ID

34625

Beskrivning

TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia

Nyckelord

Versioner (1)
  1. 2019-01-20 2019-01-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Engelsk

Period 2 Form

1 Formulär  
  1. StudyEvent: ODM
    1. Period 2 Form
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Urine Drug and Alcohol Screen
Beskrivning

Urine Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0038586
Date and time of sample taken
Beskrivning

Urine drug screening, Ethanol measurement, Sampling, Date in time, Time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202304
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Cocaine
Beskrivning

Urine drug screening, Cocaine

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Amphetamines
Beskrivning

Urine drug screening, Amphetamines

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
Benzodiazepines
Beskrivning

Urine drug screening, Benzodiazepines

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cannabinoids
Beskrivning

Urine drug screening, Cannabinoids

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Opiates
Beskrivning

Urine drug screening, Opiates

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0376196
Barbiturates
Beskrivning

Urine drug screening, Barbiturates

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Methadone
Beskrivning

Urine drug screening, Methadone

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0025605
Alcohol
Beskrivning

Urine drug screening, Ethanol measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202304
Cotinine
Beskrivning

Urine Cotinine measurement

Datatyp

text

Alias
UMLS CUI [1]
C1278256
Pregnancy Test
Beskrivning

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Date sample taken
Beskrivning

Pregnancy Tests, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Results
Beskrivning

Pregnancy test finding

Datatyp

text

Alias
UMLS CUI [1]
C0427777
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Beskrivning

Electronically transferred laboratory data (Blood) - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Planned Relative Time
Beskrivning

Chemistry, Clinical; Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beskrivning

Chemistry, Clinical; Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beskrivning

Chemistry, Clinical; Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data (Blood) - Haematology
Beskrivning

Electronically transferred laboratory data (Blood) - Haematology

Alias
UMLS CUI-1
C0018941
Planned Relative Time
Beskrivning

Hematologic tests, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beskrivning

Hematologic tests, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beskrivning

Hematologic tests; Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data (Urine) - Urinalysis
Beskrivning

Electronically transferred laboratory data (Urine) - Urinalysis

Alias
UMLS CUI-1
C0042014
Planned Relative Time
Beskrivning

Urinalysis, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beskrivning

Urinalysis, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beskrivning

Urinalysis, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Vital Signs Date

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beskrivning

Vital signs, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Actual Time
Beskrivning

Vital Signs Time

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure Supine - Systolic
Beskrivning

Systolic Pressure, Supine Position

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood Pressure Supine - Diastolic
Beskrivning

Diastolic blood pressure, Supine Position

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beskrivning

12 lead ECG, Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Date of ECG
Beskrivning

12 lead ECG, Start Date

Datatyp

date

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

12 lead ECG, Relative Time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start time of ECG
Beskrivning

12 lead ECG, Start time

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beskrivning

12 lead ECG, Ventricular Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Beskrivning

12 lead ECG, PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beskrivning

12 lead ECG, QRS complex duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beskrivning

12 lead ECG, QT interval - finding

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beskrivning

12 lead ECG, Electrocardiogram QT corrected interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
QRS Axis, if available
Beskrivning

12 lead ECG, QRS Axis

Datatyp

integer

Måttenheter
  • degrees
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429012
degrees
Result of the ECG
Beskrivning

12 lead ECG, Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Beskrivning

Electronically transferred laboratory data (Blood) - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Planned Relative Time
Beskrivning

Chemistry, Clinical; Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beskrivning

Chemistry, Clinical; Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beskrivning

Chemistry, Clinical; Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data (Blood) - Haematology
Beskrivning

Electronically transferred laboratory data (Blood) - Haematology

Alias
UMLS CUI-1
C0018941
Planned Relative Time
Beskrivning

Hematologic tests, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beskrivning

Hematologic tests, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beskrivning

Hematologic tests; Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data (Urine) - Urinalysis
Beskrivning

Electronically transferred laboratory data (Urine) - Urinalysis

Alias
UMLS CUI-1
C0042014
Planned Relative Time
Beskrivning

Urinalysis, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beskrivning

Urinalysis, Sampling, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beskrivning

Urinalysis, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Pharmacokinetics - Blood
Beskrivning

Pharmacokinetics - Blood

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

Pharmacokinetic aspects, Blood, Relative time, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Date Sample Taken
Beskrivning

Pharmacokinetic aspects, Blood, Sampling, Date in time

Datatyp

date

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

Pharmacokinetic aspects, Blood, Time

Datatyp

time

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

Pharmacokinetic aspects, Blood, Sample identification number

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Beskrivning

Experimental drug

Datatyp

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beskrivning

Experimental drug, Dosage, Date in time

Datatyp

date

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

Experimental drug, Dosage, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Total Daily Dose
Beskrivning

Experimental drug, Daily Dose

Datatyp

integer

Måttenheter
  • mg/day
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348070
mg/day
Treatment Confirmation
Beskrivning

Treatment Confirmation

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

Therapeutic procedure, Confirmation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
If No, record reason(s)
Beskrivning

Therapeutic procedure, Wrong, Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C3146298
Tillbaka till toppen

Similar models

Period 2 Form

1 Formulär
  1. StudyEvent: ODM
    1. Period 2 Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Urine Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0202274 (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
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methadone
text
C0202274 (UMLS CUI [1,1])
C0025605 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Methadone
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
text
C0202274 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cotinine
text
C1278256 (UMLS CUI [1])
Urine drug screening, Cocaine
Code List
Cotinine
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Tests, Sampling, Date in time
Item
Date sample taken
date
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Results
text
C0427777 (UMLS CUI [1])
Pregnancy test finding
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Electronically transferred laboratory data (Blood) - Clinical Chemistry
C0008000 (UMLS CUI-1)
Item
Planned Relative Time
text
C0008000 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
Chemistry, Clinical; Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Chemistry, Clinical; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Blood) - Haematology
C0018941 (UMLS CUI-1)
Item
Planned Relative Time
text
C0018941 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematologic tests; Time
Item
Actual Time
time
C0018941 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Urine) - Urinalysis
C0042014 (UMLS CUI-1)
Item
Planned Relative Time
text
C0042014 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Vital signs, Relative time, Planned
Code List
Planned Relative Time
CL Item
Predose (1)
CL Item
Predose (2)
CL Item
Predose (3)
CL Item
3 hrs (4)
Vital Signs Time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Pressure, Supine Position
Item
Blood Pressure Supine - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure, Supine Position
Item
Blood Pressure Supine - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
text
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG, Number
Code List
ECG Number
CL Item
ECG1 (1)
CL Item
ECG2 (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
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
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
12 lead ECG, Relative Time, Planned
Code List
Planned Relative Time
CL Item
Predose (1)
CL Item
Predose (2)
CL Item
Predose (3)
CL Item
3 hrs (4)
12 lead ECG, Start time
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (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 - finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
12 lead ECG, QRS Axis
Item
QRS Axis, if available
integer
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
Item
Result of the ECG
text
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
Electronically transferred laboratory data (Blood) - Clinical Chemistry
C0008000 (UMLS CUI-1)
Item
Planned Relative Time
text
C0008000 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
48 hr (48 hr)
Chemistry, Clinical; Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Chemistry, Clinical; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Blood) - Haematology
C0018941 (UMLS CUI-1)
Item
Planned Relative Time
text
C0018941 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
48 hr (48 hr)
Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematologic tests; Time
Item
Actual Time
time
C0018941 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Urine) - Urinalysis
C0042014 (UMLS CUI-1)
Item
Planned Relative Time
text
C0042014 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
48 hr (48 hr)
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pharmacokinetics - Blood
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])
C1301732 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Relative time, Planned
Code List
Planned Relative Time
CL Item
Predose (1)
CL Item
1 hr (2)
CL Item
1. hr (3)
CL Item
2h hr (4)
CL Item
2.5 hr (5)
CL Item
3 hr (6)
CL Item
4 hr (7)
CL Item
6 hr (8)
CL Item
8 hr (9)
CL Item
10 hr (10)
CL Item
12 hr (11)
CL Item
16 hr (12)
CL Item
24 hr (13)
CL Item
36 hr (14)
CL Item
48 hr (15)
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
text
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
201 (1)
CL Item
202 (2)
CL Item
203 (3)
CL Item
204 (4)
CL Item
205 (5)
CL Item
206 (6)
CL Item
207 (7)
CL Item
208 (8)
CL Item
209 (9)
CL Item
210 (10)
CL Item
211 (11)
CL Item
212 (12)
CL Item
213 (13)
CL Item
214 (14)
CL Item
215 (15)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Experimental drug
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Experimental drug, Daily Dose
Item
Total Daily Dose
integer
C0304229 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Indication
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
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