ID

13052

Description

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

Keywords

Versions (1)
  1. 1/13/16 1/13/16 -
Uploaded on

January 13, 2016

DOI

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License

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

English

Case Report Form Pharmacovigilance

1 forms  
Demographic Information
Description

Demographic Information

Patient number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Study Site number
Description

Study Site

Data type

integer

Alias
UMLS CUI [1]
C2825164
Visit number
Description

Visit number

Data type

integer

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

i.e week 1/2/...

Data type

integer

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

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient age
Description

Age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Patient Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Body height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Pharmacovigilance 1
Description

Pharmacovigilance 1

Please give the date the Adverse Event occurred
Description

Date

Data type

date

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

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

Data type

text

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

Medication plasma concentration

Data type

boolean

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

Laboratory Procedure Date

Data type

date

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

Plasma concentration

Data type

float

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

Medication

Data type

text

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

Medication dose,frequency and route of administration

Data type

text

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

Start Date

Data type

date

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

End date

Data type

date

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

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Signature Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Pharmacovigilance 2
Description

Pharmacovigilance 2

Date of first occurrence of the AE
Description

Date

Data type

date

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

Treatment of AE

Data type

boolean

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

Hospitalization

Data type

boolean

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

Date

Data type

date

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

Hospitalization

Data type

boolean

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

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

Data type

text

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

Opinion

Data type

text

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

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

Data type

text

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

Name and qualification

Data type

text

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Case Report Form Pharmacovigilance

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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