Informações:
Falhas:
ID
15693
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 Unscheduled Visit
Nerventra Study Unscheduled Visit
- StudyEvent: ODM
Similar models
Nerventra Study Unscheduled Visit
- 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
Section blank?
boolean
C0750479 (UMLS CUI [1])
CL Item
Adverse event (complete AE-Log) (1)
CL Item
Change in concomitant medication (complete concomitant medication log) (2)
CL Item
A possible exacerbation (Complete neuro-exam and exacerbation confirmation form) (3)
CL Item
Follow-up of exacerbation (Complete neuro-exam and exacerbation confirmation form if applicable) (4)
CL Item
Unscheduled study drug dispensing (complete dispensing and compliance log) (5)
CL Item
Laboratory follow-up (6)
CL Item
ET follow-up visit (7)
CL Item
Other, specify (8)
Other reason
Item
Other reason
text
C3840932 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
CL Item
oral (1)
CL Item
axillary (2)
CL Item
aural (3)
CL Item
temporal (4)
CL Item
F (1)
CL Item
C (2)
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
ECG
Item
Investigators ECG interpretation
text
C1623258 (UMLS CUI [1])
ECG
Item
ECG interpretation not done
boolean
C1623258 (UMLS CUI [1])
Chest x-ray
Item
Date of chest x-ray
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,2])
Chest x-ray
Item
Chest x-ray not done
boolean
C0039985 (UMLS CUI [1])
Chest x-ray interpretation
Item
Chest x-ray interpretation
text
C0039985 (UMLS CUI [1,1])
C0420833 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,2])
Chest x-ray
Item
Chest x-ray, if abnormal, please specify
text
C0039985 (UMLS CUI [1])
Laboratory specimen
Item
Where all required laboratory samples obtained?
boolean
C0200345 (UMLS CUI [1])
Menstruation
Item
Menstruation
boolean
C0025344 (UMLS CUI [1])
Date of onset
Item
Date of onset of symptoms of suspected exacerbation
date
C0574845 (UMLS CUI [1])
Exacerbation confirmation
Item
Relatively stable or improving neurological state for 30 days prior to onset
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
One or more neurological abnormalities appeared or re-appeared if seen previously
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
Neurological abnormalities lasted 48 hours or more
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
In the opinion of the investigator, the change in EDSS score is not solely attributed to normal fluctuations of the subjects MS symptoms and is consistent with acute exacerbation
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
There was an increase of at least one of the below: 0.5 or more on EDSS or 2 grades in score for one function of the FS or one grade in score for 2 or more functions of the FS
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
Change in EDSS or FS scores cannot be attributed solely to change in bowel/bladder function or to change in cognitive function
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation neuroexam visit date
Item
Based on neuroexam visit date
date
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,2])
Exacerbation of multiple sclerosis
Item
Did subject experience a confirmed exacerbation?
boolean
C0581392 (UMLS CUI [1])
Consent
Item
Re- consent signed
boolean
C0514044 (UMLS CUI [1])
Treatment of exacerbation
Item
Was i.v Methylprednisolone treatment instituted? If yes, complete concomitant medication log
boolean
C0087111 (UMLS CUI [1])
CL Item
No (1)
CL Item
Yes-due to neurological deterioration (2)
CL Item
Yes-due to i.v methylprednisolone treatment (3)
Stabilization date
Item
Approximate date of stabilization
date
C1293130 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Visit date
Item
Based on neuroexam visit date
date
C1320303 (UMLS CUI [1])