ID

29524

Beschreibung

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

Stichworte

Versionen (2)
  1. 04.03.18 04.03.18 -
  2. 05.04.18 05.04.18 -
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GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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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

Englisch

Serious Adverse Event

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Serious Adverse Event
Beschreibung

Serious Adverse Event

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

Date of visit/assessment

Datentyp

date

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

serious adverse event

Datentyp

boolean

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

Did SAE occur after initiation of study medication

Datentyp

boolean

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

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Onset Date
Beschreibung

Onset Date

Datentyp

date

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

End Date

Datentyp

date

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

Outcome

Datentyp

integer

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

Date of Death

Datentyp

date

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

Intensity (maximum)

Datentyp

integer

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

Action Taken

Datentyp

integer

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

Relationship investigational product

Datentyp

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?
Beschreibung

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

Datentyp

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)?
Beschreibung

undefined item

Datentyp

boolean

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

Seriousness

Datentyp

integer

Alias
UMLS CUI [1]
C1710056
General narrative comments
Beschreibung

General narrative comments

Datentyp

text

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

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
Beschreibung

Serious Adverse Event

Datentyp

text

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

Start Date of event segment

Datentyp

date

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

Start Time of event segment

Datentyp

time

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

Intensity of event segment

Datentyp

integer

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

Grade of event segment

Datentyp

integer

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

Grade or Intensity of event segment

Datentyp

integer

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

Concomitant medication

Alias
UMLS CUI-1
C2347852
Unit
Beschreibung

Unit

Datentyp

text

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

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Drug Type
Beschreibung

Drug Type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Drug name
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschreibung

eg. 500 mg

Datentyp

float

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

Primary Indication

Datentyp

text

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

start date of medication

Datentyp

date

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

End Date of medication

Datentyp

date

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

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.

Datentyp

boolean

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

Relevant medical conditions/Risk factors

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

Specific Condition name

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Date of onset
Beschreibung

Date of onset

Datentyp

date

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

Continuing?

Datentyp

integer

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

date of last occurrence

Datentyp

date

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

Relevant Diagnostic Results

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

Normal High Range

Datentyp

text

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

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Test Name
Beschreibung

Test Name

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Test Units
Beschreibung

Test Units

Datentyp

text

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

Normal Low Range

Datentyp

text

Alias
UMLS CUI [1]
C0086715
Rechallenge
Beschreibung

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?
Beschreibung

event recur after investigational products were restarted

Datentyp

integer

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

Investigational product

Alias
UMLS CUI-1
C0304229
Study Drug
Beschreibung

Study Drug

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Start Date
Beschreibung

start date

Datentyp

date

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

stop date

Datentyp

date

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

Regimen

Datentyp

integer

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0304229
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Ähnliche Modelle

Serious Adverse Event

1 Formulare
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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