ID

29524

Description

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Serious Adverse Event

Keywords

Versions (2)
  1. 3/4/18 3/4/18 -
  2. 4/5/18 4/5/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 5, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463

English

Serious Adverse Event

1 forms  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
Did the subject experience a serious adverse event during the study?
Description

serious adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Did SAE occur after initiation of study medication?
Description

Did SAE occur after initiation of study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Onset Date
Description

Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0574845
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
Date of Death
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C1148348
Intensity (maximum)
Description

Intensity (maximum)

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Respect to Investigational Drug
Description

Action Taken

Data type

integer

Alias
UMLS CUI [1]
C1547656
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Did the subject withdraw from study as a result of this AE?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Description

undefined item

Data type

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
Seriousness, Specify the reason for considering this an SAE
Description

Seriousness

Data type

integer

Alias
UMLS CUI [1]
C1710056
General narrative comments
Description

General narrative comments

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Intensity Changes
Description

Intensity Changes

Alias
UMLS CUI-1
C1710066
UMLS CUI-2
C0518690
UMLS CUI-3
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Start Date of event segment
Description

Start Date of event segment

Data type

date

Alias
UMLS CUI [1]
C2697888
Start Time of event segment
Description

Start Time of event segment

Data type

time

Alias
UMLS CUI [1]
C2697889
Intensity of event segment
Description

Intensity of event segment

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Grade of event segment
Description

Grade of event segment

Data type

integer

Alias
UMLS CUI [1]
C2985911
Grade or Intensity of event segment
Description

Grade or Intensity of event segment

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C2985911
Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Drug Type
Description

Drug Type

Data type

text

Alias
UMLS CUI [1]
C0457591
Drug name
Description

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Description

eg. 500 mg

Data type

float

Alias
UMLS CUI [1]
C2348070
Primary Indication, Enter a medical diagnosis not description
Description

Primary Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C0011900
Start Date
Description

start date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Description

End Date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Ongoing?
Description

If a medication was marked ‘Continuing’ at a previous visit, but has since had a dosage change or has been stopped, it must be recorded as a change below with the new start and end date.

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Relevant medical conditions/Risk factors
Description

Relevant medical conditions/Risk factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specific Condition name
Description

Specific Condition name

Data type

text

Alias
UMLS CUI [1]
C0012634
Date of onset
Description

Date of onset

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Continuing?
Description

Continuing?

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
No, specify date of last occurrence
Description

date of last occurrence

Data type

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Relevant Diagnostic Results
Description

Relevant Diagnostic Results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
Normal High Range
Description

Normal High Range

Data type

text

Alias
UMLS CUI [1]
C0086715
Relevant diagnostic results not noted above
Description

Relevant diagnostic results not noted above

Data type

text

Alias
UMLS CUI [1]
C0587081
Test Name
Description

Test Name

Data type

text

Alias
UMLS CUI [1]
C0022885
Test Date
Description

Test Date

Data type

date

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Test Units
Description

Test Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Description

Normal Low Range

Data type

text

Alias
UMLS CUI [1]
C0086715
Rechallenge
Description

Rechallenge

Alias
UMLS CUI-1
C2347900
UMLS CUI-2
C0304229
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Description

event recur after investigational products were restarted

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
Investigational product
Description

Investigational product

Alias
UMLS CUI-1
C0304229
Study Drug
Description

Study Drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

start date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Description

stop date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Regimen
Description

Regimen

Data type

integer

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0304229
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Similar models

Serious Adverse Event

1 forms
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Did SAE occur after initiation of study medication
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C1519255 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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)
CL Item
Fatal, record Date of Death  (5)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Intensity (maximum)
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Dose interrupted (3)
CL Item
Not applicable (4)
Relationship investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
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])
C1519255 (UMLS CUI [1,2])
undefined item
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, Specify the reason for considering this an SAE
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Seriousness, Specify the reason for considering this an SAE
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
General narrative comments
Item
General narrative comments
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Intensity Changes
C1710066 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Start Date of event segment
Item
Start Date of event segment
date
C2697888 (UMLS CUI [1])
Start Time of event segment
Item
Start Time of event segment
time
C2697889 (UMLS CUI [1])
Item
Intensity of event segment
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C2985911 (UMLS CUI [1])
Grade of event segment
Code List
Grade of event segment
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade5 (5)
Item
Grade or Intensity of event segment
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2985911 (UMLS CUI [2])
Grade or Intensity of event segment
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade l (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade4 (4)
CL Item
Grade 5 (5)
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Unit
Item
Unit
text
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Drug Type
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Primary Indication
Item
Primary Indication, Enter a medical diagnosis not description
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
Item Group
Relevant medical conditions/Risk factors
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Specific Condition name
Item
Specific Condition name
text
C0012634 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Continuing?
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing?
Code List
Continuing?
CL Item
Yes (1)
CL Item
No, specify date of last occurrence (2)
CL Item
Unknown (3)
date of last occurrence
Item
No, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Relevant Diagnostic Results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Test Name
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1])
Item Group
Rechallenge
C2347900 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
integer
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
undefined item
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Item Group
Investigational product
C0304229 (UMLS CUI-1)
Study Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
start date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
stop date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Regimen
Item
Regimen
integer
C0237125 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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