ID
26023
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
October 4, 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
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Description
If event is to be adjudicated, select all that apply.
Data type
boolean
Description
SAE as non-adjudicated endpoint
Description
[hidden] If yes, select all that apply
Data type
boolean
Description
If event is a non-adjudicated endpoint, select all that apply.
Data type
boolean
Description
If event is a non-adjudicated endpoint, select all that apply.
Data type
boolean
Description
If event is a non-adjudicated endpoint, select all that apply.
Data type
boolean
Description
Occurence of endpoints
Description
Please provide all SAE/EP details in sections 2-11 below
Data type
boolean
Description
Occurence of death
Data type
boolean
Description
Occurence of death cardiovascular
Data type
integer
Description
Occurence of Myocardial infarction
Data type
boolean
Description
Occurence of Hospitalisation for unstable angina
Data type
boolean
Description
Occurence of Coronary revascularisation
Data type
boolean
Description
Occurence of Stroke/TIA
Data type
boolean
Description
Hospitalisation for heart failure
Data type
boolean
Description
Hospitalisation for Non-adjudicated ischaemic event
Data type
boolean
Description
Hospitalisation for Limb amputation due to vascular cause
Data type
boolean
Description
Hospitalisation for Non-coronary revascularisation
Data type
boolean
Description
Hospitalisation for non-coronary ischaemic event
Data type
boolean
Description
Event adjudicated to be study endpoint
Description
Report
Description
Randomization
Description
Serious Adverse Event
Description
[read-only]
Data type
text
Description
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only
Data type
text
Description
[hidden]
Data type
text
Description
[hidden]
Data type
text
Description
[hidden]
Data type
text
Description
[hidden]
Data type
text
Description
Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Data type
date
Description
Outcome
Data type
integer
Description
If "Recovered/Resolved", "Recovered/Resolved with sequelae", or "Fatal, record Date of Death", provide End date. End Time is optional
Data type
date
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
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
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
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
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
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
Description
Action Taken with Investigational Product
Data type
text
Description
Withdrawal from study
Data type
boolean
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
Description
If AE start and end time are used this item must be hidden.
Data type
integer
Measurement units
- h
Description
If AE start and end time are used this item must be hidden.
Data type
integer
Measurement units
- min
Description
Time to Onset Since Last Dose hours
Data type
integer
Measurement units
- h
Description
This item is optional
Data type
integer
Measurement units
- min
Description
SAE caused by activities related to study participation
Data type
boolean
Description
[hidden]
Data type
boolean
Description
[hidden]
Data type
text
Description
Intensity changes
Description
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Data type
text
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
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
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
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
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
Description
Specify the reason for considering this an SAE. Check all that apply.
Description
SAE results in death
Data type
boolean
Description
SAE life-threatening
Data type
boolean
Description
SAE requires hospitalisation
Data type
boolean
Description
SAE results in disability/incapacity
Data type
boolean
Description
SAE congenital anomaly/birth defect
Data type
boolean
Description
Other SAE
Data type
boolean
Description
Other SAE specification
Data type
text
Description
Relevant concomitant / treatment medications
Description
[hidden]
Data type
text
Description
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Data type
text
Description
[hidden]
Data type
text
Description
Dose
Data type
text
Description
units of medication
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Data type
text
Description
Route of medication
Data type
text
Description
Start Date
Data type
date
Description
Ongoing medication
Data type
boolean
Description
End date medication
Data type
date
Description
Enter a medical diagnosis not description
Data type
text
Description
[hidden]
Data type
text
Description
Drug Type
Data type
text
Description
Relevant medical conditions / Risk factors
Description
[hidden]
Data type
text
Description
Enter a medical diagnosis not description.
Data type
text
Description
[hidden]
Data type
text
Description
Date of onset
Data type
date
Description
Continuing medical condition
Data type
text
Description
Medical condition last occurence
Data type
date
Description
[hidden]
Data type
text
Description
Relevant diagnostic results
Description
[hidden]
Data type
text
Description
Only allow site to choose from List of Values.
Data type
text
Description
Test Date
Data type
date
Description
Test Result
Data type
text
Description
Test Units
Data type
text
Description
Normal Low Range
Data type
text
Description
Normal High Range
Data type
text
Description
Relevant diagnostic results not noted above
Data type
text
Description
Rechallenge
Data type
text
Description
Investigational product
Description
Investigational product [hidden]
Description
Investigational product [hidden]
Description
General narrative comments
Description
Non clinical
Description
Send incomplete SAE data to GSK Safety [hidden]. This item is optional
Data type
boolean
Description
[hidden]
Data type
date
Description
[hidden]
Data type
time
Description
[hidden]
Data type
boolean
Description
[read-only]
Data type
text
Description
[hidden]
Data type
text
Description
[hidden]
Data type
text
Description
[hidden]
Data type
text
Description
[hidden]
Data type
text
Description
[hidden]
Data type
text