ID

33532

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 (5)
  1. 10/10/18 10/10/18 -
  2. 10/10/18 10/10/18 -
  3. 10/10/18 10/10/18 -
  4. 10/10/18 10/10/18 -
  5. 12/11/18 12/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 11, 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

English

Study Period

1 forms  
  1. StudyEvent: ODM
    1. Study Period
Drug and Alcohol Screen Day -1
Description

Drug and Alcohol Screen Day -1

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
Date and time of sample taken
Description

Drug Screen, Ethanol Measurement, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0202304
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Physical Examination Day -1
Description

Physical Examination Day -1

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Physical Examination, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985720
Skin - Change from Baseline
Description

Physical Examination, Skin

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
Lungs - Change from Baseline
Description

Physical Examination, Lung

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Cardiovascular - Change from Baseline
Description

Physical Examination, Cardiovascular system

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
Abdomen (liver and spleen) - Change from Baseline
Description

Physical Examination, Abdomen

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Electronically transferred laboratory data - Clinical Chemistry - Day -1
Description

Electronically transferred laboratory data - Clinical Chemistry - Day -1

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Planned Relative Time
Description

Laboratory Procedures, Chemistry, Clinical, Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0439564
Date Sample Taken
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Chemistry, Clinical, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Electronically transferred laboratory data - Haematology - Day -1
Description

Electronically transferred laboratory data - Haematology - Day -1

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Planned Relative Time
Description

Laboratory Procedures, Haematology finding, Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0439564
Date Sample Taken
Description

Laboratory Procedures, Haematology finding, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Haematology finding, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0040223
Electronically transferred laboratory data - Urinalysis - Day -1
Description

Electronically transferred laboratory data - Urinalysis - Day -1

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
Planned Relative Time
Description

Laboratory Procedures, Urinalysis, Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0439564
Date Sample Taken
Description

Laboratory Procedures, Urinalysis, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Urinalysis, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0040223
Pharmacokinetics - Blood - Day -1
Description

Pharmacokinetics - Blood - Day -1

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Description

Pharmacokinetic aspects, Blood, Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Description

Pharmacokinetic aspects, Blood, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Pharmacokinetic aspects, Blood, Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
Sample Number
Description

Pharmacokinetic aspects, Blood, Sample identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Vital signs Day 1
Description

Vital signs Day 1

Alias
UMLS CUI-1
C0518766
Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Planned relative time
Description

Vital Signs, Relative time

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure, Supine
Description

Systolic Pressure, Supine Position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood Pressure - Supine
Description

Diastolic blood pressure, Supine Position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature, Oral
Description

Body Temperature, Oral

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
12-Lead-ECG Day 1
Description

12-Lead-ECG Day 1

Alias
UMLS CUI-1
C0430456
ECG Number
Description

12 lead ECG, Electrocardiography, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1623258
UMLS CUI [1,3]
C0237753
Start date of ECG
Description

12 lead ECG, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Description

12 lead ECG, Relative Time

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Description

12 lead ECG, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart Rate
Description

12 lead ECG, Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Description

12 lead ECG, PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG, QRS Complex Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 Lead ECG, QT interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
Method of measurement
Description

For Machine reads QTcB Interval, and/or QTcF can be collected

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1299991
QTcB Interval
Description

12 lead ECG, QTcB - Bazett's Correction Formula

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1882512
msec
QTcF Interval
Description

12 lead ECG, QTcF - Fridericia's Correction Formula

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1882513
msec
QTc Interval unknown method of correction
Description

12 lead ECG, Electrocardiogram QT corrected interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Description

12 lead ECG, Result

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
12 LEAD ECG Abnormalities Day 1
Description

12 LEAD ECG Abnormalities Day 1

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
ECG Number
Description

12 lead ECG, Electrocardiography, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1623258
UMLS CUI [1,3]
C0237753
Date of ECG
Description

12 lead ECG, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Time of ECG
Description

12 lead ECG, Time

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
Rhythm
Description

12 lead ECG, Abnormality, Electrocardiogram, rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
P-Wave and QRS Morphology
Description

12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
UMLS CUI [1,4]
C0429098
Conduction
Description

12 lead ECG, Abnormality, Cardiac conduction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Myocardial Infarction
Description

12 lead ECG, Abnormality, Myocardial Infarction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Depolarisation/Repolarisation (QRS-T)
Description

12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Other abnormalities
Description

12 Lead ECG, Abnormality, Other

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
Randomisation Number Day 1
Description

Randomisation Number Day 1

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number
Description

Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigational Product Day 1
Description

Investigational Product Day 1

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

Experimental Drug

Data type

text

Alias
UMLS CUI [1]
C0304229
Date of Actual Dose
Description

Experimental drug, Dosage, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Actual Dose
Description

Experimental drug, Dosage, Time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Actual Dose
Description

Experimental Drug, Medication dose

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3174092
Units
Description

Experimental drug, Unit of measure

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519795
Route
Description

Experimental drug, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0013153
Formulation
Description

Experimental drug, Pharmaceutical Formulation

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1705957
Treatment Confirmation Day 1
Description

Treatment Confirmation Day 1

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment that the subject was assigned to) during this dosing interval?
Description

Therapeutic procedure, Correct

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
If No, record reason(s)
Description

Therapeutic procedure, Incorrect, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Pharmacokinetics Blood Day 1
Description

Pharmacokinetics Blood Day 1

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Description

Pharmacokinetic aspects, Blood, Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Description

Pharmacokinetic aspects, Blood, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Pharmacokinetic aspects, Blood, Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
Sample Number
Description

Pharmacokinetic aspects, Blood, Sample identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Pharmacokinetics Blood (Metabolite Samples) Day 1
Description

Pharmacokinetics Blood (Metabolite Samples) Day 1

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0870883
Planned Relative Time
Description

Pharmacokinetic aspects, Blood, Metabolite, Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870883
UMLS CUI [1,4]
C0439564
Date Sample Taken
Description

Pharmacokinetic aspects, Blood, Metabolite, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870883
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0011008
Actual Time
Description

Pharmacokinetic aspects, Blood, Metabolite, Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870883
UMLS CUI [1,4]
C0040223
Sample Number
Description

Pharmacokinetic aspects, Blood, Metabolite, Sample identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870883
UMLS CUI [1,4]
C1299222
Pharmacokinetic Sampling Urine Interval Collection Data Day 1
Description

Pharmacokinetic Sampling Urine Interval Collection Data Day 1

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Planned Relative Time Interval
Description

Pharmacokinetic aspects, Urine, Relative time, Interval

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1272706
Start Date
Description

Pharmacokinetic aspects, Urine, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0808070
Actual Start Time
Description

Pharmacokinetic aspects, Urine, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C1301880
Stop Date
Description

Pharmacokinetic aspects, Urine, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0806020
Actual Stop Time
Description

Pharmacokinetic aspects, Urine, End Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C1522314
Total Sample Weight
Description

Pharmacokinetic aspects, Urine, Sample weight

Data type

float

Measurement units
  • g
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0807984
g
Sample number
Description

Pharmacokinetic aspects, Urine, Sample identification number

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C1299222
Pharmacokinetic Sampling Faeces Interval Collection Data Day 1
Description

Pharmacokinetic Sampling Faeces Interval Collection Data Day 1

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0015733
Planned Relative Time Interval
Description

Pharmacokinetic aspects, Faeces, Relative time, Interval

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0015733
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1272706
Start Date
Description

Pharmacokinetic aspects, Faeces, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0015733
UMLS CUI [1,3]
C0808070
Actual Start Time
Description

Pharmacokinetic aspects, Faeces, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0015733
UMLS CUI [1,3]
C1301880
Stop Date
Description

Pharmacokinetic aspects, Faeces, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0015733
UMLS CUI [1,3]
C0806020
Actual Stop Time
Description

Pharmacokinetic aspects, Faeces, End Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0015733
UMLS CUI [1,3]
C1522314
Total Sample Weight
Description

Pharmacokinetic aspects, Faeces, Sample weight

Data type

float

Measurement units
  • g
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0015733
UMLS CUI [1,3]
C0807984
g
Sample number
Description

Pharmacokinetic aspects, Faeces, Sample identification number

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0015733
UMLS CUI [1,3]
C1299222
Entero-Test (Day 1, 2 hrs - 6.5 hrs Post-Dose)
Description

Entero-Test (Day 1, 2 hrs - 6.5 hrs Post-Dose)

Alias
UMLS CUI-1
C0430722
Planned Relative Time Interval
Description

Entero string test, Relative time, Interval

Data type

integer

Alias
UMLS CUI [1,1]
C0430722
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1272706
Procedure
Description

Entero string test, Interventional Procedure

Data type

text

Alias
UMLS CUI [1,1]
C0430722
UMLS CUI [1,2]
C0184661
Start Date
Description

Entero string test, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0430722
UMLS CUI [1,2]
C0808070
Start Time
Description

Entero string test, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1301880
Stop Time
Description

Entero string test, End Time

Data type

time

Alias
UMLS CUI [1,1]
C0430722
UMLS CUI [1,2]
C1522314
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Similar models

Study Period

1 forms
  1. StudyEvent: ODM
    1. Study Period
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Drug and Alcohol Screen Day -1
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
Drug Screen, Ethanol Measurement, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0373483 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Physical Examination Day -1
C0031809 (UMLS CUI-1)
Physical Examination, Assessment Date
Item
Date of Assessment
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Physical Examination, Skin
Item
Skin - Change from Baseline
boolean
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
Physical Examination, Lung
Item
Lungs - Change from Baseline
boolean
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Physical Examination, Cardiovascular system
Item
Cardiovascular - Change from Baseline
boolean
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
Physical Examination, Abdomen
Item
Abdomen (liver and spleen) - Change from Baseline
boolean
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Clinical Chemistry - Day -1
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedures, Haematology finding, Relative Time
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
CL Item
Unscheduled (Unscheduled)
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Electronically transferred laboratory data - Haematology - Day -1
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedures, Haematology finding, Relative Time
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
CL Item
Unscheduled (Unscheduled)
Laboratory Procedures, Haematology finding, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Haematology finding, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Electronically transferred laboratory data - Urinalysis - Day -1
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedures, Haematology finding, Relative Time
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
CL Item
Unscheduled (Unscheduled)
Laboratory Procedures, Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Pharmacokinetics - Blood - Day -1
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedures, Haematology finding, Relative Time
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
CL Item
Unscheduled (Unscheduled)
Pharmacokinetic aspects, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Sample identification number
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Item Group
Vital signs Day 1
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned relative time
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
0.5 hrs (4)
CL Item
1 hr (5)
CL Item
2 hrs (6)
CL Item
6 hrs (7)
CL Item
12 hrs (8)
CL Item
Unscheduled (9)
CL Item
Unscheduled (10)
CL Item
Unscheduled (11)
CL Item
Unscheduled (12)
CL Item
Unscheduled (13)
CL Item
Unscheduled (14)
CL Item
Unscheduled (15)
CL Item
Unscheduled (16)
Vital Signs Time
Item
Actual time
time
C2826762 (UMLS CUI [1])
Systolic Pressure, Supine Position
Item
Systolic Blood Pressure, Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure, Supine Position
Item
Diastolic Blood Pressure - Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature, Oral
Item
Temperature, Oral
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
Item Group
12-Lead-ECG Day 1
C0430456 (UMLS CUI-1)
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
12 lead ECG, Electrocardiography, Numbers
Code List
ECG Number
CL Item
ECG1 (1)
CL Item
ECG2 (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
CL Item
ECG5 (5)
CL Item
ECG6 (6)
CL Item
ECG7 (7)
CL Item
ECG8 (8)
CL Item
ECG9 (9)
CL Item
ECG10 (10)
CL Item
ECG11 (11)
CL Item
ECG12 (12)
CL Item
ECG13 (13)
CL Item
ECG14 (14)
CL Item
ECG15 (15)
CL Item
ECG16 (16)
12 lead ECG, Start Date
Item
Start date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
0.5 hrs (4)
CL Item
1 hr (5)
CL Item
2 hrs (6)
CL Item
6 hrs (7)
CL Item
12 hrs (8)
CL Item
Unscheduled (9)
CL Item
Unscheduled (10)
CL Item
Unscheduled (11)
CL Item
Unscheduled (12)
CL Item
Unscheduled (13)
CL Item
Unscheduled (14)
CL Item
Unscheduled (15)
CL Item
Unscheduled (16)
12 lead ECG, Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Heart Rate
Item
Heart Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS Complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 Lead ECG, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Item
Method of measurement
text
C0430456 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])
12 lead ECG, Measurement method
Code List
Method of measurement
CL Item
Machine (1)
CL Item
Manual (2)
12 lead ECG, QTcB - Bazett's Correction Formula
Item
QTcB Interval
integer
C0430456 (UMLS CUI [1,1])
C1882512 (UMLS CUI [1,2])
12 lead ECG, QTcF - Fridericia's Correction Formula
Item
QTcF Interval
integer
C0430456 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval unknown method of correction
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12 LEAD ECG Abnormalities Day 1
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
12 lead ECG, Electrocardiography, Numbers
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Rhythm
Code List
Rhythm
CL Item
[A 1] Sinus bradycardia (1)
CL Item
[A21] Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
[A22] Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
[A23] Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
[A 3] Sinus pause (5)
CL Item
[A 2] Sinus tachycardia (6)
CL Item
[A 4] Ectropic supraventricular beats (7)
CL Item
[A20] Ectropic supraventricular rythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate > 100 beats/min) (10)
CL Item
[A 6] Supraventricular tachycardia (Heart rate > 100 beats/min) (11)
CL Item
[A 7] Atrial flutter (12)
CL Item
[A 8] Atrial fibrillation (13)
CL Item
[A 5] Junctional rhythm (heart rate <100 beats/min) (14)
CL Item
[A25] Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 beats/min) (16)
CL Item
[A 9] Ectopic ventricular beats (17)
CL Item
[A 12] Ventricular couplets (18)
CL Item
[A 13] Bigeminy (19)
CL Item
[A 28] Trigeminy (20)
CL Item
[A 14] Electrical alternans (21)
CL Item
[A 29] R on T phenomenon (22)
CL Item
[A 18] Ventricular fibrillation (23)
CL Item
[A 19] Idioventricular rhythm (heart rate >100 beats/min) (24)
CL Item
[A 10] Sustained ventricular tachycardia (25)
CL Item
[A 11] Non-sustained ventricular tachycardia (26)
CL Item
[A 32] Wide QRS tachycardia (diagnosis unknown) (27)
CL Item
[A 33] Sinus arrhythmia (28)
CL Item
[A 27] Ventricular arrhythmia (29)
CL Item
[A 30] Monomorphic ventricular tachycardia (30)
CL Item
[A 15] Torsade de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (31)
CL Item
[A 31] Polymorphic (sustained and non-sustained) ventricular tachycardia (32)
CL Item
[A 16] Artificial pacemaker (33)
CL Item
[A 35] Atrial premature complex (34)
CL Item
[A 99] Other abnormal rhythm (35)
Item
P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
P-Wave and QRS Morphology
Code List
P-Wave and QRS Morphology
CL Item
[B 3] right ventricular hypertrophy (1)
CL Item
[B 5] Intraatrial conduction delay (2)
CL Item
[B 7] Poor R wave progression (3)
CL Item
[B 9] Left atrial abnormality (4)
CL Item
[B10] Right atrial abnormality (5)
CL Item
[A12] Ventricular couplets (6)
CL Item
[A13] Bigeminy (7)
CL Item
[A28] Trigeminy (8)
CL Item
[A14] Electrical alternans (9)
CL Item
[A29] R on T phenomenon (10)
CL Item
[A18] Ventricular vebrilation (11)
CL Item
[A19] Indioventricular rhythm (heart rate < 100 bpm) (12)
CL Item
[A10] Sustained ventricular tachycardia (13)
CL Item
[A11] Non-sustained ventricular tachycardia  (14)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A27] Ventricular tachycardia  (16)
CL Item
[A30] Monomorphic ventricular tachycardia  (17)
CL Item
[A15] Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (18)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (19)
CL Item
[A16] Artificial pacemaker  (20)
CL Item
[A35] Atrial premature complex (21)
CL Item
[A99]Other abnormal rhythm  (22)
CL Item
[B16] Late R wave transition (23)
CL Item
[D14] Increased voltage consistent with left ventricular hypertrophy (24)
CL Item
[B99] Other morphology (25)
Item
Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
Conduction
Code List
Conduction
CL Item
[C 1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C 2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C 3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block  (5)
CL Item
[C 4] Third degree AV block (6)
CL Item
[C 5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C 6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C 7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C 8] Right bundle branch block  (11)
CL Item
[C 14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
[C 15] Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
[C 9] Left bundle branch block  (14)
CL Item
[C 17] Bifascicular block (15)
CL Item
[C 10] Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (16)
CL Item
[C 11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
[C 18] AV dissociation (18)
CL Item
[C 28] Prolonged QT 450-500 (19)
CL Item
[C 29] Prolonged QT >500 (20)
CL Item
[C 30] Prolonged QTc interval 450-500 (21)
CL Item
[C 31] Prolonged QTc interval >500 (22)
CL Item
[C 99] Other Conduction (23)
Item
Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
Myocardial Infraction
Code List
Myocardial Infarction
CL Item
[D 1] Myocardial infarction, old (1)
CL Item
[D 2] Myocardial infarction, anterior (2)
CL Item
[D 3] Myocardial infarction, lateral (3)
CL Item
[D 4] Myocardial infarction, posterior (4)
CL Item
[D 5] Myocardial infarction, inferior (5)
CL Item
[D 6] Myocardial infarction, septal (6)
CL Item
[D 20] Myocardial infarction, Non-Q wave (7)
CL Item
[D 98] Other myocardial infarction (8)
Item
Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
Depolarisation/Repolarisation (QRS-T)
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
[D 7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D 8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D 9] ST depression (5)
CL Item
[D96] ST segment abnormality, not specified (6)
CL Item
[D10] U waves abnormal (7)
CL Item
[D11] T wave inversion (8)
CL Item
[D12] T wave peaked (9)
CL Item
[D15] T waves flat (10)
CL Item
[D16] T waves biphasic (11)
CL Item
[D18] Notched T waves (12)
CL Item
[D13] Low QRS voltage (13)
CL Item
[D17] T-wave flattening/inversion (14)
CL Item
[D22] Juvenile T-wave pattern, early repolarization (15)
CL Item
[D97] T-wave abnormality, not specified (16)
CL Item
[D99] Other depolarization/repolarization (17)
Item
Other abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other abnormalities
Code List
Other abnormalities
Item Group
Randomisation Number Day 1
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomization, Numbers
Item
Record randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Investigational Product Day 1
C0304229 (UMLS CUI-1)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Investigational product Day 1
Code List
Investigational Product
CL Item
14C-GW642444 (14C-GW642444)
Experimental drug, Dosage, Date in time
Item
Date of Actual Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Actual Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Actual Dose
integer
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Experimental Drug, Medication dose
Code List
Actual Dose
CL Item
200 (1)
Item
Units
text
C0304229 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Experimental drug, Unit of measure
Code List
Units
CL Item
µg (µg)
Item
Route
text
C0304229 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Experimental drug, Drug Administration Routes
Code List
Route
CL Item
PO (PO)
Item
Formulation
text
C0304229 (UMLS CUI [1,1])
C1705957 (UMLS CUI [1,2])
Experimental drug, Pharmaceutical Formulation
Code List
Formulation
CL Item
SOL (SOL)
Item Group
Treatment Confirmation Day 1
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Correct
Item
Did the subject receive the correct treatment (e.g., treatment that the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic procedure, Incorrect, Reason and justification
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Pharmacokinetics Blood Day 1
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Laboratory Procedures, Haematology finding, Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
0.25 hrs (2)
CL Item
0.5 hrs (3)
CL Item
0.75 hrs (4)
CL Item
1 hr (5)
CL Item
1.25 hrs (6)
CL Item
1.5 hrs (7)
CL Item
2 hrs (8)
CL Item
2.5 hrs (9)
CL Item
3 hrs (10)
CL Item
3.5 hrs (11)
CL Item
4 hrs (12)
CL Item
5 hrs (13)
CL Item
6 hrs (14)
CL Item
12 hrs (15)
CL Item
24 hrs (16)
CL Item
48 hrs (17)
CL Item
72 hrs (18)
CL Item
96 hrs (19)
CL Item
120 hrs (20)
CL Item
144 hrs (21)
CL Item
168 hrs (22)
CL Item
Unscheduled (23)
CL Item
Unscheduled (24)
CL Item
Unscheduled (25)
CL Item
Unscheduled (26)
Pharmacokinetic aspects, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Sample identification number
Code List
Sample Number
CL Item
103 (1)
CL Item
107 (2)
CL Item
108 (3)
CL Item
110 (4)
CL Item
111 (5)
CL Item
112 (6)
CL Item
113 (7)
CL Item
115 (8)
CL Item
116 (9)
CL Item
117 (10)
CL Item
119 (11)
CL Item
120 (12)
CL Item
121 (13)
CL Item
122 (14)
CL Item
124 (15)
CL Item
125 (16)
CL Item
129 (17)
CL Item
132 (18)
CL Item
135 (19)
CL Item
138 (20)
CL Item
141 (21)
CL Item
144 (22)
Item Group
Pharmacokinetics Blood (Metabolite Samples) Day 1
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0870883 (UMLS CUI-3)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870883 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
Laboratory Procedures, Haematology finding, Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
0.25 hrs (2)
CL Item
0.5 hrs (3)
CL Item
0.75 hrs (4)
CL Item
1 hr (5)
CL Item
1.25 hrs (6)
CL Item
1.5 hrs (7)
CL Item
2 hrs (8)
CL Item
2.5 hrs (9)
CL Item
3 hrs (10)
CL Item
3.5 hrs (11)
CL Item
4 hrs (12)
CL Item
5 hrs (13)
CL Item
6 hrs (14)
CL Item
12 hrs (15)
CL Item
24 hrs (16)
CL Item
48 hrs (17)
CL Item
72 hrs (18)
CL Item
96 hrs (19)
CL Item
120 hrs (20)
CL Item
144 hrs (21)
CL Item
168 hrs (22)
CL Item
Unscheduled (23)
CL Item
Unscheduled (24)
CL Item
Unscheduled (25)
CL Item
Unscheduled (26)
Pharmacokinetic aspects, Blood, Metabolite, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870883 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Pharmacokinetic aspects, Blood, Metabolite, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870883 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870883 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sample identification number
Code List
Sample Number
CL Item
103 (1)
CL Item
107 (2)
CL Item
108 (3)
CL Item
110 (4)
CL Item
111 (5)
CL Item
112 (6)
CL Item
113 (7)
CL Item
115 (8)
CL Item
116 (9)
CL Item
117 (10)
CL Item
119 (11)
CL Item
120 (12)
CL Item
121 (13)
CL Item
122 (14)
CL Item
124 (15)
CL Item
125 (16)
CL Item
129 (17)
CL Item
132 (18)
CL Item
135 (19)
CL Item
138 (20)
CL Item
141 (21)
CL Item
144 (22)
Item Group
Pharmacokinetic Sampling Urine Interval Collection Data Day 1
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
Item
Planned Relative Time Interval
text
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1272706 (UMLS CUI [1,4])
Planned relative time interval
Code List
Planned Relative Time Interval
CL Item
Pre-dose (1)
CL Item
0 hr - 24 hrs (2)
CL Item
24 hr - 48 hrs (3)
CL Item
48 hrs - 72 hrs (4)
CL Item
72 hrs - 96 hrs (5)
CL Item
96 hrs - 120 hrs (6)
CL Item
120 hrs - 144 hrs (7)
CL Item
144 hrs - 168 hrs (8)
CL Item
168 hrs - 192 hrs (9)
CL Item
192 hrs - 216 hrs (10)
CL Item
216 hrs - 240 hrs (11)
CL Item
unscheduled (12)
CL Item
unscheduled (13)
CL Item
unscheduled (14)
Pharmacokinetic aspects, Urine, Start Date
Item
Start Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Pharmacokinetic aspects, Urine, Start Time
Item
Actual Start Time
time
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Pharmacokinetic aspects, Urine, End Date
Item
Stop Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Pharmacokinetic aspects, Urine, End Time
Item
Actual Stop Time
time
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Pharmacokinetic aspects, Urine, Sample weight
Item
Total Sample Weight
float
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0807984 (UMLS CUI [1,3])
Item
Sample number
text
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Sample number
Code List
Sample number
CL Item
105 (1)
CL Item
127 (2)
CL Item
130 (3)
CL Item
133 (4)
CL Item
136 (5)
CL Item
139 (6)
CL Item
142 (7)
CL Item
145 (8)
CL Item
147 (9)
CL Item
149 (10)
CL Item
151 (11)
Item Group
Pharmacokinetic Sampling Faeces Interval Collection Data Day 1
C0031328 (UMLS CUI-1)
C0015733 (UMLS CUI-2)
Item
Planned Relative Time Interval
text
C0031328 (UMLS CUI [1,1])
C0015733 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1272706 (UMLS CUI [1,4])
Planned relative time interval
Code List
Planned Relative Time Interval
CL Item
Pre-dose (1)
CL Item
0 hr - 24 hrs (2)
CL Item
24 hr - 48 hrs (3)
CL Item
48 hrs - 72 hrs (4)
CL Item
72 hrs - 96 hrs (5)
CL Item
96 hrs - 120 hrs (6)
CL Item
120 hrs - 144 hrs (7)
CL Item
144 hrs - 168 hrs (8)
CL Item
168 hrs - 192 hrs (9)
CL Item
192 hrs - 216 hrs (10)
CL Item
216 hrs - 240 hrs (11)
CL Item
240 hrs - 264 hrs (12)
CL Item
264-288 hrs (13)
CL Item
288 hrs - 312 hrs (14)
CL Item
312 hrs - 336 hrs (15)
CL Item
unscheduled (16)
Pharmacokinetic aspects, Faeces, Start Date
Item
Start Date
date
C0031328 (UMLS CUI [1,1])
C0015733 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Pharmacokinetic aspects, Faeces, Start Time
Item
Actual Start Time
time
C0031328 (UMLS CUI [1,1])
C0015733 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Pharmacokinetic aspects, Faeces, End Date
Item
Stop Date
date
C0031328 (UMLS CUI [1,1])
C0015733 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Pharmacokinetic aspects, Faeces, End Time
Item
Actual Stop Time
time
C0031328 (UMLS CUI [1,1])
C0015733 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Pharmacokinetic aspects, Faeces, Sample weight
Item
Total Sample Weight
float
C0031328 (UMLS CUI [1,1])
C0015733 (UMLS CUI [1,2])
C0807984 (UMLS CUI [1,3])
Item
Sample number
text
C0031328 (UMLS CUI [1,1])
C0015733 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Sample number
Code List
Sample number
CL Item
106 (1)
CL Item
128 (2)
CL Item
131 (3)
CL Item
134 (4)
CL Item
137 (5)
CL Item
140 (6)
CL Item
143 (7)
CL Item
146 (8)
CL Item
148 (9)
CL Item
150 (10)
CL Item
152 (11)
CL Item
153 (12)
CL Item
154 (13)
CL Item
155 (14)
CL Item
156 (15)
Item Group
Entero-Test (Day 1, 2 hrs - 6.5 hrs Post-Dose)
C0430722 (UMLS CUI-1)
Item
Planned Relative Time Interval
integer
C0430722 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
Planned relative time interval
Code List
Planned Relative Time Interval
CL Item
2 (1)
CL Item
5.5 (2)
CL Item
6.5 (3)
Item
Procedure
text
C0430722 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Procedure
Code List
Procedure
CL Item
Insert capsule (1)
CL Item
Food stimulus (2)
CL Item
Remove string (3)
Entero string test, Start Date
Item
Start Date
date
C0430722 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Entero string test, Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Entero string test, End Time
Item
Stop Time
time
C0430722 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
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