ID

28315

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 Myocardial infarction - Repeating form (Scheduled visits)

Keywords

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

GlaxoSmithKline

Uploaded on

January 3, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Endpoint Myocardial infarction GSK study Chronic Coronary Heart Disease NCT00799903

English

Endpoint Myocardial infarction GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Investigator Section
Description

Investigator Section

1. Date of onset of MI symptoms
Description

Date of onset of MI symptoms

Data type

date

Alias
UMLS CUI [1]
C2985916
1. Time of onset of MI symptoms
Description

Time of onset of MI symptoms

Data type

time

Alias
UMLS CUI [1]
C0449244
2. Date of MI diagnosis
Description

Date of MI diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
2. Time of MI diagnosis
Description

Time of MI diagnosis

Data type

time

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0040223
3. Event details: Cardiac biomarkers - peak value supporting diagnosis (specify test and result)
Description

Select all that apply. Complete the Cardiac Biomarkers form

Data type

boolean

Alias
UMLS CUI [1]
C1271630
3. Event details: [A2] ECG changes
Description

Select all that apply. Complete the ECG evidence of myocardial ischemia/infarction form for ALL ECGs related to this event.

Data type

boolean

Alias
UMLS CUI [1]
C0855329
3. Event details: [A3] Symptoms of ischemia
Description

Select all that apply.

Data type

boolean

Alias
UMLS CUI [1]
C0917798
3. Event details: [A4] Associated with PCI without stent thrombosis
Description

Select all that apply.

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0687568
3. Event details: [A5] Associated with PCI and stent thrombosis confirmed by angiography or autopsy
Description

Select all that apply.

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0687568
3. Event details: [A6] Associated with CABG
Description

Select all that apply.

Data type

boolean

Alias
UMLS CUI [1]
C0010055
3. Event details: [A7] Imaging evidence
Description

Select all that apply. Complete the Cardiovascular Diagnostic Procedures form in the LOG visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0038454
3. Event details: [A8] Sudden, unexpected death, including cardiac arrest
Description

Select all that apply.

Data type

boolean

Alias
UMLS CUI [1]
C0011071
3. Event details: [A9] Pathological findings of acute myocardial infarction at autopsy
Description

Select all that apply.

Data type

boolean

Alias
UMLS CUI [1]
C0155626
4. Treatments and interventions: [1] Thrombolytic treatment
Description

Select all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0040044
4. Treatments and interventions: [2] Parenteral anti-coagulant treatment
Description

Select all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0003280
4. Treatments and interventions: [3] Parenteral anti-platelet treatment
Description

Select all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0085826
4. Treatments and interventions: [4] Coronary revascularisation
Description

Select all that apply. Complete endpoint form if appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
4. Treatments and interventions: [4] If Coronary revascularisation, select one
Description

Select all that apply.

Data type

integer

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
4. Treatments and interventions: [5] Other cardiac procedure (e.g., intra-aortic balloon, left ventricular assist device, pacemaker)
Description

Select all that apply.

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
5. Outcome
Description

If fatal, complete the Endpoint - Death form

Data type

integer

Alias
UMLS CUI [1]
C1705586
6. Provide narrative
Description

narrative

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
7. Date documents sent to CEC Document Group
Description

Date documents sent to CEC Document Group

Data type

date

Alias
UMLS CUI [1]
C2986012
CEC Section
Description

CEC Section

8. Adjudication
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0680730
If criteria for myocardial infarction not met, comment
Description

criteria myocardial infarction comment

Data type

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0947611
[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
Description

Hospitalisation for unstable angina

Data type

boolean

Alias
UMLS CUI [1]
C0002965
9. Classification of MI
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0008902
If acute, select one
Description

Acute myocardial infarction

Data type

text

Alias
UMLS CUI [1]
C0155626
If myocardial infarction diagnosed post-randomisation, select one
Description

myocardial infarction diagnosed post-randomisation

Data type

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0231290
10. STEMI / NSTEMI
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C3537184
11. Q wave/Non-Q wave
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1305738
UMLS CUI [2]
C0542269
12. Type of MI
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0027051
13. Was this event related to a stent thrombosis?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1536080
14. Unstable angina adjudication: 1. Adjudication
Description

Only to be completed for events adjudicated to be a hospitalisation for unstable angina [hidden]

Data type

text

Alias
UMLS CUI [1]
C0002965
14. Unstable angina adjudication: 2. Was ischemic discomfort at rest > 10 minutes?
Description

Only to be completed for events adjudicated to be a hospitalisation for unstable angina [hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0008031
15. Date of adjudication
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C0680730
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]
C3272886
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

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
19. Physician review #1: Date sent to reviewer
Description

[hidden]

Data type

date

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

[hidden]

Data type

date

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

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
19. Physician review #2: Date sent to reviewer
Description

[hidden]

Data type

date

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

[hidden]

Data type

date

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0947611
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
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Similar models

Endpoint Myocardial infarction 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 MI symptoms
Item
1. Date of onset of MI symptoms
date
C2985916 (UMLS CUI [1])
Time of onset of MI symptoms
Item
1. Time of onset of MI symptoms
time
C0449244 (UMLS CUI [1])
Date of MI diagnosis
Item
2. Date of MI diagnosis
date
C2316983 (UMLS CUI [1])
Time of MI diagnosis
Item
2. Time of MI diagnosis
time
C0011900 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Event details Cardiac biomarkers
Item
3. Event details: Cardiac biomarkers - peak value supporting diagnosis (specify test and result)
boolean
C1271630 (UMLS CUI [1])
Event details ECG changes
Item
3. Event details: [A2] ECG changes
boolean
C0855329 (UMLS CUI [1])
Event details Symptoms of ischemia
Item
3. Event details: [A3] Symptoms of ischemia
boolean
C0917798 (UMLS CUI [1])
Event details PCI without stent thrombosis
Item
3. Event details: [A4] Associated with PCI without stent thrombosis
boolean
C1532338 (UMLS CUI [1,1])
C0687568 (UMLS CUI [1,2])
Event details PCI and stent thrombosis
Item
3. Event details: [A5] Associated with PCI and stent thrombosis confirmed by angiography or autopsy
boolean
C1532338 (UMLS CUI [1,1])
C0687568 (UMLS CUI [1,2])
Event details Associated with CABG
Item
3. Event details: [A6] Associated with CABG
boolean
C0010055 (UMLS CUI [1])
Event details Imaging evidence
Item
3. Event details: [A7] Imaging evidence
boolean
C0024485 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
Event details Sudden death
Item
3. Event details: [A8] Sudden, unexpected death, including cardiac arrest
boolean
C0011071 (UMLS CUI [1])
Event details acute myocardial infarction
Item
3. Event details: [A9] Pathological findings of acute myocardial infarction at autopsy
boolean
C0155626 (UMLS CUI [1])
Treatments and interventions Thrombolytic treatment
Item
4. Treatments and interventions: [1] Thrombolytic treatment
boolean
C0040044 (UMLS CUI [1])
Treatments and interventions Parenteral anti-coagulant treatment
Item
4. Treatments and interventions: [2] Parenteral anti-coagulant treatment
boolean
C0003280 (UMLS CUI [1])
Treatments and interventions Parenteral anti-platelet treatment
Item
4. Treatments and interventions: [3] Parenteral anti-platelet treatment
boolean
C0085826 (UMLS CUI [1])
Treatments and interventions Coronary revascularisation
Item
4. Treatments and interventions: [4] Coronary revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Item
4. Treatments and interventions: [4] If Coronary revascularisation, select one
integer
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Treatments and interventions Coronary revascularisation specification
Code List
4. Treatments and interventions: [4] If Coronary revascularisation, select one
CL Item
PCI (1)
C1532338 (UMLS CUI-1)
(Comment:en)
CL Item
CABG (2)
C0010055 (UMLS CUI-1)
(Comment:en)
Treatments and interventions Other cardiac procedure
Item
4. Treatments and interventions: [5] Other cardiac procedure (e.g., intra-aortic balloon, left ventricular assist device, pacemaker)
boolean
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
5. Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
5. Outcome
CL Item
Fatal  (34)
CL Item
Non-fatal (35)
narrative
Item
6. Provide narrative
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date documents sent to CEC Document Group
Item
7. Date documents sent to CEC Document Group
date
C2986012 (UMLS CUI [1])
Item Group
CEC Section
Item
8. Adjudication
text
C0680730 (UMLS CUI [1])
Adjudication
Code List
8. Adjudication
CL Item
Fatal MI (34)
C0027051 (UMLS CUI-1)
C1302234 (UMLS CUI-2)
(Comment:en)
CL Item
Non-fatal MI (35)
C1705232 (UMLS CUI-1)
(Comment:en)
CL Item
Does not meet criteria for myocardial infarction (NC)
(Comment:en)
criteria myocardial infarction comment
Item
If criteria for myocardial infarction not met, comment
text
C0027051 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Hospitalisation for unstable angina
Item
[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
boolean
C0002965 (UMLS CUI [1])
Item
9. Classification of MI
integer
C0027051 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Classification of MI
Code List
9. Classification of MI
CL Item
Acute (38)
C0001314 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction diagnosed post-randomisation (80)
C0027051 (UMLS CUI-1)
C0231290 (UMLS CUI-2)
(Comment:en)
Item
If acute, select one
text
C0155626 (UMLS CUI [1])
Acute myocardial infarction
Code List
If acute, select one
CL Item
No recent revascularisation, baseline biomarkers not elevated - Rise/fall biomarkers >99th %ile URL (A25)
C0027056 (UMLS CUI-1)
(Comment:en)
CL Item
No recent revascularisation, post-MI baseline biomarkers elevated - biomarker decreasing prior to new suspect MI then re-elevation >50% of (A26)
C0027056 (UMLS CUI-1)
(Comment:en)
CL Item
previous value (previous value)
C0205156 (UMLS CUI-1)
(Comment:en)
CL Item
Sudden unexpected cardiac death involving cardiac arrest, often with symptoms of myocardial ischemia, accompanied by new ST (A08)
C0011071 (UMLS CUI-1)
C0376297 (UMLS CUI-2)
C (UMLS CUI-3)
(Comment:en)
CL Item
elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers (elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers)
C0087086 (UMLS CUI-1)
(Comment:en)
CL Item
Within 24 hours post-PCI, either 1) rise of CK-MB; OR 2) pathological findings of acute MI. Subtype is related to stent thrombosis (A27)
C1532338 (UMLS CUI-1)
(Comment:en)
CL Item
Within 72 hours post-CABG, either 1) rise of CK-MB + at least 1 additional criteria; OR 2) pathological findings of acute MI. (A28)
C1532338 (UMLS CUI-1)
(Comment:en)
CL Item
Pathological findings of acute myocardial infarction at post mortem (A09)
C0155626 (UMLS CUI-1)
C0004398 (UMLS CUI-2)
(Comment:en)
Item
If myocardial infarction diagnosed post-randomisation, select one
text
C0027051 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
myocardial infarction diagnosed post-randomisation
Code List
If myocardial infarction diagnosed post-randomisation, select one
CL Item
Development of new pathological Q waves with or without symptoms (A13)
CL Item
Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (A07)
CL Item
Pathological findings of a healed or healing myocardial infarction (A14)
Item
10. STEMI / NSTEMI
text
C1536220 (UMLS CUI [1,1])
C3537184 (UMLS CUI [1,2])
STEMI / NSTEMI
Code List
10. STEMI / NSTEMI
CL Item
STEMI (20)
C1536220 (UMLS CUI-1)
(Comment:en)
CL Item
NSTEMI (21)
C3537184 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
11. Q wave/Non-Q wave
text
C1305738 (UMLS CUI [1])
C0542269 (UMLS CUI [2])
Q wave/Non-Q wave
Code List
11. Q wave/Non-Q wave
CL Item
Q wave (A15)
C0429090 (UMLS CUI-1)
(Comment:en)
CL Item
Non-Q wave (A16)
C0542269 (UMLS CUI-1)
(Comment:en)
CL Item
Q wave undetermined - no ECG available (A24)
C1305738 (UMLS CUI-1)
(Comment:en)
Item
12. Type of MI
text
C0027051 (UMLS CUI [1])
Type of MI
Code List
12. Type of MI
CL Item
Type 1: Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as plaque erosion and/or rupture, fissuring, or (A17)
CL Item
dissection (dissection)
CL Item
Type 2: Myocardial infarction secondary to ischemia due to either increased oxygen demand or decreased supply, e.g. coronary artery spasm, coronary (A18)
CL Item
embolism, anemia, arrhythmias, hypertension, or hypotension (embolism, anemia, arrhythmias, hypertension, or hypotension)
CL Item
Type 3: Sudden unexpected cardiac death often with symptoms of myocardial ischemia, accompanied by new ST elevation or new LBBB, or fresh thrombus (A19)
CL Item
in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers (in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers)
CL Item
Type 4a: Myocardial infarction associated with PCI (A20)
CL Item
Type 4b: Myocardial infarction associated with stent thrombosis as documented by angiography or at autopsy (A21)
CL Item
Type 5: Myocardial infarction associated with CABG (A22)
Item
13. Was this event related to a stent thrombosis?
text
C1536080 (UMLS CUI [1])
event related to stent thrombosis
Code List
13. Was this event related to a stent thrombosis?
CL Item
Definite (DF)
CL Item
Probable (PB)
CL Item
No (N)
CL Item
Unknown (U)
Item
14. Unstable angina adjudication: 1. Adjudication
text
C0002965 (UMLS CUI [1])
Unstable angina adjudication
Code List
14. Unstable angina adjudication: 1. Adjudication
CL Item
Ischemic discomfort at rest associated with ECG changes leading to hospitalisation (D01)
CL Item
Ischemic discomfort at rest regardless of ECG changes leading to hospitalisation AND revascularisation during the same admission (D02)
CL Item
Ischemic discomfort at rest in hospital associated with ECG changes (D03)
CL Item
Ischemic discomfort at rest in hospital without ECG changes resulting in revascularisation during the same admission (D04)
Unstable angina adjudication ischemic discomfort
Item
14. Unstable angina adjudication: 2. Was ischemic discomfort at rest > 10 minutes?
boolean
C0002965 (UMLS CUI [1,1])
C0008031 (UMLS CUI [1,2])
Date of adjudication
Item
15. Date of adjudication
date
C0680730 (UMLS CUI [1])
Item Group
CEC STATUS
Trigger number
Item
16. Trigger number
text
C1444748 (UMLS CUI [1])
Item
17. CEC Status
integer
C3272886 (UMLS CUI [1])
CEC Status
Code List
17. CEC Status
CL Item
New (1)
C0205314 (UMLS CUI-1)
(Comment:en)
CL Item
Coordinator Screen check (2)
C1710220 (UMLS CUI-1)
(Comment:en)
CL Item
Hold (3)
C1948035 (UMLS CUI-1)
(Comment:en)
CL Item
Ready for review (4)
C3841913 (UMLS CUI-1)
(Comment:en)
CL Item
In Phase I review (5)
C0282459 (UMLS CUI-1)
C0449719 (UMLS CUI-2)
(Comment:en)
CL Item
Queried (InForm) (6)
(Comment:en)
CL Item
Additional documents required (7)
(Comment:en)
CL Item
In Phase II committee (8)
(Comment:en)
CL Item
Data change (9)
C0010995 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
(Comment:en)
CL Item
Re-Review (10)
C3166277 (UMLS CUI-1)
(Comment:en)
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
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
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
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
19. 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
19. Physician review #2: Physician
integer
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
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
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
19. 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
21. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
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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