ID

37361

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 Study Conclusion, information on the treatment blind and whether a pregnancy has occured during the study, as well as the Investigator's Signature. This form is to be completed at Follow-up or if the participant has/was withdrawn from the trial.

Link

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

Keywords

Versions (1)
  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

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

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

Date/Time of Assessment

Data type

datetime

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

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of last contact
Description

Date last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

If no: Date of last contact must match the last scheduled study visit date. If yes: complete details. Date of decision to withdraw must match the date of decision to withdraw the subject from the study before normal completion. Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Description

if applicable

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Description

if 1 = Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. if 7 = Investigator discretion, specify in next question. Select this reason if none of the other primary reasons are appropriate.

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Investigator discretion, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
Case book ready for signature [hidden]
Description

Data owner should check the box when data cleaning is complete

Data type

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
Office Use 1 [hidden]
Description

Office Use 1 [hidden]

Data type

boolean

Alias
UMLS CUI [1]
C0442603
Office Use 2 [hidden]
Description

Office Use 2 [hidden]

Data type

integer

Alias
UMLS CUI [1]
C0442603
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Description

If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate, and additional questions in this form.

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Date/time blind broken
Description

if applicable

Data type

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Description

if applicable If other, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
Specification of reason treatment blind broken
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3897431
UMLS CUI [1,3]
C2348235
Pregnancy Information (female)
Description

Pregnancy Information (female)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form

Data type

boolean

Alias
UMLS CUI [1]
C3828490
Pregnancy Information (male)
Description

Pregnancy Information (male)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form Check "Not Applicable" if female partner not of childbearing potential or no female partner.

Data type

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
Electronic Signature
Description

Electronic Signature

Alias
UMLS CUI-1
C2346576
Investigator first and last Name
Description

By my dated signature below, I [investigator first and last name] verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.

Data type

text

Alias
UMLS CUI [1]
C2826892
Date of electronic signature
Description

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort 1 (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
Cohort 4 (4)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Subject withdrawn
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Withdrawal decision date
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
primary withdrawal reason
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Specification investigator discretion
Item
Investigator discretion, specify
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Case book ready for signature [hidden]
Item
Case book ready for signature [hidden]
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Office Use 1 [hidden]
Item
Office Use 1 [hidden]
boolean
C0442603 (UMLS CUI [1])
Office Use 2 [hidden]
Item
Office Use 2 [hidden]
integer
C0442603 (UMLS CUI [1])
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Treatment blind broken
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date/time blind broken
Item
Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Specification of reason treatment blind broken
Item
Specification of reason treatment blind broken
text
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Pregnancy Information (female)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
subject became pregnant during study
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
Pregnancy Information (male)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
partner became pregnant during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
Item Group
Electronic Signature
C2346576 (UMLS CUI-1)
Investigator Name
Item
Investigator first and last Name
text
C2826892 (UMLS CUI [1])
Date of electronic signature
Item
Date of electronic signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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