ID
33327
Beskrivning
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive
Nyckelord
Versioner (2)
- 2018-12-05 2018-12-05 -
- 2018-12-10 2018-12-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
5 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181
Follow-Up Forms
- StudyEvent: ODM
Beskrivning
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beskrivning
Serious Adverse Event, Seriousness of Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beskrivning
Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1704791
Beskrivning
Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beskrivning
Possible Causes of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Beskrivning
Serious Adverse Events; Causations
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beskrivning
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Beskrivning
Serious Adverse Event; Disease, Hypersensitivity, Operative Surgical Procedures
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0020517
- UMLS CUI [1,4]
- C0543467
Beskrivning
Serious Adverse Event; Disease; Date of onset
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0574845
Beskrivning
Serious Adverse Event, Disease, Present
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0150312
Beskrivning
Serious Adverse Event, Disease, Occurrence, Date In time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0543467
Beskrivning
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Beskrivning
Provide any family history or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE. Ensure each risk factor recorded in this section is also recorded in the appropriate Medical Conditions form
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
Beskrivning
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beskrivning
Serious Adverse Event, Concomitant Agent, Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beskrivning
Serious Adverse Event, Concomitant Agent, Medication Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beskrivning
Serious Adverse Event, Concomitant Agent, Unit of Measure
Datatyp
float
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Beskrivning
Serious Adverse Event, Frequencies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3476109
Beskrivning
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beskrivning
Serious Adverse Event, Concomitant Agent, Concomitant Medication Previous Occurrence
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826667
Beskrivning
Serious Adverse Event, Concomitant Agent, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Beskrivning
Serious Adverse Event, Concomitant Agent, End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Beskrivning
Serious Adverse Event, Concomitant Medication Ongoing
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Beskrivning
Serious Adverse Event, Concomitant Agent, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Beskrivning
Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Beskrivning
Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Beskrivning
Serious Adverse Event, Evaluation, Details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1522508
Beskrivning
Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beskrivning
Investigator's Confirmation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
- UMLS CUI-3
- C2826892
Similar models
Follow-Up Forms
- StudyEvent: ODM
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C2826658 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI [1,2])
C1704791 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0085978 (UMLS CUI-2)
C0085978 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0035648 (UMLS CUI-2)
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C2826666 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C2826892 (UMLS CUI-3)