ID

26725

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: CEC - Stroke/TIA Repeating form (Scheduled visits)

Stichworte

Versionen (4)
  1. 10.10.17 10.10.17 -
  2. 16.10.17 16.10.17 -
  3. 23.10.17 23.10.17 -
  4. 11.01.18 11.01.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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CEC - Stroke/TIA study Chronic Coronary Heart Disease NCT00799903

Englisch

CEC - Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
CEC - MI
Beschreibung

CEC - MI

1. Date of onset of symptoms
Beschreibung

[hidden]

Datentyp

date

1. Time of onset of symptoms
Beschreibung

[hidden]

Datentyp

time

2. Date of symptom resolution
Beschreibung

[hidden]

Datentyp

date

2. Time of symptom resolution
Beschreibung

[hidden]

Datentyp

time

Stroke - CEC Section
Beschreibung

Stroke - CEC Section

3. Adjudication
Beschreibung

[hidden]

Datentyp

text

If non-fatal stroke, select one
Beschreibung

[hidden]

Datentyp

integer

If non-fatal stroke of uncertain type, comment
Beschreibung

[hidden]

Datentyp

text

If fatal stroke, select one
Beschreibung

[hidden]

Datentyp

integer

If fatal stroke of uncertain type, comment
Beschreibung

[hidden]

Datentyp

text

If criteria for stroke not met, comment
Beschreibung

[hidden]

Datentyp

text

If criteria for stroke not met, select one
Beschreibung

[hidden]

Datentyp

text

If other, please comment
Beschreibung

[hidden]

Datentyp

text

4. Date of adjudication
Beschreibung

[hidden]

Datentyp

date

CEC STATUS
Beschreibung

CEC STATUS

5. Trigger number
Beschreibung

[hidden]

Datentyp

text

6. CEC Status
Beschreibung

[read-only]

Datentyp

integer

7. Date of status change
Beschreibung

[read-only]

Datentyp

date

8. Physician review #1: Physician
Beschreibung

[hidden]

Datentyp

integer

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

date

9. Physician review #2: Physician
Beschreibung

[hidden]

Datentyp

integer

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

date

10. CEC Coordinator comments
Beschreibung

[hidden]

Datentyp

text

11. CV event number
Beschreibung

[hidden]

Datentyp

text

12. 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

13. Adverse event term
Beschreibung

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

Datentyp

text

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Ähnliche Modelle

CEC - Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
CEC - MI
Date of onset of symptoms
Item
1. Date of onset of symptoms
date
Time of onset of symptoms
Item
1. Time of onset of symptoms
time
Date of symptom resolution
Item
2. Date of symptom resolution
date
Time of symptom resolution
Item
2. Time of symptom resolution
time
Item Group
Stroke - CEC Section
Item
3. Adjudication
text
Adjudication
Code List
3. Adjudication
CL Item
Does not meet criteria for stroke (NC)
CL Item
Non-fatal stroke (44)
CL Item
Fatal stroke (45)
Item
If non-fatal stroke, select one
integer
non-fatal stroke
Code List
If non-fatal stroke, select one
CL Item
Ischemic (7)
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
CL Item
Hemorrhagic (37)
CL Item
Type uncertain (8)
Non-fatal stroke type uncertain
Item
If non-fatal stroke of uncertain type, comment
text
Item
If fatal stroke, select one
integer
non-fatal stroke
Code List
If fatal stroke, select one
CL Item
Ischemic (7)
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
CL Item
Hemorrhagic (37)
CL Item
Type uncertain (8)
Fatal stroke type uncertain
Item
If fatal stroke of uncertain type, comment
text
criteria for stroke not met comment
Item
If criteria for stroke not met, comment
text
Item
If criteria for stroke not met, select one
text
criteria for stroke not met
Code List
If criteria for stroke not met, select one
CL Item
TIA (6)
CL Item
Other (OT)
Item
If other, please comment
text
criteria for stroke not met
Code List
If other, please comment
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
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
14 (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
44 (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
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
14 (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
44 (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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