ID

28295

Beschreibung

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

Stichworte

Versionen (4)
  1. 12.10.17 12.10.17 -
  2. 16.10.17 16.10.17 -
  3. 23.10.17 23.10.17 -
  4. 02.01.18 02.01.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

2. Januar 2018

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Subject status and major events
Beschreibung

Subject status and major events

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

Yes - complete SAE and MI or ANG endpoint form

Datentyp

text

Alias
UMLS CUI [1]
C1320716
2. Has the subject experienced a stroke / TIA event since the last visit?
Beschreibung

Yes - complete SAE and Stroke/TIA endpoint form

Datentyp

text

Alias
UMLS CUI [1]
C3844446
3. Has the subject been hospitalized for heart failure since the last visit?
Beschreibung

Yes - complete SAE and Hospitalisation for Heart Failure endpoint form

Datentyp

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0581377
4. Has the subject undergone a coronary revascularisation since the last visit?
Beschreibung

Yes - complete SAE and Revascularisation endpoint form

Datentyp

text

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
Beschreibung

Yes - complete SAE and Other Endpoint form

Datentyp

text

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0151744
6. Has the subject undergone a non-coronary revascularisation since the last visit?
Beschreibung

Yes - complete SAE and Other Endpoint form

Datentyp

text

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0543467
7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
Beschreibung

Yes - complete SAE and Other Endpoint form

Datentyp

text

Alias
UMLS CUI [1]
C0002689
8. Has the subject been diagnosed with new onset diabetes since the last visit?
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0746890
UMLS CUI [1,2]
C0011849
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?
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0006826
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?
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C0282493
11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
Beschreibung

Yes - record details on the Cardiovascular Diagnostic Procedures form

Datentyp

text

Alias
UMLS CUI [1]
C0430022
12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
Beschreibung

Yes - complete Serious Adverse Event form

Datentyp

text

Alias
UMLS CUI [1]
C1519255
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C1320716 (UMLS CUI [1])
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
C3844446 (UMLS CUI [1])
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
C0019993 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
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
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
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
C1956346 (UMLS CUI [1,1])
C0151744 (UMLS CUI [1,2])
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
C0877341 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
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
C0002689 (UMLS CUI [1])
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
C0746890 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
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
C0006826 (UMLS CUI [1])
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
C0282493 (UMLS CUI [1])
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
C0430022 (UMLS CUI [1])
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
C1519255 (UMLS CUI [1])
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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