ID

28195

Descrição

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)

Palavras-chave

Versões (6)
  1. 27/09/2017 27/09/2017 -
  2. 04/10/2017 04/10/2017 -
  3. 13/10/2017 13/10/2017 -
  4. 23/10/2017 23/10/2017 -
  5. 26/12/2017 26/12/2017 -
  6. 28/12/2017 28/12/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

28 de dezembro de 2017

DOI

Para um pedido faça login.

Licença

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

Inglês

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

1 Formulários  
SAE as possible study endpoint
Descrição

SAE as possible study endpoint

1. Is event a possible study endpoint?
Descrição

[hidden] If yes, select all that apply.

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

SAE to be adjudicated

2. Is this an event to be adjudicated?
Descrição

[hidden] If yes, select all that apply.

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

SAE as non-adjudicated endpoint

Is event a non-adjudicated endpoint?
Descrição

[hidden] If yes, select all that apply

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680730
UMLS CUI [1,2]
C2349179
Other endpoints: [7] Limb amputation due to vascular cause
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002689
Other endpoints: [9] Non-coronary revascularisation
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680730
UMLS CUI [1,2]
C0877341
Other endpoints: [10] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680730
UMLS CUI [1,2]
C0018802
Occurence of endpoints
Descrição

Occurence of endpoints

4. Did any of these endpoints occur?
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347784
[D] Death
Descrição

Occurence of death

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011065
[D]Death: Cardiovascular?
Descrição

Occurence of death cardiovascular

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0037088
[M] Myocardial infarction
Descrição

Occurence of Myocardial infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
[U] Hospitalisation for unstable angina
Descrição

Occurence of Hospitalisation for unstable angina

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002965
[R] Coronary revascularisation (any PCI or CABG)
Descrição

Occurence of Coronary revascularisation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
[1] Stroke/TIA
Descrição

Occurence of Stroke/TIA

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3844446
[2] Hospitalisation for heart failure
Descrição

Hospitalisation for heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0581377
[6] Non-adjudicated ischaemic event
Descrição

Hospitalisation for Non-adjudicated ischaemic event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151744
[3] Limb amputation due to vascular cause
Descrição

Hospitalisation for Limb amputation due to vascular cause

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002689
[4] Non-coronary revascularisation
Descrição

Hospitalisation for Non-coronary revascularisation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877341
[5] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
Descrição

Hospitalisation for non-coronary ischaemic event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151744
Event adjudicated to be study endpoint
Descrição

Event adjudicated to be study endpoint

Was event adjudicated to be a study endpoint?
Descrição

[hidden]

Tipo de dados

integer

Alias
UMLS CUI [1]
C2349179
Report
Descrição

Report

6. Initial report
Descrição

[hidden]

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0684224
7. Follow-up report
Descrição

Follow-up report

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1704685
Randomization
Descrição

Randomization

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

SAE after initiation of study medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1519255
Serious Adverse Event
Descrição

Serious Adverse Event

9.a SAE Sequence Number
Descrição

[read-only]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
9.b Serious Adverse Event
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
9.c Modified term
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
9.d Start Date
Descrição

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

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
9.e Outcome
Descrição

Outcome

Tipo de dados

integer

Alias
UMLS CUI [1]
C1705586
9.e End date
Descrição

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

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
9.f Maximum Intensity
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
9.g Intensity at onset of event
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
9.h Maximum Grade
Descrição

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.

Tipo de dados

integer

Alias
UMLS CUI [1]
C0441799
9.i Grade at onset of event
Descrição

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

Tipo de dados

integer

Alias
UMLS CUI [1]
C2985911
9.j Maximum Grade or Intensity
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
9.k Grade or Intensity at onset of event
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
9.l Action Taken with Investigational Product(s) as a Result of the AE
Descrição

Action Taken with Investigational Product

Tipo de dados

text

Alias
UMLS CUI [1]
C1704758
9.m Did the subject withdraw from study as a result of this AE?
Descrição

Withdrawal from study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0422727
9.n Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrição

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.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
9.o Duration of AE if < 24 hours (hours)
Descrição

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

Tipo de dados

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
h
9.o Duration of AE if < 24 hours (minutes)
Descrição

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

Tipo de dados

integer

Unidades de medida
  • min
Alias
UMLS CUI [1]
C0449238
min
9.p Time to Onset Since Last Dose (hours)
Descrição

Time to Onset Since Last Dose hours

Tipo de dados

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
h
9.p Time to Onset Since Last Dose (minutes)
Descrição

This item is optional

Tipo de dados

integer

Unidades de medida
  • min
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min
9.q Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Descrição

SAE caused by activities related to study participation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C1519255
9.r Was the event serious?
Descrição

[hidden]

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
9.s Related Investigational Product
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C0304229
Intensity changes
Descrição

Intensity changes

10.a Serious Adverse Event
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
10.b Start Date of event segment
Descrição

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.

Tipo de dados

date

Alias
UMLS CUI [1]
C2697888
10.b Start Time of event segment Hr:Min (00:00-23:59)
Descrição

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.

Tipo de dados

time

Alias
UMLS CUI [1]
C2697889
10.c Intensity of event segment
Descrição

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.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
10.d Grade of event segment
Descrição

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.

Tipo de dados

integer

Alias
UMLS CUI [1]
C2985911
10.e Grade or Intensity of event segment
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Specify the reason for considering this an SAE. Check all that apply.
Descrição

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

[A] Results in death
Descrição

SAE results in death

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0231170
[B] Is life-threatening
Descrição

SAE life-threatening

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2826244
UMLS CUI [1,2]
C0231170
[C] Requires hospitalisation or prolongation of existing hospitalisation
Descrição

SAE requires hospitalisation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0019993
[D] Results in disability/incapacity
Descrição

SAE results in disability/incapacity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
[E] Congenital anomaly/birth defect
Descrição

SAE congenital anomaly/birth defect

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0231170
[F] Other
Descrição

Other SAE

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
[F] Other, specify within general narrative comment
Descrição

Other SAE specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
Relevant concomitant / treatment medications
Descrição

Relevant concomitant / treatment medications

12.a CM Sequence Number
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C2348184
12.b Drug name
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
12.c Modified reported term
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C2826819
12.d Dose
Descrição

Dose

Tipo de dados

text

Alias
UMLS CUI [1]
C3174092
12.e Unit
Descrição

units of medication

Tipo de dados

text

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

Frequency

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
12.g Route
Descrição

Route of medication

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
12.h Start Date
Descrição

Start Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
12.i Ongoing?
Descrição

Ongoing medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2826666
If no ongoing medication, specify end date
Descrição

End date medication

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
12.j Primary Indication
Descrição

Enter a medical diagnosis not description

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
12.k Modified reported term
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C2826819
12.l Drug Type
Descrição

Drug Type

Tipo de dados

text

Alias
UMLS CUI [1]
C0457591
Relevant medical conditions / Risk factors
Descrição

Relevant medical conditions / Risk factors

13.a MHx Sequence Number
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C2348184
13.b Specific Condition Name
Descrição

Enter a medical diagnosis not description.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
13.c Modified reported term
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C2826819
13.d Date of onset
Descrição

Date of onset

Tipo de dados

date

Alias
UMLS CUI [1]
C0574845
13.e Continuing?
Descrição

Continuing medical condition

Tipo de dados

text

Alias
UMLS CUI [1]
C0012634
13.e If no continuing medical condition, specify date of last occurrence
Descrição

Medical condition last occurence

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2745955
14. Relevant Medical History / Risk Factors not noted above
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
Relevant diagnostic results
Descrição

Relevant diagnostic results

15.a Lab Sequence Number
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1]
C2348184
15.b Test Name
Descrição

Only allow site to choose from List of Values.

Tipo de dados

text

Alias
UMLS CUI [1]
C0022885
15.c Test Date
Descrição

Test Date

Tipo de dados

date

Alias
UMLS CUI [1]
C2826247
15.d Test Result
Descrição

Test Result

Tipo de dados

text

Alias
UMLS CUI [1]
C0456984
15.e Test Units
Descrição

Test Units

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
15.f Normal Low Range
Descrição

Normal Low Range

Tipo de dados

text

Alias
UMLS CUI [1]
C2700150
15.g Normal High Range
Descrição

Normal High Range

Tipo de dados

text

Alias
UMLS CUI [1]
C2700149
16. Relevant diagnostic results not noted above
Descrição

Relevant diagnostic results not noted above

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
17. If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Descrição

Rechallenge

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
Investigational product
Descrição

Investigational product

18.a Study Drug
Descrição

Study Drug

Tipo de dados

text

Alias
UMLS CUI [1]
C0304229
18.b Start Date
Descrição

Time is optional

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
18.c Stop Date
Descrição

Time is optional

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
Investigational product [hidden]
Descrição

Investigational product [hidden]

19.a Study Drug
Descrição

Study Drug

Tipo de dados

text

Alias
UMLS CUI [1]
C0304229
19.b Start Date
Descrição

Time is optional

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
19.c Stop Date
Descrição

Time is optional

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
Investigational product [hidden]
Descrição

Investigational product [hidden]

20.a Study Drug
Descrição

Study Drug

Tipo de dados

text

Alias
UMLS CUI [1]
C0304229
20.b Start Date
Descrição

Time is optional

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
20.c Stop Date
Descrição

Time is optional

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
20.d Dose
Descrição

Dose

Tipo de dados

text

Alias
UMLS CUI [1]
C3174092
20.e Cumulative Dose
Descrição

This item is conditional

Tipo de dados

text

Alias
UMLS CUI [1]
C2986497
General narrative comments
Descrição

General narrative comments

21. General narrative comments
Descrição

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.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Non clinical
Descrição

Non clinical

22. [3] Incomplete SAE
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1710056
23. Receipt by GSK date
Descrição

[hidden]

Tipo de dados

date

Alias
UMLS CUI [1]
C2985846
23. Receipt by GSK date
Descrição

[hidden]

Tipo de dados

date

Alias
UMLS CUI [1]
C2985846
24. Was the event serious?
Descrição

[hidden]

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
25. SAE Sequence Number
Descrição

[read-only]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
26. Version Number
Descrição

[hidden]

Tipo de dados

integer

Alias
UMLS CUI [1]
C2985700
27. Case ID
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
28. Randomisation Number
Descrição

[hidden]

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
29. OCEANS Code
Descrição

[hidden]

Tipo de dados

text

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

[hidden]

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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
C0680730 (UMLS CUI [1,1])
C2349179 (UMLS CUI [1,2])
Non-adjudicated endpoint Limb amputation due to vascular cause
Item
Other endpoints: [7] Limb amputation due to vascular cause
boolean
C0002689 (UMLS CUI [1])
Non-adjudicated endpoint Non-coronary revascularisation
Item
Other endpoints: [9] Non-coronary revascularisation
boolean
C0680730 (UMLS CUI [1,1])
C0877341 (UMLS CUI [1,2])
Non-adjudicated endpoint Hospitalisation for non-coronary ischaemic event
Item
Other endpoints: [10] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
boolean
C0680730 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
Item Group
Occurence of endpoints
Occurence of endpoints
Item
4. Did any of these endpoints occur?
boolean
C2347784 (UMLS CUI [1])
Occurence of death
Item
[D] Death
boolean
C0011065 (UMLS CUI [1])
Item
[D]Death: Cardiovascular?
integer
C0011065 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Occurence of death cardiovascular
Code List
[D]Death: Cardiovascular?
CL Item
Cardiovascular (1)
C0007226 (UMLS CUI-1)
(Comment:en)
CL Item
Non-cardiovascular (2)
C0007222 (UMLS CUI-1)
(Comment:en)
Occurence of Myocardial infarction
Item
[M] Myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Occurence of Hospitalisation for unstable angina
Item
[U] Hospitalisation for unstable angina
boolean
C0002965 (UMLS CUI [1])
Occurence of Coronary revascularisation
Item
[R] Coronary revascularisation (any PCI or CABG)
boolean
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Occurence of Stroke/TIA
Item
[1] Stroke/TIA
boolean
C3844446 (UMLS CUI [1])
Hospitalisation for heart failure
Item
[2] Hospitalisation for heart failure
boolean
C0019993 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
Hospitalisation for Non-adjudicated ischaemic event
Item
[6] Non-adjudicated ischaemic event
boolean
C0151744 (UMLS CUI [1])
Hospitalisation for Limb amputation due to vascular cause
Item
[3] Limb amputation due to vascular cause
boolean
C0002689 (UMLS CUI [1])
Hospitalisation for Non-coronary revascularisation
Item
[4] Non-coronary revascularisation
boolean
C0877341 (UMLS CUI [1])
Hospitalisation for non-coronary ischaemic event
Item
[5] Hospitalisation for non-coronary ischaemic event (except Stroke or TIA)
boolean
C0151744 (UMLS CUI [1])
Item Group
Event adjudicated to be study endpoint
Item
Was event adjudicated to be a study endpoint?
integer
C2349179 (UMLS CUI [1])
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
C0684224 (UMLS CUI [1])
Follow-up report
Item
7. Follow-up report
boolean
C1704685 (UMLS CUI [1])
Item Group
Randomization
SAE after initiation of study medication
Item
8. Did SAE occur after initiation of study medication?
boolean
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
SAE Sequence Number
Item
9.a SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
9.b Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Modified term
Item
9.c Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start Date
Item
9.d Start Date
date
C0808070 (UMLS CUI [1])
Item
9.e Outcome
integer
C1705586 (UMLS CUI [1])
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
C0806020 (UMLS CUI [1])
Item
9.f Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
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
C0441799 (UMLS CUI [1])
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
C2985911 (UMLS CUI [1])
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
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
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
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
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
C1704758 (UMLS CUI [1])
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)
C1875319 (UMLS CUI-1)
(Comment:en)
CL Item
Dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
Dose not changed (4)
C0178602 (UMLS CUI-1)
C0443172 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Withdrawal from study
Item
9.m Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
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
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE hours
Item
9.o Duration of AE if < 24 hours (hours)
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE minutes
Item
9.o Duration of AE if < 24 hours (minutes)
integer
C0449238 (UMLS CUI [1])
Time to Onset Since Last Dose hours
Item
9.p Time to Onset Since Last Dose (hours)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Time to Onset Since Last Dose minutes
Item
9.p Time to Onset Since Last Dose (minutes)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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
C1510821 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious event
Item
9.r Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Related Investigational Product
Item
9.s Related Investigational Product
text
C0304229 (UMLS CUI [1])
Item Group
Intensity changes
Serious Adverse Event Intensity changes
Item
10.a Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Start Date of event segment
Item
10.b Start Date of event segment
date
C2697888 (UMLS CUI [1])
Start Time of event segment
Item
10.b Start Time of event segment Hr:Min (00:00-23:59)
time
C2697889 (UMLS CUI [1])
Item
10.c Intensity of event segment
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
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
C2985911 (UMLS CUI [1])
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
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
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
C0011065 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE life-threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0231170 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Other SAE
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other SAE specification
Item
[F] Other, specify within general narrative comment
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Relevant concomitant / treatment medications
CM Sequence Number
Item
12.a CM Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
12.b Drug name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
12.c Modified reported term
text
C2826819 (UMLS CUI [1])
Dose
Item
12.d Dose
text
C3174092 (UMLS CUI [1])
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
C3476109 (UMLS CUI [1])
Frequency
Code List
12.f Frequency
CL Item
3 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
Q12H (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
QPM (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
QID (4D)
CL Item
TID (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
C0013153 (UMLS CUI [1])
Route of medication
Code List
12.g Route
CL Item
Both eyes (047)
C0229118 (UMLS CUI-1)
(Comment:en)
CL Item
Epidural (008)
C0014537 (UMLS CUI-1)
(Comment:en)
CL Item
Gastrostomy tube (GT)
C0017196 (UMLS CUI-1)
C0041281 (UMLS CUI-2)
(Comment:en)
CL Item
Inhalation (055)
C0004048 (UMLS CUI-1)
(Comment:en)
CL Item
Injection (INJ)
C1272883 (UMLS CUI-1)
(Comment:en)
CL Item
Intra-arterial (013)
C0694634 (UMLS CUI-1)
(Comment:en)
CL Item
Intra-bursa (IBU)
C0230212 (UMLS CUI-1)
(Comment:en)
CL Item
Intralesional (026)
C1512954 (UMLS CUI-1)
(Comment:en)
CL Item
Intramuscular (030)
C0442117 (UMLS CUI-1)
(Comment:en)
CL Item
Nasal (045)
C0442118 (UMLS CUI-1)
(Comment:en)
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
C0808070 (UMLS CUI [1])
Ongoing medication
Item
12.i Ongoing?
boolean
C2826666 (UMLS CUI [1])
End date medication
Item
If no ongoing medication, specify end date
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication
Item
12.j Primary Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Modified reported term
Item
12.k Modified reported term
text
C2826819 (UMLS CUI [1])
Item
12.l Drug Type
text
C0457591 (UMLS CUI [1])
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
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Specific Condition Name
Item
13.b Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified reported term
Item
13.c Modified reported term
text
C2826819 (UMLS CUI [1])
Date of onset
Item
13.d Date of onset
date
C0574845 (UMLS CUI [1])
Item
13.e Continuing?
text
C0012634 (UMLS CUI [1])
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
C0877248 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Relevant Medical History / Risk Factors not noted above
Item
14. Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Relevant diagnostic results
Lab Sequence Number
Item
15.a Lab Sequence Number
text
C2348184 (UMLS CUI [1])
Item
15.b Test Name
text
C0022885 (UMLS CUI [1])
Test Name
Code List
15.b Test Name
CL Item
Activated partial thromboplastin time (Activated partial thromboplastin time)
C0030605 (UMLS CUI-1)
(Comment:en)
CL Item
Alanine Amino Transferase (Alanine aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
Albumin (Albumin)
C0201838 (UMLS CUI-1)
(Comment:en)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
C0201850 (UMLS CUI-1)
(Comment:en)
CL Item
Amylase (Amylase)
C0201883 (UMLS CUI-1)
(Comment:en)
CL Item
Aspartate Amino Transferase (Aspartate aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
Basophils (Basophils)
C0004827 (UMLS CUI-1)
(Comment:en)
CL Item
Bicarbonate (Bicarbonate)
C0202059 (UMLS CUI-1)
(Comment:en)
CL Item
Bilirubin (Bilirubin)
C1278039 (UMLS CUI-1)
(Comment:en)
CL Item
Bilirubin direct (Bilirubin direct)
C0201916 (UMLS CUI-1)
(Comment:en)
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
C2826247 (UMLS CUI [1])
Test Result
Item
15.d Test Result
text
C0456984 (UMLS CUI [1])
Test Units
Item
15.e Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
15.f Normal Low Range
text
C2700150 (UMLS CUI [1])
Normal High Range
Item
15.g Normal High Range
text
C2700149 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
16. Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
17. If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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
C0304229 (UMLS CUI [1])
Study Drug
Code List
18.a Study Drug
CL Item
Blinded trial medication (Blinded trial medication)
Start Date
Item
18.b Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
18.c Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Investigational product [hidden]
Item
19.a Study Drug
text
C0304229 (UMLS CUI [1])
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
C0808070 (UMLS CUI [1])
Stop Date
Item
19.c Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Investigational product [hidden]
Item
20.a Study Drug
text
C0304229 (UMLS CUI [1])
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
C0808070 (UMLS CUI [1])
Stop Date
Item
20.c Stop Date
date
C0806020 (UMLS CUI [1])
Dose
Item
20.d Dose
text
C3174092 (UMLS CUI [1])
Cumulative Dose
Item
20.e Cumulative Dose
text
C2986497 (UMLS CUI [1])
Item Group
General narrative comments
General narrative comments
Item
21. General narrative comments
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Non clinical
incomplete SAE data GSK Safety
Item
22. [3] Incomplete SAE
boolean
C1710056 (UMLS CUI [1])
Receipt by GSK date
Item
23. Receipt by GSK date
date
C2985846 (UMLS CUI [1])
Receipt by GSK date
Item
23. Receipt by GSK date
date
C2985846 (UMLS CUI [1])
serious SAE
Item
24. Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
25. SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
26. Version Number
integer
C2985700 (UMLS CUI [1])
Case ID
Item
27. Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
28. Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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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