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