ID

42871

Beschrijving

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 in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.

Link

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

Trefwoorden

Versies (2)
  1. 20-07-19 20-07-19 -
  2. 17-09-21 17-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840

Engels

Logs and Repeats

1 Formulieren  
  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Date/time of visit/assessment
Beschrijving

Date/time of visit/assessment

Datatype

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0545082
UMLS CUI [2,1]
C1264639
UMLS CUI [2,2]
C1516048
Subject ID
Beschrijving

Subject ID

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Beschrijving

Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-3
C2347852
UMLS CUI-5
C0205341
UMLS CUI-6
C0220825
Did the subject experience any non-serious adverse events during the study?
Beschrijving

non-serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Beschrijving

serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Were any concomitant medications taken by the subject during the study?
Beschrijving

concomitant medication

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Were any blood products / blood supportive care products taken by the subject between trauma and 48hrs after Day 3?
Beschrijving

blood products

Datatype

boolean

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Beschrijving

abnormal, clinically significant ECG

Datatype

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
Were any repeat ECGs performed?
Beschrijving

repeat ECGs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Were any repeat haematology or clinical chemistry samples taken during the study?
Beschrijving

repeat haematology or clinical chemistry samples taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0200345
UMLS CUI [2,3]
C0205341
Were any repeat urinalysis samples taken?
Beschrijving

repeat urinalysis samples

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0042014
Were any repeat Blood pharmacodynamic samples taken for external analysis?
Beschrijving

repeat Blood pharmacodynamic samples taken for external analysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C1277698
UMLS CUI [1,3]
C3844314
UMLS CUI [1,4]
C0851347
Were any repeat Urine pharmacodynamic samples taken for external analysis?
Beschrijving

repeat urine pharmacodynamic samples taken for external analysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0200354
UMLS CUI [1,3]
C3844314
UMLS CUI [1,4]
C0851347
Were any repeat pharmocodynamic samples taken for analysis at site?
Beschrijving

repeat pharmocodynamic samples taken for analysis at site

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0851347
UMLS CUI [1,4]
C2825164
Were any repeat pharmacokinetic samples taken?
Beschrijving

repeat pharmacokinetic samples

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0031328
Were any repeat vital signs recorded?
Beschrijving

repeat vital signs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0518766
Liver Event
Beschrijving

Liver Event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Beschrijving

If yes, please complete the Liver Event form(s).

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C2746065
UMLS CUI [1,5]
C0304229
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Similar models

Logs and Repeats

1 Formulieren
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date/time of visit/assessment
Item
Date/time of visit/assessment
datetime
C1264639 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
concomitant medication
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
blood products
Item
Were any blood products / blood supportive care products taken by the subject between trauma and 48hrs after Day 3?
boolean
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
abnormal, clinically significant ECG
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
repeat ECGs
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken during the study?
boolean
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
repeat urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0200345 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
repeat Blood pharmacodynamic samples taken for external analysis
Item
Were any repeat Blood pharmacodynamic samples taken for external analysis?
boolean
C0205341 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C3844314 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,4])
repeat urine pharmacodynamic samples taken for external analysis
Item
Were any repeat Urine pharmacodynamic samples taken for external analysis?
boolean
C0205341 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C3844314 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,4])
repeat pharmocodynamic samples taken for analysis at site
Item
Were any repeat pharmocodynamic samples taken for analysis at site?
boolean
C0205341 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0851347 (UMLS CUI [1,3])
C2825164 (UMLS CUI [1,4])
repeat pharmacokinetic samples
Item
Were any repeat pharmacokinetic samples taken?
boolean
C0205341 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
repeat vital signs
Item
Were any repeat vital signs recorded?
boolean
C0205341 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item Group
Liver Event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
liver chemistry results reached/exceeded investigational product stopping criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023901 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
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