ID

37372

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 is to be filled with data on how much fluid the participant has received, and is to be filled in on Day 1, 2 and 3.

Link

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

Keywords

  1. 7/20/19 7/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 20, 2019

DOI

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License

Creative Commons BY-NC 3.0

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SB-681323 in ALI/ARDS risk patients - NCT00996840

Fluid Intake

  1. StudyEvent: ODM
    1. Fluid Intake
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Visit Day
Description

fill in for all three days

Data type

integer

Alias
UMLS CUI [1]
C2827038
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Fluid Intake
Description

Fluid Intake

Alias
UMLS CUI-1
C0429791
Fluid intake start time
Description

Fluid intake start time

Data type

text

Alias
UMLS CUI [1,1]
C0429791
UMLS CUI [1,2]
C3897500
Fluid intake specific start time
Description

if applicable

Data type

datetime

Alias
UMLS CUI [1,1]
C0429791
UMLS CUI [1,2]
C3897500
UMLS CUI [1,3]
C2348235
Fluid intake stop time
Description

Fluid intake stop time

Data type

text

Alias
UMLS CUI [1,1]
C0429791
UMLS CUI [1,2]
C1522314
Fluid intake specific stop time
Description

Fluid intake specific stop time

Data type

datetime

Alias
UMLS CUI [1,1]
C0429791
UMLS CUI [1,2]
C1522314
UMLS CUI [1,3]
C2348235
Total volume of fluid
Description

Fluid volume

Data type

float

Measurement units
  • mL
Alias
UMLS CUI [1]
C0429646
mL

Similar models

Fluid Intake

  1. StudyEvent: ODM
    1. Fluid Intake
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Item
Visit Day
integer
C2827038 (UMLS CUI [1])
Code List
Visit Day
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item Group
Fluid Intake
C0429791 (UMLS CUI-1)
Item
Fluid intake start time
text
C0429791 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Code List
Fluid intake start time
CL Item
As date/time of visit (V)
CL Item
Specify (S)
Fluid intake specific start time
Item
Fluid intake specific start time
datetime
C0429791 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Fluid intake stop time
text
C0429791 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Code List
Fluid intake stop time
CL Item
Specify (S)
CL Item
As date/time of next visit (N)
Fluid intake specific stop time
Item
Fluid intake specific stop time
datetime
C0429791 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fluid volume
Item
Total volume of fluid
float
C0429646 (UMLS CUI [1])

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