ID

33327

Descripción

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

Palabras clave

Versiones (2)
  1. 5/12/18 5/12/18 -
  2. 10/12/18 10/12/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de diciembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

Inglés

Follow-Up Forms

1 formularios  
  1. StudyEvent: ODM
    1. Follow-Up Forms
Serious Adverse Events - Section 1
Descripción

Serious Adverse Events - Section 1

Alias
UMLS CUI-1
C1519255
Did the subject experience a SAE during the study?
Descripción

Serious Adverse Event, During, Clinical Trials

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event
Descripción

Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Start Date
Descripción

Serious Adverse Event, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Start Time
Descripción

Serious Adverse Event, Start Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome
Descripción

Serious Adverse Event, Adverse Event Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date
Descripción

Serious Adverse Event, Adverse Event End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697886
End Time
Descripción

Serious Adverse Event, Adverse Event End Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826658
Maximum Intensity
Descripción

Serious Adverse Event, Seriousness of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Action taken with Investigational Product(s) as a result of the SAE
Descripción

Serious Adverse Event, Action Taken with Study Treatment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this SAE?
Descripción

Serious Adverse Event, Withdraw

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

Serious Adverse Event, Experimental Drug, Causations

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
if FATAL, was a post-mortem/autopsy performed
Descripción

Serious Adverse Event, Fatal, Autopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Seriousness
Descripción

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness
Descripción

Serious Adverse Event, Seriousness of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Demography Data
Descripción

Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1704791
Date of Birth
Descripción

Patient date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Investigational Products
Descripción

Investigational Products

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Descripción

Serious Adverse Event, Relationship, Experimental Drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Possible Causes of SAE
Descripción

Possible Causes of SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible causes of SAE other than Investigational Product(s)
Descripción

Serious Adverse Events; Causations

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Relevant Medical Conditions
Descripción

Relevant Medical Conditions

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
Descripción

Serious Adverse Event; Disease, Hypersensitivity, Operative Surgical Procedures

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0020517
UMLS CUI [1,4]
C0543467
Date of onset
Descripción

Serious Adverse Event; Disease; Date of onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0574845
Condition Present at Time of the SAE?
Descripción

Serious Adverse Event, Disease, Present

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0150312
If NO, Date of Last Occurrence
Descripción

Serious Adverse Event, Disease, Occurrence, Date In time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0543467
Other Relevant Risk Factors
Descripción

Other Relevant Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
Other relevant risk factors
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0205394
Relevant Concomitant Medications
Descripción

Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Descripción

Serious Adverse Event, Concomitant Agent, Medication name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Descripción

Serious Adverse Event, Concomitant Agent, Medication Dose

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
Unit
Descripción

Serious Adverse Event, Concomitant Agent, Unit of Measure

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Frequency
Descripción

Serious Adverse Event, Frequencies

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3476109
Route
Descripción

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Taken prior to study?
Descripción

Serious Adverse Event, Concomitant Agent, Concomitant Medication Previous Occurrence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826667
Start Date
Descripción

Serious Adverse Event, Concomitant Agent, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Stop Date
Descripción

Serious Adverse Event, Concomitant Agent, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Ongoing Medication?
Descripción

Serious Adverse Event, Concomitant Medication Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
Reason for Medication
Descripción

Serious Adverse Event, Concomitant Agent, Indication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Details of Investigational Product(s)
Descripción

Details of Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
UMLS CUI-3
C1522508
Details of Investigational Product(s)
Descripción

Serious Adverse Event, Experimental Drug, Details

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1522508
Details of Relevant Assessments
Descripción

Details of Relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
UMLS CUI-3
C1522508
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
Descripción

Serious Adverse Event, Evaluation, Details

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1522508
Narrative Remarks
Descripción

Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Provide a brief narrative description of the SAE and details of treatment given.
Descripción

Serious Adverse Event, Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator's Confirmation
Descripción

Investigator's Confirmation

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
UMLS CUI-3
C2826892
Investigator's signature
Descripción

Confirming that the data on the SAE pages are accurate and complete

Tipo de datos

text

Investigator's name (print)
Descripción

Investigator's name (print)

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

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Follow-Up Forms

1 formularios
  1. StudyEvent: ODM
    1. Follow-Up Forms
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Serious Adverse Events - Section 1
C1519255 (UMLS CUI-1)
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])
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])
Serious Adverse Event, Start Time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Outcome
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])
Serious Adverse Event, Adverse Event End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Maximum Intensity
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])
Serious Adverse Event, Action Taken with Study Treatment
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])
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])
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])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness
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)
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
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)
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])
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
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)
Item
Possible causes of SAE other than Investigational Product(s)
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Section 5 Possible causes of SAE other than Investigational Product(s)
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)
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])
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])
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])
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])
Item Group
Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
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])
Item Group
Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
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])
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])
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])
Serious Adverse Event, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
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])
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])
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])
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])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
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])
Item Group
Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
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])
Item Group
Details of Relevant Assessments
C1519255 (UMLS CUI-1)
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])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
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])
Item Group
Investigator's Confirmation
C1519255 (UMLS CUI-1)
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
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