ID

28176

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: Non-serious adverse event - Repeating form (Scheduled visits)

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GlaxoSmithKline

Hochgeladen am

26. Dezember 2017

DOI

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

Englisch

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

1 Formulare  
Non-serious adverse event
Beschreibung

Non-serious adverse event

1. Sequence Number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2348184
2. Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1518404
3. Modified term
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschreibung

[hidden]

Datentyp

text

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

Condition item 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
5. Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
5. End date
Beschreibung

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

Datentyp

date

Alias
UMLS CUI [1]
C0806020
6. Frequency
Beschreibung

This item is optional

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
7. Maximum Intensity
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]
C1710066
8. Intensity at onset of event
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]
C1710066
9. Maximum Grade
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
10. Grade at onset of event
Beschreibung

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 [1,1]
C2985916
UMLS CUI [1,2]
C0441799
11. Maximum Grade or Intensity
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]
C0441799
UMLS CUI [1,2]
C1710066
12. Grade or Intensity at onset of event
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]
C1710066
13. Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken with Investigational Product

Datentyp

text

Alias
UMLS CUI [1]
C1704758
14. Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdrawal from study

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
15. Is there a reasonable possibility that the AE may have been caused by the investigational product?
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
16. Duration of AE if < 24 hours (hours)
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]
C1519255
h
16. Duration of AE if < 24 hours (minutes)
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
min
17. Time to Onset Since Last Dose (hours)
Beschreibung

[hidden] This item is optional

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
h
17. Time to Onset Since Last Dose (minutes)
Beschreibung

[hidden] This item is optional

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-serious adverse event
Sequence Number
Item
1. Sequence Number
text
C2348184 (UMLS CUI [1])
Non-serious adverse event
Item
2. Event
text
C1518404 (UMLS CUI [1])
Modified term
Item
3. Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
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
C0808070 (UMLS CUI [1])
Item
5. Outcome
integer
C1705586 (UMLS CUI [1])
Outcome / End Date
Code List
5. Outcome
CL Item
Recovered/Resolved, provide End Date (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
C1709862 (UMLS CUI-1)
(Comment:en)
End date
Item
5. End date
date
C0806020 (UMLS CUI [1])
Item
6. Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
6. Frequency
CL Item
Single Episode (1)
C0332189 (UMLS CUI-1)
(Comment:en)
CL Item
Intermittent (2)
C0205267 (UMLS CUI-1)
(Comment:en)
Item
7. Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
7. Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
8. Intensity at onset of event
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
8. Intensity at onset of event
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
9. Maximum Grade
integer
C0441799 (UMLS CUI [1])
Maximum Grade
Code List
9. Maximum Grade
CL Item
Grade 1 (1)
C0687695 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 2 (2)
C1522446 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 3 (3)
C0450094 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 4 (4)
C0547054 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 5 (5)
C2985911 (UMLS CUI-1)
(Comment:en)
Item
10. Grade at onset of event
integer
C2985916 (UMLS CUI [1,1])
C0441799 (UMLS CUI [1,2])
Maximum Grade
Code List
10. Grade at onset of event
CL Item
Grade 1 (1)
C0687695 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 2 (2)
C1522446 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 3 (3)
C0450094 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 4 (4)
C0547054 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 5 (5)
C2985911 (UMLS CUI-1)
(Comment:en)
Item
11. Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
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
C1710066 (UMLS CUI [1])
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
C1704758 (UMLS CUI [1])
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)
C0304229 (UMLS CUI-1)
(Comment:en)
CL Item
Dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
Dose not changed (4)
C0178602 (UMLS CUI-1)
C0443172 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Withdrawal from study
Item
14. Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
AE caused by investigational product
Item
15. Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE hours
Item
16. Duration of AE if < 24 hours (hours)
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of AE minutes
Item
16. Duration of AE if < 24 hours (minutes)
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose hours
Item
17. Time to Onset Since Last Dose (hours)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Time to Onset Since Last Dose minutes
Item
17. Time to Onset Since Last Dose (minutes)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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