ID

15691

Description

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)

Keywords

Versions (1)
  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Nerventra Study Liver enzyme evaluation

English

Nerventra Study Liver enzyme evaluation

1 forms  
Demographic Information
Description

Demographic Information

Protocol Number
Description

Protocol Number

Data type

text

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

i.e "Screening"

Data type

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Study site number
Description

Study site

Data type

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Description

Subject number

Data type

integer

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

Blank

Data type

boolean

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

Evaluation of liver enzymes

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

Date of diagnosis

Data type

date

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

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

Data type

boolean

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

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

Data type

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
Description

Risk factor medical history

Data type

integer

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

Risk factor alcohol use

Data type

boolean

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

Substance use disorder start date

Data type

date

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

Substance use disorder end date

Data type

date

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

Substance use disorder ongoing

Data type

boolean

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

Alcohol consumption

Data type

text

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

If yes, update medication log

Data type

boolean

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

Environmental exposure

Data type

boolean

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

Environmental exposure

Data type

text

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

Start date

Data type

date

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

End date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing environmental exposure
Description

Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Hepatitis A
Description

Hepatitis serology

Data type

integer

Alias
UMLS CUI [1]
C0744862
Hepatitis B
Description

Hepatitis serology

Data type

integer

Alias
UMLS CUI [1]
C0744862
Hepatitis C
Description

Hepatitis serology

Data type

integer

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

Autoimmune Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C0241910
Anti-SM
Description

Autoimmune Hepatitis

Data type

integer

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

Autoimmune Hepatitis

Data type

integer

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

Ultrasound

Data type

integer

Alias
UMLS CUI [1]
C0041618
Ultrasound date performed
Description

Ultrasound date

Data type

date

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

Result

Data type

text

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

Other diagnostic procedure

Data type

integer

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

Date of procedure

Data type

date

Alias
UMLS CUI [1]
C2584899
Specification of procedure
Description

Specification

Data type

text

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Nerventra Study Liver enzyme evaluation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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