ID
33327
Description
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
Keywords
Versions (2)
- 12/5/18 12/5/18 -
- 12/10/18 12/10/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 5, 2018
DOI
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License
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
Description
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Serious Adverse Event, Seriousness of Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Description
Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1704791
Description
Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Possible Causes of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Description
Serious Adverse Events; Causations
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Description
Serious Adverse Event; Disease, Hypersensitivity, Operative Surgical Procedures
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0020517
- UMLS CUI [1,4]
- C0543467
Description
Serious Adverse Event; Disease; Date of onset
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0574845
Description
Serious Adverse Event, Disease, Present
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0150312
Description
Serious Adverse Event, Disease, Occurrence, Date In time
Data type
date
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0543467
Description
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
Description
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
Serious Adverse Event, Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Description
Serious Adverse Event, Concomitant Agent, Medication Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Description
Serious Adverse Event, Concomitant Agent, Unit of Measure
Data type
float
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Description
Serious Adverse Event, Frequencies
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3476109
Description
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Description
Serious Adverse Event, Concomitant Agent, Concomitant Medication Previous Occurrence
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826667
Description
Serious Adverse Event, Concomitant Agent, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Description
Serious Adverse Event, Concomitant Agent, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Description
Serious Adverse Event, Concomitant Medication Ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Description
Serious Adverse Event, Concomitant Agent, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Description
Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Description
Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Description
Serious Adverse Event, Evaluation, Details
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1522508
Description
Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
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)