ID

41687

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 at the P1 D-1, P2 D-1, P1 D1 and P2 D1 Visits.

Stichworte

Versionen (1)
  1. 17.12.20 17.12.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. 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

Meal

1 Formulare  
  1. StudyEvent: ODM
    1. Meal
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 has to be filled out for the P1 D1 and P2 D1 Visits.

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
Meal
Beschreibung

Meal

Alias
UMLS CUI-1
C1998602
time of meal relative to dosage
Beschreibung

please fill out all of the meal times at which you have eaten for the P1 D1 and P2 D1 visits. For the P1 D-1 and P2 D-1 Visits, the meal pre-dose is a breakfast, please check the "pre-dose" box.

Datentyp

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C0178602
meal type
Beschreibung

meal type

Datentyp

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0332307
meal: date and start time
Beschreibung

meal: date and start time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1998602
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C1998602
meal: date and stop time
Beschreibung

meal: date and stop time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1998602
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C1998602
has the totality of the meal been ingested?
Beschreibung

totality of meal ingested

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
if the totality of the meal has not been ingested, please specify the % of meal consumed:
Beschreibung

% of meal consumed:

Datentyp

text

Alias
UMLS CUI [1]
C3468056
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Ähnliche Modelle

Meal

1 Formulare
  1. StudyEvent: ODM
    1. Meal
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
P1 D-1 (1)
CL Item
P2 D-1 (2)
CL Item
P1 D1 (3)
CL Item
P2 D1 (4)
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
Meal
C1998602 (UMLS CUI-1)
Item
time of meal relative to dosage
text
C1998602 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
time of meal relative to dosage
Code List
time of meal relative to dosage
CL Item
evening snack  (1)
CL Item
lunch 4hr - post dose (2)
CL Item
dinner 10hr - post dose  (3)
CL Item
breakfast 24hr post dose (4)
CL Item
lunch 28hr post dose (5)
CL Item
dinner 34hr - post dose  (6)
CL Item
breakfast 48hr - post dose (7)
CL Item
dinner 60hr - post dose (8)
CL Item
pre-dose (9)
Item
meal type
text
C1998602 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
meal type
Code List
meal type
CL Item
Breakfast (1)
CL Item
Lunch (2)
CL Item
Dinner (3)
CL Item
Snack (4)
meal: date and start time
Item
meal: date and start time
datetime
C0011008 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
meal: date and stop time
Item
meal: date and stop time
datetime
C0011008 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
totality of meal ingested
Item
has the totality of the meal been ingested?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
if the totality of the meal has not been ingested, please specify the % of meal consumed:
text
C3468056 (UMLS CUI [1])
% of meal consumed:
Code List
if the totality of the meal has not been ingested, please specify the % of meal consumed:
CL Item
0% (1)
CL Item
1-25% (2)
CL Item
26-50% (3)
CL Item
51-75% (4)
CL Item
76-100= (5)
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