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ID
16785
Beschrijving
QUTENZA™ versus Pregabalin in Subjects with Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study Medicine or Vaccine (generic name) capsaicin Visit: Week 2 - 4 Telephone Contact in Week 6 Sponsor Identification Number QTZ-EC-0004 Trial Registry Identification Number(#'s) NCT01713426 EudraCT Number: 2011-005872-41
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Versies (1)
- 07-08-16 07-08-16 -
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7 augustus 2016
DOI
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Creative Commons BY-NC-ND 3.0
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Visit and Telephone Contact QTZ-EC-0004 ELEVATE NCT01713426
Visit and Telephone Contact QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Similar models
Visit and Telephone Contact QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Visit
Item
Was the visit performed? If No, then all other forms with the Form Not Done field in this visit will be marked not done. If Yes, please provide the Date of Visit:
boolean
C0545082 (UMLS CUI [1])
Date of visit
Item
If Yes, please provide the Date of Visit.
date
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
text
C1704738 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Number of contacts for Neuropathic Pains
Item
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit.
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
Number of contacts: Specification
Item
Number of contacts with a healthcare professional for other causes, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
text
C3274448 (UMLS CUI [1])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Adverse Event
Item
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
boolean
C0877248 (UMLS CUI [1])
Item Group
Telephone Contact: Date
C0420309 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
Telephone Contact
Item
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.
boolean
C0420309 (UMLS CUI [1])
Telephone Contact: Date
Item
If Yes, please provide the Date of Visit
date
C0420309 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Telephone Contact: Tolerability Assessment
C0420309 (UMLS CUI-1)
C3274448 (UMLS CUI-2)
C3274448 (UMLS CUI-2)
Item
Form Not Done (Form Not Done should only be marekd for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/DISPRENSED STUDY DRUG").
text
C0420309 (UMLS CUI [1,1])
C3274448 (UMLS CUI [1,2])
C3274448 (UMLS CUI [1,2])
Code List
Form Not Done (Form Not Done should only be marekd for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/DISPRENSED STUDY DRUG").
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Telephone Contact: Adverse Event
Item
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
boolean
C0420309 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])