ID

41693

Beschrijving

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 Follow-Up Visit.

Trefwoorden

Versies (1)
  1. 18-12-20 18-12-20 -
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GlaxoSmithKline

Geüploaded op

18 december 2020

DOI

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Licentie

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

Engels

Study Conclusion and Pregnancy Information

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit
Beschrijving

date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
subject ID
Beschrijving

subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
date and time of subject completion or withdrawal
Beschrijving

date and time of subject completion or withdrawal

Datatype

datetime

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C2348577
UMLS CUI [2,2]
C0040223
UMLS CUI [3,1]
C1710677
UMLS CUI [3,2]
C0011008
UMLS CUI [4,1]
C1710677
UMLS CUI [4,2]
C0040223
was the subject withdrawn from the study?
Beschrijving

subject withdrawn from study

Datatype

text

Alias
UMLS CUI [1]
C0422727
if the subject was withdrawn from the study, please specify primary reason for withdrawal:
Beschrijving

subject withdrawn from study; primary reason

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
if other reason for withdrawal, please specify:
Beschrijving

other reason for withdrawal, specification

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
UMLS CUI [1,3]
C2348235
case book ready for signature
Beschrijving

Data owner should check the box when data cleaning is complete

Datatype

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1519316
office use 1
Beschrijving

office use 1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C1524063
office use 2
Beschrijving

office use 2

Datatype

text

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C1524063
Pregnancy information
Beschrijving

Pregnancy information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
did the subject become pregnant during the study?
Beschrijving

if yes, complete the paper Pregnancy Notification form

Datatype

boolean

Alias
UMLS CUI [1]
C3828490
did a female partner of the male subject become pregnant during the study?
Beschrijving

If Yes, complete the paper Pregnancy Notification form

Datatype

text

Alias
UMLS CUI [1,1]
C3828490
UMLS CUI [1,2]
C0919624
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Similar models

Study Conclusion and Pregnancy Information

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
date and time of subject completion or withdrawal
Item
date and time of subject completion or withdrawal
datetime
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2348577 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1710677 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C1710677 (UMLS CUI [4,1])
C0040223 (UMLS CUI [4,2])
Item
was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
subject withdrawn from study
Code List
was the subject withdrawn from the study?
CL Item
Yes (1)
CL Item
2 No (2 No)
Item
if the subject was withdrawn from the study, please specify primary reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
subject withdrawn from study; primary reason
Code List
if the subject was withdrawn from the study, please specify primary reason for withdrawal:
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Other (6)
other reason for withdrawal, specification
Item
if other reason for withdrawal, please specify:
text
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
case book ready for signature
text
C1516308 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
case book ready for signature
Code List
case book ready for signature
CL Item
Yes (1)
office use 1
Item
office use 1
boolean
C0442603 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Item
office use 2
text
C0442603 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
office use 2
Code List
office use 2
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
subject becoming pregnant during study
Item
did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item
did a female partner of the male subject become pregnant during the study?
text
C3828490 (UMLS CUI [1,1])
C0919624 (UMLS CUI [1,2])
female partner of male subject becoming pregnant during study
Code List
did a female partner of the male subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes  (2)
CL Item
Not applicable (female partner not of childbearing potential or no female partner) (3)
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