Information:
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ID
13030
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)
- 1/12/16 1/12/16 -
Uploaded on
January 12, 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 Visit 4
Case report form Visit 4
- StudyEvent: ODM
Similar models
Case report form Visit 4
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
Otoscopy
Item
Please specify findings of Otoscopy
text
C0419361 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
Rinne test
Item
Please specify findings of Rinne test
text
C0278245 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
Webers test
Item
Please specify findings of Webers test
text
C0278247 (UMLS CUI [1])
CL Item
horizontal (1)
CL Item
vertical (2)
CL Item
rotating (3)
CL Item
small (1)
CL Item
medium (2)
CL Item
heavy (3)
CL Item
little (1)
CL Item
medium (2)
CL Item
high (3)
CL Item
little (1)
CL Item
distinctly (2)
CL Item
severe (3)
Item
Any significant findings during computerized dynamic posturography procedure
text
C0519978 (UMLS CUI [1])
Code List
Any significant findings during computerized dynamic posturography procedure
CL Item
None (1)
CL Item
Yes (2)
Computerized dynamic posturography procedure
Item
Please specify findings during computerized dynamic posturography procedure
text
C0519978 (UMLS CUI [1])
Questionnaire
Item
DHI-Questionnaire given to patient
boolean
C0034394 (UMLS CUI [1])
Trial medication
Item
Remaining trial medication retrieved from patient?
boolean
C0013227 (UMLS CUI [1])
Trial medication
Item
Number of tablets of trial medication retrieved from patient
integer
C0013227 (UMLS CUI [1])
Patient questions
Item
Any questions the patient might have have been answered.
boolean
C0547398 (UMLS CUI [1])
Patient questions
Item
Please note questions and answers given
text
C0547398 (UMLS CUI [1])
Date
Item
Signature date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Comorbidities
Item
Have comorbidities changed?
boolean
C0009488 (UMLS CUI [1])
Comorbidities
Item
Please specify comorbidities by ICD-Code
text
C0009488 (UMLS CUI [1])
Concomitant agent
Item
Has concomitant medication been subject to change?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent
Item
Please specify medication name,dose,start and end date of therapy
text
C2347852 (UMLS CUI [1])
additional comments
Item
additional comments
text
C1830770 (UMLS CUI [1])
CL Item
very good (1)
CL Item
good (2)
CL Item
fair (3)
CL Item
poor (4)
CL Item
very good (1)
CL Item
good (2)
CL Item
fair (3)
CL Item
poor (4)
Date
Item
Signature date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
adverse reaction
Item
During this trial period,have there been adverse reactions to the study drug?
boolean
C0559546 (UMLS CUI [1])
Adverse event
Item
Please specify the adverse event or reaction
text
C0877248 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life-threatening (4)
CL Item
None (1)
CL Item
dose reduction (2)
CL Item
dose omission (3)
CL Item
discontinuation (4)
CL Item
antidote (5)
CL Item
concomitant medication changed (6)
CL Item
other (7)
CL Item
subsided (1)
CL Item
decreased (2)
CL Item
persistent (3)
CL Item
increased (4)
CL Item
fatal (5)
CL Item
unknown (6)
CL Item
other (7)
CL Item
by underlying disease (1)
CL Item
none (2)
CL Item
possible (3)
CL Item
likely (4)
CL Item
affirmative (5)
additional comments
Item
Please give further information about countermeasures, development,outcome and judgment of the AE
text
C1830770 (UMLS CUI [1])
Date
Item
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
CL Item
planned end of trial (0)
CL Item
lack of efficacy (1)
CL Item
Allergy/Hypersensitivity (2)
CL Item
Allergy to trial substance (3)
CL Item
Other SAE´s (4)
CL Item
informed consent withdrawn (5)
CL Item
Use of prohibited drugs/substances (6)
CL Item
lack of compliance (7)
CL Item
exclusion criteria occurred (8)
CL Item
violation of protocol (9)
CL Item
discontinuation of patient due to administrative or other reasons (10)
CL Item
other (11)
discontinuation
Item
Please specify other reasons for discontinuation of the patient
text
C0457454 (UMLS CUI [1])
Date and time of discontinuation
Item
Date and time of discontinuation
datetime
C0011008 (UMLS CUI [1])
C0457454 (UMLS CUI [2])
C0457454 (UMLS CUI [2])
CL Item
Patient (1)
CL Item
Investigator (2)
CL Item
Study Director (3)
Discontinuation of trial
Item
Discontinuation of whole trial
boolean
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
Discontinuation of trial
Item
Date of discontinuation of trial
date
C0457454 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0008976 (UMLS CUI [2])
Item
Trial discontinued by
text
C0457454 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0008976 (UMLS CUI [2])
CL Item
Sponsor (1)
CL Item
Study Director (2)
Date
Item
Date of completion of this form
date
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])