ID

41681

Beschreibung

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening Visit, the P1 D1 and P2 D1, the Follow-Up Visit and whenever a repeat ECG measurement was conducted during the study.

Stichworte

Versionen (1)
  1. 12.12.20 12.12.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. Dezember 2020

DOI

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Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

Englisch

12-Lead ECG

1 Formulare  
  1. StudyEvent: ODM
    1. 12-Lead ECG
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit
Beschreibung

date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
subject ID
Beschreibung

subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
visit type
Beschreibung

visit type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date and time
Beschreibung

Dosing date and time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
dosing date and time
Beschreibung

this item only needs to be filled out for the P1 D1 and P2 D1 visit

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
date of ECG
Beschreibung

this item only needs to be filled out for the Screening Visit , Follow-Up Visit and possible Repeat Visits.

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
time relative to dosing
Beschreibung

this item only has to be filled out for the P1 D1 and P2 D1 visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0178602
time of ECG
Beschreibung

time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
ECG: heart rate
Beschreibung

ECG: heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
ECG: PR interval
Beschreibung

ECG: PR interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
ECG: QRS duration
Beschreibung

ECG: QRS duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
ECG: uncorrected QT-interval
Beschreibung

ECG: uncorrected QT-interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
ECG: QTc interval
Beschreibung

ECG: QTc interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
result of the ECG
Beschreibung

result of the ECG

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
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Ähnliche Modelle

12-Lead ECG

1 Formulare
  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit
Item
date of visit
date
C1320303 (UMLS CUI [1])
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Screening Visit (1)
CL Item
Follow-Up Visit (2)
CL Item
P1 D1 (3)
CL Item
P2 D1 (4)
CL Item
Repeats (5)
Item Group
Dosing date and time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
dosing date and time
Item
dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
date of ECG
Item
date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
time relative to dosing
text
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
time relative to dosing
Code List
time relative to dosing
CL Item
pre-dose 1 of 3 (1)
CL Item
pre-dose 2 of 3 (2)
CL Item
pre-dose 3 of 3 (3)
CL Item
3 hour (4)
time of ECG
Item
time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
ECG: heart rate
Item
ECG: heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
ECG: PR interval
Item
ECG: PR interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
ECG: QRS duration
Item
ECG: QRS duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
ECG: uncorrected QT-interval
Item
ECG: uncorrected QT-interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
ECG: QTc interval
Item
ECG: QTc interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
result of the ECG
Code List
result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
no result (not available) (4)
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