ID

28404

Description

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 - Hospitalisation for heart failure Repeating form (Scheduled visits)

Keywords

Versions (4)
  1. 10/10/17 10/10/17 -
  2. 10/16/17 10/16/17 -
  3. 10/23/17 10/23/17 -
  4. 1/11/18 1/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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CEC - Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

English

CEC - Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
CEC - Hospitalisation for heart failure
Description

CEC - Hospitalisation for heart failure

1. Date of event
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C2985916
1. Time of event
Description

[hidden]

Data type

time

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1320528
Hospitalisation for heart failure - CEC Section
Description

Hospitalisation for heart failure - CEC Section

2. Adjudication
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0680730
2. If criteria for heart failure not met, specify
Description

criteria for heart failure not met specification

Data type

text

Alias
UMLS CUI [1]
C0018801
3. Date of adjudication
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C3260278
CEC Status
Description

CEC Status

4. Trigger number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1444748
5. CEC Status
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C0449438
6. Date of status change
Description

[read-only]

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
7. Physician review #1: Physician
Description

[hidden]

Data type

integer

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

[hidden]

Data type

date

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

[hidden]

Data type

date

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

[hidden]

Data type

integer

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

[hidden]

Data type

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 #2: Date received from reviewer
Description

[hidden]

Data type

date

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0947611
10. CV event number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2826275
11. Adverse event reference identifier
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
12. Adverse event term
Description

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

Data type

text

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

CEC - Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CEC - Hospitalisation for heart failure
Date of event
Item
1. Date of event
date
C2985916 (UMLS CUI [1])
Time of event
Item
1. Time of event
time
C0877248 (UMLS CUI [1,1])
C1320528 (UMLS CUI [1,2])
Item Group
Hospitalisation for heart failure - CEC Section
Item
2. Adjudication
text
C0680730 (UMLS CUI [1])
Adjudication
Code List
2. Adjudication
CL Item
Does not meet criteria for heart failure (NC)
CL Item
Hospitalisation for heart failure (72)
criteria for heart failure not met specification
Item
2. If criteria for heart failure not met, specify
text
C0018801 (UMLS CUI [1])
Date of adjudication
Item
3. Date of adjudication
date
C3260278 (UMLS CUI [1])
Item Group
CEC Status
Trigger number
Item
4. Trigger number
text
C1444748 (UMLS CUI [1])
Item
5. CEC Status
integer
C0449438 (UMLS CUI [1])
CEC Status
Code List
5. 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
6. Date of status change
date
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
7. Physician review #1: Physician
integer
C0184806 (UMLS CUI [1])
Physician review 1 Physician
Code List
7. 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
4 (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
4 (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
7. 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
7. 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
8. Physician review #2: Physician
integer
C0184806 (UMLS CUI [1])
Physician review 1 Physician
Code List
8. 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
4 (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
4 (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
8. 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
8. 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
9. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
CV event number
Item
10. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
11. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
12. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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