Informações:
Falhas:
ID
15670
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 Visit 1
Nerventra Study Visit 1
- StudyEvent: ODM
Similar models
Nerventra Study Visit 1
- 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])
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 not done
Item
ECG interpretation not done
boolean
C1623258 (UMLS CUI [1,1])
C0420795 (UMLS CUI [1,2])
C0420795 (UMLS CUI [1,2])
Laboratory specimen
Item
Where all required laboratory samples obtained?
boolean
C0200345 (UMLS CUI [1])
Menstruation
Item
Menstruation
boolean
C0025344 (UMLS CUI [1])
Population Pharmacokinetics
Item
Was Population Pharmacokinetics performed?
boolean
C0031328 (UMLS CUI [1])
Population Pharmacokinetics not done
Item
Please specify why population pharmacokinetics was not done
text
C0031328 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
Population Pharmacokinetics
Item
If Population Pharmacokinetics was performed, did the subject eat this morning?
boolean
C0031328 (UMLS CUI [1])
Time of last food intake
Item
Meal time
time
C0578574 (UMLS CUI [1])
Compliance behavior
Item
Did the subject take the study drug regularly during the past week?
boolean
C1321605 (UMLS CUI [1])
Compliance behavior
Item
If the study drug was not taken regularly, please specify
text
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
Last dose
Item
Date of last study drug dose prior to blood sample
date
C3173975 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
Last dose
Item
Time of last study drug dose prior to blood sample
time
C3173975 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
PPK Blood sample
Item
Date of PPK Blood sample
date
C0190979 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
PPK Blood sample
Item
Time of PPK Blood sample
time
C0190979 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])