ID

37360

Description

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 (See https://clinicaltrials.gov/ct2/show/NCT00996840) Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains the participant's demographic data and is to be filled in at Screening.

Lien

https://clinicaltrials.gov/ct2/show/NCT00996840)

Mots-clés

Versions (1)
  1. 20/07/2019 20/07/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

20 juillet 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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SB-681323 in ALI/ARDS risk patients - NCT00996840

Anglais

Demography

1 Formulaires  
  1. StudyEvent: ODM
    1. Demography
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Description

Date/Time of Assessment

Type de données

datetime

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1264639
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Subject Initials (hidden)
Description

hidden and set to "---"

Type de données

text

Alias
UMLS CUI [1]
C2986440
Gender
Description

Female: Record child-bearing potential

Type de données

text

Alias
UMLS CUI [1]
C0079399
If female, record child-bearing potential
Description

if applicable

Type de données

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Type de données

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Description

Geographic ancestry

Alias
UMLS CUI-1
C3841890
African American/African Heritage
Description

African American/African Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

American Indian or Alaskan Native

Type de données

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

Central/South Asian Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

East Asian Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Description

Japanese Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

South East Asian Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

Native Hawaiian or Other Pacific Islander

Type de données

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

White - Arabic/North African Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
White - White/Caucasian/European Heritage
Description

White/Caucasian/European Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Demography

1 Formulaires
  1. StudyEvent: ODM
    1. Demography
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Subject Initials
Item
Subject Initials (hidden)
text
C2986440 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
If female, record child-bearing potential
integer
C3831118 (UMLS CUI [1])
child-bearing potential
Code List
If female, record child-bearing potential
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Geographic ancestry
C3841890 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
Retour au début de la page 

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