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