ID

35198

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 purpouse of this form is to record the results of the subjects laboratory tests and should be filled out at Visit 1, 6 (liver tests only) , 8, EW, Day 7 Follow Up, Day 14 Follow Up. Laboratory tests are mandatory at Day 7 FU visit except where Day 7 FU follows Early Withdrawal Visit.

Link

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

Keywords

Versions (2)
  1. 2/24/19 2/24/19 -
  2. 11/10/19 11/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 24, 2019

DOI

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License

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

English

Laboratory Tests

1 forms  
  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

Data type

date

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

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Patient No.

Data type

text

Alias
UMLS CUI [1]
C1830427
Haematology
Description

Haematology

Alias
UMLS CUI-1
C0018941
Haematology sample taken
Description

If sample taken, fill in date and time

Data type

boolean

Alias
UMLS CUI [1]
C0018941
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Clinical Chemistry
Description

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Clinical Chemistry sample taken
Description

If sample taken, fill in date and time

Data type

boolean

Alias
UMLS CUI [1]
C0008000
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Urinalysis sample taken
Description

If sample taken, fill in date and time

Data type

boolean

Alias
UMLS CUI [1]
C0042014
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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Similar models

Laboratory Tests

1 forms
  1. StudyEvent: ODM
    1. Laboratory Tests
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Haematology
C0018941 (UMLS CUI-1)
Haematology Tests
Item
Haematology sample taken
boolean
C0018941 (UMLS CUI [1])
Date
Item
Date
date
C2985720 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Clinical Chemistry
Item
Clinical Chemistry sample taken
boolean
C0008000 (UMLS CUI [1])
Date
Item
Date
date
C2985720 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Urinalysis
Item
Urinalysis sample taken
boolean
C0042014 (UMLS CUI [1])
Date
Item
Date
date
C2985720 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
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