ID

32494

Beskrivning

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Nyckelord

Versioner (2)
  1. 2018-11-05 2018-11-05 -
  2. 2018-11-30 2018-11-30 -
Rättsinnehavare

GSK group of companies

Uppladdad den

5 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Engelsk

Non-Serious Adverse Event Form

1 Formulär  
Non-Serious Adverse Event (AE)
Beskrivning

Non-Serious Adverse Event (AE)

Sequence Number
Beskrivning

Sequence Number

Datatyp

integer

Event
Beskrivning

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatyp

text

Modified Term
Beskrivning

Modified Term

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

End Date
Beskrivning

End Date

Datatyp

date

Outcome
Beskrivning

Outcome

Datatyp

text

Frequency
Beskrivning

Frequency

Datatyp

text

Maximum Intensity
Beskrivning

Record maximum intensity throughout duration of event

Datatyp

text

Intensity at onset of event
Beskrivning

Intensity at onset of event

Datatyp

text

Maximum Grade
Beskrivning

Maximum Grade

Datatyp

text

Grade at onset of event
Beskrivning

Grade at onset of event

Datatyp

text

Maximum Grade or Intensity
Beskrivning

Maximum Grade or Intensity

Datatyp

text

Grade or Intensity at onset of event
Beskrivning

Grade or Intensity at onset of event

Datatyp

text

Action Taken with Investigational Product(s) as a result of the AE
Beskrivning

Action Taken with Investigational Product(s) as a result of the AE

Datatyp

text

Did the subject withdraw from study as a result of this AE?
Beskrivning

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

Datatyp

boolean

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

Ue best judgement at initial entry. May be amended when additional information becomes available.

Datatyp

boolean

Duration of AE if < 24 hours
Beskrivning

HH:MM

Datatyp

integer

Time to Onset Since Last Dose
Beskrivning

Time to Onset Since Last Dose

Datatyp

time

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Similar models

Non-Serious Adverse Event Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Non-Serious Adverse Event (AE)
Sequence Number
Item
Sequence Number
integer
Event
Item
Event
text
Modified Term
Item
Modified Term
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[X] Not applicable (4)
Item
Intensity at onset of event
text
Intensity at onset of event
Code List
Intensity at onset of event
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[X] Not applicable (4)
Item
Maximum Grade
text
Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Grade at onset of event
text
Grade at onset of event
Code List
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
Maximum Grade or Intensity
text
Maximum Grade or Intensity
Code List
Maximum Grade or Intensity
CL Item
[1] Mild or Grade 1 (1)
CL Item
[2] Moderate or Grade 2 (2)
CL Item
[3] Severe or Grade 3 (3)
CL Item
[4] Grade 4 (4)
CL Item
[5] Grade 5 (5)
CL Item
[X] Not applicable (6)
Item
Grade or Intensity at onset of event
text
Grade or Intensity at onset of event
Code List
Grade or Intensity at onset of event
CL Item
[1] Mild or Grade 1 (1)
CL Item
[2] Moderate or Grade 2 (2)
CL Item
[3] Severe or Grade 3 (3)
CL Item
[4] Grade 4 (4)
CL Item
[5] Grade 5 (5)
CL Item
[X] Not applicable (6)
Item
Action Taken with Investigational Product(s) as a result of the AE
text
Action Taken with Investigational Product(s) as a result of the AE
Code List
Action Taken with Investigational Product(s) as a result of the AE
CL Item
[1] Investigational product(s) withdrawn (1)
CL Item
[2] Dose reduced (2)
CL Item
[3] Dose increased (3)
CL Item
[4] Dose not changed (4)
CL Item
[5] Dose interrupted (5)
CL Item
[X] Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
time
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