ID
33172
Description
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
Mots-clés
Versions (2)
- 02/11/2018 02/11/2018 -
- 30/11/2018 30/11/2018 -
Détendeur de droits
GSK group of companies
Téléchargé le
30 novembre 2018
DOI
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Licence
Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
Initial Serious Adverse Event Form
- StudyEvent: ODM
Description
Serious Adverse Event Entry
Alias
- UMLS CUI-1
- C1519255
Description
Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Description
Outcome
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
if FATAL, Date of Death
Type de données
date
Alias
- UMLS CUI [1,1]
- C2697886
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity of Serious Adverse Event
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Intensity at onset of event
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0332162
Description
Maximum Grade
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
Description
Grade at onset of event
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0806909
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Description
Record maximum grade or intensity throughout duration of event
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0441800
- UMLS CUI [1,4]
- C0806909
Description
Record grade of intensity at the onset of the event
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Description
Action taken with Investigational Product(s) as a result of AE?
Type de données
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Did the subject withdraw from the study as a result of AE?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0422727
- UMLS CUI [2]
- C1519255
Description
Use best judgement at initial entry. May be amended when additional information becomes available.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1518404
Description
HH:MM
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
Time to Onset since last Dose
Type de données
time
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C1517741
Description
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2,1]
- C2603343
- UMLS CUI [2,2]
- C0679823
- UMLS CUI [3]
- C0304229
- UMLS CUI [4]
- C2700391
- UMLS CUI [5]
- C0005834
- UMLS CUI [6]
- C1710661
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1710056
Description
Related Investigational Product
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Relevant Concomitant/Treatment Medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0013227
Description
Iclude any details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Description
Enter drug name, not description (Generic name preferred. If combination product, enter Trade Name).
Type de données
text
Alias
- UMLS CUI [1]
- C2360065
Description
Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
Dose
Type de données
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Type de données
text
Alias
- UMLS CUI [1]
- C2826646
Description
Frequency
Type de données
integer
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Route
Type de données
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Medication Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Is medication ongoing?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
If NO, specify End Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
Enter a medical diagnosis not description
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
Drug Type
Type de données
text
Alias
- UMLS CUI [1]
- C0457591
Description
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0035648
Description
MHx Sequence Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Enter a medical diagnosis not description.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826923
Description
Date of onset
Type de données
date
Alias
- UMLS CUI [1]
- C0574845
Description
Continuing?
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
If NO, specify date of last occurrence
Type de données
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Description
Relevant Diagnosis Results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
Description
Provide details of any tests or procedures carried out to diagnose the SAE.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Test Name
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0027365
Description
Test Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Type de données
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Description
Normal High Range
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0205251
- UMLS CUI [1,2]
- C0205250
Description
Relevant diagnostic results not noted above
Type de données
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0205394
Description
Rechallenge
Alias
- UMLS CUI-1
- C2347900
Description
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C2745955
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Study Drug
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Regimen
Type de données
text
Alias
- UMLS CUI [1]
- C1276413
Description
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Description
possible other causes of the event (e.g., lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of treatment.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Description
Non Clinical
Alias
- UMLS CUI-1
- C0205210
- UMLS CUI-2
- C1298908
Description
Send incomplete SAE data to GSK Safety
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Description
Receipt by GSK date
Type de données
date
Alias
- UMLS CUI [1]
- C2985846
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Sequence number
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Description
Case ID
Type de données
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Description
Randomisation Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
OCEANS Code
Type de données
text
Alias
- UMLS CUI [1]
- C0805701
Similar models
Initial Serious Adverse Event Form
- StudyEvent: ODM
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C2697888 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C2700391 (UMLS CUI [4])
C0005834 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
C0013227 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0035648 (UMLS CUI-2)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0456984 (UMLS CUI-2)
C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])