ID

28176

Beskrivning

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)

Nyckelord

Versioner (4)
  1. 2017-09-24 2017-09-24 -
  2. 2017-10-04 2017-10-04 -
  3. 2017-10-23 2017-10-23 -
  4. 2017-12-26 2017-12-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 december 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

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

1 Formulär  
Non-serious adverse event
Beskrivning

Non-serious adverse event

1. Sequence Number
Beskrivning

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C2348184
2. Event
Beskrivning

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatyp

text

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

[hidden]

Datatyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beskrivning

[hidden]

Datatyp

text

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

[hidden]

Datatyp

text

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

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

Datatyp

date

Alias
UMLS CUI [1]
C0808070
5. Outcome
Beskrivning

Outcome

Datatyp

integer

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

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

Datatyp

date

Alias
UMLS CUI [1]
C0806020
6. Frequency
Beskrivning

This item is optional

Datatyp

integer

Alias
UMLS CUI [1]
C3476109
7. Maximum Intensity
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C1710066
8. Intensity at onset of event
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C1710066
9. Maximum Grade
Beskrivning

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.

Datatyp

integer

Alias
UMLS CUI [1]
C0441799
10. Grade at onset of event
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0441799
11. Maximum Grade or Intensity
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
12. Grade or Intensity at onset of event
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C1710066
13. Action Taken with Investigational Product(s) as a Result of the AE
Beskrivning

Action Taken with Investigational Product

Datatyp

text

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

Withdrawal from study

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
15. Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
16. Duration of AE if < 24 hours (hours)
Beskrivning

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

Datatyp

integer

Måttenheter
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
h
16. Duration of AE if < 24 hours (minutes)
Beskrivning

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

Datatyp

integer

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

[hidden] This item is optional

Datatyp

integer

Måttenheter
  • 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)
Beskrivning

[hidden] This item is optional

Datatyp

integer

Måttenheter
  • min
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial