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])
Item
Otoscopy
text
C0419361 (UMLS CUI [1])
Otoscopy
Item
Please specify findings of Otoscopy
text
C0419361 (UMLS CUI [1])
Item
Rinne test
text
C0278245 (UMLS CUI [1])
Rinne test
Item
Please specify findings of Rinne test
text
C0278245 (UMLS CUI [1])
Item
Webers test
text
C0278247 (UMLS CUI [1])
Webers test
Item
Please specify findings of Webers test
text
C0278247 (UMLS CUI [1])
Item
direction of eye movement with frenzel lens eyeglasses
text
C0028738 (UMLS CUI [1])
Code List
direction of eye movement with frenzel lens eyeglasses
Item
amplitude of eye movement with frenzel lens eyeglasses
text
C0028738 (UMLS CUI [1])
Code List
amplitude of eye movement with frenzel lens eyeglasses
Item
Frequency of eye movement with frenzel lens eyeglasses
text
C0028738 (UMLS CUI [1])
Code List
Frequency of eye movement with frenzel lens eyeglasses
Item
Dizziness with frenzel lens eyeglasses
text
C0012833 (UMLS CUI [1])
Code List
Dizziness with frenzel lens eyeglasses
Item
Any significant findings during computerized dynamic posturography procedure
text
C0519978 (UMLS CUI [1])
Code List
Any significant findings during computerized dynamic posturography procedure
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])
Item
General tolerance of trial substance
text
C0556444 (UMLS CUI [1])
Code List
General tolerance of trial substance
Item
General therapeutic effectiveness
text
C0087113 (UMLS CUI [1])
Code List
General therapeutic effectiveness
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])
Item
Severity of adverse event or reaction
integer
C1710066 (UMLS CUI [1])
Code List
Severity of adverse event or reaction
CL Item
Life-threatening (4)
Item
Treatment of AE
text
C0087111 (UMLS CUI [1])
Code List
Treatment of AE
CL Item
dose reduction (2)
CL Item
dose omission (3)
CL Item
discontinuation (4)
CL Item
concomitant medication changed (6)
Item
Development of adverse event or reaction
text
C0243107 (UMLS CUI [1])
Code List
Development of adverse event or reaction
Item
Association with trial substance
text
C0544075 (UMLS CUI [1])
Code List
Association with trial substance
CL Item
by underlying disease (1)
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])
Item
Reason for discontinuation
integer
C0457454 (UMLS CUI [1])
Code List
Reason for discontinuation
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
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)
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])
Item
Participation discontinued by
text
C0457454 (UMLS CUI [1])
Code List
Participation discontinued by
CL Item
Study Director (3)
Discontinuation of trial
Item
Discontinuation of whole trial
boolean
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Discontinuation of trial
Item
Date of discontinuation of trial
date
C0457454 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Item
Trial discontinued by
text
C0457454 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Code List
Trial discontinued by
CL Item
Study Director (2)
Date
Item
Date of completion of this form
date
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])