Informações:
Falhas:
ID
15691
Descrição
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)
Palavras-chave
Versões (1)
- 08/06/2016 08/06/2016 -
Transferido a
8 de junho de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Nerventra Study Liver enzyme evaluation
Nerventra Study Liver enzyme evaluation
- StudyEvent: ODM
Similar models
Nerventra Study Liver enzyme evaluation
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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])
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])
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])
C0262926 (UMLS CUI [1,2])
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])
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])
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])
C0806020 (UMLS CUI [1,2])
Substance use disorder ongoing
Item
ongoing alcohol abuse
boolean
C0038586 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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])
CL Item
Done (1)
CL Item
Not Done (2)
CL Item
Done (1)
CL Item
Not Done (2)
CL Item
Done (1)
CL Item
Not Done (2)
CL Item
Done (1)
CL Item
Not Done (2)
CL Item
Done (1)
CL Item
Not Done (2)
CL Item
Done (1)
CL Item
Not Done (2)
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])
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])
C0205394 (UMLS CUI [1,2])
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])