ID
31983
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 (6)
- 10/9/18 10/9/18 -
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 10/10/18 10/10/18 -
- 12/5/18 12/5/18 -
- 9/17/21 9/17/21 -
Copyright Holder
GSK group of companies
Uploaded on
October 10, 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
Screening visit
- StudyEvent: ODM
Description
Vital signs
Description
Height
Data type
integer
Description
Weight
Data type
float
Description
Body mass index
Data type
integer
Measurement units
- kg / m2
Description
Day Month Year e.g., 01 JAN 08
Data type
text
Description
e.g., 15 min
Data type
text
Description
HR : MN (00:00 - 23:59) e.g., 13:02
Data type
text
Description
Supine mmHg Systolic Diastolic e.g.,110 80
Data type
text
Measurement units
- mmHg
Description
beats/min e.g., 75
Data type
text
Measurement units
- bpm
Description
°C e.g., 36.5
Data type
float
Measurement units
- °C
Description
12-lead ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1623258
- UMLS CUI-3
- C0031809
Description
ECG Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348792
- UMLS CUI [1,2]
- C0430456
Description
Day Month Year
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
Planned Relative Time ECG
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
Description
Start Time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
Heart Rate
Data type
integer
Measurement units
- Beats/min
Alias
- UMLS CUI [1,1]
- C2189285
- UMLS CUI [1,2]
- C0430456
Description
PR Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C0430456
Description
QRS Duration
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Description
Uncorrected QT Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Description
1=Machine, 2=Manual For machine read ECGs, QTcB and/or QTcF can be collected.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0430456
Description
If machine, QTcB interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0430456
Description
If machine, QTcF interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0430456
Description
If machine, QTc interval unknown method of correction
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0430456
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Description
Important
Data type
text
Description
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
A. Rhythm
Data type
text
Description
B. P-Wave and QRS Morphology
Data type
integer
Description
C. Conduction
Data type
integer
Description
D. Myocardial Infraction
Data type
integer
Description
E. Depolarisation/Repolarisation (QRS-T)
Data type
integer
Description
Other abnormalities
Data type
integer
Description
Date of ECG
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1]
- C2826640
Description
Time of ECG
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Summary Holter (12HRS)
Description
Holter Results
Data type
text
Description
Start date of Holter
Data type
date
Description
Start time of Holter
Data type
time
Description
Stop time of Holter
Data type
time
Description
Interpretation of Holter tick one
Data type
text
Description
Holter monitoring method tick one
Data type
text
Description
Summary Holter Abnormalities
Description
tick all that apply
Data type
text
Description
Medical conditions
Description
Physical Examination
Description
Date of Assessment
Data type
date
Description
Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely: [different findings should be separated by either a (;) or a (/)].
Data type
text
Description
1. Head
Data type
text
Description
2. Eyes
Data type
text
Description
3. Ears
Data type
text
Description
4. Nose
Data type
text
Description
5. Throat
Data type
text
Description
6. Skin
Data type
text
Description
7. Thyroid
Data type
text
Description
8. Neurological
Data type
text
Description
9. Lungs
Data type
text
Description
10. Cardiovascular
Data type
text
Description
11. Abdomen (Liver and Spleen)
Data type
text
Description
12. Lymph Nodes
Data type
text
Description
13. Extremities
Data type
text
Description
Alcohol and Tobacco Use
Description
What is the subject's history of smoking use?
Data type
text
Description
When did the subject last smoke?
Data type
date
Description
If former smoker, answer the following:
Data type
text
Description
Date sample taken
Data type
date
Description
Does the subject consume alcohol?
Data type
text
Description
if Yes, do the following
Data type
float
Description
Date and time of sample taken
Data type
datetime
Description
Electronically transferred laboratory data
Description
Pharmacokinetics
Description
Inclusion and exclusion criteria
Description
Eligibility question
Data type
text
Description
tick the boxes corresponding to any of the inclusion criteria the subject failed.
Data type
text
Description
tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
text
Similar models
Screening visit
- StudyEvent: ODM
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C0013798 (UMLS CUI [1,2])