ID

37358

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 (repeatedly, if necessary) during the study and/or at the end of the study in case of non-serious adverse events.

Link

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

Trefwoorden

Versies (1)
  1. 20-07-19 20-07-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 juli 2019

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

Non-serious AE

1 Formulieren  
  1. StudyEvent: ODM
    1. Non-serious AE
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Date/Time of Assessment
Beschrijving

Date/Time of Assessment

Datatype

datetime

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

Subject ID

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Non-serious adverse event
Beschrijving

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Sequence Number
Beschrijving

Hidden

Datatype

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschrijving

Diagnosis or Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C3540840
Adverse Event Modified Reported Term
Beschrijving

Hidden

Datatype

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Beschrijving

Hidden

Datatype

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschrijving

Hidden

Datatype

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschrijving

Hidden

Datatype

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date and Time
Beschrijving

Start Date/Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826806
Outcome
Beschrijving

if Recovered/Resolved (with or without sequelae) provide End Date and Time

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End Date and Time
Beschrijving

if applicable

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Non-serious adverse event frequency
Beschrijving

Non-serious adverse event frequency

Datatype

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Adverse Event Maximum Intensity
Beschrijving

Adverse Event Maximum Intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Adverse Event Maximum Grade
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Adverse Event Maximum Grade or Intensity
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action regarding Investigational Product because of non-serious adverse event

Datatype

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschrijving

subject withdrawal because of non-serious adverse event

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
Beschrijving

AE possibly caused by investigational product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Duration of AE if < 24 hours
Beschrijving

[hidden]

Datatype

time

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Beschrijving

[hidden]

Datatype

time

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0439659
UMLS CUI [1,5]
C1518404
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Similar models

Non-serious AE

1 Formulieren
  1. StudyEvent: ODM
    1. Non-serious AE
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
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
Non-serious adverse event
C1518404 (UMLS CUI-1)
Non-serious AE Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Diagnosis or Sign/Symptom
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1])
C3540840 (UMLS CUI [2])
Adverse Event Modified Reported Term
Item
Adverse Event Modified Reported Term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start Date/Time
Item
Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved,  (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date/Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Non-serious adverse event frequency
integer
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency
Code List
Non-serious adverse event frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Adverse Event Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Adverse Event Maximum Grade
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade
Code List
Adverse Event Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Adverse Event Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1518404 (UMLS CUI [2,2])
Maximum Grade
Code List
Adverse Event Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Action regarding Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
subject withdrawal because of non-serious adverse event
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
AE possibly caused by investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Duration of AE
Item
Duration of AE if < 24 hours
time
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Interval between Last Dose and AE Onset
Item
Time to Onset Since Last Dose
time
C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
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