ID

34627

Beschreibung

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

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Versionen (1)
  1. 20.01.19 20.01.19 -
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GlaxoSmithKline

Hochgeladen am

20. Januar 2019

DOI

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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Englisch

Unscheduled Assessments Form

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Vital Signs Date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beschreibung

Vital signs, Relative time, Planned

Datentyp

text

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

Vital Signs Time

Datentyp

time

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

Systolic Pressure, Supine Position

Datentyp

integer

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

Diastolic blood pressure, Supine Position

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschreibung

12 lead ECG, Number

Datentyp

text

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

12 lead ECG, Start Date

Datentyp

date

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

12 lead ECG, Relative Time, Planned

Datentyp

text

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

12 lead ECG, Start time

Datentyp

time

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

12 lead ECG, Ventricular Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Beschreibung

12 lead ECG, PR Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschreibung

12 lead ECG, QRS complex duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschreibung

12 lead ECG, QT interval - finding

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschreibung

12 lead ECG, Electrocardiogram QT corrected interval

Datentyp

integer

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

12 lead ECG, QRS Axis

Datentyp

integer

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

12 lead ECG, Result

Datentyp

text

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

Electronically transferred laboratory data (Blood) - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Planned Relative Time
Beschreibung

Chemistry, Clinical; Relative time, Planned

Datentyp

text

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

Chemistry, Clinical; Sampling, Date in time

Datentyp

date

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

Chemistry, Clinical; Time

Datentyp

time

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

Electronically transferred laboratory data (Blood) - Haematology

Alias
UMLS CUI-1
C0018941
Planned Relative Time
Beschreibung

Hematologic tests, Relative time, Planned

Datentyp

text

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

Hematologic tests, Sampling, Date in time

Datentyp

date

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

Hematologic tests; Time

Datentyp

time

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

Electronically transferred laboratory data (Urine) - Urinalysis

Alias
UMLS CUI-1
C0042014
Planned Relative Time
Beschreibung

Urinalysis, Relative time, Planned

Datentyp

text

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

Urinalysis, Sampling, Date in time

Datentyp

date

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

Urinalysis, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
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Ähnliche Modelle

Unscheduled Assessments Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
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
Unscheduled (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
CL Item
Unscheduled (4)
CL Item
Unscheduled (5)
CL Item
Unscheduled (6)
CL Item
Unscheduled (7)
CL Item
Unscheduled (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)
CL Item
Unscheduled (17)
CL Item
Unscheduled (18)
CL Item
Unscheduled (19)
CL Item
Unscheduled (20)
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)
CL Item
ECG5 (5)
CL Item
ECG6 (6)
CL Item
ECG7 (7)
CL Item
ECG8 (8)
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
Unscheduled (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
CL Item
Unscheduled (4)
CL Item
Unscheduled (5)
CL Item
Unscheduled (6)
CL Item
Unscheduled (7)
CL Item
Unscheduled (8)
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
Unscheduled (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
CL Item
Unscheduled (4)
CL Item
Unscheduled (5)
CL Item
Unscheduled (6)
CL Item
Unscheduled (7)
CL Item
Unscheduled (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)
CL Item
Unscheduled (17)
CL Item
Unscheduled (18)
CL Item
Unscheduled (19)
CL Item
Unscheduled (20)
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
Unscheduled (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
CL Item
Unscheduled (4)
CL Item
Unscheduled (5)
CL Item
Unscheduled (6)
CL Item
Unscheduled (7)
CL Item
Unscheduled (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)
CL Item
Unscheduled (17)
CL Item
Unscheduled (18)
CL Item
Unscheduled (19)
CL Item
Unscheduled (20)
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
Unscheduled (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
CL Item
Unscheduled (4)
CL Item
Unscheduled (5)
CL Item
Unscheduled (6)
CL Item
Unscheduled (7)
CL Item
Unscheduled (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)
CL Item
Unscheduled (17)
CL Item
Unscheduled (18)
CL Item
Unscheduled (19)
CL Item
Unscheduled (20)
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])
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