ID
28195
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)
- 27-09-17 27-09-17 -
- 04-10-17 04-10-17 -
- 13-10-17 13-10-17 -
- 23-10-17 23-10-17 -
- 26-12-17 26-12-17 -
- 28-12-17 28-12-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
28 december 2017
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
SAE to be adjudicated
Beschrijving
[hidden] If yes, select all that apply.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0680730
Beschrijving
If event is to be adjudicated, select all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0680730
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
Beschrijving
If event is to be adjudicated, select all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0680730
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
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
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
Beschrijving
SAE as non-adjudicated endpoint
Beschrijving
[hidden] If yes, select all that apply
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C2349179
Beschrijving
If event is a non-adjudicated endpoint, select all that apply.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002689
Beschrijving
If event is a non-adjudicated endpoint, select all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C0877341
Beschrijving
If event is a non-adjudicated endpoint, select all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C0018802
Beschrijving
Occurence of endpoints
Beschrijving
Please provide all SAE/EP details in sections 2-11 below
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347784
Beschrijving
Occurence of death
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschrijving
Occurence of death cardiovascular
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0037088
Beschrijving
Occurence of Myocardial infarction
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Occurence of Hospitalisation for unstable angina
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002965
Beschrijving
Occurence of Coronary revascularisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877341
- UMLS CUI [1,2]
- C1532338
Beschrijving
Occurence of Stroke/TIA
Datatype
boolean
Alias
- UMLS CUI [1]
- C3844446
Beschrijving
Hospitalisation for heart failure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0581377
Beschrijving
Hospitalisation for Non-adjudicated ischaemic event
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151744
Beschrijving
Hospitalisation for Limb amputation due to vascular cause
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002689
Beschrijving
Hospitalisation for Non-coronary revascularisation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877341
Beschrijving
Hospitalisation for non-coronary ischaemic event
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151744
Beschrijving
Event adjudicated to be study endpoint
Beschrijving
Report
Beschrijving
Randomization
Beschrijving
Serious Adverse Event
Beschrijving
[read-only]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826302
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C1140263
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
If "Recovered/Resolved", "Recovered/Resolved with sequelae", or "Fatal, record Date of Death", provide End date. End Time is optional
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
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
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
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
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
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
Alias
- UMLS CUI [1]
- C0441799
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
Alias
- UMLS CUI [1]
- C2985911
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
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
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
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beschrijving
Action Taken with Investigational Product
Datatype
text
Alias
- UMLS CUI [1]
- C1704758
Beschrijving
Withdrawal from study
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
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
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1518404
Beschrijving
If AE start and end time are used this item must be hidden.
Datatype
integer
Maateenheden
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beschrijving
If AE start and end time are used this item must be hidden.
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1]
- C0449238
Beschrijving
Time to Onset Since Last Dose hours
Datatype
integer
Maateenheden
- h
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C1518404
Beschrijving
This item is optional
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C1518404
Beschrijving
SAE caused by activities related to study participation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1510821
- UMLS CUI [1,2]
- C1519255
Beschrijving
[hidden]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Intensity changes
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
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
Alias
- UMLS CUI [1]
- C2697888
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
Alias
- UMLS CUI [1]
- C2697889
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
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
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
Alias
- UMLS CUI [1]
- C2985911
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
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beschrijving
Specify the reason for considering this an SAE. Check all that apply.
Beschrijving
SAE results in death
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0231170
Beschrijving
SAE life-threatening
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826244
- UMLS CUI [1,2]
- C0231170
Beschrijving
SAE requires hospitalisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0231170
- UMLS CUI [1,2]
- C0019993
Beschrijving
SAE results in disability/incapacity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beschrijving
SAE congenital anomaly/birth defect
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0231170
Beschrijving
Other SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other SAE specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348235
Beschrijving
Relevant concomitant / treatment medications
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
units of medication
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route of medication
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Ongoing medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
End date medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C1521826
- UMLS CUI [1,2]
- C0806020
Beschrijving
Enter a medical diagnosis not description
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
Drug Type
Datatype
text
Alias
- UMLS CUI [1]
- C0457591
Beschrijving
Relevant medical conditions / Risk factors
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C2348184
Beschrijving
Enter a medical diagnosis not description.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
Date of onset
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Continuing medical condition
Datatype
text
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Medical condition last occurence
Datatype
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2745955
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relevant diagnostic results
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Only allow site to choose from List of Values.
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Test Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Test Result
Datatype
text
Alias
- UMLS CUI [1]
- C0456984
Beschrijving
Test Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschrijving
Normal Low Range
Datatype
text
Alias
- UMLS CUI [1]
- C2700150
Beschrijving
Normal High Range
Datatype
text
Alias
- UMLS CUI [1]
- C2700149
Beschrijving
Relevant diagnostic results not noted above
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Beschrijving
Rechallenge
Datatype
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Beschrijving
Investigational product
Beschrijving
Investigational product [hidden]
Beschrijving
Investigational product [hidden]
Beschrijving
Study Drug
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Time is optional
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Time is optional
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
This item is conditional
Datatype
text
Alias
- UMLS CUI [1]
- C2986497
Beschrijving
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
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1519255
Beschrijving
Non clinical
Beschrijving
Send incomplete SAE data to GSK Safety [hidden]. This item is optional
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
[hidden]
Datatype
date
Alias
- UMLS CUI [1]
- C2985846
Beschrijving
[hidden]
Datatype
date
Alias
- UMLS CUI [1]
- C2985846
Beschrijving
[hidden]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
[read-only]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
[hidden]
Datatype
integer
Alias
- UMLS CUI [1]
- C2985700
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Beschrijving
[hidden]
Datatype
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])