ID

28416

Beschrijving

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)

Trefwoorden

Versies (6)
  1. 07-10-17 07-10-17 -
  2. 16-10-17 16-10-17 -
  3. 23-10-17 23-10-17 -
  4. 11-01-18 11-01-18 -
  5. 14-01-18 14-01-18 -
  6. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

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11 januari 2018

DOI

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Licentie

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

Engels

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

1 Formulieren  
Investigator section
Beschrijving

Investigator section

1. Date of event
Beschrijving

Date of event

Datatype

date

Alias
UMLS CUI [1]
C2697888
1. Time of event
Beschrijving

Time of event

Datatype

time

2. Treatments: [E01] Intravenous diuretic
Beschrijving

Select all that apply

Datatype

boolean

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

Select all that apply

Datatype

boolean

Alias
UMLS CUI [1]
C3816728
2. Treatments: [E03] Administration of inotropes
Beschrijving

Select all that apply

Datatype

boolean

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

Select all that apply

Datatype

boolean

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

Select all that apply [hidden]

Datatype

boolean

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

Select all that apply [hidden]

Datatype

boolean

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

Select all that apply [hidden]

Datatype

boolean

3. Method of diagnosis: [E08] BNP
Beschrijving

Select all that apply [hidden]

Datatype

boolean

BNP, enter value
Beschrijving

Hidden BNP value

Datatype

float

Maateenheden
  • pg/ml
pg/ml
BNP result not available
Beschrijving

Hidden BNP result not available

Datatype

boolean

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

Select all that apply [hidden]

Datatype

boolean

NT pro-BNP, enter value
Beschrijving

Hidden NT pro-BNP value

Datatype

float

Maateenheden
  • pg/ml
pg/ml
NT pro-BNP result not available
Beschrijving

Hidden NT pro-BNP result not available

Datatype

boolean

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

Select all that apply

Datatype

boolean

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

Select all that apply

Datatype

boolean

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

Select all that apply

Datatype

boolean

4. Method of diagnosis: [E15] BNP
Beschrijving

Select all that apply

Datatype

boolean

BNP, enter value
Beschrijving

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'

Datatype

float

Maateenheden
  • pg/ml
pg/ml
BNP result not available
Beschrijving

BNP result not available

Datatype

boolean

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

Select all that apply

Datatype

boolean

NT pro-BNP, enter value
Beschrijving

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'

Datatype

float

Maateenheden
  • pg/ml
pg/ml
NT pro-BNP result not available
Beschrijving

NT pro-BNP result not available

Datatype

boolean

5. NYHA functional class code
Beschrijving

NYHA functional class code

Datatype

text

6. Provide narrative
Beschrijving

narrative

Datatype

text

7. Date documents sent to CEC Document Group
Beschrijving

Date documents sent to CEC Document Group

Datatype

date

CEC Section
Beschrijving

CEC Section

8. Adjudication
Beschrijving

[hidden]

Datatype

text

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

criteria for heart failure not met specification

Datatype

text

9. Date of adjudication
Beschrijving

[hidden]

Datatype

date

CEC Status
Beschrijving

CEC Status

10. Trigger number
Beschrijving

[hidden]

Datatype

text

11. CEC Status
Beschrijving

[read-only]

Datatype

integer

12. Date of status change
Beschrijving

[read-only]

Datatype

date

13. Physician review #1: Physician
Beschrijving

[hidden]

Datatype

integer

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

[hidden]

Datatype

date

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

[hidden]

Datatype

date

14. Physician review #2: Physician
Beschrijving

[hidden]

Datatype

integer

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

[hidden]

Datatype

date

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

[hidden]

Datatype

date

15. CEC Coordinator comments
Beschrijving

[hidden]

Datatype

text

16. CV event number
Beschrijving

[hidden]

Datatype

text

17. Adverse event reference identifier
Beschrijving

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

Datatype

text

18. Adverse event term
Beschrijving

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

Datatype

text

Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Investigator section
Date of event
Item
1. Date of event
date
C2697888 (UMLS CUI [1])
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
C3816728 (UMLS CUI [1])
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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