ID

28324

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

  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

January 4, 2018

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

Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

Investigator Section
Description

Investigator Section

1. Date of onset of symptoms
Description

Date of onset of symptoms

Data type

date

Alias
UMLS CUI [1]
C0574845
1. Time of onset of symptoms
Description

Time of onset of symptoms

Data type

time

Alias
UMLS CUI [1]
C0449244
2. Date of of symptom resolution
Description

Date of of symptom resolution

Data type

date

Alias
UMLS CUI [1]
C2985918
2. Time of of symptom resolution
Description

Time of of symptom resolution

Data type

time

Alias
UMLS CUI [1]
C2826658
3. Event
Description

Event

Data type

integer

Alias
UMLS CUI [1]
C0877248
4. Symptoms: [B01] Motor and/or sensory loss in face,arm,leg
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3176213
4. Symptoms: [B02] Dysphasia/aphasia (difficulty with language)
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0973461
4. Symptoms: [B03] Dysarthria/dysphagia (difficulty with speech and swallowing)
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0011168
UMLS CUI [1,2]
C0013362
4. Symptoms: [B04] Hemianopsia
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0018979
4. Symptoms: [B05] Dizziness/vertigo
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0042571
4. Symptoms: [B06] Ataxia
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0004134
4. Symptoms: [B07] Nystagmus
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0028738
4. Symptoms: [B08] Diplopia
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0012569
4. Symptoms: [B09] Acute confusion/cognitive change
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0009676
4. Symptoms: [B10] Decreased consciousness
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0517960
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

Alias
UMLS CUI [1]
C0746857
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

Alias
UMLS CUI [1]
C0333559
6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
Description

ischemic defect neuro-imaging

Data type

text

Alias
UMLS CUI [1]
C0027853
7. Method of diagnosis: [B11] Neurological exam
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0027853
7. Method of diagnosis: [B12] Neuro-ophthalmologic exam (retinal embolism, infarction)
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0027853
7. Method of diagnosis: [B13] CT scan
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0040405
7. Method of diagnosis: [B14] MRI scan
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0917711
7. Method of diagnosis: [B15] Invasive angiography
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0085532
7. Method of diagnosis: [B16] Autopsy
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0011900
7. Method of diagnosis: [OT] Other
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C2911685
8. Was there a change in the modified Rankin Scale grade?
Description

change in modified Rankin Scale grade

Data type

text

Alias
UMLS CUI [1]
C2984908
8. Most recent pre-event modified Rankin Scale grade
Description

Most recent pre-event modified Rankin Scale grade

Data type

integer

Alias
UMLS CUI [1]
C2984908
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

Alias
UMLS CUI [1]
C2984908
8. Latest post-event modified Rankin Scale grade
Description

Latest post-event modified Rankin Scale grade

Data type

integer

Alias
UMLS CUI [1]
C2984908
8. Date of latest post-event modified Rankin Scale grade
Description

Date of latest post-event modified Rankin Scale grade

Data type

date

Alias
UMLS CUI [1]
C2984908
9. Type of stroke
Description

Type of stroke

Data type

text

Alias
UMLS CUI [1]
C3897486
10. Provide narrative
Description

narrative

Data type

text

Alias
UMLS CUI [1]
C1135957
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

Alias
UMLS CUI [1]
C0680730
If non-fatal stroke, select one
Description

non-fatal stroke

Data type

integer

Alias
UMLS CUI [1]
C0038454
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

Alias
UMLS CUI [1]
C0038454
If type of fatal stroke uncertain, comment
Description

Fatal stroke, type uncertain

Data type

text

Alias
UMLS CUI [1]
C0393963
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

Alias
UMLS CUI [1]
C3260278
CEC STATUS
Description

CEC STATUS

16. Trigger number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1444748
17. CEC Status
Description

[read-only]

Data type

integer

Alias
UMLS CUI [1]
C0449438
18. Date of status change
Description

[read-only]

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
19. Physician review #1: Physician
Description

[hidden]

Data type

integer

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

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C1515022
UMLS CUI [1,2]
C0011008
19. Physician review #1: Date received from reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C0011008
19. Physician review #2: Physician
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C3166277
19. Physician review #2: Date sent to reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C1515023
UMLS CUI [1,2]
C0011008
19. Physician review #2: Date received from reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C3166277
UMLS CUI [1,2]
C0011008
21. CEC Coordinator comments
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1710220
UMLS CUI [1,2]
C0282411
22. CV event number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2826275
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

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
24. Adverse event term
Description

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

Data type

text

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

Similar models

Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

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
C0574845 (UMLS CUI [1])
Time of onset of symptoms
Item
1. Time of onset of symptoms
time
C0449244 (UMLS CUI [1])
Date of of symptom resolution
Item
2. Date of of symptom resolution
date
C2985918 (UMLS CUI [1])
Time of of symptom resolution
Item
2. Time of of symptom resolution
time
C2826658 (UMLS CUI [1])
Item
3. Event
integer
C0877248 (UMLS CUI [1])
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
C3176213 (UMLS CUI [1])
Symptoms Dysphasia/aphasia
Item
4. Symptoms: [B02] Dysphasia/aphasia (difficulty with language)
boolean
C0973461 (UMLS CUI [1])
Symptoms Dysarthria/dysphagia
Item
4. Symptoms: [B03] Dysarthria/dysphagia (difficulty with speech and swallowing)
boolean
C0011168 (UMLS CUI [1,1])
C0013362 (UMLS CUI [1,2])
Symptoms Hemianopsia
Item
4. Symptoms: [B04] Hemianopsia
boolean
C0018979 (UMLS CUI [1])
Symptoms Dizziness/vertigo
Item
4. Symptoms: [B05] Dizziness/vertigo
boolean
C0042571 (UMLS CUI [1])
Symptoms Ataxia
Item
4. Symptoms: [B06] Ataxia
boolean
C0004134 (UMLS CUI [1])
Symptoms Nystagmus
Item
4. Symptoms: [B07] Nystagmus
boolean
C0028738 (UMLS CUI [1])
Symptoms Diplopia
Item
4. Symptoms: [B08] Diplopia
boolean
C0012569 (UMLS CUI [1])
Symptoms Acute confusion/cognitive change
Item
4. Symptoms: [B09] Acute confusion/cognitive change
boolean
C0009676 (UMLS CUI [1])
Symptoms Decreased consciousness
Item
4. Symptoms: [B10] Decreased consciousness
boolean
C0517960 (UMLS CUI [1])
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
C0746857 (UMLS CUI [1])
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
C0333559 (UMLS CUI [1])
Item
6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
text
C0027853 (UMLS CUI [1])
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
C0027853 (UMLS CUI [1])
Method of diagnosis Neuro-ophthalmologic exam
Item
7. Method of diagnosis: [B12] Neuro-ophthalmologic exam (retinal embolism, infarction)
boolean
C0027853 (UMLS CUI [1])
Method of diagnosis CT scan
Item
7. Method of diagnosis: [B13] CT scan
boolean
C0040405 (UMLS CUI [1])
Method of diagnosis MRI scan
Item
7. Method of diagnosis: [B14] MRI scan
boolean
C0917711 (UMLS CUI [1])
Method of diagnosis Invasive angiography
Item
7. Method of diagnosis: [B15] Invasive angiography
boolean
C0085532 (UMLS CUI [1])
Method of diagnosis Autopsy
Item
7. Method of diagnosis: [B16] Autopsy
boolean
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Method of diagnosis Other
Item
7. Method of diagnosis: [OT] Other
boolean
C2911685 (UMLS CUI [1])
Item
8. Was there a change in the modified Rankin Scale grade?
text
C2984908 (UMLS CUI [1])
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
C2984908 (UMLS CUI [1])
Date of most recent pre-event modified Rankin Scale grade
Item
8. Date of most recent pre-event modified Rankin Scale grade
date
C2984908 (UMLS CUI [1])
Latest post-event modified Rankin Scale grade
Item
8. Latest post-event modified Rankin Scale grade
integer
C2984908 (UMLS CUI [1])
Date of latest post-event modified Rankin Scale grade
Item
8. Date of latest post-event modified Rankin Scale grade
date
C2984908 (UMLS CUI [1])
Item
9. Type of stroke
text
C3897486 (UMLS CUI [1])
Code List
9. Type of stroke
CL Item
Ischemic (7)
C0948008 (UMLS CUI-1)
(Comment:en)
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
C0007785 (UMLS CUI-1)
C2937358 (UMLS CUI-2)
(Comment:en)
CL Item
Hemorrhagic (37)
C0333275 (UMLS CUI-1)
(Comment:en)
CL Item
Type uncertain (8)
C0087130 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (NP)
C1272460 (UMLS CUI-1)
(Comment:en)
narrative
Item
10. Provide narrative
text
C1135957 (UMLS CUI [1])
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
C0680730 (UMLS CUI [1])
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
C0038454 (UMLS CUI [1])
Code List
If non-fatal stroke, select one
CL Item
Ischemic (7)
C0948008 (UMLS CUI-1)
(Comment:en)
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
(Comment:en)
CL Item
Hemorrhagic (37)
(Comment:en)
CL Item
Type uncertain (8)
(Comment:en)
Non-fatal stroke type uncertain
Item
If type of non-fatal stroke uncertain, comment
text
Item
If fatal stroke, select one
integer
C0038454 (UMLS CUI [1])
Code List
If fatal stroke, select one
CL Item
Ischemic (7)
C0948008 (UMLS CUI-1)
(Comment:en)
CL Item
Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
(Comment:en)
CL Item
Hemorrhagic (37)
C0333275 (UMLS CUI-1)
(Comment:en)
CL Item
Type uncertain (8)
(Comment:en)
Fatal stroke, type uncertain
Item
If type of fatal stroke uncertain, comment
text
C0393963 (UMLS CUI [1])
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
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
C3260278 (UMLS CUI [1])
Item Group
CEC STATUS
Trigger number
Item
16. Trigger number
text
C1444748 (UMLS CUI [1])
Item
17. CEC Status
integer
C0449438 (UMLS CUI [1])
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
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
19. Physician review #1: Physician
integer
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
C1515022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Physician review 1 Date received from reviewer
Item
19. Physician review #1: Date received from reviewer
date
C0011008 (UMLS CUI [1])
Item
19. Physician review #2: Physician
integer
C3166277 (UMLS CUI [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
C1515023 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Physician review 2 Date received from reviewer
Item
19. Physician review #2: Date received from reviewer
date
C3166277 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CEC Coordinator comments
Item
21. CEC Coordinator comments
text
C1710220 (UMLS CUI [1,1])
C0282411 (UMLS CUI [1,2])
CV event number
Item
22. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
23. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
24. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])

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