ID
26023
Beschreibung
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)
Stichworte
Versionen (6)
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- 04.10.17 04.10.17 -
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- 23.10.17 23.10.17 -
- 26.12.17 26.12.17 -
- 28.12.17 28.12.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
4. Oktober 2017
DOI
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Lizenz
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
Beschreibung
SAE to be adjudicated
Beschreibung
[hidden] If yes, select all that apply.
Datentyp
boolean
Beschreibung
If event is to be adjudicated, select all that apply.
Datentyp
boolean
Beschreibung
If event is to be adjudicated, select all that apply.
Datentyp
boolean
Beschreibung
If event is to be adjudicated, select all that apply.
Datentyp
boolean
Beschreibung
If event is to be adjudicated, select all that apply.
Datentyp
boolean
Beschreibung
If event is to be adjudicated, select all that apply.
Datentyp
boolean
Beschreibung
If event is to be adjudicated, select all that apply.
Datentyp
boolean
Beschreibung
SAE as non-adjudicated endpoint
Beschreibung
[hidden] If yes, select all that apply
Datentyp
boolean
Beschreibung
If event is a non-adjudicated endpoint, select all that apply.
Datentyp
boolean
Beschreibung
If event is a non-adjudicated endpoint, select all that apply.
Datentyp
boolean
Beschreibung
If event is a non-adjudicated endpoint, select all that apply.
Datentyp
boolean
Beschreibung
Occurence of endpoints
Beschreibung
Please provide all SAE/EP details in sections 2-11 below
Datentyp
boolean
Beschreibung
Occurence of death
Datentyp
boolean
Beschreibung
Occurence of death cardiovascular
Datentyp
integer
Beschreibung
Occurence of Myocardial infarction
Datentyp
boolean
Beschreibung
Occurence of Hospitalisation for unstable angina
Datentyp
boolean
Beschreibung
Occurence of Coronary revascularisation
Datentyp
boolean
Beschreibung
Occurence of Stroke/TIA
Datentyp
boolean
Beschreibung
Hospitalisation for heart failure
Datentyp
boolean
Beschreibung
Hospitalisation for Non-adjudicated ischaemic event
Datentyp
boolean
Beschreibung
Hospitalisation for Limb amputation due to vascular cause
Datentyp
boolean
Beschreibung
Hospitalisation for Non-coronary revascularisation
Datentyp
boolean
Beschreibung
Hospitalisation for non-coronary ischaemic event
Datentyp
boolean
Beschreibung
Event adjudicated to be study endpoint
Beschreibung
Report
Beschreibung
Randomization
Beschreibung
Serious Adverse Event
Beschreibung
[read-only]
Datentyp
text
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Datentyp
date
Beschreibung
Outcome
Datentyp
integer
Beschreibung
If "Recovered/Resolved", "Recovered/Resolved with sequelae", or "Fatal, record Date of Death", provide End date. End Time is optional
Datentyp
date
Beschreibung
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.
Datentyp
text
Beschreibung
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.
Datentyp
text
Beschreibung
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.
Datentyp
integer
Beschreibung
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
Datentyp
integer
Beschreibung
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.
Datentyp
text
Beschreibung
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
Datentyp
text
Beschreibung
Action Taken with Investigational Product
Datentyp
text
Beschreibung
Withdrawal from study
Datentyp
boolean
Beschreibung
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.
Datentyp
boolean
Beschreibung
If AE start and end time are used this item must be hidden.
Datentyp
integer
Maßeinheiten
- h
Beschreibung
If AE start and end time are used this item must be hidden.
Datentyp
integer
Maßeinheiten
- min
Beschreibung
Time to Onset Since Last Dose hours
Datentyp
integer
Maßeinheiten
- h
Beschreibung
This item is optional
Datentyp
integer
Maßeinheiten
- min
Beschreibung
SAE caused by activities related to study participation
Datentyp
boolean
Beschreibung
[hidden]
Datentyp
boolean
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Intensity changes
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Datentyp
text
Beschreibung
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.
Datentyp
date
Beschreibung
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.
Datentyp
time
Beschreibung
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.
Datentyp
integer
Beschreibung
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.
Datentyp
integer
Beschreibung
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.
Datentyp
text
Beschreibung
Specify the reason for considering this an SAE. Check all that apply.
Beschreibung
SAE results in death
Datentyp
boolean
Beschreibung
SAE life-threatening
Datentyp
boolean
Beschreibung
SAE requires hospitalisation
Datentyp
boolean
Beschreibung
SAE results in disability/incapacity
Datentyp
boolean
Beschreibung
SAE congenital anomaly/birth defect
Datentyp
boolean
Beschreibung
Other SAE
Datentyp
boolean
Beschreibung
Other SAE specification
Datentyp
text
Beschreibung
Relevant concomitant / treatment medications
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Dose
Datentyp
text
Beschreibung
units of medication
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Frequency
Datentyp
text
Beschreibung
Route of medication
Datentyp
text
Beschreibung
Start Date
Datentyp
date
Beschreibung
Ongoing medication
Datentyp
boolean
Beschreibung
End date medication
Datentyp
date
Beschreibung
Enter a medical diagnosis not description
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Drug Type
Datentyp
text
Beschreibung
Relevant medical conditions / Risk factors
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Enter a medical diagnosis not description.
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Date of onset
Datentyp
date
Beschreibung
Continuing medical condition
Datentyp
text
Beschreibung
Medical condition last occurence
Datentyp
date
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Relevant diagnostic results
Beschreibung
[hidden]
Datentyp
text
Beschreibung
Only allow site to choose from List of Values.
Datentyp
text
Beschreibung
Test Date
Datentyp
date
Beschreibung
Test Result
Datentyp
text
Beschreibung
Test Units
Datentyp
text
Beschreibung
Normal Low Range
Datentyp
text
Beschreibung
Normal High Range
Datentyp
text
Beschreibung
Relevant diagnostic results not noted above
Datentyp
text
Beschreibung
Rechallenge
Datentyp
text
Beschreibung
Investigational product
Beschreibung
Investigational product [hidden]
Beschreibung
Investigational product [hidden]
Beschreibung
General narrative comments
Beschreibung
Non clinical
Beschreibung
Send incomplete SAE data to GSK Safety [hidden]. This item is optional
Datentyp
boolean
Beschreibung
[hidden]
Datentyp
date
Beschreibung
[hidden]
Datentyp
time
Beschreibung
[hidden]
Datentyp
boolean
Beschreibung
[read-only]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text
Beschreibung
[hidden]
Datentyp
text