ID

41690

Description

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 P1 D-1, P1 D1, P2 D-1 and P2 D1 Visits and possible Repeat Measurements . Slight variations are remarked under the concerning items.

Keywords

Versions (2)
  1. 12/12/20 12/12/20 -
  2. 12/18/20 12/18/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 18, 2020

DOI

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License

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

English

Vital Signs, P1 D-1, P1 D1, P2 D-1, P2 D1 and Repeats

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit
Description

date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
subject ID
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
visit type
Description

visit type

Data type

text

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

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
Description

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

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Vital Signs Measurement
Description

Vital Signs Measurement

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0242485
actual date and time
Description

vital signs: actual date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0518766
UMLS CUI [2,2]
C0040223
time relative to dosing
Description

for the Repeats Visit, the following measurements have to be executed and filled out once. for the P1, D-1 and P2 D-1 visit, the following measurements have to be executed and filled out three times. for the P1 D1 and P2 D1 visit, the following measurements have to be executed and filled out three times pre-dose, three times 4 hours after the administration of the dosis, three times 8 hours after the administration of the dosis and three times 12 hours after the administration of the dosis.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
systolic blood pressure
Description

systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
diastolic blood pressure
Description

diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
heart rate
Description

heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Vital Signs, P1 D-1, P1 D1, P2 D-1, P2 D1 and Repeats

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
P1 D-1 (1)
CL Item
P1 D1 (2)
CL Item
P2 D-1 (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])
C0040223 (UMLS CUI [1,4])
Item Group
Vital Signs Measurement
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
vital signs: actual date and time
Item
actual date and time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item
time relative to dosing
text
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
time relative to dosing
Code List
time relative to dosing
CL Item
D-1 Measurement 1 (1)
CL Item
D-1 Measurement 2 (2)
CL Item
D-1 Measurement 3 (3)
CL Item
Pre-Dose Measurement 1 (4)
CL Item
Pre-Dose Measurement 2 (5)
CL Item
Pre-Dose Measurement 3 (6)
CL Item
4hr Measurement 1 (7)
CL Item
4hr Measurement 2 (8)
CL Item
4hr Measurement 3 (9)
CL Item
8hr Measurement 1 (10)
CL Item
8hr Measurement 2 (11)
CL Item
8hr Measurement 3 (12)
CL Item
12hr Measurement 1 (13)
CL Item
12hr Measurement 2 (14)
CL Item
12hr Measurement 3 (15)
CL Item
Repeats Measurement (16)
systolic blood pressure
Item
systolic blood pressure
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
heart rate
Item
heart rate
integer
C0018810 (UMLS CUI [1])
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