ID

26178

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: CEC - MI Repeating form (Scheduled visits)

Stichworte

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Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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CEC - MI GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

CEC - MI GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
CEC - MI
Beschreibung

CEC - MI

1. Date of onset of MI symptoms
Beschreibung

Date of onset of MI symptoms

Datentyp

date

1. Time of onset of MI symptoms
Beschreibung

Time of onset of MI symptoms

Datentyp

time

2. Date of MI diagnosis
Beschreibung

Date of MI diagnosis

Datentyp

date

2. Time of MI diagnosis
Beschreibung

Time of MI diagnosis

Datentyp

date

Myocardial infarction - CEC Section
Beschreibung

Myocardial infarction - CEC Section

3. Adjudication
Beschreibung

[hidden]

Datentyp

text

If criteria for myocardial infarction not met, comment
Beschreibung

criteria myocardial infarction comment

Datentyp

text

[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
Beschreibung

Hospitalisation for unstable angina

Datentyp

boolean

4. Classification of MI
Beschreibung

[hidden]

Datentyp

integer

If acute, select one
Beschreibung

Acute myocardial infarction

Datentyp

text

If myocardial infarction diagnosed post-randomisation, select one
Beschreibung

myocardial infarction diagnosed post-randomisation

Datentyp

text

5. STEMI / NSTEMI
Beschreibung

[hidden]

Datentyp

text

6. Q wave/Non-Q wave
Beschreibung

[hidden]

Datentyp

text

7. Type of MI
Beschreibung

[hidden]

Datentyp

text

8. Was this event related to a stent thrombosis?
Beschreibung

[hidden]

Datentyp

text

9. Date of adjudication
Beschreibung

[hidden]

Datentyp

date

CEC STATUS
Beschreibung

CEC STATUS

10. Trigger number
Beschreibung

[hidden]

Datentyp

text

11. CEC Status
Beschreibung

[read-only]

Datentyp

integer

12. Date of status change
Beschreibung

[read-only]

Datentyp

date

13. Physician review #1: Physician
Beschreibung

[hidden]

Datentyp

integer

13. Physician review #1: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

13. Physician review #1: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

14. Physician review #2: Physician
Beschreibung

[hidden]

Datentyp

integer

14. Physician review #2: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

14. Physician review #2: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

15. CEC Coordinator comments
Beschreibung

[hidden]

Datentyp

text

16. CV event number
Beschreibung

[hidden]

Datentyp

text

17. Adverse event reference identifier
Beschreibung

Use SAE Sequence number from the corresponding SAE form (the last item on the form, in the "Non- Clinical" section) [hidden]

Datentyp

text

18. Adverse event term
Beschreibung

Copy Serious Adverse Event term from corresponding SAE form [hidden]

Datentyp

text

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Ähnliche Modelle

CEC - MI GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
CEC - MI
Date of onset of MI symptoms
Item
1. Date of onset of MI symptoms
date
Time of onset of MI symptoms
Item
1. Time of onset of MI symptoms
time
Date of MI diagnosis
Item
2. Date of MI diagnosis
date
Time of MI diagnosis
Item
2. Time of MI diagnosis
date
Item Group
Myocardial infarction - CEC Section
Item
3. Adjudication
text
Adjudication
Code List
3. Adjudication
CL Item
Fatal MI (34)
CL Item
Non-fatal MI (35)
CL Item
Does not meet criteria for myocardial infarction (NC)
criteria myocardial infarction comment
Item
If criteria for myocardial infarction not met, comment
text
Hospitalisation for unstable angina
Item
[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
boolean
Item
4. Classification of MI
integer
Classification of MI
Code List
4. Classification of MI
CL Item
Acute (38)
CL Item
Myocardial infarction diagnosed post-randomisation (80)
Item
If acute, select one
text
Acute myocardial infarction
Code List
If acute, select one
CL Item
No recent revascularisation, baseline biomarkers not elevated - Rise/fall biomarkers >99th %ile URL (A25)
CL Item
No recent revascularisation, post-MI baseline biomarkers elevated - biomarker decreasing prior to new suspect MI then re-elevation >50% of (A26)
CL Item
previous value (previous value)
CL Item
Sudden unexpected cardiac death involving cardiac arrest, often with symptoms of myocardial ischemia, accompanied by new ST (A08)
CL Item
elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers (elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers)
CL Item
Within 24 hours post-PCI, either 1) rise of CK-MB; OR 2) pathological findings of acute MI. Subtype is related to stent thrombosis (A27)
CL Item
Within 72 hours post-CABG, either 1) rise of CK-MB + at least 1 additional criteria; OR 2) pathological findings of acute MI. (A28)
CL Item
Pathological findings of acute myocardial infarction at post mortem (A09)
Item
If myocardial infarction diagnosed post-randomisation, select one
text
myocardial infarction diagnosed post-randomisation
Code List
If myocardial infarction diagnosed post-randomisation, select one
CL Item
Development of new pathological Q waves with or without symptoms (A13)
CL Item
Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (A07)
CL Item
Pathological findings of a healed or healing myocardial infarction (A14)
Item
5. STEMI / NSTEMI
text
STEMI / NSTEMI
Code List
5. STEMI / NSTEMI
CL Item
STEMI (20)
CL Item
NSTEMI (21)
CL Item
Not applicable (X)
Item
6. Q wave/Non-Q wave
text
Q wave/Non-Q wave
Code List
6. Q wave/Non-Q wave
CL Item
Q wave (A15)
CL Item
Non-Q wave (A16)
CL Item
Q wave undetermined - no ECG available (A24)
Item
7. Type of MI
text
Type of MI
Code List
7. Type of MI
CL Item
Type 1: Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as plaque erosion and/or rupture, fissuring, or (A17)
CL Item
dissection (dissection)
CL Item
Type 2: Myocardial infarction secondary to ischemia due to either increased oxygen demand or decreased supply, e.g. coronary artery spasm, coronary (A18)
CL Item
embolism, anemia, arrhythmias, hypertension, or hypotension (embolism, anemia, arrhythmias, hypertension, or hypotension)
CL Item
Type 3: Sudden unexpected cardiac death often with symptoms of myocardial ischemia, accompanied by new ST elevation or new LBBB, or fresh thrombus (A19)
CL Item
in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers (in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers)
CL Item
Type 4a: Myocardial infarction associated with PCI (A20)
CL Item
Type 4b: Myocardial infarction associated with stent thrombosis as documented by angiography or at autopsy (A21)
CL Item
Type 5: Myocardial infarction associated with CABG (A22)
Item
8. Was this event related to a stent thrombosis?
text
event related to stent thrombosis
Code List
8. Was this event related to a stent thrombosis?
CL Item
Definite (DF)
CL Item
Probable (PB)
CL Item
No (N)
CL Item
Unknown (U)
Date of adjudication
Item
9. Date of adjudication
date
Item Group
CEC STATUS
Trigger number
Item
10. Trigger number
text
Item
11. CEC Status
integer
CEC Status
Code List
11. CEC Status
CL Item
New (1)
CL Item
Coordinator Screen check (2)
CL Item
Hold (3)
CL Item
Ready for review (4)
CL Item
In Phase I review (5)
CL Item
Queried (InForm) (6)
CL Item
Additional documents required (7)
CL Item
In Phase II committee (8)
CL Item
Data change (9)
CL Item
Re-Review (10)
CL Item
Completed event (11)
CL Item
No event to adjudicate (12)
CL Item
QC Random sample (13)
CL Item
In Translation (14)
Date of status change
Item
12. Date of status change
date
Item
13. Physician review #1: Physician
integer
Physician review 1
Code List
13. Physician review #1: Physician
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33 (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47 (47)
CL Item
48 (48)
CL Item
49 (49)
CL Item
50 (50)
Physician review 1 Date sent to reviewer
Item
13. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
13. Physician review #1: Date received from reviewer
date
Item
14. Physician review #2: Physician
integer
Physician review 1
Code List
14. Physician review #2: Physician
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33 (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47 (47)
CL Item
48 (48)
CL Item
49 (49)
CL Item
50 (50)
Physician review 2 Date sent to reviewer
Item
14. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
14. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
15. CEC Coordinator comments
text
CV event number
Item
16. CV event number
text
Adverse event reference identifier
Item
17. Adverse event reference identifier
text
Adverse event term
Item
18. Adverse event term
text
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