ID
28195
Beskrivning
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)
Nyckelord
Versioner (6)
- 2017-09-27 2017-09-27 -
- 2017-10-04 2017-10-04 -
- 2017-10-13 2017-10-13 -
- 2017-10-23 2017-10-23 -
- 2017-12-26 2017-12-26 -
- 2017-12-28 2017-12-28 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
28 december 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903
Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903
Beskrivning
SAE to be adjudicated
Beskrivning
[hidden] If yes, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0680730
Beskrivning
If event is to be adjudicated, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0680730
Beskrivning
If event is to be adjudicated, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0680730
- UMLS CUI [1,3]
- C0680730
Beskrivning
If event is to be adjudicated, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0680730
Beskrivning
If event is to be adjudicated, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877341
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0680730
Beskrivning
If event is to be adjudicated, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0002965
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C0680730
Beskrivning
If event is to be adjudicated, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0581377
- UMLS CUI [1,3]
- C0680730
Beskrivning
SAE as non-adjudicated endpoint
Beskrivning
[hidden] If yes, select all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C2349179
Beskrivning
If event is a non-adjudicated endpoint, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002689
Beskrivning
If event is a non-adjudicated endpoint, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C0877341
Beskrivning
If event is a non-adjudicated endpoint, select all that apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C0018802
Beskrivning
Occurence of endpoints
Beskrivning
Please provide all SAE/EP details in sections 2-11 below
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347784
Beskrivning
Occurence of death
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beskrivning
Occurence of death cardiovascular
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0037088
Beskrivning
Occurence of Myocardial infarction
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Occurence of Hospitalisation for unstable angina
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002965
Beskrivning
Occurence of Coronary revascularisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877341
- UMLS CUI [1,2]
- C1532338
Beskrivning
Occurence of Stroke/TIA
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3844446
Beskrivning
Hospitalisation for heart failure
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0581377
Beskrivning
Hospitalisation for Non-adjudicated ischaemic event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151744
Beskrivning
Hospitalisation for Limb amputation due to vascular cause
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002689
Beskrivning
Hospitalisation for Non-coronary revascularisation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877341
Beskrivning
Hospitalisation for non-coronary ischaemic event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151744
Beskrivning
Event adjudicated to be study endpoint
Beskrivning
Report
Beskrivning
Randomization
Beskrivning
Serious Adverse Event
Beskrivning
[read-only]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
If "Recovered/Resolved", "Recovered/Resolved with sequelae", or "Fatal, record Date of Death", provide End date. End Time is optional
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0441799
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1]
- C2985911
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beskrivning
Action Taken with Investigational Product
Datatyp
text
Alias
- UMLS CUI [1]
- C1704758
Beskrivning
Withdrawal from study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1518404
Beskrivning
If AE start and end time are used this item must be hidden.
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beskrivning
If AE start and end time are used this item must be hidden.
Datatyp
integer
Måttenheter
- min
Alias
- UMLS CUI [1]
- C0449238
Beskrivning
Time to Onset Since Last Dose hours
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C1518404
Beskrivning
This item is optional
Datatyp
integer
Måttenheter
- min
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C1518404
Beskrivning
SAE caused by activities related to study participation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1510821
- UMLS CUI [1,2]
- C1519255
Beskrivning
[hidden]
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Intensity changes
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beskrivning
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.
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
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.
Datatyp
time
Alias
- UMLS CUI [1]
- C2697889
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1]
- C2985911
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beskrivning
Specify the reason for considering this an SAE. Check all that apply.
Beskrivning
SAE results in death
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0231170
Beskrivning
SAE life-threatening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826244
- UMLS CUI [1,2]
- C0231170
Beskrivning
SAE requires hospitalisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0231170
- UMLS CUI [1,2]
- C0019993
Beskrivning
SAE results in disability/incapacity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beskrivning
SAE congenital anomaly/birth defect
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0231170
Beskrivning
Other SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other SAE specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348235
Beskrivning
Relevant concomitant / treatment medications
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826819
Beskrivning
Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
units of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Route of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Ongoing medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
End date medication
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1521826
- UMLS CUI [1,2]
- C0806020
Beskrivning
Enter a medical diagnosis not description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826819
Beskrivning
Drug Type
Datatyp
text
Alias
- UMLS CUI [1]
- C0457591
Beskrivning
Relevant medical conditions / Risk factors
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C2348184
Beskrivning
Enter a medical diagnosis not description.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826819
Beskrivning
Date of onset
Datatyp
date
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Continuing medical condition
Datatyp
text
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
Medical condition last occurence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2745955
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relevant diagnostic results
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Only allow site to choose from List of Values.
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Test Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Test Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beskrivning
Normal Low Range
Datatyp
text
Alias
- UMLS CUI [1]
- C2700150
Beskrivning
Normal High Range
Datatyp
text
Alias
- UMLS CUI [1]
- C2700149
Beskrivning
Relevant diagnostic results not noted above
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Beskrivning
Rechallenge
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Beskrivning
Investigational product
Beskrivning
Investigational product [hidden]
Beskrivning
Investigational product [hidden]
Beskrivning
Study Drug
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Time is optional
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Time is optional
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
This item is conditional
Datatyp
text
Alias
- UMLS CUI [1]
- C2986497
Beskrivning
General narrative comments
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1519255
Beskrivning
Non clinical
Beskrivning
Send incomplete SAE data to GSK Safety [hidden]. This item is optional
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
[hidden]
Datatyp
date
Alias
- UMLS CUI [1]
- C2985846
Beskrivning
[hidden]
Datatyp
date
Alias
- UMLS CUI [1]
- C2985846
Beskrivning
[hidden]
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
[read-only]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
[hidden]
Datatyp
integer
Alias
- UMLS CUI [1]
- C2985700
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C0013849
Similar models
Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903
C0019993 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,2])
C0042373 (UMLS CUI [1,2])
C0948089 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
C0680730 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
C0581377 (UMLS CUI [1,2])
C0680730 (UMLS CUI [1,3])
C2349179 (UMLS CUI [1,2])
C0877341 (UMLS CUI [1,2])
C0018802 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
C1532338 (UMLS CUI [1,2])
C0581377 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C0443172 (UMLS CUI-2)
(Comment:en)
C0178602 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C0041281 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0806020 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
(Comment:en)
C0201836 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0201836 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0587081 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,2])