ID

35341

Beschrijving

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders The purpose of this form is to check if the subject will return for the next visit and should be filled out at visit 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00992160

Trefwoorden

Versies (2)
  1. 01-03-19 01-03-19 -
  2. 10-11-19 10-11-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 maart 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Engels

Study Continuation

1 Formulieren  
  1. StudyEvent: ODM
    1. Study Continuation
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Site
Beschrijving

Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Beschrijving

Patient No.

Datatype

text

Alias
UMLS CUI [1]
C1830427
Study Continuation
Beschrijving

Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Will the subject continue to the next visit?
Beschrijving

Study Continuation

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Was this subject a screen failure?
Beschrijving

Screen Failure

Datatype

boolean

Alias
UMLS CUI [1]
C1710476
Screen Failure Date
Beschrijving

Screen Failure Date

Datatype

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Reason for Failure: Did not meet inclusion/exclusion Criteria
Beschrijving

Reason for Failure: Inclusion/Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
UMLS CUI [3,1]
C0566251
UMLS CUI [3,2]
C1710476
Reason for Failure: Investigator Discretion
Beschrijving

Reason for Failure: Investigator Discretion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1710476
UMLS CUI [2,1]
C0008961
UMLS CUI [2,2]
C0022423
Reason for Failure: Failed PSG inclusion criteria on Central PSG judgement
Beschrijving

Reason for Failure:Failed PSG inclusion criteria on Central PSG judgement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1710476
UMLS CUI [2,1]
C0162701
UMLS CUI [2,2]
C1512693
Reason for Failure: Failed PSG inclusion criteria on Investigator judgement
Beschrijving

Reason for Failure: Failed PSG inclusion criteria on Investigator judgement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1710476
UMLS CUI [2,1]
C0162701
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C0008961
UMLS CUI [3,2]
C0022423
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
Beschrijving

By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as licking and submitting if; that is, the signature will be invalidated in both instances.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C2346576
Is this casebook ready to sign?
Beschrijving

lf not, click on the RETURN button below

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Study Continuation

1 Formulieren
  1. StudyEvent: ODM
    1. Study Continuation
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient No.
Item
Patient No.
text
C1830427 (UMLS CUI [1])
Item Group
Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Study Continuation
Item
Will the subject continue to the next visit?
boolean
C2348568 (UMLS CUI [1])
Screen Failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Screen Failure Date
Item
Screen Failure Date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Reason for Failure: Inclusion/Exclusion Criteria
Item
Reason for Failure: Did not meet inclusion/exclusion Criteria
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0566251 (UMLS CUI [3,1])
C1710476 (UMLS CUI [3,2])
Reason for Failure: Investigator Discretion
Item
Reason for Failure: Investigator Discretion
boolean
C0566251 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
Reason for Failure:Failed PSG inclusion criteria on Central PSG judgement
Item
Reason for Failure: Failed PSG inclusion criteria on Central PSG judgement
boolean
C0566251 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C0162701 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Reason for Failure: Failed PSG inclusion criteria on Investigator judgement
Item
Reason for Failure: Failed PSG inclusion criteria on Investigator judgement
boolean
C0566251 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C0162701 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0008961 (UMLS CUI [3,1])
C0022423 (UMLS CUI [3,2])
Investigator Re-Sign
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
boolean
C1706256 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Casebook Ready to Sign
Item
Is this casebook ready to sign?
text
C2346576 (UMLS CUI [1])
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