ID

26081

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: Endpoint Hospitalisation for heart failure - Repeating form (Scheduled visits)

Nyckelord

Versioner (6)
  1. 2017-10-07 2017-10-07 -
  2. 2017-10-16 2017-10-16 -
  3. 2017-10-23 2017-10-23 -
  4. 2018-01-11 2018-01-11 -
  5. 2018-01-14 2018-01-14 -
  6. 2021-09-20 2021-09-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

7 oktober 2017

DOI

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Licens

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

Engelsk

Endpoint Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär  
Investigator section
Beskrivning

Investigator section

1. Date of event
Beskrivning

Date of event

Datatyp

date

1. Time of event
Beskrivning

Time of event

Datatyp

time

2. Treatments: [E01] Intravenous diuretic
Beskrivning

Select all that apply

Datatyp

boolean

2. Treatments: [E02] Escalation of diuretic dose
Beskrivning

Select all that apply

Datatyp

boolean

2. Treatments: [E03] Administration of inotropes
Beskrivning

Select all that apply

Datatyp

boolean

2. Treatments: [E04] Intra-aortic balloon pump
Beskrivning

Select all that apply

Datatyp

boolean

3. Method of diagnosis: [E05] Chest x-ray
Beskrivning

Select all that apply [hidden]

Datatyp

boolean

3. Method of diagnosis: [E06] Pulmonary edema, rales > 1/3 up the lung fields thought to be of cardiac causes
Beskrivning

Select all that apply [hidden]

Datatyp

boolean

3. Method of diagnosis: [E07] PCWP > 18 mmHg
Beskrivning

Select all that apply [hidden]

Datatyp

boolean

3. Method of diagnosis: [E08] BNP
Beskrivning

Select all that apply [hidden]

Datatyp

boolean

BNP, enter value
Beskrivning

Hidden BNP value

Datatyp

float

Måttenheter
  • pg/ml
pg/ml
BNP result not available
Beskrivning

Hidden BNP result not available

Datatyp

boolean

3. Method of diagnosis: [E09] NT pro-BNP
Beskrivning

Select all that apply [hidden]

Datatyp

boolean

NT pro-BNP, enter value
Beskrivning

Hidden NT pro-BNP value

Datatyp

float

Måttenheter
  • pg/ml
pg/ml
NT pro-BNP result not available
Beskrivning

Hidden NT pro-BNP result not available

Datatyp

boolean

4. Method of diagnosis: [E14] Chest imaging
Beskrivning

Select all that apply

Datatyp

boolean

4. Method of diagnosis: [E06] Pulmonary edema (i.e., rales > 1/3 up the lung fields thought to be of cardiac causes)
Beskrivning

Select all that apply

Datatyp

boolean

4. Method of diagnosis: [E07] Pulmonary capillary wedge pressure > 18 mmHg
Beskrivning

Select all that apply

Datatyp

boolean

4. Method of diagnosis: [E15] BNP
Beskrivning

Select all that apply

Datatyp

boolean

BNP, enter value
Beskrivning

Please note the standard units for laboratory test values. If laboratory reports the test in a different unit, refer to conversion table in InForm portal tab 'Biomarker Units'

Datatyp

float

Måttenheter
  • pg/ml
pg/ml
BNP result not available
Beskrivning

BNP result not available

Datatyp

boolean

4. Method of diagnosis: [E16] NT pro-BNP
Beskrivning

Select all that apply

Datatyp

boolean

NT pro-BNP, enter value
Beskrivning

Please note the standard units for laboratory test values. If laboratory reports the test in a different unit, refer to conversion table in InForm portal tab 'Biomarker Units'

Datatyp

float

Måttenheter
  • pg/ml
pg/ml
NT pro-BNP result not available
Beskrivning

NT pro-BNP result not available

Datatyp

boolean

5. NYHA functional class code
Beskrivning

NYHA functional class code

Datatyp

text

6. Provide narrative
Beskrivning

narrative

Datatyp

text

7. Date documents sent to CEC Document Group
Beskrivning

Date documents sent to CEC Document Group

Datatyp

date

CEC Section
Beskrivning

CEC Section

8. Adjudication
Beskrivning

[hidden]

Datatyp

text

8. If criteria for heart failure not met, specify
Beskrivning

criteria for heart failure not met specification

Datatyp

text

9. Date of adjudication
Beskrivning

[hidden]

Datatyp

date

CEC Status
Beskrivning

CEC Status

10. Trigger number
Beskrivning

[hidden]

Datatyp

text

11. CEC Status
Beskrivning

[read-only]

Datatyp

integer

12. Date of status change
Beskrivning

[read-only]

Datatyp

date

13. Physician review #1: Physician
Beskrivning

[hidden]

Datatyp

integer

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

[hidden]

Datatyp

date

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

[hidden]

Datatyp

date

14. Physician review #2: Physician
Beskrivning

[hidden]

Datatyp

integer

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

[hidden]

Datatyp

date

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

[hidden]

Datatyp

date

15. CEC Coordinator comments
Beskrivning

[hidden]

Datatyp

text

16. CV event number
Beskrivning

[hidden]

Datatyp

text

17. 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

18. Adverse event term
Beskrivning

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

Datatyp

text

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Similar models

Endpoint Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Investigator section
Date of event
Item
1. Date of event
date
Time of event
Item
1. Time of event
time
Treatments Intravenous diuretic
Item
2. Treatments: [E01] Intravenous diuretic
boolean
Treatments Escalation of diuretic dose
Item
2. Treatments: [E02] Escalation of diuretic dose
boolean
Treatments Administration of inotropes
Item
2. Treatments: [E03] Administration of inotropes
boolean
Treatments Intra-aortic balloon pump
Item
2. Treatments: [E04] Intra-aortic balloon pump
boolean
Hidden Method of diagnosis Chest x-ray
Item
3. Method of diagnosis: [E05] Chest x-ray
boolean
Hidden method of diagnosis Pulmonary edema
Item
3. Method of diagnosis: [E06] Pulmonary edema, rales > 1/3 up the lung fields thought to be of cardiac causes
boolean
Hidden Method of diagnosis PCWP
Item
3. Method of diagnosis: [E07] PCWP > 18 mmHg
boolean
Hidden Method of diagnosis BNP
Item
3. Method of diagnosis: [E08] BNP
boolean
Hidden BNP value
Item
BNP, enter value
float
Hidden BNP result not available
Item
BNP result not available
boolean
Hidden Method of diagnosis NT pro-BNP
Item
3. Method of diagnosis: [E09] NT pro-BNP
boolean
Hidden NT pro-BNP value
Item
NT pro-BNP, enter value
float
Hidden NT pro-BNP result not available
Item
NT pro-BNP result not available
boolean
Method of diagnosis Chest imaging
Item
4. Method of diagnosis: [E14] Chest imaging
boolean
Method of diagnosis Pulmonary edema
Item
4. Method of diagnosis: [E06] Pulmonary edema (i.e., rales > 1/3 up the lung fields thought to be of cardiac causes)
boolean
Method of diagnosis Pulmonary capillary wedge pressure
Item
4. Method of diagnosis: [E07] Pulmonary capillary wedge pressure > 18 mmHg
boolean
Method of diagnosis BNP
Item
4. Method of diagnosis: [E15] BNP
boolean
BNP value
Item
BNP, enter value
float
BNP result not available
Item
BNP result not available
boolean
Method of diagnosis NT pro-BNP
Item
4. Method of diagnosis: [E16] NT pro-BNP
boolean
NT pro-BNP value
Item
NT pro-BNP, enter value
float
NT pro-BNP result not available
Item
NT pro-BNP result not available
boolean
Item
5. NYHA functional class code
text
NYHA functional class code
Code List
5. NYHA functional class code
CL Item
Class I (E10)
CL Item
Class II (E11)
CL Item
Class III (E12)
CL Item
Class IV (E13)
narrative
Item
6. Provide narrative
text
Date documents sent to CEC Document Group
Item
7. Date documents sent to CEC Document Group
date
Item Group
CEC Section
Item
8. Adjudication
text
Adjudication
Code List
8. 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
8. If criteria for heart failure not met, specify
text
Date of adjudication
Item
9. Date of adjudication
date
Item Group
CEC Status
Trigger number
Item
10. Trigger number
text
Item
11. CEC Status
integer
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
Item
13. Physician review #1: Physician
integer
Physician review 1 Physician
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
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
13. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
13. Physician review #1: Date received from reviewer
date
Item
14. Physician review #2: Physician
integer
Physician review 1 Physician
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
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
14. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
14. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
15. CEC Coordinator comments
text
CV event number
Item
16. CV event number
text
Adverse event reference identifier
Item
17. Adverse event reference identifier
text
Adverse event term
Item
18. Adverse event term
text
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