ID

26334

Description

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 Stroke/TIA - Repeating form (Scheduled visits)

Keywords

Versions (6)
  1. 10/6/17 10/6/17 -
  2. 10/6/17 10/6/17 -
  3. 10/16/17 10/16/17 -
  4. 10/23/17 10/23/17 -
  5. 1/3/18 1/3/18 -
  6. 1/4/18 1/4/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2017

DOI

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License

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

English

Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Investigator Section
Description

Investigator Section

1. Date of onset of symptoms
Description

Date of onset of symptoms

Data type

date

1. Time of onset of symptoms
Description

Time of onset of symptoms

Data type

time

2. Date of of symptom resolution
Description

Date of of symptom resolution

Data type

date

2. Time of of symptom resolution
Description

Time of of symptom resolution

Data type

date

3. Event
Description

Event

Data type

integer

4. Symptoms: [B01] Motor and/or sensory loss in face,arm,leg
Description

Check all that apply

Data type

boolean

4. Symptoms: [B02] Dysphasia/aphasia (difficulty with language)
Description

Check all that apply

Data type

boolean

4. Symptoms: [B03] Dysarthria/dysphagia (difficulty with speech and swallowing)
Description

Check all that apply

Data type

boolean

4. Symptoms: [B04] Hemianopsia
Description

Check all that apply

Data type

boolean

4. Symptoms: [B05] Dizziness/vertigo
Description

Check all that apply

Data type

boolean

4. Symptoms: [B06] Ataxia
Description

Check all that apply

Data type

boolean

4. Symptoms: [B07] Nystagmus
Description

Check all that apply

Data type

boolean

4. Symptoms: [B08] Diplopia
Description

Check all that apply

Data type

boolean

4. Symptoms: [B09] Acute confusion/cognitive change
Description

Check all that apply

Data type

boolean

4. Symptoms: [B10] Decreased consciousness
Description

Check all that apply

Data type

boolean

5. Did the subject have a new focal neurologic deficit thought to be of vascular origin, with signs or symptoms lasting >24 hours?
Description

new focal neurologic deficit

Data type

boolean

5. If neurologic symptoms <24 hours, was new brain lesion confirmed by diffusion-weighted MRI showing the presence of a new brain infarct?
Description

new brain infarct

Data type

boolean

6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
Description

ischemic defect neuro-imaging

Data type

text

7. Method of diagnosis: [B11] Neurological exam
Description

Check all that apply

Data type

boolean

7. Method of diagnosis: [B12] Neuro-ophthalmologic exam (retinal embolism, infarction)
Description

Check all that apply

Data type

boolean

7. Method of diagnosis: [B13] CT scan
Description

Check all that apply

Data type

boolean

7. Method of diagnosis: [B14] MRI scan
Description

Check all that apply

Data type

boolean

7. Method of diagnosis: [B15] Invasive angiography
Description

Check all that apply

Data type

boolean

7. Method of diagnosis: [B16] Autopsy
Description

Check all that apply

Data type

boolean

7. Method of diagnosis: [OT] Other
Description

Check all that apply

Data type

boolean

8. Was there a change in the modified Rankin Scale grade?
Description

change in modified Rankin Scale grade

Data type

text

8. Most recent pre-event modified Rankin Scale grade
Description

Most recent pre-event modified Rankin Scale grade

Data type

integer

8. Date of most recent pre-event modified Rankin Scale grade
Description

Date of most recent pre-event modified Rankin Scale grade

Data type

date

8. Latest post-event modified Rankin Scale grade
Description

Latest post-event modified Rankin Scale grade

Data type

integer

8. Date of latest post-event modified Rankin Scale grade
Description

Date of latest post-event modified Rankin Scale grade

Data type

date

9. Type of stroke
Description

Type of stroke

Data type

text

10. Provide narrative
Description

narrative

Data type

text

11. Date documents sent to CEC Document Group
Description

Date documents sent to CEC Document Group

Data type

date

CEC Section
Description

CEC Section

8. Adjudication
Description

[hidden]

Data type

text

If non-fatal stroke, select one
Description

non-fatal stroke

Data type

integer

If type of non-fatal stroke uncertain, comment
Description

Non-fatal stroke type uncertain

Data type

text

If fatal stroke, select one
Description

fatal stroke

Data type

integer

If type of fatal stroke uncertain, comment
Description

Fatal stroke, type uncertain

Data type

text

Does not meet criteria for stroke, comment
Description

criteria for stroke not met, comment

Data type

text

If criteria for stroke are not met, selet one
Description

criteria for stroke not met

Data type

text

If other, please comment
Description

If criteria for stroke not met

Data type

text

15. Date of adjudication
Description

[hidden]

Data type

date

CEC STATUS
Description

CEC STATUS

16. Trigger number
Description

[hidden]

Data type

text

17. CEC Status
Description

[read-only]

Data type

integer

18. Date of status change
Description

[read-only]

Data type

date

19. Physician review #1: Physician
Description

[hidden]

Data type

integer

19. Physician review #1: Date sent to reviewer
Description

[hidden]

Data type

date

19. Physician review #1: Date received from reviewer
Description

[hidden]

Data type

date

19. Physician review #2: Physician
Description

[hidden]

Data type

integer

19. Physician review #2: Date sent to reviewer
Description

[hidden]

Data type

date

19. Physician review #2: Date received from reviewer
Description

[hidden]

Data type

date

21. CEC Coordinator comments
Description

[hidden]

Data type

text

22. CV event number
Description

[hidden]

Data type

text

23. Adverse event reference identifier
Description

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

Data type

text

24. Adverse event term
Description

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

Data type

text

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Similar models

Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigator Section
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 of symptom resolution
Item
2. Date of of symptom resolution
date
Time of of symptom resolution
Item
2. Time of of symptom resolution
date
Item
3. Event
integer
Event
Code List
3. Event
CL Item
Non-fatal stroke (44)
CL Item
Fatal stroke (45)
CL Item
TIA (6)
Symptoms Motor and/or sensory loss
Item
4. Symptoms: [B01] Motor and/or sensory loss in face,arm,leg
boolean
Symptoms Dysphasia/aphasia
Item
4. Symptoms: [B02] Dysphasia/aphasia (difficulty with language)
boolean
Symptoms Dysarthria/dysphagia
Item
4. Symptoms: [B03] Dysarthria/dysphagia (difficulty with speech and swallowing)
boolean
Symptoms Hemianopsia
Item
4. Symptoms: [B04] Hemianopsia
boolean
Symptoms Dizziness/vertigo
Item
4. Symptoms: [B05] Dizziness/vertigo
boolean
Symptoms Ataxia
Item
4. Symptoms: [B06] Ataxia
boolean
Symptoms Nystagmus
Item
4. Symptoms: [B07] Nystagmus
boolean
Symptoms Diplopia
Item
4. Symptoms: [B08] Diplopia
boolean
Symptoms Acute confusion/cognitive change
Item
4. Symptoms: [B09] Acute confusion/cognitive change
boolean
Symptoms Decreased consciousness
Item
4. Symptoms: [B10] Decreased consciousness
boolean
new focal neurologic deficit
Item
5. Did the subject have a new focal neurologic deficit thought to be of vascular origin, with signs or symptoms lasting >24 hours?
boolean
new brain infarct
Item
5. If neurologic symptoms <24 hours, was new brain lesion confirmed by diffusion-weighted MRI showing the presence of a new brain infarct?
boolean
Item
6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
text
ischemic defect neuro-imaging
Code List
6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not done (ND)
Method of diagnosis Neurological exam
Item
7. Method of diagnosis: [B11] Neurological exam
boolean
Method of diagnosis Neuro-ophthalmologic exam
Item
7. Method of diagnosis: [B12] Neuro-ophthalmologic exam (retinal embolism, infarction)
boolean
Method of diagnosis CT scan
Item
7. Method of diagnosis: [B13] CT scan
boolean
Method of diagnosis MRI scan
Item
7. Method of diagnosis: [B14] MRI scan
boolean
Method of diagnosis Invasive angiography
Item
7. Method of diagnosis: [B15] Invasive angiography
boolean
Method of diagnosis Autopsy
Item
7. Method of diagnosis: [B16] Autopsy
boolean
Method of diagnosis Other
Item
7. Method of diagnosis: [OT] Other
boolean
Item
8. Was there a change in the modified Rankin Scale grade?
text
change in modified Rankin Scale grade
Code List
8. Was there a change in the modified Rankin Scale grade?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not available (NV)
Most recent pre-event modified Rankin Scale grade
Item
8. Most recent pre-event modified Rankin Scale grade
integer
Date of most recent pre-event modified Rankin Scale grade
Item
8. Date of most recent pre-event modified Rankin Scale grade
date
Latest post-event modified Rankin Scale grade
Item
8. Latest post-event modified Rankin Scale grade
integer
Date of latest post-event modified Rankin Scale grade
Item
8. Date of latest post-event modified Rankin Scale grade
date
Item
9. Type of stroke
text
Type of stroke
Code List
9. Type of stroke
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)
CL Item
Not applicable (NP)
narrative
Item
10. Provide narrative
text
Date documents sent to CEC Document Group
Item
11. 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 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 type of non-fatal stroke uncertain, comment
text
Item
If fatal stroke, select one
integer
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 type of fatal stroke uncertain, comment
text
criteria for stroke not met, comment
Item
Does not meet criteria for stroke, comment
text
Item
If criteria for stroke are not met, selet one
text
criteria for stroke not met
Code List
If criteria for stroke are not met, selet one
CL Item
TIA (6)
CL Item
Other (OT)
criteria for stroke not met, other
Item
If other, please comment
text
Date of adjudication
Item
15. Date of adjudication
date
Item Group
CEC STATUS
Trigger number
Item
16. Trigger number
text
Item
17. CEC Status
integer
CEC Status
Code List
17. 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
18. Date of status change
date
Item
19. Physician review #1: Physician
integer
Physician review 1
Code List
19. 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
19. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
19. Physician review #1: Date received from reviewer
date
Item
19. Physician review #2: Physician
integer
Physician review 1
Code List
19. 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
19. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
19. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
21. CEC Coordinator comments
text
CV event number
Item
22. CV event number
text
Adverse event reference identifier
Item
23. Adverse event reference identifier
text
Adverse event term
Item
24. Adverse event term
text
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