ID

38857

Descrizione

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.

collegamento

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

Keywords

versioni (2)
  1. 24/02/19 24/02/19 -
  2. 10/11/19 10/11/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

10 novembre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Laboratory Tests

1 moduli  
  1. StudyEvent: ODM
    1. Laboratory Tests
Administrative Data
Descrizione

Administrative Data

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

Date of Visit/Assessment

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Descrizione

Study site

Tipo di dati

text

Alias
UMLS CUI [1]
C2825164
Patient
Descrizione

Patient

Tipo di dati

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Descrizione

Subject No.

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Study Visit
Descrizione

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.

Tipo di dati

text

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

Lab

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

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

Tipo di dati

text

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

If done. Not applicable to Visit 6.

Tipo di dati

datetime

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

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.

Tipo di dati

text

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

If done and other day than haematology

Tipo di dati

datetime

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

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

Tipo di dati

text

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

If done. Not applicable to Visit 6.

Tipo di dati

datetime

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

Electronically Transferred Lab Data

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

Record each repeat lab in a separate record

Tipo di dati

text

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

Date/Time of sample

Tipo di dati

datetime

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

Laboratory Tests

1 moduli
  1. StudyEvent: ODM
    1. Laboratory Tests
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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