ID
28195
Description
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)
Keywords
Versions (6)
- 9/27/17 9/27/17 -
- 10/4/17 10/4/17 -
- 10/13/17 10/13/17 -
- 10/23/17 10/23/17 -
- 12/26/17 12/26/17 -
- 12/28/17 12/28/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 28, 2017
DOI
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License
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
Description
SAE to be adjudicated
Description
[hidden] If yes, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1]
- C0680730
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0680730
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0680730
- UMLS CUI [1,3]
- C0680730
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0680730
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877341
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0680730
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002965
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C0680730
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0581377
- UMLS CUI [1,3]
- C0680730
Description
SAE as non-adjudicated endpoint
Description
[hidden] If yes, select all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C2349179
Description
If event is a non-adjudicated endpoint, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1]
- C0002689
Description
If event is a non-adjudicated endpoint, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C0877341
Description
If event is a non-adjudicated endpoint, select all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C0018802
Description
Occurence of endpoints
Description
Please provide all SAE/EP details in sections 2-11 below
Data type
boolean
Alias
- UMLS CUI [1]
- C2347784
Description
Occurence of death
Data type
boolean
Alias
- UMLS CUI [1]
- C0011065
Description
Occurence of death cardiovascular
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0037088
Description
Occurence of Myocardial infarction
Data type
boolean
Alias
- UMLS CUI [1]
- C0027051
Description
Occurence of Hospitalisation for unstable angina
Data type
boolean
Alias
- UMLS CUI [1]
- C0002965
Description
Occurence of Coronary revascularisation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877341
- UMLS CUI [1,2]
- C1532338
Description
Occurence of Stroke/TIA
Data type
boolean
Alias
- UMLS CUI [1]
- C3844446
Description
Hospitalisation for heart failure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0581377
Description
Hospitalisation for Non-adjudicated ischaemic event
Data type
boolean
Alias
- UMLS CUI [1]
- C0151744
Description
Hospitalisation for Limb amputation due to vascular cause
Data type
boolean
Alias
- UMLS CUI [1]
- C0002689
Description
Hospitalisation for Non-coronary revascularisation
Data type
boolean
Alias
- UMLS CUI [1]
- C0877341
Description
Hospitalisation for non-coronary ischaemic event
Data type
boolean
Alias
- UMLS CUI [1]
- C0151744
Description
Event adjudicated to be study endpoint
Description
Report
Description
Randomization
Description
Serious Adverse Event
Description
[read-only]
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826302
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C1140263
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C3898442
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
If "Recovered/Resolved", "Recovered/Resolved with sequelae", or "Fatal, record Date of Death", provide End date. End Time is optional
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Description
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.
Data type
integer
Alias
- UMLS CUI [1]
- C0441799
Description
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
Data type
integer
Alias
- UMLS CUI [1]
- C2985911
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Description
Action Taken with Investigational Product
Data type
text
Alias
- UMLS CUI [1]
- C1704758
Description
Withdrawal from study
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1518404
Description
If AE start and end time are used this item must be hidden.
Data type
integer
Measurement units
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Description
If AE start and end time are used this item must be hidden.
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1]
- C0449238
Description
Time to Onset Since Last Dose hours
Data type
integer
Measurement units
- h
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C1518404
Description
This item is optional
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C1518404
Description
SAE caused by activities related to study participation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1510821
- UMLS CUI [1,2]
- C1519255
Description
[hidden]
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
Intensity changes
Description
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Description
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.
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
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.
Data type
time
Alias
- UMLS CUI [1]
- C2697889
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Description
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.
Data type
integer
Alias
- UMLS CUI [1]
- C2985911
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Description
Specify the reason for considering this an SAE. Check all that apply.
Description
SAE results in death
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0231170
Description
SAE life-threatening
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826244
- UMLS CUI [1,2]
- C0231170
Description
SAE requires hospitalisation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0231170
- UMLS CUI [1,2]
- C0019993
Description
SAE results in disability/incapacity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Description
SAE congenital anomaly/birth defect
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0231170
Description
Other SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Description
Other SAE specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348235
Description
Relevant concomitant / treatment medications
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
Dose
Data type
text
Alias
- UMLS CUI [1]
- C3174092
Description
units of medication
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route of medication
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Ongoing medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
End date medication
Data type
date
Alias
- UMLS CUI [1,1]
- C1521826
- UMLS CUI [1,2]
- C0806020
Description
Enter a medical diagnosis not description
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
Drug Type
Data type
text
Alias
- UMLS CUI [1]
- C0457591
Description
Relevant medical conditions / Risk factors
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C2348184
Description
Enter a medical diagnosis not description.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
Date of onset
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Continuing medical condition
Data type
text
Alias
- UMLS CUI [1]
- C0012634
Description
Medical condition last occurence
Data type
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2745955
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Description
Relevant diagnostic results
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Only allow site to choose from List of Values.
Data type
text
Alias
- UMLS CUI [1]
- C0022885
Description
Test Date
Data type
date
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Data type
text
Alias
- UMLS CUI [1]
- C0456984
Description
Test Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Data type
text
Alias
- UMLS CUI [1]
- C2700150
Description
Normal High Range
Data type
text
Alias
- UMLS CUI [1]
- C2700149
Description
Relevant diagnostic results not noted above
Data type
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Description
Rechallenge
Data type
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Description
Investigational product
Description
Investigational product [hidden]
Description
Investigational product [hidden]
Description
Study Drug
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
Time is optional
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Time is optional
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Dose
Data type
text
Alias
- UMLS CUI [1]
- C3174092
Description
This item is conditional
Data type
text
Alias
- UMLS CUI [1]
- C2986497
Description
General narrative comments
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1519255
Description
Non clinical
Description
Send incomplete SAE data to GSK Safety [hidden]. This item is optional
Data type
boolean
Alias
- UMLS CUI [1]
- C1710056
Description
[hidden]
Data type
date
Alias
- UMLS CUI [1]
- C2985846
Description
[hidden]
Data type
date
Alias
- UMLS CUI [1]
- C2985846
Description
[hidden]
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
[read-only]
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
[hidden]
Data type
integer
Alias
- UMLS CUI [1]
- C2985700
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C0013849
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