ID

35346

Descripción

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 subjects current medical conditions and should be filled out at visit 1 and visit 2.

Link

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

Palabras clave

Versiones (3)
  1. 23/2/19 23/2/19 -
  2. 1/3/19 1/3/19 -
  3. 10/11/19 10/11/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de marzo de 2019

DOI

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Licencia

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

Inglés

Medical Conditions

1 formularios  
  1. StudyEvent: ODM
    1. Medical Conditions
Administrative Data
Descripción

Administrative Data

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

Date of Visit/Assessment

Tipo de datos

date

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

Site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Patient
Descripción

Patient

Tipo de datos

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Descripción

Patient No.

Tipo de datos

text

Alias
UMLS CUI [1]
C1269815
Study Visit
Descripción

Study Visit

Tipo de datos

text

Alias
UMLS CUI [1]
C0545082
Medical Conditions
Descripción

Medical Conditions

Alias
UMLS CUI-1
C0262926
MedRA System Organ Class
Descripción

Check only one response for each MedDRA System Organ Class

Tipo de datos

integer

Alias
UMLS CUI [1]
C2347091
Current
Descripción

Current

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0521116
Past
Descripción

Past

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1444637
No Medical History
Descripción

No Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
Not Assessed
Descripción

Not Assessed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846720
No Medical Condition
Descripción

No Medical Condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1699700
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Similar models

Medical Conditions

1 formularios
  1. StudyEvent: ODM
    1. Medical Conditions
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
C1269815 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Visit 1 (Visit 1)
CL Item
Visit 2 (Visit 2)
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 Condition
Item
No Medical Condition
boolean
C1699700 (UMLS CUI [1])
Volver a la parte superior de la página 

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