Information:
Fel:
ID
13052
Beskrivning
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
Nyckelord
Versioner (1)
- 2016-01-13 2016-01-13 -
Uppladdad den
13 januari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Moxaverine 200mg p.o. in patients with central nervous vertigo Pharmacovigilance
Case Report Form Pharmacovigilance
- StudyEvent: ODM
Similar models
Case Report Form Pharmacovigilance
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
C0683150 (UMLS CUI [2])
Laboratory Procedure Date
Item
Laboratory Procedure Date
date
C0022885 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
Plasma concentration
Item
Please specify plasma concentration of trial substance
float
C0022885 (UMLS CUI [1])
C0683150 (UMLS CUI [2])
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])
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])
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])
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])
C1547648 (UMLS CUI [2])
Date
Item
Signature Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])