ID

38857

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 record the results of the subject's laboratory tests and should be filled out at Visit 1, 6 (liver tests only) , 8, EW, Day 7 Follow Up (unless Day 7 FU follows Early Withdrawal Visit) and Day 14 Follow Up (only if abnormal at previous Visit). Additionally, this form is used to record unscheduled (repeat) measurements.

Lien

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

Mots-clés

Versions (2)
  1. 24/02/2019 24/02/2019 -
  2. 10/11/2019 10/11/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

10 novembre 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

Laboratory Tests

1 Formulaires  
  1. StudyEvent: ODM
    1. Laboratory Tests
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]
C1320303
UMLS CUI [2]
C2985720
Site
Description

Study 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

Subject No.

Type de données

text

Alias
UMLS CUI [1]
C2348585
Study Visit
Description

At Visit 6, record Clinical Chemistry/Liver Function Tests only. Do not record Day 7 FU if it follows the Early Withdrawal Visit. Record Day 14 Follow Up only if tests were abnormal at previous Visit. For Logs/Repeats (i.e. unscheduled measurements), use second itemgroup, and fill in for each test.

Type de données

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Lab
Description

Lab

Alias
UMLS CUI-1
C0022885
Haematology Date and time sample taken
Description

If done, fill in date/time below. Not applicable to Visit 6.

Type de données

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
Haematology Date and time sample taken
Description

If done. Not applicable to Visit 6.

Type de données

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Clinical Chemistry Date and time sample taken
Description

If done and other day than haematology, fill in date/time below At Visit 6, record Clinical Chemistry/Liver Function tests only. Hence, option "Same as the Haematology sample" is not available at this visit.

Type de données

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
Clinical Chemistry Date and time sample taken
Description

If done and other day than haematology

Type de données

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis Date and time sample taken
Description

If done, fill in date/time below. Not applicable to Visit 6.

Type de données

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
Urinalysis Date and time sample taken
Description

If done. Not applicable to Visit 6.

Type de données

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0205341
Laboratory Test Type
Description

Record each repeat lab in a separate record

Type de données

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Date and time sample taken
Description

Date/Time of sample

Type de données

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
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Similar models

Laboratory Tests

1 Formulaires
  1. StudyEvent: ODM
    1. Laboratory Tests
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])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Study Visit
CL Item
Visit 1 (Screening) (Visit 1 (Screening))
CL Item
Visit 6 (Visit 6)
CL Item
Visit 8 (Visit 8)
CL Item
EW (EW)
CL Item
Day 7 Follow-Up (Day 7 Follow-Up)
CL Item
Day 14 Follow-Up (Day 14 Follow-Up)
CL Item
Logs/Repeats (Logs/Repeats)
Item Group
Lab
C0022885 (UMLS CUI-1)
Item
Haematology Date and time sample taken
text
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Haematology sample taken?
Code List
Haematology Date and time sample taken
CL Item
Date (Date)
CL Item
Not Done (Not Done)
Date/Time haematology sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Clinical Chemistry Date and time sample taken
text
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Haematology sample taken?
Code List
Clinical Chemistry Date and time sample taken
CL Item
Date (Date)
CL Item
Not Done (Not Done)
CL Item
Same as the Haematology sample (Same as the Haematology sample)
Date/Time Clinical Chemistry sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis Date and time sample taken
text
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Haematology sample taken?
Code List
Urinalysis Date and time sample taken
CL Item
Date (Date)
CL Item
Not Done (Not Done)
Date/Time Urinalysis sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Laboratory Test Type
Code List
Laboratory Test Type
CL Item
Haematology (Haematology)
CL Item
Clinical Chemistry (Clinical Chemistry)
CL Item
Urinalysis (Urinalysis)
Date/Time of sample
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
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