ID

16785

Descripción

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

Palabras clave

Versiones (1)
  1. 7/8/16 7/8/16 -
Subido en

7 de agosto de 2016

DOI

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Licencia

Creative Commons BY-NC-ND 3.0
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Visit and Telephone Contact QTZ-EC-0004 ELEVATE NCT01713426

Inglés

Visit and Telephone Contact QTZ-EC-0004 ELEVATE NCT01713426

1 formularios  
Date of Visit
Descripción

Date of Visit

Alias
UMLS CUI-1
C1320303
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:
Descripción

Visit

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0545082
If Yes, please provide the Date of Visit.
Descripción

Date of visit

Tipo de datos

date

Unidades de medida
  • dd/MMM/yyyy
dd/MMM/yyyy
Healthcare Resource Use
Descripción

Healthcare Resource Use

Alias
UMLS CUI-1
C1704738
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
Descripción

Healthcare Resource Use

Tipo de datos

text

Alias
UMLS CUI [1]
C1704738
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit.
Descripción

Number of contacts for Neuropathic Pains

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1444281
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C3714625
Number of contacts with a healthcare professional for other causes, since the last visit
Descripción

Number of contacts: Specification

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1444281
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C2348235
Tolerability Assessment
Descripción

Tolerability Assessment

Alias
UMLS CUI-1
C3274448
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
Descripción

Tolerability Assessment

Tipo de datos

text

Alias
UMLS CUI [1]
C3274448
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
Descripción

Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
Telephone Contact: Date
Descripción

Telephone Contact: Date

Alias
UMLS CUI-1
C0420309
UMLS CUI-2
C0011008
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.
Descripción

Telephone Contact

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0420309
If Yes, please provide the Date of Visit
Descripción

Telephone Contact: Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0420309
UMLS CUI [1,2]
C0011008
Telephone Contact: Tolerability Assessment
Descripción

Telephone Contact: Tolerability Assessment

Alias
UMLS CUI-1
C0420309
UMLS CUI-2
C3274448
Form Not Done (Form Not Done should only be marekd for subjects that are "RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/DISPRENSED STUDY DRUG").
Descripción

Telephone Contact: Tolerability Assessment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0420309
UMLS CUI [1,2]
C3274448
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
Descripción

Telephone Contact: Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0420309
UMLS CUI [1,2]
C0877248
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Similar models

Visit and Telephone Contact QTZ-EC-0004 ELEVATE NCT01713426

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
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 Group
Healthcare Resource Use
C1704738 (UMLS CUI-1)
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])
Healthcare Resource Use
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])
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])
Item Group
Tolerability Assessment
C3274448 (UMLS CUI-1)
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])
Tolerability Assessment
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)
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])
Item Group
Telephone Contact: Tolerability Assessment
C0420309 (UMLS CUI-1)
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])
Telephone Contact: Tolerability Assessment
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])
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