ID

35189

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 subjects current medical conditions and should be filled out at visit 1.

Link

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

Keywords

Versions (3)
  1. 2/23/19 2/23/19 -
  2. 3/1/19 3/1/19 -
  3. 11/10/19 11/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 23, 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

Medical Conditions

1 forms  
  1. StudyEvent: ODM
    1. Medical Conditions
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
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0262926
MedRA System Organ Class
Description

Check only one response for each MedDRA System Organ Class

Data type

integer

Alias
UMLS CUI [1]
C2347091
Current
Description

Current

Data type

boolean

Alias
UMLS CUI [1]
C0521116
Past
Description

Past

Data type

boolean

Alias
UMLS CUI [1]
C1444637
No Medical History
Description

No Medical History

Data type

boolean

Alias
UMLS CUI [1]
C0262926
Not Assessed
Description

Not Assessed

Data type

boolean

Alias
UMLS CUI [1]
C3846720
No Medical Indication
Description

No Medical Indication

Data type

boolean

Alias
UMLS CUI [1]
C3146298
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Similar models

Medical Conditions

1 forms
  1. StudyEvent: ODM
    1. Medical Conditions
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
Medical Conditions
C0262926 (UMLS CUI-1)
Item
MedRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MedRA System Organ Class
Code List
MedRA System Organ Class
CL Item
Blood an lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Ear and labyrinth disorders (3)
CL Item
Endocrine disorders (4)
CL Item
Eye disorders (5)
CL Item
Gastrointestinal disorders (6)
CL Item
Hepatobiliary disorders (7)
CL Item
Immune system disorders (8)
CL Item
Metabolism and nutrition disorders (9)
CL Item
Musculoskeletal and connective tissue disorders (10)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (11)
CL Item
Nervous system disorders (12)
CL Item
Psychiatric disorders (13)
CL Item
Renal and urinary disorders (14)
CL Item
Reproductive System and Breast Disorders (15)
CL Item
Respiratory, Thoracic and mediastinal disorders (16)
CL Item
Skin and subcutaneous disorders (17)
CL Item
Vascular disorders (18)
CL Item
Infections and infestations (19)
CL Item
Congenital, familial and genetic disorders (20)
CL Item
General disorders and administration site conditions (21)
CL Item
Injury, poisoning and procedural complications (22)
CL Item
Investigations (23)
Current
Item
Current
boolean
C0521116 (UMLS CUI [1])
Past
Item
Past
boolean
C1444637 (UMLS CUI [1])
No Medical History
Item
No Medical History
boolean
C0262926 (UMLS CUI [1])
Not Assessed
Item
Not Assessed
boolean
C3846720 (UMLS CUI [1])
No Medical Indication
Item
No Medical Indication
boolean
C3146298 (UMLS CUI [1])
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