ID

33706

Beschreibung

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Non-Serious Adverse Events (AE). It has to be filled in if a non-serious AE occurs during study.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Stichworte

Versionen (3)
  1. 20.12.18 20.12.18 -
  2. 20.12.18 20.12.18 -
  3. 21.12.18 21.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Dezember 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Englisch

Non-Serious Adverse Events (AE)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Sequence Number [hidden]
Beschreibung

Item is not required

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Event
Beschreibung

Oiagnosis only (if known) otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
Modified term [hidden]
Beschreibung

Item is not required

Datentyp

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym [hidden]
Beschreibung

Item is not required

Datentyp

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C0871468
MedDRA lower level term code [hidden]
Beschreibung

Item is not required

Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding [hidden]
Beschreibung

Item is not required

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start date of AE
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Start time of AE
Beschreibung

00:00-23:59. Start time is optional

Datentyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1518404
Outcome of AE
Beschreibung

Outcome of AE

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
End date of AE
Beschreibung

day month year. Please fill in if the AE is 1) recovered/resolvedor 2) recovered/resolved with sequelae

Datentyp

date

Alias
UMLS CUI [1]
C2697886
End time of AE
Beschreibung

00:00-23:59. End Time is optional. Please fill in if the AE is 1) recovered/resolvedor 2) recovered/resolved with sequelae

Datentyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0877248
Frequency of AE
Beschreibung

This item is optional

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Maximum Intensity of AE
Beschreibung

Item is not required. Optional Item: This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used. Grade 5 is optional.

Datentyp

text

Alias
UMLS CUI [1]
C1710056
Action Taken with investigational Product(s) as a Result of the AE
Beschreibung

Action taken with investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdrawing as result of AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Investigational product causing AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0877248
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Ähnliche Modelle

Non-Serious Adverse Events (AE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number [hidden]
text
C2348184 (UMLS CUI [1])
Event Diagnosis
Item
Event
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Modified term
Item
Modified term [hidden]
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym [hidden]
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code [hidden]
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start date of AE
Item
Start date of AE
date
C2697888 (UMLS CUI [1])
Start time of AE
Item
Start time of AE
time
C1301880 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome of AE
integer
C1705586 (UMLS CUI [1])
Outcome of AE
Code List
Outcome of AE
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End date of AE
Item
End date of AE
date
C2697886 (UMLS CUI [1])
End time of AE
Item
End time of AE
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Frequency of AE
integer
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency of AE
Code List
Frequency of AE
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity of AE
text
C1710056 (UMLS CUI [1])
Maximum Intensity of AE
Code List
Maximum Intensity of AE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not aplicable (X)
Item
Action Taken with investigational Product(s) as a Result of the AE
text
C0304229 (UMLS CUI [1])
Action taken with investigational Product(s)
Code List
Action Taken with investigational Product(s) as a Result of the AE
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawing as result of AE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Investigational product causing AE
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
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