ID

28328

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 unstable angina 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. 1/4/18 1/4/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 4, 2018

DOI

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License

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

English

CEC - Hospitalisation for unstable angina GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Hospitalisation for unstable angina
Description

Hospitalisation for unstable angina

1. Date of hospital admission
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C0806429
Hospitalisation for unstable angina - CEC Section
Description

Hospitalisation for unstable angina - CEC Section

2. Adjudication
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0680730
2. If yes, select one
Description

Adjudication Ischemic discomfort at rest

Data type

text

Alias
UMLS CUI [1]
C3898664
2. Was ischemic discomfort at rest > 10 minutes?
Description

adjudication ischemic discomfort at rest duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0443144
UMLS CUI [1,2]
C3898664
2. If criteria for unstable angina are not met, specify
Description

criteria for unstable angina not met specification

Data type

text

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C3897171
2. If criteria for unstable angina are not met: [41] Meets criteria for MI
Description

criteria for MI met

Data type

boolean

Alias
UMLS CUI [1,1]
C3897171
UMLS CUI [1,2]
C0027051
3. Was this event related to a stent thrombosis?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C3897493
4. Date of adjudication
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C0680730
UMLS CUI [1,2]
C0011008
CEC Status
Description

CEC Status

5. Trigger number
Description

[hidden]

Data type

text

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

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0540683
7. Date of status change
Description

[hidden]

Data type

date

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

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C3166277
8. Physician review #1: Date sent to reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C0011008
8. Physician review #1: Date received from reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C3166277
UMLS CUI [1,2]
C0011008
9. Physician review #2: Physician
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C3166277
9. Physician review #2: Date sent to reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C0011008
9. Physician review #2: Date received from reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C3166277
UMLS CUI [1,2]
C0011008
10. CEC Coordinator comments
Description

[hidden]

Data type

text

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

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
12. 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]
C0877248
13. 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 unstable angina GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Hospitalisation for unstable angina
Date of hospital admission
Item
1. Date of hospital admission
date
C0806429 (UMLS CUI [1])
Item Group
Hospitalisation for unstable angina - CEC Section
Item
2. Adjudication
text
C0680730 (UMLS CUI [1])
Adjudication
Code List
2. Adjudication
CL Item
Yes (36)
CL Item
Does not meet criteria for unstable angina (NC)
Item
2. If yes, select one
text
C3898664 (UMLS CUI [1])
Ischemic discomfort at rest
Code List
2. If yes, select one
CL Item
Ischemic discomfort at rest associated with ECG changes leading to hospitalisation (D01)
C3898664 (UMLS CUI-1)
C0855329 (UMLS CUI-2)
(Comment:en)
CL Item
Ischemic discomfort at rest regardless of ECG changes leading to hospitalisation AND revascularisation during the (D02)
C3898664 (UMLS CUI-1)
(Comment:en)
CL Item
same admission (same admission)
(Comment:en)
CL Item
Ischemic discomfort at rest in hospital associated with ECG changes (D03)
C3898664 (UMLS CUI-1)
C0855329 (UMLS CUI-2)
(Comment:en)
CL Item
Ischemic discomfort at rest in hospital without ECG changes resulting in revascularisation during the same admission (D04)
C3898664 (UMLS CUI-1)
C0581603 (UMLS CUI-2)
(Comment:en)
adjudication ischemic discomfort at rest duration
Item
2. Was ischemic discomfort at rest > 10 minutes?
boolean
C0443144 (UMLS CUI [1,1])
C3898664 (UMLS CUI [1,2])
criteria for unstable angina not met specification
Item
2. If criteria for unstable angina are not met, specify
text
C0002965 (UMLS CUI [1,1])
C3897171 (UMLS CUI [1,2])
criteria for MI met
Item
2. If criteria for unstable angina are not met: [41] Meets criteria for MI
boolean
C3897171 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Item
3. Was this event related to a stent thrombosis?
text
C3897493 (UMLS CUI [1])
event related to stent thrombosis
Code List
3. 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
4. Date of adjudication
date
C0680730 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
CEC Status
Trigger number
Item
5. Trigger number
text
C1444748 (UMLS CUI [1])
Item
6. CEC Status
integer
C0449438 (UMLS CUI [1,1])
C0540683 (UMLS CUI [1,2])
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
C3166277 (UMLS CUI [1])
Physician review 1 Physician
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
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
8. Physician review #1: Date sent to reviewer
date
C0011008 (UMLS CUI [1])
Physician review 1 Date received from reviewer
Item
8. Physician review #1: Date received from reviewer
date
C3166277 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
9. Physician review #2: Physician
integer
C3166277 (UMLS CUI [1])
Physician review 1 Physician
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
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
9. Physician review #2: Date sent to reviewer
date
C0011008 (UMLS CUI [1])
Physician review 2 Date received from reviewer
Item
9. Physician review #2: Date received from reviewer
date
C3166277 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CEC Coordinator comments
Item
10. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
CV event number
Item
11. CV event number
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse event reference identifier
Item
12. Adverse event reference identifier
text
C0877248 (UMLS CUI [1])
Adverse event term
Item
13. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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