental exposure
Descripción

Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549178
Hepatitis A
Descripción

Hepatitis serology

Tipo de datos

integer

Alias
UMLS CUI [1]
C0744862
Hepatitis B
Descripción

Hepatitis serology

Tipo de datos

integer

Alias
UMLS CUI [1]
C0744862
Hepatitis C
Descripción

Hepatitis serology

Tipo de datos

integer

Alias
UMLS CUI [1]
C0744862
Anti-nuclear Antibodies
Descripción

Autoimmune Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0241910
Anti-SM
Descripción

Autoimmune Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0241910
Anti-LKM Antibodies
Descripción

Autoimmune Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0241910
Ultrasound of liver and biliary tract
Descripción

Ultrasound

Tipo de datos

integer

Alias
UMLS CUI [1]
C0041618
Ultrasound date performed
Descripción

Ultrasound date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1456803
UMLS CUI [1,2]
C0011008
Result of Ultrasound
Descripción

Result

Tipo de datos

text

Alias
UMLS CUI [1]
C1274040
Other diagnostic procedure i.e experts consultation
Descripción

Other diagnostic procedure

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0205394
Date of procedure
Descripción

Date of procedure

Tipo de datos

date

Alias
UMLS CUI [1]
C2584899
Specification of procedure
Descripción

Specification

Tipo de datos

text

Alias
UMLS CUI [1]
C2348235
Resolution date/Stabilization of laboratory abnormalities
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Nerventra Study Liver enzyme evaluation

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Demographic Information
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI [1])
Blank
Item
No data to report
boolean
C0750479 (UMLS CUI [1])
Item Group
Evaluation of liver enzymes
Date of diagnosis
Item
Date of sample in which elevation of ALT/AST >3XULN was first noted
date
C2316983 (UMLS CUI [1])
Signs and Symptoms
Item
Were any signs and symptoms compatible with liver disease reported/observed from subjects complaints/physical examination?
boolean
C0037088 (UMLS CUI [1])
Risk factors liver enzyme elevations
Item
History of liver enzyme elevations or any liver disease prior to entering the study
boolean
C0035648 (UMLS CUI [1,1])
C0235996 (UMLS CUI [1,2])
Item
Checking with the subject that all medical history conditions and adverse events of the subject were reported and captured in the appropriate eCRF e.g. AE,MH
integer
C0035648 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Risk factor
Code List
Checking with the subject that all medical history conditions and adverse events of the subject were reported and captured in the appropriate eCRF e.g. AE,MH
CL Item
Done (1)
CL Item
Not Done (2)
Risk factor alcohol use
Item
Alcohol use (chronic or acute)
boolean
C0035648 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
Substance use disorder start date
Item
If alcohol is being used, specify when the subject started using
date
C0038586 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Substance use disorder end date
Item
If alcohol has been used, specify when the subject stopped using
date
C0038586 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Substance use disorder ongoing
Item
ongoing alcohol abuse
boolean
C0038586 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Alcohol consumption
Item
Type and amount of alcohol consumption
text
C0001948 (UMLS CUI [1])
Concomitant medication
Item
Use of prescribed and/or over the counter drugs,including herbs, dietary supplements,recreational drugs
boolean
C2347852 (UMLS CUI [1])
Environmental exposure
Item
Exposure to environmental chemical agents? If yes, specify
boolean
C0014412 (UMLS CUI [1])
Environmental exposure
Item
Exposure to environmental chemical agents,please specify type
text
C0014412 (UMLS CUI [1])
Start date
Item
Start date of environmental exposure
date
C0808070 (UMLS CUI [1])
End date
Item
End date of environmental exposure
date
C0806020 (UMLS CUI [1])
Ongoing
Item
Ongoing environmental exposure
boolean
C0549178 (UMLS CUI [1])
Item
Hepatitis A
integer
C0744862 (UMLS CUI [1])
Risk factor
Code List
Hepatitis A
CL Item
Done (1)
CL Item
Not Done (2)
Item
Hepatitis B
integer
C0744862 (UMLS CUI [1])
Risk factor
Code List
Hepatitis B
CL Item
Done (1)
CL Item
Not Done (2)
Item
Hepatitis C
integer
C0744862 (UMLS CUI [1])
Risk factor
Code List
Hepatitis C
CL Item
Done (1)
CL Item
Not Done (2)
Item
Anti-nuclear Antibodies
integer
C0241910 (UMLS CUI [1])
Risk factor
Code List
Anti-nuclear Antibodies
CL Item
Done (1)
CL Item
Not Done (2)
Item
Anti-SM
integer
C0241910 (UMLS CUI [1])
Risk factor
Code List
Anti-SM
CL Item
Done (1)
CL Item
Not Done (2)
Item
Anti-LKM Antibodies
integer
C0241910 (UMLS CUI [1])
Risk factor
Code List
Anti-LKM Antibodies
CL Item
Done (1)
CL Item
Not Done (2)
Item
Ultrasound of liver and biliary tract
integer
C0041618 (UMLS CUI [1])
Risk factor
Code List
Ultrasound of liver and biliary tract
CL Item
Done (1)
CL Item
Not Done (2)
Ultrasound date
Item
Ultrasound date performed
date
C1456803 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Result
Item
Result of Ultrasound
text
C1274040 (UMLS CUI [1])
Item
Other diagnostic procedure i.e experts consultation
integer
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Risk factor
Code List
Other diagnostic procedure i.e experts consultation
CL Item
Done (1)
CL Item
Not Done (2)
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
Specification
Item
Specification of procedure
text
C2348235 (UMLS CUI [1])
Date
Item
Resolution date/Stabilization of laboratory abnormalities
date
C0011008 (UMLS CUI [1])
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