ID
32475
Beskrivning
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
Nyckelord
Versioner (2)
- 2018-11-02 2018-11-02 -
- 2018-11-30 2018-11-30 -
Rättsinnehavare
GSK group of companies
Uppladdad den
2 november 2018
DOI
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Licens
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
Beskrivning
Serious Adverse Event Entry
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Start Date
Datatyp
date
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Outcome
Datatyp
text
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if FATAL, Date of Death
Datatyp
date
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Maximum Intensity
Datatyp
text
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Intensity at onset of event
Datatyp
text
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Maximum Grade
Datatyp
text
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Grade at onset of event
Datatyp
text
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Record maximum grade or intensity throughout duration of event
Datatyp
text
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Record grade of intensity at the onset of the event
Datatyp
text
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Action taken with Investigational Product(s) as a result of AE?
Datatyp
text
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Did the subject withdraw from the study as a result of AE?
Datatyp
boolean
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Use best judgement at initial entry. May be amended when additional information becomes available.
Datatyp
boolean
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HH:MM
Datatyp
text
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Time to Onset since last Dose
Datatyp
time
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Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Datatyp
boolean
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Was the event serious?
Datatyp
boolean
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Related Investigational Product
Datatyp
text
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Seriousness
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Relevant Concomitant/Treatment Medication
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Iclude any details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
Datatyp
text
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Enter drug name, not description (Generic name preferred. If combination product, enter Trade Name).
Datatyp
text
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Modified reported term
Datatyp
text
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Dose
Datatyp
float
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Unit
Datatyp
text
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Frequency
Datatyp
text
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Route
Datatyp
text
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Start Date
Datatyp
date
Beskrivning
Ongoing?
Datatyp
boolean
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If NO, specify End Date
Datatyp
date
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Enter a medical diagnosis not description
Datatyp
text
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Modified reported term
Datatyp
text
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Drug Type
Datatyp
text
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Relevant Medical Conditions/Risk Factors
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MHx Sequence Number
Datatyp
text
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Enter a medical diagnosis not description.
Datatyp
text
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Modified reported term
Datatyp
text
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Date of onset
Datatyp
date
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Continuing?
Datatyp
text
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If NO, specify date of last occurrence
Datatyp
date
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Relevant Diagnosis Results
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Provide details of any tests or procedures carried out to diagnose the SAE.
Datatyp
text
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Test Name
Datatyp
text
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Test Date
Datatyp
date
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Test Result
Datatyp
text
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Test Units
Datatyp
text
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Normal Low Range
Datatyp
integer
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Normal High Range
Datatyp
integer
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Relevant diagnostic results not noted above
Datatyp
text
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Rechallenge
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If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Datatyp
text
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Investigational Product
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General narrative comments
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Non Clinical
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Send incomplete SAE data to GSK Safety
Datatyp
text
Beskrivning
Receipt by GSK date
Datatyp
date
Beskrivning
Was the event serious?
Datatyp
boolean
Beskrivning
SAE Sequence number
Datatyp
text
Beskrivning
Version Number
Datatyp
text
Beskrivning
Case ID
Datatyp
text
Beskrivning
Randomisation Number
Datatyp
text
Beskrivning
OCEANS Code
Datatyp
text
Similar models
Initial Serious Adverse Event Form
- StudyEvent: ODM