ID

32494

Beschrijving

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

Trefwoorden

Versies (2)
  1. 05-11-18 05-11-18 -
  2. 30-11-18 30-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

5 november 2018

DOI

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Licentie

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

Engels

Non-Serious Adverse Event Form

1 Formulieren  
Non-Serious Adverse Event (AE)
Beschrijving

Non-Serious Adverse Event (AE)

Sequence Number
Beschrijving

Sequence Number

Datatype

integer

Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Modified Term
Beschrijving

Modified Term

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

End Date
Beschrijving

End Date

Datatype

date

Outcome
Beschrijving

Outcome

Datatype

text

Frequency
Beschrijving

Frequency

Datatype

text

Maximum Intensity
Beschrijving

Record maximum intensity throughout duration of event

Datatype

text

Intensity at onset of event
Beschrijving

Intensity at onset of event

Datatype

text

Maximum Grade
Beschrijving

Maximum Grade

Datatype

text

Grade at onset of event
Beschrijving

Grade at onset of event

Datatype

text

Maximum Grade or Intensity
Beschrijving

Maximum Grade or Intensity

Datatype

text

Grade or Intensity at onset of event
Beschrijving

Grade or Intensity at onset of event

Datatype

text

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

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

Datatype

text

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

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

Datatype

boolean

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

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

Datatype

boolean

Duration of AE if < 24 hours
Beschrijving

HH:MM

Datatype

integer

Time to Onset Since Last Dose
Beschrijving

Time to Onset Since Last Dose

Datatype

time

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Similar models

Non-Serious Adverse Event Form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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