ID

26346

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 Hospitalisation for unstable angina 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. 2018-01-04 2018-01-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 oktober 2017

DOI

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

Engelsk

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

1 Formulär  
Hospitalisation for unstable angina
Beskrivning

Hospitalisation for unstable angina

1. Date of hospital admission
Beskrivning

[hidden]

Datatyp

date

Hospitalisation for unstable angina - CEC Section
Beskrivning

Hospitalisation for unstable angina - CEC Section

2. Adjudication
Beskrivning

[hidden]

Datatyp

text

2. If yes, select one
Beskrivning

Adjudication Ischemic discomfort at rest

Datatyp

text

2. Was ischemic discomfort at rest > 10 minutes?
Beskrivning

adjudication ischemic discomfort at rest duration

Datatyp

boolean

2. If criteria for unstable angina are not met, specify
Beskrivning

criteria for unstable angina not met specification

Datatyp

text

2. If criteria for unstable angina are not met: [41] Meets criteria for MI
Beskrivning

criteria for MI met

Datatyp

boolean

3. Was this event related to a stent thrombosis?
Beskrivning

[hidden]

Datatyp

text

4. Date of adjudication
Beskrivning

[hidden]

Datatyp

date

CEC Status
Beskrivning

CEC Status

5. Trigger number
Beskrivning

[hidden]

Datatyp

text

6. CEC Status
Beskrivning

[hidden]

Datatyp

integer

7. Date of status change
Beskrivning

[hidden]

Datatyp

date

8. Physician review #1: Physician
Beskrivning

[hidden]

Datatyp

integer

8. Physician review #1: Date sent to reviewer
Beskrivning

[hidden]

Datatyp

date

8. Physician review #1: Date received from reviewer
Beskrivning

[hidden]

Datatyp

date

9. Physician review #2: Physician
Beskrivning

[hidden]

Datatyp

integer

9. Physician review #2: Date sent to reviewer
Beskrivning

[hidden]

Datatyp

date

9. Physician review #2: Date received from reviewer
Beskrivning

[hidden]

Datatyp

date

10. CEC Coordinator comments
Beskrivning

[hidden]

Datatyp

text

11. CV event number
Beskrivning

[hidden]

Datatyp

text

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

13. Adverse event term
Beskrivning

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

Datatyp

text

Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Hospitalisation for unstable angina
Date of hospital admission
Item
1. Date of hospital admission
date
Item Group
Hospitalisation for unstable angina - CEC Section
Item
2. Adjudication
text
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
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)
CL Item
Ischemic discomfort at rest regardless of ECG changes leading to hospitalisation AND revascularisation during the (D02)
CL Item
same admission (same admission)
CL Item
Ischemic discomfort at rest in hospital associated with ECG changes (D03)
CL Item
Ischemic discomfort at rest in hospital without ECG changes resulting in revascularisation during the same admission (D04)
adjudication ischemic discomfort at rest duration
Item
2. Was ischemic discomfort at rest > 10 minutes?
boolean
criteria for unstable angina not met specification
Item
2. If criteria for unstable angina are not met, specify
text
criteria for MI met
Item
2. If criteria for unstable angina are not met: [41] Meets criteria for MI
boolean
Item
3. Was this event related to a stent thrombosis?
text
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
Item Group
CEC Status
Trigger number
Item
5. Trigger number
text
Item
6. CEC Status
integer
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
Item
8. Physician review #1: Physician
integer
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
Physician review 1 Date received from reviewer
Item
8. Physician review #1: Date received from reviewer
date
Item
9. Physician review #2: Physician
integer
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
Physician review 2 Date received from reviewer
Item
9. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
10. CEC Coordinator comments
text
CV event number
Item
11. CV event number
text
Adverse event reference identifier
Item
12. Adverse event reference identifier
text
Adverse event term
Item
13. Adverse event term
text
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