ID

35341

Description

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.

Lien

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

Mots-clés

Versions (2)
  1. 01.03.19 01.03.19 -
  2. 10.11.19 10.11.19 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

1. März 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Anglais

Study Continuation

1 Formulaires  
  1. StudyEvent: ODM
    1. Study Continuation
Administrative Data
Description

Administrative Data

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

Date of Visit/Assessment

Type de données

date

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

Site

Type de données

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Type de données

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Patient No.

Type de données

text

Alias
UMLS CUI [1]
C1830427
Study Continuation
Description

Study Continuation

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

Study Continuation

Type de données

boolean

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

Screen Failure

Type de données

boolean

Alias
UMLS CUI [1]
C1710476
Screen Failure Date
Description

Screen Failure Date

Type de données

date

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

Reason for Failure: Inclusion/Exclusion Criteria

Type de données

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
Description

Reason for Failure: Investigator Discretion

Type de données

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
Description

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

Type de données

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
Description

Reason for Failure: Failed PSG inclusion criteria on Investigator judgement

Type de données

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
Description

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.

Type de données

boolean

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

lf not, click on the RETURN button below

Type de données

text

Alias
UMLS CUI [1]
C2346576
Retour au début de la page

Similar models

Study Continuation

1 Formulaires
  1. StudyEvent: ODM
    1. Study Continuation
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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