ID

28413

Description

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Study conclusion

Keywords

Versions (4)
  1. 10/9/17 10/9/17 -
  2. 10/13/17 10/13/17 -
  3. 10/23/17 10/23/17 -
  4. 1/11/18 1/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Study conclusion GSK study Chronic Coronary Heart Disease NCT00799903

English

Study conclusion GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Study conclusion
Description

Study conclusion

1. Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
Description

subject withdrawal

Data type

text

Alias
UMLS CUI [1]
C0422727
3. Primary reason for withdrawal
Description

Item is not required

Data type

integer

If lost to Follow-up, provide comment
Description

Pre-defined sub-reasons are optional. The following primary reasons are optional : 2, 4 and 7. Pre-defined sub-reasons may/should be moved under appropriate primary reasons. See specific note for Group DSRS8.

Data type

text

Alias
UMLS CUI [1,1]
C1302313
UMLS CUI [1,2]
C0947611
If subject withdrew consent, provide comment
Description

Pre-defined sub-reasons are optional. The following primary reasons are optional : 2, 4 and 7. Pre-defined sub-reasons may/should be moved under appropriate primary reasons. See specific note for Group DSRS8.

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1707492
If investigator site closed, provide comment
Description

Pre-defined sub-reasons are optional. The following primary reasons are optional : 2, 4 and 7. Pre-defined sub-reasons may/should be moved under appropriate primary reasons. See specific note for Group DSRS8.

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1710101
4. For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
Description

By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances. [hidden]. Item is not required.

Data type

integer

Alias
UMLS CUI [1]
C1706256
5. Q1
Description

[hidden] Item is not required

Data type

boolean

6. Q2
Description

[hidden] Item is not required

Data type

text

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Similar models

Study conclusion GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study conclusion
Date of subject completion or withdrawal
Item
1. Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
text
C0422727 (UMLS CUI [1])
subject withdrawal
Code List
2. Was the subject withdrawn from the study before study reached GSK target number of primary clinical endpoints?
CL Item
No (N)
CL Item
Yes, complete primary reason for withdrawal (Y)
Item
3. Primary reason for withdrawal
integer
Primary reason for withdrawal
Code List
3. Primary reason for withdrawal
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Withdrew consent (8)
CL Item
Investigator site closed (12)
lost to Follow-up comment
Item
If lost to Follow-up, provide comment
text
C1302313 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
withdrawal of consent comment
Item
If subject withdrew consent, provide comment
text
C0947611 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
investigator site closed comment
Item
If investigator site closed, provide comment
text
C0947611 (UMLS CUI [1,1])
C1710101 (UMLS CUI [1,2])
Item
4. For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
integer
C1706256 (UMLS CUI [1])
e-sign the case book
Code List
4. For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
CL Item
1 (1)
Q1
Item
5. Q1
boolean
Item
6. Q2
text
Q2
Code List
6. Q2
CL Item
PF_SC_LOST (PF_SC_LOST)
CL Item
[?] PF_SC_DEATH ([?] PF_SC_DEATH)
CL Item
[?] PF_SC_SPONSORDECISION ([?] PF_SC_SPONSORDECISION)
CL Item
PF_SC_PHYSICIANDECISION (PF_SC_PHYSICIANDECISION)
CL Item
PF_SC_PATIENTDECISION (PF_SC_PATIENTDECISION)
CL Item
PF_SC_AE (PF_SC_AE)
CL Item
PF_SC_ALE (PF_SC_ALE)
CL Item
PF_SC_CRITERIA (PF_SC_CRITERIA)
CL Item
PF_SC_OTHER (PF_SC_OTHER)
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