ID

41691

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 Screening, the P1 D-1, P1 D1, P2 D-1, P2 D1, the Follow-Up Visits and in case of repeat measurements.

Trefwoorden

Versies (2)
  1. 17-12-20 17-12-20 -
  2. 18-12-20 18-12-20 - Sarah Riepenhausen
Houder van rechten

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

Electronically transferred lab data

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
visit type
Beschrijving

visit type

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Safety Labs
Beschrijving

Safety Labs

Alias
UMLS CUI-1
C0681902
laboratory measurement sample type
Beschrijving

for most of the visits defined in the study description, all of the tests are necessary. for possible repeating visits, only the repeated tests have to be filled out.

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0332307
date and time sample taken
Beschrijving

if clinical chemistry is taken at the same time as hematology, please choose the option "same as previous sample". The option "same as previous sample" cannot be chosen for possible repeating visits. Please specify the date of the sampling.

Datatype

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
date and time
Beschrijving

date and time sample collection

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
lab test type code
Beschrijving

lab test type code

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
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Similar models

Electronically transferred lab data

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
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 D-1 (3)
CL Item
P1 D1 (4)
CL Item
P2 D-1 (5)
CL Item
P2 D1 (6)
CL Item
Repeats (7)
Item Group
Safety Labs
C0681902 (UMLS CUI-1)
Item
laboratory measurement sample type
text
C0022885 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
haematology date and time sample taken
Code List
laboratory measurement sample type
CL Item
haematology (1)
CL Item
clinical chemistry (2)
CL Item
urinalysis (3)
CL Item
coagulation (4)
Item
date and time sample taken
text
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
date and time sample taken
Code List
date and time sample taken
CL Item
same as previous sample (1)
CL Item
date (2)
CL Item
not done (3)
date and time sample collection
Item
date and time
datetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
lab test type code
Item
lab test type code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
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