ID

28405

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: CEC - Stroke/TIA Repeating form (Scheduled visits)

Nyckelord

Versioner (4)
  1. 2017-10-10 2017-10-10 -
  2. 2017-10-16 2017-10-16 -
  3. 2017-10-23 2017-10-23 -
  4. 2018-01-11 2018-01-11 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 januari 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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CEC - Stroke/TIA study Chronic Coronary Heart Disease NCT00799903

Engelsk

CEC - Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär  
CEC - MI
Beskrivning

CEC - MI

1. Date of onset of symptoms
Beskrivning

[hidden]

Datatyp

date

Alias
UMLS CUI [1]
C2985916
1. Time of onset of symptoms
Beskrivning

[hidden]

Datatyp

time

Alias
UMLS CUI [1]
C0449244
2. Date of symptom resolution
Beskrivning

[hidden]

Datatyp

date

Alias
UMLS CUI [1]
C2985918
2. Time of symptom resolution
Beskrivning

[hidden]

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C1518404
Stroke - CEC Section
Beskrivning

Stroke - CEC Section

3. Adjudication
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C0680730
If non-fatal stroke, select one
Beskrivning

[hidden]

Datatyp

integer

Alias
UMLS CUI [1,1]
C1302234
UMLS CUI [1,2]
C0038454
If non-fatal stroke of uncertain type, comment
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C0393963
If fatal stroke, select one
Beskrivning

[hidden]

Datatyp

integer

If fatal stroke of uncertain type, comment
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C0393963
If criteria for stroke not met, comment
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1,1]
C3897171
UMLS CUI [1,2]
C0027051
If criteria for stroke not met, select one
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C0038454
If other, please comment
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C0947611
4. Date of adjudication
Beskrivning

[hidden]

Datatyp

date

Alias
UMLS CUI [1]
C3260278
CEC STATUS
Beskrivning

CEC STATUS

5. Trigger number
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C1444748
6. CEC Status
Beskrivning

[read-only]

Datatyp

integer

Alias
UMLS CUI [1]
C0449438
7. Date of status change
Beskrivning

[read-only]

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
8. Physician review #1: Physician
Beskrivning

[hidden]

Datatyp

integer

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

[hidden]

Datatyp

date

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

[hidden]

Datatyp

date

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

[hidden]

Datatyp

integer

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

[hidden]

Datatyp

date

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

[hidden]

Datatyp

date

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

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C0947611
11. CV event number
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C2826275
12. Adverse event reference identifier
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
13. Adverse event term
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C2826934
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Similar models

CEC - Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
CEC - MI
Date of onset of symptoms
Item
1. Date of onset of symptoms
date
C2985916 (UMLS CUI [1])
Time of onset of symptoms
Item
1. Time of onset of symptoms
time
C0449244 (UMLS CUI [1])
Date of symptom resolution
Item
2. Date of symptom resolution
date
C2985918 (UMLS CUI [1])
Time of symptom resolution
Item
2. Time of symptom resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
Stroke - CEC Section
Item
3. Adjudication
text
C0680730 (UMLS CUI [1])
Adjudication
Code List
3. Adjudication
CL Item
Does not meet criteria for stroke (NC)
C0038454 (UMLS CUI-1)
C2919401 (UMLS CUI-2)
(Comment:en)
CL Item
Non-fatal stroke (44)
C1302234 (UMLS CUI-1)
C1302234 (UMLS CUI-2)
(Comment:en)
CL Item
Fatal stroke (45)
C1302234 (UMLS CUI-1)
C1302234 (UMLS CUI-2)
(Comment:en)
Item
If non-fatal stroke, select one
integer
C1302234 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
non-fatal stroke
Code List
If non-fatal stroke, select one
CL Item
Ischemic (7)
C0948008 (UMLS CUI-1)
(Comment:en)
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
C0007785 (UMLS CUI-1)
(Comment:en)
CL Item
Hemorrhagic (37)
C0333275 (UMLS CUI-1)
(Comment:en)
CL Item
Type uncertain (8)
C0087130 (UMLS CUI-1)
(Comment:en)
Non-fatal stroke type uncertain
Item
If non-fatal stroke of uncertain type, comment
text
C0393963 (UMLS CUI [1])
Item
If fatal stroke, select one
integer
non-fatal stroke
Code List
If fatal stroke, select one
CL Item
Ischemic (7)
C0948008 (UMLS CUI-1)
(Comment:en)
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
C0007785 (UMLS CUI-1)
(Comment:en)
CL Item
Hemorrhagic (37)
C0333275 (UMLS CUI-1)
(Comment:en)
CL Item
Type uncertain (8)
C0087130 (UMLS CUI-1)
(Comment:en)
Fatal stroke type uncertain
Item
If fatal stroke of uncertain type, comment
text
C0393963 (UMLS CUI [1])
criteria for stroke not met comment
Item
If criteria for stroke not met, comment
text
C3897171 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Item
If criteria for stroke not met, select one
text
C0038454 (UMLS CUI [1])
criteria for stroke not met
Code List
If criteria for stroke not met, select one
CL Item
TIA (6)
C0007787 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
criteria for stroke not met other
Item
If other, please comment
text
C0947611 (UMLS CUI [1])
Date of adjudication
Item
4. Date of adjudication
date
C3260278 (UMLS CUI [1])
Item Group
CEC STATUS
Trigger number
Item
5. Trigger number
text
C1444748 (UMLS CUI [1])
Item
6. CEC Status
integer
C0449438 (UMLS CUI [1])
CEC Status
Code List
6. 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
7. Date of status change
date
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
8. Physician review #1: Physician
integer
C0184806 (UMLS CUI [1])
Physician review 1
Code List
8. 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
8. 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
8. 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
9. Physician review #2: Physician
integer
C0184806 (UMLS CUI [1])
Physician review 1
Code List
9. 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
9. 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
9. 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
10. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
CV event number
Item
11. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
12. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
13. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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