ID

15678

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 Termination/Early termination

Inglés

Nerventra Study Termination/Early termination

1 formularios  
Demographic Information Termination Visit
Descripción

Demographic Information Termination Visit

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
Section blank?
Descripción

Blank

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0750479
Termination/Early termination
Descripción

Termination/Early termination

Date of last dose of study drug
Descripción

Last dose

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C3854006
Was the study drug code broken
Descripción

Clinical trial drug code broken

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0349677
UMLS CUI [1,3]
C0175566
If Study drug code was broken, please specify
Descripción

Study drug code broken

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0349677
UMLS CUI [1,3]
C0175566
Did the subject complete the entire duration of the study? If yes, stop here and do not complete the remainder of this module
Descripción

Completion of trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2732579
What was the primary reason for withdrawal?
Descripción

Withdrawal

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
Please specify reason for withdrawal if applicable
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2349954
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Similar models

Nerventra Study Termination/Early termination

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Demographic Information Termination Visit
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
Section blank?
boolean
C0750479 (UMLS CUI [1])
Item Group
Termination/Early termination
Last dose
Item
Date of last dose of study drug
date
C1762893 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Clinical trial drug code broken
Item
Was the study drug code broken
boolean
C3854006 (UMLS CUI [1,1])
C0349677 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
Study drug code broken
Item
If Study drug code was broken, please specify
text
C3854006 (UMLS CUI [1,1])
C0349677 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
Completion of trial
Item
Did the subject complete the entire duration of the study? If yes, stop here and do not complete the remainder of this module
boolean
C2732579 (UMLS CUI [1])
Item
What was the primary reason for withdrawal?
integer
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Withdrawal
Code List
What was the primary reason for withdrawal?
CL Item
Death (complete AE Log and SAE report) (1)
CL Item
Adverse event (complete AE Log) specify (2)
CL Item
Refusal to sign re-consent form following a confirmed relapse or an increase in EDSS in >2.0 points, sustained for >=3 months (3)
CL Item
Subject withdrew consent, specify (4)
CL Item
Request of primary care physician or investigator, please specify (5)
CL Item
Non-compliance/protocol violation, please specify (6)
CL Item
Pregnancy (7)
CL Item
TEVA requested subject to be withdrawn, please specify (8)
CL Item
Failed to return/Lost to follow-up (9)
CL Item
Other,please specify (10)
Comments
Item
Please specify reason for withdrawal if applicable
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Volver a la parte superior de la página 

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