ID

44432

Beschreibung

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)

Stichworte

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  6. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Investigator section
Beschreibung

Investigator section

1. Date of event
Beschreibung

Date of event

Datentyp

date

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

Time of event

Datentyp

time

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1320528
2. Treatments: [E01] Intravenous diuretic
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348016
UMLS CUI [1,2]
C0012798
2. Treatments: [E02] Escalation of diuretic dose
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3816728
UMLS CUI [1,2]
C0012798
2. Treatments: [E03] Administration of inotropes
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1]
C0304509
2. Treatments: [E04] Intra-aortic balloon pump
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1]
C0021860
3. Method of diagnosis: [E05] Chest x-ray
Beschreibung

Select all that apply [hidden]

Datentyp

boolean

Alias
UMLS CUI [1]
C0039985
3. Method of diagnosis: [E06] Pulmonary edema, rales > 1/3 up the lung fields thought to be of cardiac causes
Beschreibung

Select all that apply [hidden]

Datentyp

boolean

Alias
UMLS CUI [1]
C0034063
3. Method of diagnosis: [E07] PCWP > 18 mmHg
Beschreibung

Select all that apply [hidden]

Datentyp

boolean

Alias
UMLS CUI [1]
C0086879
3. Method of diagnosis: [E08] BNP
Beschreibung

Select all that apply [hidden]

Datentyp

boolean

Alias
UMLS CUI [1]
C1095989
BNP, enter value
Beschreibung

Hidden BNP value

Datentyp

float

Maßeinheiten
  • pg/ml
Alias
UMLS CUI [1,1]
C1095989
UMLS CUI [1,2]
C1522609
pg/ml
BNP result not available
Beschreibung

Hidden BNP result not available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686905
UMLS CUI [1,2]
C1095989
3. Method of diagnosis: [E09] NT pro-BNP
Beschreibung

Select all that apply [hidden]

Datentyp

boolean

Alias
UMLS CUI [1]
C0669479
NT pro-BNP, enter value
Beschreibung

Hidden NT pro-BNP value

Datentyp

float

Maßeinheiten
  • pg/ml
Alias
UMLS CUI [1,1]
C1522609
UMLS CUI [1,2]
C0669479
pg/ml
NT pro-BNP result not available
Beschreibung

Hidden NT pro-BNP result not available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0669479
UMLS CUI [1,2]
C0686905
4. Method of diagnosis: [E14] Chest imaging
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1]
C0039985
4. Method of diagnosis: [E06] Pulmonary edema (i.e., rales > 1/3 up the lung fields thought to be of cardiac causes)
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1]
C0034063
4. Method of diagnosis: [E07] Pulmonary capillary wedge pressure > 18 mmHg
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1]
C0086879
4. Method of diagnosis: [E15] BNP
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1]
C1095989
BNP, enter value
Beschreibung

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'

Datentyp

float

Maßeinheiten
  • pg/ml
Alias
UMLS CUI [1,1]
C1095989
UMLS CUI [1,2]
C1519795
pg/ml
BNP result not available
Beschreibung

BNP result not available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1095989
UMLS CUI [1,2]
C1519795
UMLS CUI [1,3]
C0686905
4. Method of diagnosis: [E16] NT pro-BNP
Beschreibung

Select all that apply

Datentyp

boolean

Alias
UMLS CUI [1]
C0669479
NT pro-BNP, enter value
Beschreibung

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'

Datentyp

float

Maßeinheiten
  • pg/ml
Alias
UMLS CUI [1,1]
C1522609
UMLS CUI [1,2]
C0669479
pg/ml
NT pro-BNP result not available
Beschreibung

NT pro-BNP result not available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0669479
UMLS CUI [1,2]
C0686905
5. NYHA functional class code
Beschreibung

NYHA functional class code

Datentyp

text

Alias
UMLS CUI [1]
C1275491
6. Provide narrative
Beschreibung

narrative

Datentyp

text

Alias
UMLS CUI [1]
C1135957
7. Date documents sent to CEC Document Group
Beschreibung

Date documents sent to CEC Document Group

Datentyp

date

CEC Section
Beschreibung

CEC Section

8. Adjudication
Beschreibung

[hidden]

Datentyp

text

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

criteria for heart failure not met specification

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0018801
9. Date of adjudication
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1]
C3260278
CEC Status
Beschreibung

CEC Status

10. Trigger number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C1444748
11. CEC Status
Beschreibung

[read-only]

Datentyp

integer

Alias
UMLS CUI [1]
C0449438
12. Date of status change
Beschreibung

[read-only]

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
13. Physician review #1: Physician
Beschreibung

[hidden]

Datentyp

integer

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

integer

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C0947611
16. CV event number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2826275
17. Adverse event reference identifier
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
18. Adverse event term
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C2826934
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C0877248 (UMLS CUI [1,1])
C1320528 (UMLS CUI [1,2])
Treatments Intravenous diuretic
Item
2. Treatments: [E01] Intravenous diuretic
boolean
C0348016 (UMLS CUI [1,1])
C0012798 (UMLS CUI [1,2])
Treatments Escalation of diuretic dose
Item
2. Treatments: [E02] Escalation of diuretic dose
boolean
C3816728 (UMLS CUI [1,1])
C0012798 (UMLS CUI [1,2])
Treatments Administration of inotropes
Item
2. Treatments: [E03] Administration of inotropes
boolean
C0304509 (UMLS CUI [1])
Treatments Intra-aortic balloon pump
Item
2. Treatments: [E04] Intra-aortic balloon pump
boolean
C0021860 (UMLS CUI [1])
Hidden Method of diagnosis Chest x-ray
Item
3. Method of diagnosis: [E05] Chest x-ray
boolean
C0039985 (UMLS CUI [1])
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
C0034063 (UMLS CUI [1])
Hidden Method of diagnosis PCWP
Item
3. Method of diagnosis: [E07] PCWP > 18 mmHg
boolean
C0086879 (UMLS CUI [1])
Hidden Method of diagnosis BNP
Item
3. Method of diagnosis: [E08] BNP
boolean
C1095989 (UMLS CUI [1])
Hidden BNP value
Item
BNP, enter value
float
C1095989 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Hidden BNP result not available
Item
BNP result not available
boolean
C0686905 (UMLS CUI [1,1])
C1095989 (UMLS CUI [1,2])
Hidden Method of diagnosis NT pro-BNP
Item
3. Method of diagnosis: [E09] NT pro-BNP
boolean
C0669479 (UMLS CUI [1])
Hidden NT pro-BNP value
Item
NT pro-BNP, enter value
float
C1522609 (UMLS CUI [1,1])
C0669479 (UMLS CUI [1,2])
Hidden NT pro-BNP result not available
Item
NT pro-BNP result not available
boolean
C0669479 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
Method of diagnosis Chest imaging
Item
4. Method of diagnosis: [E14] Chest imaging
boolean
C0039985 (UMLS CUI [1])
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
C0034063 (UMLS CUI [1])
Method of diagnosis Pulmonary capillary wedge pressure
Item
4. Method of diagnosis: [E07] Pulmonary capillary wedge pressure > 18 mmHg
boolean
C0086879 (UMLS CUI [1])
Method of diagnosis BNP
Item
4. Method of diagnosis: [E15] BNP
boolean
C1095989 (UMLS CUI [1])
BNP value
Item
BNP, enter value
float
C1095989 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
BNP result not available
Item
BNP result not available
boolean
C1095989 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0686905 (UMLS CUI [1,3])
Method of diagnosis NT pro-BNP
Item
4. Method of diagnosis: [E16] NT pro-BNP
boolean
C0669479 (UMLS CUI [1])
NT pro-BNP value
Item
NT pro-BNP, enter value
float
C1522609 (UMLS CUI [1,1])
C0669479 (UMLS CUI [1,2])
NT pro-BNP result not available
Item
NT pro-BNP result not available
boolean
C0669479 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
Item
5. NYHA functional class code
text
C1275491 (UMLS CUI [1])
NYHA functional class code
Code List
5. NYHA functional class code
CL Item
Class I (E10)
C1882084 (UMLS CUI-1)
(Comment:en)
CL Item
Class II (E11)
C1882085 (UMLS CUI-1)
(Comment:en)
CL Item
Class III (E12)
C1882086 (UMLS CUI-1)
(Comment:en)
CL Item
Class IV (E13)
C1882087 (UMLS CUI-1)
(Comment:en)
narrative
Item
6. Provide narrative
text
C1135957 (UMLS CUI [1])
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
C0680730 (UMLS CUI [1])
Adjudication
Code List
8. Adjudication
CL Item
Does not meet criteria for heart failure (NC)
C0018801 (UMLS CUI-2)
(Comment:en)
CL Item
Hospitalisation for heart failure (72)
C0018801 (UMLS CUI-2)
(Comment:en)
criteria for heart failure not met specification
Item
8. If criteria for heart failure not met, specify
text
C2348235 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Date of adjudication
Item
9. Date of adjudication
date
C3260278 (UMLS CUI [1])
Item Group
CEC Status
Trigger number
Item
10. Trigger number
text
C1444748 (UMLS CUI [1])
Item
11. CEC Status
integer
C0449438 (UMLS CUI [1])
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
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
13. Physician review #1: Physician
integer
C0184806 (UMLS CUI [1])
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
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
13. 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
14. Physician review #2: Physician
integer
C0184806 (UMLS CUI [1])
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
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
14. 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
15. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
CV event number
Item
16. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
17. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
18. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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