ID

41678

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 Screening Visit.

Keywords

Versions (1)
  1. 12/12/20 12/12/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 12, 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, Screening

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs, Screening
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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
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
vital signs - sequence number
Description

height, weight, BMI and temperature only have to be filled out once. The other items each have to be filled out for each of the three measurements.

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348184
height
Description

height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
weight
Description

weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
body mass index
Description

body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
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
temperature
Description

temperature

Data type

integer

Measurement units
  • degrees Celsius
Alias
UMLS CUI [1]
C0005903
degrees Celsius
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Similar models

Vital Signs, Screening

1 forms
  1. StudyEvent: ODM
    1. Vital Signs, Screening
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 Group
Vital Signs
C0518766 (UMLS CUI-1)
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
vital signs - sequence number
text
C0518766 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
vital signs - sequence number
Code List
vital signs - sequence number
CL Item
1 of 3 (1)
CL Item
2 of 3 (2)
CL Item
3 of 3 (3)
height
Item
height
integer
C0005890 (UMLS CUI [1])
weight
Item
weight
float
C0005910 (UMLS CUI [1])
body mass index
Item
body mass index
float
C1305855 (UMLS CUI [1])
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])
temperature
Item
temperature
integer
C0005903 (UMLS CUI [1])
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