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Informations:
Erreur:
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
Mots-clés
Versions (2)
- 05/12/2018 05/12/2018 -
- 10/12/2018 10/12/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
5 décembre 2018
DOI
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Licence
Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181
Similar models
Follow-Up Forms
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Serious Adverse Event, During, Clinical Trials
Item
Did the subject experience a SAE during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event
Item
Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start Time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
Serious Adverse Event, Adverse Event End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
C2826658 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with Investigational Product(s) as a result of the SAE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
Code List
Action taken with Investigational Product(s) as a result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Experimental Drug, Causations
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Autopsy
Item
if FATAL, was a post-mortem/autopsy performed
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI-2)
Item
Seriousness
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify______________________________ (6)
CL Item
Liver injury and impaired liver function (7)
Item Group
Demography Data
C1519255 (UMLS CUI-1)
C1704791 (UMLS CUI-2)
C1704791 (UMLS CUI-2)
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Investigational Products
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
Item
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Possible Causes of SAE
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C0085978 (UMLS CUI-2)
Item
Possible causes of SAE other than Investigational Product(s)
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
Code List
Possible causes of SAE other than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify______________________ (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify________________ (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify ________________________________ (7)
Item Group
Relevant Medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI-2)
Serious Adverse Event; Disease, Hypersensitivity, Operative Surgical Procedures
Item
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Serious Adverse Event; Disease; Date of onset
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Present
Item
Condition Present at Time of the SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Occurrence, Date In time
Item
If NO, Date of Last Occurrence
date
C0020517 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
Item Group
Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0035648 (UMLS CUI-2)
Serious Adverse Event, risk factors, Other
Item
Other relevant risk factors
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication Dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
float
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Concomitant Medication Previous Occurrence
Item
Taken prior to study?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Indication
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Serious Adverse Event, Experimental Drug, Details
Item
Details of Investigational Product(s)
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Details of Relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Serious Adverse Event, Evaluation, Details
Item
Provide details of any tests or procedures carried out to diagnose or confirm the SAE (e.g., laboratory data with units and normal range) of data for this SAE have not been previously entered, and the CRF includes a page for the test, ensure the data is also entered on the page
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Provide a brief narrative description of the SAE and details of treatment given.
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's Confirmation
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
C2826892 (UMLS CUI-3)
C2346576 (UMLS CUI-2)
C2826892 (UMLS CUI-3)
Investigator's signature
Item
Investigator's signature
text
Investigator's name (print)
Item
Investigator's name (print)
text
Date
Item
Date
date