ID

28406

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)

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GlaxoSmithKline

Hochgeladen am

11. Januar 2018

DOI

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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

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0027051
1. Time of onset of MI symptoms
Beschreibung

Time of onset of MI symptoms

Datentyp

time

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0449244
2. Date of MI diagnosis
Beschreibung

Date of MI diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C2316983
2. Time of MI diagnosis
Beschreibung

Time of MI diagnosis

Datentyp

time

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0040223
Myocardial infarction - CEC Section
Beschreibung

Myocardial infarction - CEC Section

3. Adjudication
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C0680730
If criteria for myocardial infarction not met, comment
Beschreibung

criteria myocardial infarction comment

Datentyp

text

Alias
UMLS CUI [1]
C0027051
[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
Beschreibung

Hospitalisation for unstable angina

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0019993
4. Classification of MI
Beschreibung

[hidden]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0008902
If acute, select one
Beschreibung

Acute myocardial infarction

Datentyp

text

Alias
UMLS CUI [1]
C0155626
If myocardial infarction diagnosed post-randomisation, select one
Beschreibung

myocardial infarction diagnosed post-randomisation

Datentyp

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0231290
5. STEMI / NSTEMI
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C3537184
6. Q wave/Non-Q wave
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C0542269
7. Type of MI
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C0027051
8. Was this event related to a stent thrombosis?
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C1536080
9. Date of adjudication
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1]
C3260278
CEC STATUS
Beschreibung

CEC STATUS

10. Trigger number
Beschreibung

[hidden]

Datentyp

integer

Alias
UMLS CUI [1]
C1444748
11. CEC Status
Beschreibung

[read-only]

Datentyp

integer

Alias
UMLS CUI [1]
C0449438
12. Date of status change
Beschreibung

[read-only]

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
13. Physician review #1: Physician
Beschreibung

[hidden]

Datentyp

integer

Alias
UMLS CUI [1]
C0184806
13. Physician review #1: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1515023
UMLS CUI [1,4]
C0011008
13. Physician review #1: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C0011008
14. Physician review #2: Physician
Beschreibung

[hidden]

Datentyp

integer

Alias
UMLS CUI [1]
C0184806
14. Physician review #2: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1515023
UMLS CUI [1,4]
C0011008
14. Physician review #2: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C0011008
15. CEC Coordinator comments
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C0947611
16. CV event number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2826275
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

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
18. Adverse event term
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C2826934
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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
C2985916 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Time of onset of MI symptoms
Item
1. Time of onset of MI symptoms
time
C0027051 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
Date of MI diagnosis
Item
2. Date of MI diagnosis
date
C0027051 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Time of MI diagnosis
Item
2. Time of MI diagnosis
time
C0027051 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Myocardial infarction - CEC Section
Item
3. Adjudication
text
C0680730 (UMLS CUI [1])
Adjudication
Code List
3. Adjudication
CL Item
Fatal MI (34)
C0206277 (UMLS CUI-1)
C0027051 (UMLS CUI-2)
(Comment:en)
CL Item
Non-fatal MI (35)
C0027051 (UMLS CUI-1)
(Comment:en)
CL Item
Does not meet criteria for myocardial infarction (NC)
C0027051 (UMLS CUI-1)
(Comment:en)
criteria myocardial infarction comment
Item
If criteria for myocardial infarction not met, comment
text
C0027051 (UMLS CUI [1])
Hospitalisation for unstable angina
Item
[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
boolean
C0002965 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item
4. Classification of MI
integer
C0027051 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Classification of MI
Code List
4. Classification of MI
CL Item
Acute (38)
C0948089 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction diagnosed post-randomisation (80)
C0027051 (UMLS CUI-1)
C0231290 (UMLS CUI-2)
(Comment:en)
Item
If acute, select one
text
C0155626 (UMLS CUI [1])
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
C0027051 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
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)
C1305738 (UMLS CUI-1)
C1521733 (UMLS CUI-2)
(Comment:en)
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)
C0027061 (UMLS CUI-1)
(Comment:en)
CL Item
Pathological findings of a healed or healing myocardial infarction (A14)
C0027051 (UMLS CUI-1)
(Comment:en)
Item
5. STEMI / NSTEMI
text
C1536220 (UMLS CUI [1,1])
C3537184 (UMLS CUI [1,2])
STEMI / NSTEMI
Code List
5. STEMI / NSTEMI
CL Item
STEMI (20)
C1536220 (UMLS CUI-1)
(Comment:en)
CL Item
NSTEMI (21)
C3537184 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
(Comment:en)
Item
6. Q wave/Non-Q wave
text
C1305738 (UMLS CUI [1,1])
C0542269 (UMLS CUI [1,2])
Q wave/Non-Q wave
Code List
6. Q wave/Non-Q wave
CL Item
Q wave (A15)
C1305738 (UMLS CUI-1)
(Comment:en)
CL Item
Non-Q wave (A16)
C1305738 (UMLS CUI-1)
C0542269 (UMLS CUI-2)
(Comment:en)
CL Item
Q wave undetermined - no ECG available (A24)
(Comment:en)
Item
7. Type of MI
text
C0027051 (UMLS CUI [1])
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
C1536080 (UMLS CUI [1])
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
C3260278 (UMLS CUI [1])
Item Group
CEC STATUS
Trigger number
Item
10. Trigger number
integer
C1444748 (UMLS CUI [1])
Item
11. CEC Status
integer
C0449438 (UMLS CUI [1])
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
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
13. Physician review #1: Physician
integer
C0184806 (UMLS CUI [1])
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
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Physician review 1 Date received from reviewer
Item
13. Physician review #1: Date received from reviewer
date
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
14. Physician review #2: Physician
integer
C0184806 (UMLS CUI [1])
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
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Physician review 2 Date received from reviewer
Item
14. Physician review #2: Date received from reviewer
date
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
CEC Coordinator comments
Item
15. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
CV event number
Item
16. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
17. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
18. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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