ID

28177

Beschrijving

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: Serious adverse events - Repeating form (Scheduled visits)

Trefwoorden

Versies (6)
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  4. 23-10-17 23-10-17 -
  5. 26-12-17 26-12-17 -
  6. 28-12-17 28-12-17 -
Houder van rechten

GlaxoSmithKline

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26 december 2017

DOI

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Creative Commons BY-NC 3.0
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Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

Engels

Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
SAE as possible study endpoint
Beschrijving

SAE as possible study endpoint

1. Is event a possible study endpoint?
Beschrijving

[hidden] If yes, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Primary adjudicated endpoints: [1] Death
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C0011065
Primary adjudicated endpoints: [2] Myocardial infarction
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
Primary adjudicated endpoints: [3] Stroke/TIA
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C3844446
Other adjudicated endpoints: [4] Coronary revascularisation
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C0877341
Other adjudicated endpoints: [5] Hospitalisation for unstable angina
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0019993
Other adjudicated endpoints: [8] Hospitalisation for heart failure
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0018801
Other endpoints: [7] Limb amputation due to vascular cause
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002689
UMLS CUI [1,2]
C0042373
Other endpoints: [9] Non-coronary revascularisation
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C0877341
Other endpoints: [10] Hospitalisation for non-coronary ischaemic event
Beschrijving

If event is a possible study endpoint, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0948089
SAE to be adjudicated
Beschrijving

SAE to be adjudicated

2. Is this an event to be adjudicated?
Beschrijving

[hidden] If yes, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1]
C0680730
Primary adjudicated endpoints: [1] Death
Beschrijving

If event is to be adjudicated, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C0680730
Primary adjudicated endpoints: [2] Myocardial infarction
Beschrijving

If event is to be adjudicated, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C0680730
Primary adjudicated endpoints: [3] Stroke/TIA
Beschrijving

If event is to be adjudicated, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0680730
UMLS CUI [1,3]
C0680730
Other adjudicated endpoints: [4] Coronary revascularisation
Beschrijving

If event is to be adjudicated, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0680730
Other adjudicated endpoints: [5] Hospitalisation for unstable angina
Beschrijving

If event is to be adjudicated, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C0680730
Other adjudicated endpoints: [8] Hospitalisation for heart failure
Beschrijving

If event is to be adjudicated, select all that apply.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0581377
UMLS CUI [1,3]
C0680730
SAE as non-adjudicated endpoint
Beschrijving

SAE as non-adjudicated endpoint

Is event a non-adjudicated endpoint?
Beschrijving

[hidden] If yes, select all that apply

Datatype

boolean

Other endpoints: [7] Limb amputation due to vascular cause
Beschrijving

If event is a non-adjudicated endpoint, select all that apply.

Datatype

boolean

Other endpoints: [9] Non-coronary revascularisation
Beschrijving

If event is a non-adjudicated endpoint, select all that apply.

Datatype

boolean

Other endpoints: [10] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
Beschrijving

If event is a non-adjudicated endpoint, select all that apply.

Datatype

boolean

Occurence of endpoints
Beschrijving

Occurence of endpoints

4. Did any of these endpoints occur?
Beschrijving

Please provide all SAE/EP details in sections 2-11 below

Datatype

boolean

[D] Death
Beschrijving

Occurence of death

Datatype

boolean

[D]Death: Cardiovascular?
Beschrijving

Occurence of death cardiovascular

Datatype

integer

[M] Myocardial infarction
Beschrijving

Occurence of Myocardial infarction

Datatype

boolean

[U] Hospitalisation for unstable angina
Beschrijving

Occurence of Hospitalisation for unstable angina

Datatype

boolean

[R] Coronary revascularisation (any PCI or CABG)
Beschrijving

Occurence of Coronary revascularisation

Datatype

boolean

[1] Stroke/TIA
Beschrijving

Occurence of Stroke/TIA

Datatype

boolean

[2] Hospitalisation for heart failure
Beschrijving

Hospitalisation for heart failure

Datatype

boolean

[6] Non-adjudicated ischaemic event
Beschrijving

Hospitalisation for Non-adjudicated ischaemic event

Datatype

boolean

[3] Limb amputation due to vascular cause
Beschrijving

Hospitalisation for Limb amputation due to vascular cause

Datatype

boolean

[4] Non-coronary revascularisation
Beschrijving

Hospitalisation for Non-coronary revascularisation

Datatype

boolean

[5] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
Beschrijving

Hospitalisation for non-coronary ischaemic event

Datatype

boolean

Event adjudicated to be study endpoint
Beschrijving

Event adjudicated to be study endpoint

Was event adjudicated to be a study endpoint?
Beschrijving

[hidden]

Datatype

integer

Report
Beschrijving

Report

6. Initial report
Beschrijving

[hidden]

Datatype

boolean

7. Follow-up report
Beschrijving

Follow-up report

Datatype

boolean

Randomization
Beschrijving

Randomization

8. Did SAE occur after initiation of study medication?
Beschrijving

SAE after initiation of study medication

Datatype

boolean

Serious Adverse Event
Beschrijving

Serious Adverse Event

9.a SAE Sequence Number
Beschrijving

[read-only]

Datatype

text

9.b Serious Adverse Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only

Datatype

text

9.c Modified term
Beschrijving

[hidden]

Datatype

text

MedDRA synonym
Beschrijving

[hidden]

Datatype

text

MedDRA lower level term code
Beschrijving

[hidden]

Datatype

text

Failed coding
Beschrijving

[hidden]

Datatype

text

9.d Start Date
Beschrijving

Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.

Datatype

date

9.e Outcome
Beschrijving

Outcome

Datatype

integer

9.e End date
Beschrijving

If "Recovered/Resolved", "Recovered/Resolved with sequelae", or "Fatal, record Date of Death", provide End date. End Time is optional

Datatype

date

9.f Maximum Intensity
Beschrijving

Record maximum intensity throughout duration of event. Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.

Datatype

text

9.g Intensity at onset of event
Beschrijving

Record intensity at the onset of the event [hidden]. Conditional item Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used.

Datatype

text

9.h Maximum Grade
Beschrijving

Record maximum grade throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.

Datatype

integer

9.i Grade at onset of event
Beschrijving

Record grade at the onset of the event [hidden]. Conditional item Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional

Datatype

integer

9.j Maximum Grade or Intensity
Beschrijving

Record maximum grade or intensity throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

Datatype

text

9.k Grade or Intensity at onset of event
Beschrijving

Record grade or intensity at the onset of the event [hidden]. Conditional item Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional

Datatype

text

9.l Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action Taken with Investigational Product

Datatype

text

9.m Did the subject withdraw from study as a result of this AE?
Beschrijving

Withdrawal from study

Datatype

boolean

9.n Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Use best judgment at initial entry. May be amended when additional information becomes available. If the study has multiple IP then remove Yes and keep Yes, select appropriate investigational product(s)' and set selection value to Y. Otherwise remove Yes, select appropriate investigational product(s) and keep Yes.

Datatype

boolean

9.o Duration of AE if < 24 hours (hours)
Beschrijving

If AE start and end time are used this item must be hidden.

Datatype

integer

Maateenheden
  • h
h
9.o Duration of AE if < 24 hours (minutes)
Beschrijving

If AE start and end time are used this item must be hidden.

Datatype

integer

Maateenheden
  • min
min
9.p Time to Onset Since Last Dose (hours)
Beschrijving

Time to Onset Since Last Dose hours

Datatype

integer

Maateenheden
  • h
h
9.p Time to Onset Since Last Dose (minutes)
Beschrijving

This item is optional

Datatype

integer

Maateenheden
  • min
min
9.q Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Beschrijving

SAE caused by activities related to study participation

Datatype

boolean

9.r Was the event serious?
Beschrijving

[hidden]

Datatype

boolean

9.s Related Investigational Product
Beschrijving

[hidden]

Datatype

text

Intensity changes
Beschrijving

Intensity changes

10.a Serious Adverse Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

Datatype

text

10.b Start Date of event segment
Beschrijving

If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

Datatype

date

10.b Start Time of event segment Hr:Min (00:00-23:59)
Beschrijving

If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

Datatype

time

10.c Intensity of event segment
Beschrijving

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section.

Datatype

integer

10.d Grade of event segment
Beschrijving

Optional item: This item may be hidden if either the Intensity of event segment or Grade or intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

Datatype

integer

10.e Grade or Intensity of event segment
Beschrijving

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

Datatype

text

Specify the reason for considering this an SAE. Check all that apply.
Beschrijving

Specify the reason for considering this an SAE. Check all that apply.

[A] Results in death
Beschrijving

SAE results in death

Datatype

boolean

[B] Is life-threatening
Beschrijving

SAE life-threatening

Datatype

boolean

[C] Requires hospitalisation or prolongation of existing hospitalisation
Beschrijving

SAE requires hospitalisation

Datatype

boolean

[D] Results in disability/incapacity
Beschrijving

SAE results in disability/incapacity

Datatype

boolean

[E] Congenital anomaly/birth defect
Beschrijving

SAE congenital anomaly/birth defect

Datatype

boolean

[F] Other
Beschrijving

Other SAE

Datatype

boolean

[F] Other, specify within general narrative comment
Beschrijving

Other SAE specification

Datatype

text

Relevant concomitant / treatment medications
Beschrijving

Relevant concomitant / treatment medications

12.a CM Sequence Number
Beschrijving

[hidden]

Datatype

text

12.b Drug name
Beschrijving

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Datatype

text

12.c Modified reported term
Beschrijving

[hidden]

Datatype

text

12.d Dose
Beschrijving

Dose

Datatype

text

12.e Unit
Beschrijving

units of medication

Datatype

text

Alias
UMLS CUI [1]
C1519795
12.f Frequency
Beschrijving

Frequency

Datatype

text

12.g Route
Beschrijving

Route of medication

Datatype

text

12.h Start Date
Beschrijving

Start Date

Datatype

date

12.i Ongoing?
Beschrijving

Ongoing medication

Datatype

boolean

If no ongoing medication, specify end date
Beschrijving

End date medication

Datatype

date

12.j Primary Indication
Beschrijving

Enter a medical diagnosis not description

Datatype

text

12.k Modified reported term
Beschrijving

[hidden]

Datatype

text

12.l Drug Type
Beschrijving

Drug Type

Datatype

text

Relevant medical conditions / Risk factors
Beschrijving

Relevant medical conditions / Risk factors

13.a MHx Sequence Number
Beschrijving

[hidden]

Datatype

text

13.b Specific Condition Name
Beschrijving

Enter a medical diagnosis not description.

Datatype

text

13.c Modified reported term
Beschrijving

[hidden]

Datatype

text

13.d Date of onset
Beschrijving

Date of onset

Datatype

date

13.e Continuing?
Beschrijving

Continuing medical condition

Datatype

text

13.e If no continuing medical condition, specify date of last occurrence
Beschrijving

Medical condition last occurence

Datatype

date

14. Relevant Medical History / Risk Factors not noted above
Beschrijving

[hidden]

Datatype

text

Relevant diagnostic results
Beschrijving

Relevant diagnostic results

15.a Lab Sequence Number
Beschrijving

[hidden]

Datatype

text

15.b Test Name
Beschrijving

Only allow site to choose from List of Values.

Datatype

text

15.c Test Date
Beschrijving

Test Date

Datatype

date

15.d Test Result
Beschrijving

Test Result

Datatype

text

15.e Test Units
Beschrijving

Test Units

Datatype

text

15.f Normal Low Range
Beschrijving

Normal Low Range

Datatype

text

15.g Normal High Range
Beschrijving

Normal High Range

Datatype

text

16. Relevant diagnostic results not noted above
Beschrijving

Relevant diagnostic results not noted above

Datatype

text

17. If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Beschrijving

Rechallenge

Datatype

text

Investigational product
Beschrijving

Investigational product

18.a Study Drug
Beschrijving

Study Drug

Datatype

text

18.b Start Date
Beschrijving

Time is optional

Datatype

date

18.c Stop Date
Beschrijving

Time is optional

Datatype

date

Investigational product [hidden]
Beschrijving

Investigational product [hidden]

19.a Study Drug
Beschrijving

Study Drug

Datatype

text

19.b Start Date
Beschrijving

Time is optional

Datatype

date

19.c Stop Date
Beschrijving

Time is optional

Datatype

date

Investigational product [hidden]
Beschrijving

Investigational product [hidden]

20.a Study Drug
Beschrijving

Study Drug

Datatype

text

20.b Start Date
Beschrijving

Time is optional

Datatype

date

20.c Stop Date
Beschrijving

Time is optional

Datatype

date

20.d Dose
Beschrijving

Dose

Datatype

text

20.e Cumulative Dose
Beschrijving

This item is conditional

Datatype

text

General narrative comments
Beschrijving

General narrative comments

21. General narrative comments
Beschrijving

Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.

Datatype

text

Non clinical
Beschrijving

Non clinical

22. [3] Incomplete SAE
Beschrijving

Send incomplete SAE data to GSK Safety [hidden]. This item is optional

Datatype

boolean

23. Receipt by GSK date
Beschrijving

[hidden]

Datatype

date

23. Receipt by GSK date
Beschrijving

[hidden]

Datatype

time

24. Was the event serious?
Beschrijving

[hidden]

Datatype

boolean

25. SAE Sequence Number
Beschrijving

[read-only]

Datatype

text

26. Version Number
Beschrijving

[hidden]

Datatype

text

27. Case ID
Beschrijving

[hidden]

Datatype

text

28. Randomisation Number
Beschrijving

[hidden]

Datatype

text

29. OCEANS Code
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1516728
Email Flag
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C0013849
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Similar models

Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
SAE as possible study endpoint
SAE possible study endpoint
Item
1. Is event a possible study endpoint?
boolean
C1519255 (UMLS CUI [1])
Death
Item
Primary adjudicated endpoints: [1] Death
boolean
C0011065 (UMLS CUI [1])
Myocardial infarction
Item
Primary adjudicated endpoints: [2] Myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Stroke/TIA
Item
Primary adjudicated endpoints: [3] Stroke/TIA
boolean
C3844446 (UMLS CUI [1])
Coronary revascularisation
Item
Other adjudicated endpoints: [4] Coronary revascularisation
boolean
C0877341 (UMLS CUI [1])
Hospitalisation for unstable angina
Item
Other adjudicated endpoints: [5] Hospitalisation for unstable angina
boolean
C0002965 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Hospitalisation for heart failure
Item
Other adjudicated endpoints: [8] Hospitalisation for heart failure
boolean
C0019993 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Limb amputation due to vascular cause
Item
Other endpoints: [7] Limb amputation due to vascular cause
boolean
C0002689 (UMLS CUI [1,1])
C0042373 (UMLS CUI [1,2])
Non-coronary revascularisation
Item
Other endpoints: [9] Non-coronary revascularisation
boolean
C0877341 (UMLS CUI [1])
Hospitalisation for non-coronary ischaemic event
Item
Other endpoints: [10] Hospitalisation for non-coronary ischaemic event
boolean
C0019993 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
Item Group
SAE to be adjudicated
event to be adjudicated
Item
2. Is this an event to be adjudicated?
boolean
C0680730 (UMLS CUI [1])
adjudicated event Death
Item
Primary adjudicated endpoints: [1] Death
boolean
C1705232 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
adjudicated event Myocardial infarction
Item
Primary adjudicated endpoints: [2] Myocardial infarction
boolean
C0027051 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
adjudicated event Stroke/TIA
Item
Primary adjudicated endpoints: [3] Stroke/TIA
boolean
C0038454 (UMLS CUI [1,1])
C0680730 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
adjudicated event Coronary revascularisation
Item
Other adjudicated endpoints: [4] Coronary revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
adjudicated event Hospitalisation for unstable angina
Item
Other adjudicated endpoints: [5] Hospitalisation for unstable angina
boolean
C0002965 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
adjudicated event Hospitalisation for heart failure
Item
Other adjudicated endpoints: [8] Hospitalisation for heart failure
boolean
C0019993 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
Item Group
SAE as non-adjudicated endpoint
event non-adjudicated endpoint
Item
Is event a non-adjudicated endpoint?
boolean
Non-adjudicated endpoint Limb amputation due to vascular cause
Item
Other endpoints: [7] Limb amputation due to vascular cause
boolean
Non-adjudicated endpoint Non-coronary revascularisation
Item
Other endpoints: [9] Non-coronary revascularisation
boolean
Non-adjudicated endpoint Hospitalisation for non-coronary ischaemic event
Item
Other endpoints: [10] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
boolean
Item Group
Occurence of endpoints
Occurence of endpoints
Item
4. Did any of these endpoints occur?
boolean
Occurence of death
Item
[D] Death
boolean
Item
[D]Death: Cardiovascular?
integer
Occurence of death cardiovascular
Code List
[D]Death: Cardiovascular?
CL Item
Cardiovascular (1)
CL Item
Non-cardiovascular (2)
Occurence of Myocardial infarction
Item
[M] Myocardial infarction
boolean
Occurence of Hospitalisation for unstable angina
Item
[U] Hospitalisation for unstable angina
boolean
Occurence of Coronary revascularisation
Item
[R] Coronary revascularisation (any PCI or CABG)
boolean
Occurence of Stroke/TIA
Item
[1] Stroke/TIA
boolean
Hospitalisation for heart failure
Item
[2] Hospitalisation for heart failure
boolean
Hospitalisation for Non-adjudicated ischaemic event
Item
[6] Non-adjudicated ischaemic event
boolean
Hospitalisation for Limb amputation due to vascular cause
Item
[3] Limb amputation due to vascular cause
boolean
Hospitalisation for Non-coronary revascularisation
Item
[4] Non-coronary revascularisation
boolean
Hospitalisation for non-coronary ischaemic event
Item
[5] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
boolean
Item Group
Event adjudicated to be study endpoint
Item
Was event adjudicated to be a study endpoint?
integer
event adjudicated to be a study endpoint
Code List
Was event adjudicated to be a study endpoint?
CL Item
Yes (1)
CL Item
No (2)
CL Item
No adjudicated event (3)
CL Item
Pending adjudication (4)
Item Group
Report
Initial report
Item
6. Initial report
boolean
Follow-up report
Item
7. Follow-up report
boolean
Item Group
Randomization
SAE after initiation of study medication
Item
8. Did SAE occur after initiation of study medication?
boolean
Item Group
Serious Adverse Event
SAE Sequence Number
Item
9.a SAE Sequence Number
text
Serious Adverse Event
Item
9.b Serious Adverse Event
text
Modified term
Item
9.c Modified term
text
MedDRA synonym
Item
MedDRA synonym
text
MedDRA lower level term code
Item
MedDRA lower level term code
text
Failed coding
Item
Failed coding
text
Start Date
Item
9.d Start Date
date
Item
9.e Outcome
integer
Outcome / End Date
Code List
9.e Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
End date
Item
9.e End date
date
Item
9.f Maximum Intensity
text
Intensity at onset of event
Code List
9.f Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
9.g Intensity at onset of event
text
Intensity at onset of event
Code List
9.g Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
9.h Maximum Grade
integer
Maximum Grade
Code List
9.h Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
9.i Grade at onset of event
integer
Grade at onset of event
Code List
9.i Grade at onset of event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
9.j Maximum Grade or Intensity
text
Maximum Grade or Intensity
Code List
9.j Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
9.k Grade or Intensity at onset of event
text
Maximum Grade or Intensity
Code List
9.k Grade or Intensity at onset of event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
9.l Action Taken with Investigational Product(s) as a Result of the AE
text
Action Taken with Investigational Product
Code List
9.l Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Withdrawal from study
Item
9.m Did the subject withdraw from study as a result of this AE?
boolean
AE caused by investigational product
Item
9.n Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Duration of AE hours
Item
9.o Duration of AE if < 24 hours (hours)
integer
Duration of AE minutes
Item
9.o Duration of AE if < 24 hours (minutes)
integer
Time to Onset Since Last Dose hours
Item
9.p Time to Onset Since Last Dose (hours)
integer
Time to Onset Since Last Dose minutes
Item
9.p Time to Onset Since Last Dose (minutes)
integer
SAE caused by activities related to study participation
Item
9.q Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
Serious event
Item
9.r Was the event serious?
boolean
Related Investigational Product
Item
9.s Related Investigational Product
text
Item Group
Intensity changes
Serious Adverse Event Intensity changes
Item
10.a Serious Adverse Event
text
Start Date of event segment
Item
10.b Start Date of event segment
date
Start Time of event segment
Item
10.b Start Time of event segment Hr:Min (00:00-23:59)
time
Item
10.c Intensity of event segment
integer
Maximum Intensity
Code List
10.c Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
10.d Grade of event segment
integer
Grade at onset of event
Code List
10.d Grade of event segment
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
10.e Grade or Intensity of event segment
text
Grade or Intensity at onset of event
Code List
10.e Grade or Intensity of event segment
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Specify the reason for considering this an SAE. Check all that apply.
SAE results in death
Item
[A] Results in death
boolean
SAE life-threatening
Item
[B] Is life-threatening
boolean
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
SAE congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
Other SAE
Item
[F] Other
boolean
Other SAE specification
Item
[F] Other, specify within general narrative comment
text
Item Group
Relevant concomitant / treatment medications
CM Sequence Number
Item
12.a CM Sequence Number
text
Drug name
Item
12.b Drug name
text
Modified reported term
Item
12.c Modified reported term
text
Dose
Item
12.d Dose
text
Item
12.e Unit
text
C1519795 (UMLS CUI [1])
units of medication
Code List
12.e Unit
CL Item
Actuation (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (AP)
CL Item
Bottle  (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops  (031)
CL Item
Gram (002)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre (011)
CL Item
Litre per minute (LM)
CL Item
Lozenge (LOZ)
CL Item
Megaunits (million units) (MEGU)
CL Item
Microgram (UG) (004)
CL Item
Microgram (UG) (004)
CL Item
Microgram/kilogram  (008)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Microlitre (013)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligram (003)
CL Item
Milligrams percent (MGPER)
CL Item
Milligram per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/kilogram per minute (MGKM)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre (012)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million international units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebule (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet (SAC)
CL Item
Spray (SPR)
CL Item
Suppository (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial (VIA)
Item
12.f Frequency
text
Frequency
Code List
12.f Frequency
CL Item
times per week (2W)
CL Item
3 times per week (2W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
AC (AC)
CL Item
BID (2D)
CL Item
Continuous infusion (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3W)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
At Bedtime (1N)
CL Item
Once a month (MO)
CL Item
Once a week (WE)
CL Item
Once daily (1D)
CL Item
Once only (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H (6D)
CL Item
Q6H (4D)
CL Item
Q8H (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (1N)
CL Item
TID (3D)
CL Item
Unknown (U)
Item
12.g Route
text
Route of medication
Code List
12.g Route
CL Item
Both eyes (047)
CL Item
Epidural (008)
CL Item
Gastrostomy tube (GT)
CL Item
Inhalation (055)
CL Item
Injection (INJ)
CL Item
Intra-arterial (013)
CL Item
Intra-bursa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Intranasal (045)
CL Item
Intraocular (031)
CL Item
Intraosteal (IOS)
CL Item
Intraperitoneal (033)
CL Item
Intrathecal (037)
CL Item
Intrauterine (015)
CL Item
Intravenous (042)
CL Item
Nasal (045)
CL Item
Oral (048)
CL Item
Rectal (054)
CL Item
Subcutaneous (058)
CL Item
Sublingual (060)
CL Item
Topical (061)
CL Item
Transdermal (062)
CL Item
Unknown (065)
CL Item
Vaginal (067)
Start Date
Item
12.h Start Date
date
Ongoing medication
Item
12.i Ongoing?
boolean
End date medication
Item
If no ongoing medication, specify end date
date
Primary Indication
Item
12.j Primary Indication
text
Modified reported term
Item
12.k Modified reported term
text
Item
12.l Drug Type
text
Drug Type
Code List
12.l Drug Type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Relevant medical conditions / Risk factors
MHx Sequence Number
Item
13.a MHx Sequence Number
text
Specific Condition Name
Item
13.b Specific Condition Name
text
Modified reported term
Item
13.c Modified reported term
text
Date of onset
Item
13.d Date of onset
date
Item
13.e Continuing?
text
Continuing medical condition
Code List
13.e Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Medical condition last occurence
Item
13.e If no continuing medical condition, specify date of last occurrence
date
Relevant Medical History / Risk Factors not noted above
Item
14. Relevant Medical History / Risk Factors not noted above
text
Item Group
Relevant diagnostic results
Lab Sequence Number
Item
15.a Lab Sequence Number
text
Item
15.b Test Name
text
Test Name
Code List
15.b Test Name
CL Item
Activated partial thromboplastin time (Activated partial thromboplastin time)
CL Item
Alanine Amino Transferase (Alanine aminotransferase)
CL Item
Albumin (Albumin)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
CL Item
Amylase (Amylase)
CL Item
Aspartate Amino Transferase (Aspartate aminotransferase)
CL Item
Basophils (Basophils)
CL Item
Bicarbonate (Bicarbonate)
CL Item
Bilirubin (Bilirubin)
CL Item
Bilirubin direct (Bilirubin direct)
CL Item
Bilirubin total (Bilirubin total)
CL Item
Blood myoglobin (Blood myoglobin)
CL Item
Blood pH (Blood pH)
CL Item
Blood pressure (Blood pressure)
CL Item
Blood urea nitrogen (Blood urea nitrogen)
CL Item
Body temperature (Body temperature)
CL Item
Calcium (Calcium)
CL Item
CD4 lymphocytes (CD4 lymphocytes)
CL Item
CD8 lymphocytes (CD8 lymphocytes)
CL Item
Chloride (Chloride)
CL Item
Cholesterol total (Cholesterol total)
CL Item
C-reactive protein (C-reactive protein)
CL Item
Creatine (Creatine)
CL Item
Creatine phosphokinase (Creatine phosphokinase)
CL Item
Creatine phosphokinase MB (Creatine phosphokinase MB)
CL Item
Creatinine (Creatinine)
CL Item
Creatinine clearance (Creatinine clearance)
CL Item
Diastolic blood pressure (Diastolic blood pressure)
CL Item
Eosinophils (Eosinophils)
CL Item
Erythrocyte sedimentation rate (Erythrocyte sedimentation rate)
CL Item
Fasting blood glucose (Fasting blood glucose)
CL Item
FEV 1 (FEV 1)
CL Item
Gamma-glutamyltransferase (Gamma-glutamyltransferase)
CL Item
HbA1c (HbA1c)
CL Item
HBV-DNA decreased (HBV-DNA decreased)
CL Item
HBV-DNA increased (HBV-DNA increased)
CL Item
Heart rate (Heart rate)
CL Item
Hematocrit (Hematocrit)
CL Item
Hemoglobin (Hemoglobin)
CL Item
High density lipoprotein (High density lipoprotein)
CL Item
HIV viral load (HIV viral load)
CL Item
INR (INR)
CL Item
Lactic dehydrogenase (Lactic dehydrogenase)
CL Item
Lipase (Lipase)
CL Item
Low density lipoprotein (Low density lipoprotein)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Magnesium (Magnesium)
CL Item
Mean cell hemoglobin concentration (Mean cell hemoglobin concentration)
CL Item
Mean corpuscular hemoglobin (Mean corpuscular hemoglobin)
CL Item
Mean corpuscular volume (Mean corpuscular volume)
CL Item
Monocytes (Monocytes)
CL Item
Neutrophils (Neutrophils)
CL Item
Oxygen saturation (Oxygen saturation)
CL Item
pCO2 (pCO2)
CL Item
pH (pH)
CL Item
Phosphate (Phosphate)
CL Item
Platelet count (Platelet count)
CL Item
pO2 (pO2)
CL Item
Potassium (Potassium)
CL Item
Protein total (Protein total)
CL Item
Prothrombin time (Prothrombin time)
CL Item
Red blood cell count (Red blood cell count)
CL Item
Respiratory rate (Respiratory rate)
CL Item
Reticulocyte count (Reticulocyte count)
CL Item
Serum glucose (Serum glucose)
CL Item
Serum uric acid (Serum uric acid)
CL Item
Sodium (Sodium)
CL Item
Systolic blood pressure (Systolic blood pressure)
CL Item
Thrombin time (Thrombin time)
CL Item
Total lung capacity (Total lung capacity)
CL Item
Triglycerides (Triglycerides)
CL Item
Troponin (Troponin)
CL Item
Troponin I (Troponin I)
CL Item
Troponin T (Troponin T)
CL Item
Urine myoglobin (Urine myoglobin)
CL Item
Urine pH (Urine pH)
CL Item
Vital capacity (Vital capacity)
CL Item
White blood cell count (White blood cell count)
Test Date
Item
15.c Test Date
date
Test Result
Item
15.d Test Result
text
Test Units
Item
15.e Test Units
text
Normal Low Range
Item
15.f Normal Low Range
text
Normal High Range
Item
15.g Normal High Range
text
Relevant diagnostic results not noted above
Item
16. Relevant diagnostic results not noted above
text
Item
17. If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
Rechallenge
Code List
17. If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Investigational product
Item
18.a Study Drug
text
Study Drug
Code List
18.a Study Drug
CL Item
Blinded trial medication (Blinded trial medication)
Start Date
Item
18.b Start Date
date
Stop Date
Item
18.c Stop Date
date
Item Group
Investigational product [hidden]
Item
19.a Study Drug
text
Study Drug
Code List
19.a Study Drug
CL Item
Dose level 1 (Dose level 1)
CL Item
Dose level 2 (Dose level 2)
CL Item
Dose level 3 (Dose level 3)
Start Date
Item
19.b Start Date
date
Stop Date
Item
19.c Stop Date
date
Item Group
Investigational product [hidden]
Item
20.a Study Drug
text
Study Drug
Code List
20.a Study Drug
CL Item
Course 1 (Course 1)
CL Item
Course 2 (Course 2)
CL Item
Course 3 (Course 3)
Start Date
Item
20.b Start Date
date
Stop Date
Item
20.c Stop Date
date
Dose
Item
20.d Dose
text
Cumulative Dose
Item
20.e Cumulative Dose
text
Item Group
General narrative comments
General narrative comments
Item
21. General narrative comments
text
Item Group
Non clinical
incomplete SAE data GSK Safety
Item
22. [3] Incomplete SAE
boolean
Receipt by GSK date
Item
23. Receipt by GSK date
date
Receipt by GSK date
Item
23. Receipt by GSK date
time
serious SAE
Item
24. Was the event serious?
boolean
SAE Sequence Number
Item
25. SAE Sequence Number
text
Version Number
Item
26. Version Number
text
Case ID
Item
27. Case ID
text
Randomisation Number
Item
28. Randomisation Number
text
OCEANS Code
Item
29. OCEANS Code
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
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