ID

33187

Descripción

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

Palabras clave

Versiones (2)
  1. 5/11/18 5/11/18 -
  2. 30/11/18 30/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

30 de noviembre de 2018

DOI

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Licencia

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

Inglés

Non-Serious Adverse Event Form

1 formularios  
Non-Serious Adverse Event (AE)
Descripción

Non-Serious Adverse Event (AE)

Alias
UMLS CUI-1
C1518404
Sequence Number
Descripción

Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1518404
Event
Descripción

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
Modified Term
Descripción

Modified Term

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
Non- Serious Adverse Event Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Non- Serious Adverse Event End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non- Serious Adverse Event Outcome
Descripción

Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non- Serious Adverse Event Frequency
Descripción

Frequency

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Descripción

Record maximum intensity throughout duration of event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0806909
Intensity at onset of event
Descripción

Intensity at onset of event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0332162
Maximum Grade
Descripción

Maximum Grade

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0806909
Grade at onset of event
Descripción

Grade at onset of event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0332162
Maximum Grade or Intensity
Descripción

Maximum Grade or Intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0806909
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
Grade or Intensity at onset of event
Descripción

Grade or Intensity at onset of event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0332162
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0332162
Action Taken with Investigational Product(s) as a result of the AE
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C1704758
UMLS CUI [2]
C0877248
Did the subject withdraw from study as a result of this AE?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
Duration of AE if < 24 hours
Descripción

HH:MM

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Descripción

Time to Onset Since Last Dose

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
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Similar models

Non-Serious Adverse Event Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Non-Serious Adverse Event (AE)
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Event
Item
Event
text
C1518404 (UMLS CUI [1])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date
Item
Non- Serious Adverse Event Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
Non- Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non- Serious Adverse Event Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome
Code List
Non- Serious Adverse Event 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
Non- Serious Adverse Event Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency
Code List
Non- Serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
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
C0518690 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
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
C0441800 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
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
C0441800 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
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
C0441800 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
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
C0441800 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
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
C1704758 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
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
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
time
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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