ID

28345

Descrizione

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 revascularisation - Repeating form (Scheduled visits)

Keywords

versioni (4)
  1. 07/10/17 07/10/17 -
  2. 16/10/17 16/10/17 -
  3. 23/10/17 23/10/17 -
  4. 05/01/18 05/01/18 -
Titolare del copyright

GlaxoSmithKline

Caricato su

5 gennaio 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Endpoint revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli  
Coronary revascularisation
Descrizione

Coronary revascularisation

1. Date of procedure
Descrizione

Date of procedure

Tipo di dati

date

Alias
UMLS CUI [1]
C2584899
1. Start time of procedure
Descrizione

Start time of procedure

Tipo di dati

time

Alias
UMLS CUI [1,1]
C2700391
UMLS CUI [1,2]
C1301880
2. Revascularisation procedure
Descrizione

Revascularisation procedure

Tipo di dati

text

Alias
UMLS CUI [1]
C0581603
If PCI - single vessel, select one
Descrizione

PCI single vessel

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0856737
If PCI - single vessel with stent: C02 Bare metal
Descrizione

PCI single vessel with stent Bare metal

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0856737
If PCI - single vessel with stent (bare metal), indicate number of stents
Descrizione

number of stents bare metal single vessel

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2024081
UMLS CUI [1,2]
C2825200
If PCI - single vessel with stent: C03 Drug-eluting
Descrizione

PCI single vessel with stent Drug-eluting

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1322815
If PCI - single vessel with stent (drug-eluting), indicate number of stents
Descrizione

number of stents drug-eluting single vessel

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2024081
UMLS CUI [1,2]
C1262327
If PCI - multiple vessels, select one
Descrizione

PCI multiple vessels

Tipo di dati

text

Alias
UMLS CUI [1]
C0202886
If PCI - multiple vessels with stent: C05 Bare metal
Descrizione

PCI multiple vessels with stent Bare metal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2825200
If PCI - multiple vessels with stent (bare metal), indicate number of stents
Descrizione

number of stents bare metal multiple vessels

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2024081
UMLS CUI [1,2]
C2825200
If PCI - multiple vessels with stent: C06 Drug-eluting
Descrizione

PCI multiple vessels with stent Drug-eluting

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1322815
If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
Descrizione

number of stents drug-eluting multiple vessels

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2024081
UMLS CUI [1,2]
C1262327
If CABG: C07 Arterial graft
Descrizione

CABG Arterial graft

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0371564
Number of grafts
Descrizione

CABG arterial graft number

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0371564
UMLS CUI [1,2]
C0237753
If CABG: C08 Saphenous vein graft
Descrizione

CABG Saphenous vein graft

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0729538
Number of grafts
Descrizione

CABG Saphenous vein graft number

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0729538
UMLS CUI [1,2]
C2183050
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
Descrizione

revascularisation of a target lesion from PCI

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C2986546
4. Did subject have ischemic discomfort at rest?
Descrizione

ischemic discomfort at rest

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0235710
UMLS CUI [1,2]
C0035253
Did ischemic disomfort at rest prompt coronary revascularisation (PCI or CABG) during the same hospitalisation?
Descrizione

ischemic disomfort prompting coronary revascularisation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0745417
Did ischemic discomfort at rest result in hospital transfer for the purpose of coronary revascularisation?
Descrizione

ischemic discomfort resulting in hospital transfer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0745417
UMLS CUI [1,4]
C2065834
Was ischemic discomfort at rest > 10 minutes?
Descrizione

ischemic discomfort less than 10 minutes

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0235710
UMLS CUI [1,2]
C0035253
UMLS CUI [1,3]
C0449238
5. Other interventions: [6] ECG
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205394
5. Other interventions: [7] Cardiac biomarkers
Descrizione

Select all that apply. Complete the Cardiac Biomarkers form

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1271630
6. Provide narrative
Descrizione

narrative

Tipo di dati

text

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

Date documents sent to CEC Document Group

Tipo di dati

date

Alias
UMLS CUI [1]
C2986012
Urgent coronary revascularisation for myocardial ischemia
Descrizione

Urgent coronary revascularisation for myocardial ischemia

6. Adjudication
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C3260278
If criteria for urgent coronary revscularisation for myocardial ischemia not met, comment
Descrizione

criteria for urgent coronary revscularisation for myocardial ischemia not met

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0948089
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
Descrizione

Non-urgent coronary revascularisation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0543467
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [99] Revascularisation was a treatment for MI
Descrizione

Revascularisation was a treatment for MI

Tipo di dati

boolean

9. Was this event related to a stent thrombosis?
Descrizione

[hidden]

Tipo di dati

text

10. Additional Findings: 1. Adjudication
Descrizione

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Tipo di dati

integer

Alias
UMLS CUI [1]
C0243095
10. Additional Findings: 2. Classification of MI
Descrizione

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Tipo di dati

integer

Alias
UMLS CUI [1]
C1317081
If acute, select one
Descrizione

Acute MI

Tipo di dati

text

Alias
UMLS CUI [1]
C0155626
If prior MI (occurred after randomisation), select one
Descrizione

prior MI

Tipo di dati

text

Alias
UMLS CUI [1]
C1275835
10. Additional Findings: 3. STEMI / NSTEMI
Descrizione

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C1536220
UMLS CUI [2]
C3537184
10. Additional Findings: 4. Q wave/Non-Q wave
Descrizione

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C1305738
10. Additional Findings: 5. Type of MI
Descrizione

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C1275835
11. Date of adjudication
Descrizione

[hidden]

Tipo di dati

date

Alias
UMLS CUI [1]
C3260278
CEC Status
Descrizione

CEC Status

12. Trigger number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C1444748
13. CEC Status
Descrizione

[read-only]

Tipo di dati

integer

Alias
UMLS CUI [1]
C0449438
14. Date of status change
Descrizione

[read-only]

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
15. Physician review #1: Physician
Descrizione

[hidden]

Tipo di dati

integer

Alias
UMLS CUI [1]
C0031831
15. Physician review #1: Date sent to reviewer
Descrizione

[hidden]

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2082575
UMLS CUI [1,3]
C1519246
15. Physician review #1: Date received from reviewer
Descrizione

[hidden]

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0184806
UMLS CUI [1,2]
C1115441
16. Physician review #2: Physician
Descrizione

[hidden]

Tipo di dati

integer

Alias
UMLS CUI [1]
C0031831
16. Physician review #2: Date sent to reviewer
Descrizione

[hidden]

Tipo di dati

date

Alias
UMLS CUI [1]
C3166278
16. Physician review #2: Date received from reviewer
Descrizione

[hidden]

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0184806
UMLS CUI [1,2]
C1115441
17. CEC Coordinator comments
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C0947611
18. CV event number
Descrizione

[hidden]

Tipo di dati

text

Alias
UMLS CUI [1]
C2826275
19. Adverse event reference identifier
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
20. Adverse event term
Descrizione

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

Tipo di dati

text

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

Endpoint revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Coronary revascularisation
Date of procedure
Item
1. Date of procedure
date
C2584899 (UMLS CUI [1])
Start time of procedure
Item
1. Start time of procedure
time
C2700391 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
2. Revascularisation procedure
text
C0581603 (UMLS CUI [1])
Revascularisation procedure
Code List
2. Revascularisation procedure
CL Item
PCI - single vessel (CA)
C0856737 (UMLS CUI-1)
C1532338 (UMLS CUI-2)
(Comment:en)
CL Item
PCI - multiple vessels (CC)
C0202886 (UMLS CUI-1)
(Comment:en)
CL Item
CABG (CE)
C0010055 (UMLS CUI-1)
(Comment:en)
CL Item
Revascularisation procedure attempted but not successful (C09)
C0581603 (UMLS CUI-1)
C1272704 (UMLS CUI-2)
(Comment:en)
Item
If PCI - single vessel, select one
text
C1532338 (UMLS CUI [1,1])
C0856737 (UMLS CUI [1,2])
PCI single vessel
Code List
If PCI - single vessel, select one
CL Item
without stent (C01)
C0687568 (UMLS CUI-1)
(Comment:en)
CL Item
with stent (CB)
C0038257 (UMLS CUI-1)
(Comment:en)
PCI single vessel with stent Bare metal
Item
If PCI - single vessel with stent: C02 Bare metal
boolean
C1532338 (UMLS CUI [1,1])
C0856737 (UMLS CUI [1,2])
number of stents bare metal single vessel
Item
If PCI - single vessel with stent (bare metal), indicate number of stents
integer
C2024081 (UMLS CUI [1,1])
C2825200 (UMLS CUI [1,2])
PCI single vessel with stent Drug-eluting
Item
If PCI - single vessel with stent: C03 Drug-eluting
boolean
C1322815 (UMLS CUI [1])
number of stents drug-eluting single vessel
Item
If PCI - single vessel with stent (drug-eluting), indicate number of stents
integer
C2024081 (UMLS CUI [1,1])
C1262327 (UMLS CUI [1,2])
Item
If PCI - multiple vessels, select one
text
C0202886 (UMLS CUI [1])
PCI single vessel
Code List
If PCI - multiple vessels, select one
CL Item
without stent (C04)
C0038257 (UMLS CUI-1)
(Comment:en)
CL Item
with stent (CD)
C0038257 (UMLS CUI-1)
(Comment:en)
PCI multiple vessels with stent Bare metal
Item
If PCI - multiple vessels with stent: C05 Bare metal
boolean
C2825200 (UMLS CUI [1])
number of stents bare metal multiple vessels
Item
If PCI - multiple vessels with stent (bare metal), indicate number of stents
integer
C2024081 (UMLS CUI [1,1])
C2825200 (UMLS CUI [1,2])
PCI multiple vessels with stent Drug-eluting
Item
If PCI - multiple vessels with stent: C06 Drug-eluting
boolean
C1322815 (UMLS CUI [1])
number of stents drug-eluting multiple vessels
Item
If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
integer
C2024081 (UMLS CUI [1,1])
C1262327 (UMLS CUI [1,2])
CABG Arterial graft
Item
If CABG: C07 Arterial graft
boolean
C0371564 (UMLS CUI [1])
CABG arterial graft number
Item
Number of grafts
integer
C0371564 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
CABG Saphenous vein graft
Item
If CABG: C08 Saphenous vein graft
boolean
C0729538 (UMLS CUI [1])
CABG Saphenous vein graft number
Item
Number of grafts
integer
C0729538 (UMLS CUI [1,1])
C2183050 (UMLS CUI [1,2])
Item
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
text
C1299991 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
revascularisation of a target lesion from PCI
Code List
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
ischemic discomfort at rest
Item
4. Did subject have ischemic discomfort at rest?
boolean
C0235710 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
ischemic disomfort prompting coronary revascularisation
Item
Did ischemic disomfort at rest prompt coronary revascularisation (PCI or CABG) during the same hospitalisation?
boolean
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0745417 (UMLS CUI [1,3])
ischemic discomfort resulting in hospital transfer
Item
Did ischemic discomfort at rest result in hospital transfer for the purpose of coronary revascularisation?
boolean
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0745417 (UMLS CUI [1,3])
C2065834 (UMLS CUI [1,4])
ischemic discomfort less than 10 minutes
Item
Was ischemic discomfort at rest > 10 minutes?
text
C0235710 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Other interventions ECG
Item
5. Other interventions: [6] ECG
boolean
C0013798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other interventions Cardiac biomarkers
Item
5. Other interventions: [7] Cardiac biomarkers
boolean
C1271630 (UMLS CUI [1])
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
C2986012 (UMLS CUI [1])
Item Group
Urgent coronary revascularisation for myocardial ischemia
Item
6. Adjudication
text
C3260278 (UMLS CUI [1])
Adjudication
Code List
6. Adjudication
CL Item
Urgent coronary revascularisation for myocardial ischemia (70)
C2093667 (UMLS CUI-1)
(Comment:en)
CL Item
Does not meet criteria for urgent coronary revscularisation for myocardial ischemia (NC)
C2093667 (UMLS CUI-1)
C3897171 (UMLS CUI-2)
(Comment:en)
criteria for urgent coronary revscularisation for myocardial ischemia not met
Item
If criteria for urgent coronary revscularisation for myocardial ischemia not met, comment
text
C0151744 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
Non-urgent coronary revascularisation
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Revascularisation was a treatment for MI
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [99] Revascularisation was a treatment for MI
boolean
Item
9. Was this event related to a stent thrombosis?
text
Was this event related to a stent thrombosis?
Code List
9. 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
10. Additional Findings: 1. Adjudication
integer
C0243095 (UMLS CUI [1])
Additional Findings
Code List
10. Additional Findings: 1. Adjudication
CL Item
Fatal MI (34)
CL Item
Non-fatal MI (35)
Item
10. Additional Findings: 2. Classification of MI
integer
C1317081 (UMLS CUI [1])
Additional Findings
Code List
10. Additional Findings: 2. Classification of MI
CL Item
Acute (38)
C0205178 (UMLS CUI-1)
(Comment:en)
CL Item
Prior MI (occurred after randomisation) (39)
C1275835 (UMLS CUI-1)
(Comment:en)
Item
If acute, select one
text
C0155626 (UMLS CUI [1])
Acute MI
Code List
If acute, select one
CL Item
No recent revascularisation, baseline biomarkers not elevated - Rise/fall biomarkers >99th %ile URL (A25)
CL Item
No recent revascularisation, post-MI baseline biomarkers elevated - biomarker decreasing prior to new suspect MI then re-elevation >50% of (A26)
CL Item
previous value (previous value)
CL Item
Sudden unexpected cardiac death involving cardiac arrest, often with symptoms of myocardial ischemia, accompanied by new ST (A08)
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)
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)
CL Item
Annotated Trial Design Page 206 of 307 (Annotated Trial Design Page 206 of 307)
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)
CL Item
Pathological findings of acute myocardial infarction at post mortem (A09)
Item
If prior MI (occurred after randomisation), select one
text
C1275835 (UMLS CUI [1])
prior MI
Code List
If prior MI (occurred after 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. Additional Findings: 3. STEMI / NSTEMI
text
C1536220 (UMLS CUI [1])
C3537184 (UMLS CUI [2])
Additional Findings
Code List
10. Additional Findings: 3. 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
10. Additional Findings: 4. Q wave/Non-Q wave
text
C1305738 (UMLS CUI [1])
Additional Findings
Code List
10. Additional Findings: 4. Q wave/Non-Q wave
CL Item
Q wave (A15)
C1305738 (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)
C0429090 (UMLS CUI-1)
C0027051 (UMLS CUI-2)
(Comment:en)
Item
10. Additional Findings: 5. Type of MI
text
C1275835 (UMLS CUI [1])
Additional Findings
Code List
10. Additional Findings: 5. 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)
C0027051 (UMLS CUI-1)
C0151744 (UMLS CUI-2)
(Comment:en)
CL Item
dissection (dissection)
C0012737 (UMLS CUI-1)
(Comment:en)
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)
C0027051 (UMLS CUI-1)
C1956346 (UMLS CUI-2)
(Comment:en)
CL Item
embolism, anemia, arrhythmias, hypertension, or hypotension (embolism, anemia, arrhythmias, hypertension, or hypotension)
C0020538 (UMLS CUI-1)
C0020649 (UMLS CUI-2)
(Comment:en)
CL Item
Type 3: Sudden unexpected cardiac death often with symptoms of myocardial ischemia, accompanied by new ST elevation or new LBBB, or fresh (A19)
C0520886 (UMLS CUI-1)
C0023211 (UMLS CUI-2)
(Comment:en)
CL Item
thrombus in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers (thrombus in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers)
(Comment:en)
CL Item
Type 4a: Myocardial infarction associated with PCI (A20)
(Comment:en)
CL Item
Type 4b: Myocardial infarction associated with stent thrombosis as documented by angiography or at autopsy (A21)
(Comment:en)
CL Item
Type 5: Myocardial infarction associated with CABG (A22)
C0027051 (UMLS CUI-1)
(Comment:en)
Date of adjudication
Item
11. Date of adjudication
date
C3260278 (UMLS CUI [1])
Item Group
CEC Status
Trigger number
Item
12. Trigger number
text
C1444748 (UMLS CUI [1])
Item
13. CEC Status
integer
C0449438 (UMLS CUI [1])
CEC Status
Code List
13. 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
14. Date of status change
date
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
15. Physician review #1: Physician
integer
C0031831 (UMLS CUI [1])
Physician review 1 Physician
Code List
15. 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
15. Physician review #1: Date sent to reviewer
date
C0011008 (UMLS CUI [1,1])
C2082575 (UMLS CUI [1,2])
C1519246 (UMLS CUI [1,3])
Physician review 1 Date received from reviewer
Item
15. Physician review #1: Date received from reviewer
date
C0184806 (UMLS CUI [1,1])
C1115441 (UMLS CUI [1,2])
Item
16. Physician review #2: Physician
integer
C0031831 (UMLS CUI [1])
Physician review 1 Physician
Code List
16. 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
16. Physician review #2: Date sent to reviewer
date
C3166278 (UMLS CUI [1])
Physician review 2 Date received from reviewer
Item
16. Physician review #2: Date received from reviewer
date
C0184806 (UMLS CUI [1,1])
C1115441 (UMLS CUI [1,2])
CEC Coordinator comments
Item
17. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
CV event number
Item
18. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
19. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
20. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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