ID

35197

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 ECG and should be filled out at Visit 1, 6, 7, EW, Day 7 Follow Up and Day 14 Follow Up.

Link

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

Keywords

Versions (3)
  1. 2/24/19 2/24/19 -
  2. 3/1/19 3/1/19 -
  3. 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

12-Lead-ECG

1 forms  
  1. StudyEvent: ODM
    1. 12-Lead-ECG
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
12-Lead-ECG
Description

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Dosing Date
Description

This item applies for all visit except visit 1

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing Time
Description

This item applies for all visit except visit 1

Data type

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Result of the ECG
Description

Result of the ECG

Data type

text

Alias
UMLS CUI [1]
C0438154
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Similar models

12-Lead-ECG

1 forms
  1. StudyEvent: ODM
    1. 12-Lead-ECG
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
12-Lead-ECG
C0430456 (UMLS CUI-1)
Dosing Date
Item
Dosing Date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing Time
Item
Dosing Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (Normal)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
CL Item
Abnormal - Clinically significant (complete the AE/orm if the abnormality meets the protocol definition for an AE) (Abnormal - Clinically significant (complete the AE/orm if the abnormality meets the protocol definition for an AE))
CL Item
No result (not available) (No result (not available))
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