ID

25882

Beschrijving

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: Non-serious adverse event - Repeating form

Trefwoorden

Versies (4)
  1. 24-09-17 24-09-17 -
  2. 04-10-17 04-10-17 -
  3. 23-10-17 23-10-17 -
  4. 26-12-17 26-12-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

24 september 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Non-serious adverse event Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

Engels

Non-serious adverse event Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
Non-serious adverse event
Beschrijving

Non-serious adverse event

1. Sequence Number
Beschrijving

[hidden]

Datatype

text

2. Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

3. Modified term
Beschrijving

[hidden]

Datatype

text

MedDRA synonym
Beschrijving

[hidden]

Datatype

text

MedDRA lower level term code
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
4. Start Date
Beschrijving

Condition item Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.

Datatype

date

5. Outcome
Beschrijving

Outcome

Datatype

integer

5. End date
Beschrijving

If outcome "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date.

Datatype

date

6. Frequency
Beschrijving

This item is optional

Datatype

integer

7. Maximum Intensity
Beschrijving

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.

Datatype

text

8. Intensity at onset of event
Beschrijving

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.

Datatype

text

9. Maximum Grade
Beschrijving

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.

Datatype

integer

10. Grade at onset of event
Beschrijving

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

Datatype

integer

11. Maximum Grade or Intensity
Beschrijving

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.

Datatype

text

12. Grade or Intensity at onset of event
Beschrijving

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

Datatype

text

13. Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action Taken with Investigational Product

Datatype

text

14. Did the subject withdraw from study as a result of this AE?
Beschrijving

Withdrawal from study

Datatype

boolean

15. Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

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.

Datatype

boolean

16. Duration of AE if < 24 hours (hours)
Beschrijving

If AE start and end time are used this item must be hidden.

Datatype

integer

Maateenheden
  • h
h
16. Duration of AE if < 24 hours (minutes)
Beschrijving

If AE start and end time are used this item must be hidden.

Datatype

integer

Maateenheden
  • min
min
17. Time to Onset Since Last Dose (hours)
Beschrijving

[hidden] This item is optional

Datatype

integer

Maateenheden
  • h
h
17. Time to Onset Since Last Dose (minutes)
Beschrijving

[hidden] This item is optional

Datatype

integer

Maateenheden
  • min
min
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Similar models

Non-serious adverse event Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-serious adverse event
Sequence Number
Item
1. Sequence Number
text
Non-serious adverse event
Item
2. Event
text
Modified term
Item
3. Modified term
text
MedDRA synonym
Item
MedDRA synonym
text
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date
Item
4. Start Date
date
Item
5. Outcome
integer
Outcome / End Date
Code List
5. Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
End date
Item
5. End date
date
Item
6. Frequency
integer
Frequency
Code List
6. Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
7. Maximum Intensity
text
Maximum Intensity
Code List
7. Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
8. Intensity at onset of event
text
Maximum Intensity
Code List
8. Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
9. Maximum Grade
integer
Maximum Grade
Code List
9. Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
10. Grade at onset of event
integer
Maximum Grade
Code List
10. Grade at onset of event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
11. Maximum Grade or Intensity
text
Maximum Grade or Intensity
Code List
11. Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
12. Grade or Intensity at onset of event
text
Maximum Grade or Intensity
Code List
12. Grade or Intensity at onset of event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
13. Action Taken with Investigational Product(s) as a Result of the AE
text
Action Taken with Investigational Product
Code List
13. Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Withdrawal from study
Item
14. Did the subject withdraw from study as a result of this AE?
boolean
AE caused by investigational product
Item
15. Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Duration of AE hours
Item
16. Duration of AE if < 24 hours (hours)
integer
Duration of AE minutes
Item
16. Duration of AE if < 24 hours (minutes)
integer
Time to Onset Since Last Dose hours
Item
17. Time to Onset Since Last Dose (hours)
integer
Time to Onset Since Last Dose minutes
Item
17. Time to Onset Since Last Dose (minutes)
integer
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