ID

13052

Descripción

Placebo controlled,double blind and randomized parallel group trial to verify effectivity and tolerability of moxaverine p.o. in patients with central nervous vertigo. Sponsor: URSAPHARM Industriestrasse 66129 Saarbrücken Phone 06805-9292-0 Fax 06805- 929288 Head of clinical trial: Univ.-Prof.Dr.med. Ralph Mösges Medical Faculty, University of Cologne Phone 0221-4783456 Fax 0221-4783465

Palabras clave

Versiones (1)
  1. 13/1/16 13/1/16 -
Subido en

13 de enero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Moxaverine 200mg p.o. in patients with central nervous vertigo Pharmacovigilance

Inglés

Case Report Form Pharmacovigilance

1 formularios  
Demographic Information
Descripción

Demographic Information

Patient number
Descripción

Patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Study Site number
Descripción

Study Site

Tipo de datos

integer

Alias
UMLS CUI [1]
C2825164
Visit number
Descripción

Visit number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1549755
Week as outlined in Follow-up schedule
Descripción

i.e week 1/2/...

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439230
Patient Initials: first three characters of given and last name
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Patient age
Descripción

Age

Tipo de datos

integer

Alias
UMLS CUI [1]
C0001779
Patient Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Body height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Pharmacovigilance 1
Descripción

Pharmacovigilance 1

Please give the date the Adverse Event occurred
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Please give a detailed discription of the AE
Descripción

i.e relevant clinical data,lab results, recent medical history and comorbidities

Tipo de datos

text

Alias
UMLS CUI [1]
C0678257
Plasma concentration of trial substance determinated?
Descripción

Medication plasma concentration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0683150
Laboratory Procedure Date
Descripción

Laboratory Procedure Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0011008
Please specify plasma concentration of trial substance
Descripción

Plasma concentration

Tipo de datos

float

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0683150
Please specify any medication used starting with trial substance
Descripción

Medication

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Please specify dose of applied substance, frequency and route of administration
Descripción

Medication dose,frequency and route of administration

Tipo de datos

text

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C0439603
UMLS CUI [3]
C0013153
Date the medication was started
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Date medication was stopped
Descripción

End date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Please specify any Indication for medications administered using ICD Codes
Descripción

Indication

Tipo de datos

text

Alias
UMLS CUI [1]
C3146298
Signature Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Signature
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Pharmacovigilance 2
Descripción

Pharmacovigilance 2

Date of first occurrence of the AE
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Has the trial substance been discontinued?
Descripción

Treatment of AE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
Event resulted in a hospitalization
Descripción

Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019993
Date of hospitalization due to the AE
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Has the hospitalization of an inpatient been prolonged due to the AE?
Descripción

Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019993
Please give a detailed description of actions taken
Descripción

i.e: timing, determining factors,discontinuation of medications,clinical status of patient at this point,...

Tipo de datos

text

Alias
UMLS CUI [1]
C0678257
Please give your opinion on the correlation of the reported AE with the trial
Descripción

Opinion

Tipo de datos

text

Alias
UMLS CUI [1]
C0871010
Please list all enclosed documents
Descripción

i.e: hospital report,lab test report, other tests contributing to a diagnose

Tipo de datos

text

Alias
UMLS CUI [1]
C1301746
Please give name and qualification of completing health care professional
Descripción

Name and qualification

Tipo de datos

text

Alias
UMLS CUI [1]
C0027365
UMLS CUI [2]
C1547648
Signature Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Signature
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Case Report Form Pharmacovigilance

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Demographic Information
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Study Site
Item
Study Site number
integer
C2825164 (UMLS CUI [1])
Visit number
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Week
Item
Week as outlined in Follow-up schedule
integer
C0439230 (UMLS CUI [1])
Patient Initials
Item
Patient Initials: first three characters of given and last name
text
C2986440 (UMLS CUI [1])
Age
Item
Patient age
integer
C0001779 (UMLS CUI [1])
Item
Patient Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Patient Gender
CL Item
Male (m)
CL Item
Female (f)
Height
Item
Body height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item Group
Pharmacovigilance 1
Date
Item
Please give the date the Adverse Event occurred
date
C0011008 (UMLS CUI [1])
Description
Item
Please give a detailed discription of the AE
text
C0678257 (UMLS CUI [1])
Medication plasma concentration
Item
Plasma concentration of trial substance determinated?
boolean
C0013227 (UMLS CUI [1])
C0683150 (UMLS CUI [2])
Laboratory Procedure Date
Item
Laboratory Procedure Date
date
C0022885 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Plasma concentration
Item
Please specify plasma concentration of trial substance
float
C0022885 (UMLS CUI [1])
C0683150 (UMLS CUI [2])
Medication
Item
Please specify any medication used starting with trial substance
text
C0013227 (UMLS CUI [1])
Medication dose,frequency and route of administration
Item
Please specify dose of applied substance, frequency and route of administration
text
C3174092 (UMLS CUI [1])
C0439603 (UMLS CUI [2])
C0013153 (UMLS CUI [3])
Start Date
Item
Date the medication was started
date
C0808070 (UMLS CUI [1])
End date
Item
Date medication was stopped
date
C0806020 (UMLS CUI [1])
Indication
Item
Please specify any Indication for medications administered using ICD Codes
text
C3146298 (UMLS CUI [1])
Date
Item
Signature Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Item Group
Pharmacovigilance 2
Date
Item
Date of first occurrence of the AE
date
C0011008 (UMLS CUI [1])
Treatment of AE
Item
Has the trial substance been discontinued?
boolean
C0087111 (UMLS CUI [1])
Hospitalization
Item
Event resulted in a hospitalization
boolean
C0019993 (UMLS CUI [1])
Date
Item
Date of hospitalization due to the AE
date
C0011008 (UMLS CUI [1])
Hospitalization
Item
Has the hospitalization of an inpatient been prolonged due to the AE?
boolean
C0019993 (UMLS CUI [1])
Description
Item
Please give a detailed description of actions taken
text
C0678257 (UMLS CUI [1])
Item
Please give your opinion on the correlation of the reported AE with the trial
text
C0871010 (UMLS CUI [1])
Opinion
Code List
Please give your opinion on the correlation of the reported AE with the trial
CL Item
no obvious correlation with the study (1)
CL Item
questionable influence of trial substance (2)
CL Item
possible influence of trial substance (3)
CL Item
likely influence of trial substance (4)
CL Item
cannot be determined at this point (5)
Documents
Item
Please list all enclosed documents
text
C1301746 (UMLS CUI [1])
Name and qualification
Item
Please give name and qualification of completing health care professional
text
C0027365 (UMLS CUI [1])
C1547648 (UMLS CUI [2])
Date
Item
Signature Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Volver a la parte superior de la página 

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