ID

26358

Beskrivning

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: Subject status and major events

Nyckelord

Versioner (4)
  1. 2017-10-12 2017-10-12 -
  2. 2017-10-16 2017-10-16 -
  3. 2017-10-23 2017-10-23 -
  4. 2018-01-02 2018-01-02 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 oktober 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

Engelsk

Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär  
Subject status and major events
Beskrivning

Subject status and major events

1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
Beskrivning

Yes - complete SAE and MI or ANG endpoint form

Datatyp

text

2. Has the subject experienced a stroke / TIA event since the last visit?
Beskrivning

Yes - complete SAE and Stroke/TIA endpoint form

Datatyp

text

3. Has the subject been hospitalized for heart failure since the last visit?
Beskrivning

Yes - complete SAE and Hospitalisation for Heart Failure endpoint form

Datatyp

text

4. Has the subject undergone a coronary revascularisation since the last visit?
Beskrivning

Yes - complete SAE and Revascularisation endpoint form

Datatyp

text

5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
Beskrivning

Yes - complete SAE and Other Endpoint form

Datatyp

text

6. Has the subject undergone a non-coronary revascularisation since the last visit?
Beskrivning

Yes - complete SAE and Other Endpoint form

Datatyp

text

7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
Beskrivning

Yes - complete SAE and Other Endpoint form

Datatyp

text

8. Has the subject been diagnosed with new onset diabetes since the last visit?
Beskrivning

Yes - record details on New Onset Diabetes form, and the Non-Serious Adverse Event or Serious Adverse Event form, as appropriate

Datatyp

text

9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
Beskrivning

Yes - record details on Cancer/GI Neoplasm/Polyp Report form and the Non-Serious Adverse Event or Serious Adverse Event form, as appropriate

Datatyp

text

10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
Beskrivning

Yes - complete the GI procedures form. Note: If question is being asked for the first time please report GI endoscopic procedure(s) that have been performed from randomization visit until this visit. If question has already been answered at an earlier visit then only refer back to the last time this question was asked.

Datatyp

text

11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
Beskrivning

Yes - record details on the Cardiovascular Diagnostic Procedures form

Datatyp

text

12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
Beskrivning

Yes - complete Serious Adverse Event form

Datatyp

text

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Similar models

Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Subject status and major events
Item
1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
text
cardiac endpoint event
Code List
1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
2. Has the subject experienced a stroke / TIA event since the last visit?
text
cardiac endpoint event
Code List
2. Has the subject experienced a stroke / TIA event since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
3. Has the subject been hospitalized for heart failure since the last visit?
text
cardiac endpoint event
Code List
3. Has the subject been hospitalized for heart failure since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
4. Has the subject undergone a coronary revascularisation since the last visit?
text
cardiac endpoint event
Code List
4. Has the subject undergone a coronary revascularisation since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
text
cardiac endpoint event
Code List
5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
6. Has the subject undergone a non-coronary revascularisation since the last visit?
text
cardiac endpoint event
Code List
6. Has the subject undergone a non-coronary revascularisation since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
text
cardiac endpoint event
Code List
7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
8. Has the subject been diagnosed with new onset diabetes since the last visit?
text
cardiac endpoint event
Code List
8. Has the subject been diagnosed with new onset diabetes since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
text
cardiac endpoint event
Code List
9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
text
cardiac endpoint event
Code List
10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
text
cardiac endpoint event
Code List
11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
text
cardiac endpoint event
Code List
12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
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