ID
33327
Beschrijving
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
Trefwoorden
Versies (2)
- 05-12-18 05-12-18 -
- 10-12-18 10-12-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 december 2018
DOI
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Licentie
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
Beschrijving
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschrijving
Serious Adverse Event, Seriousness of Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beschrijving
Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1704791
Beschrijving
Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschrijving
Possible Causes of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Beschrijving
Serious Adverse Events; Causations
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Beschrijving
Serious Adverse Event; Disease, Hypersensitivity, Operative Surgical Procedures
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0020517
- UMLS CUI [1,4]
- C0543467
Beschrijving
Serious Adverse Event; Disease; Date of onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0574845
Beschrijving
Serious Adverse Event, Disease, Present
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0150312
Beschrijving
Serious Adverse Event, Disease, Occurrence, Date In time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0543467
Beschrijving
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
Beschrijving
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschrijving
Serious Adverse Event, Concomitant Agent, Medication name
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beschrijving
Serious Adverse Event, Concomitant Agent, Medication Dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beschrijving
Serious Adverse Event, Concomitant Agent, Unit of Measure
Datatype
float
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Beschrijving
Serious Adverse Event, Frequencies
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3476109
Beschrijving
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beschrijving
Serious Adverse Event, Concomitant Agent, Concomitant Medication Previous Occurrence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826667
Beschrijving
Serious Adverse Event, Concomitant Agent, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Beschrijving
Serious Adverse Event, Concomitant Agent, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Beschrijving
Serious Adverse Event, Concomitant Medication Ongoing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Beschrijving
Serious Adverse Event, Concomitant Agent, Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Beschrijving
Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Beschrijving
Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Beschrijving
Serious Adverse Event, Evaluation, Details
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1522508
Beschrijving
Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschrijving
Investigator's Confirmation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
- UMLS CUI-3
- C2826892
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Follow-Up Forms
- StudyEvent: ODM
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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)