ID

41727

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, if concomitant medication has been taken by subject during the study.

Stichworte

Versionen (1)
  1. 09.01.21 09.01.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Januar 2021

DOI

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

Englisch

Concomitant medication

1 Formulare  
  1. StudyEvent: ODM
    1. Concomitant medication
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschreibung

GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Beschreibung

GSK Drug Collection code

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Unit Dose
Beschreibung

Unit Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0869039
UMLS CUI [1,2]
C2347852
Units
Beschreibung

Units of concomitant medication

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Beschreibung

Frequency of concomitant medication

Datentyp

text

Alias
UMLS CUI [1]
C2826654
Route
Beschreibung

Route of concomitant medication

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Start Date and time
Beschreibung

Start Date and Time of concomitant medication

Datentyp

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C2347852
Taken Prior to Study?
Beschreibung

Concomitant medication prior to study

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Beschreibung

Concomitant medication ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
If no, please specify end date and time
Beschreibung

Concomitat medication end date and time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1522314
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Ähnliche Modelle

Concomitant medication

1 Formulare
  1. StudyEvent: ODM
    1. Concomitant medication
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
text
C0869039 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Units
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units of concomitant medication
Code List
Units
CL Item
actuation  (1)
CL Item
ampoule (2)
CL Item
application (3)
CL Item
bottle  (4)
CL Item
capsule (5)
CL Item
cubic centimeter (6)
CL Item
drops (7)
CL Item
gram  (8)
CL Item
international units (9)
CL Item
international units per kilogram  (10)
CL Item
international units per millilitre (11)
CL Item
litre (12)
CL Item
litre per minute (13)
CL Item
lozenge (14)
CL Item
megaunits (million units) (15)
CL Item
microgram (MCG) (16)
CL Item
microgram (UG) (17)
CL Item
microgram/kilogram (18)
CL Item
microgram/kilogram/minute (19)
CL Item
micrograms/minute (20)
CL Item
microlitre (21)
CL Item
milliequivalent (22)
CL Item
milliequivalent/24 hours (23)
CL Item
milligram (24)
CL Item
milligrams percent  (25)
CL Item
milligram/hour (26)
CL Item
milligram/kilogram  (27)
CL Item
milligram/kilogram/hour (28)
CL Item
milligram/kilogram/minute (29)
CL Item
milligram/metre squared (30)
CL Item
milligram/millilitre (31)
CL Item
millilitre (32)
CL Item
millilitre/hour (33)
CL Item
millilitre/minute (34)
CL Item
millimole (35)
CL Item
million international units (36)
CL Item
minimum alveolar concentration (37)
CL Item
nebule (38)
CL Item
patch (39)
CL Item
percent  (40)
CL Item
puff (41)
CL Item
sachet (42)
CL Item
spray (43)
CL Item
suppository (44)
CL Item
tablespoon (45)
CL Item
tablet (46)
CL Item
teaspoon (47)
CL Item
units (48)
CL Item
unknown  (49)
CL Item
vial (50)
Item
Frequency
text
C2826654 (UMLS CUI [1])
Units of concomitant medication
Code List
Frequency
CL Item
2 times per week  (2XWK)
CL Item
3 times per week  (3XWK)
CL Item
4 times per week  (4XWK)
CL Item
5 times per day  (5XD)
CL Item
5 times per week  (5XWK)
CL Item
AC (AC)
CL Item
BID (BID)
CL Item
Continuous infusion (CINF)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Q2H (Q2H)
CL Item
Every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 months (Q3M)
CL Item
Every 3 weeks (Q3WK)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QH (QH)
CL Item
QID (QID)
CL Item
Once a month (QM)
CL Item
Every other day (QOD)
CL Item
QPM (QPM)
CL Item
Once a week (QWK)
CL Item
TID (TID)
CL Item
Unknown (UNK)
Item
Route
text
C2826730 (UMLS CUI [1])
Route of concomitant medication
Code List
Route
CL Item
Epidural  (EP)
CL Item
Gastrostomy tube  (GTT)
CL Item
Intra-arterial  (IA)
CL Item
Intra-bursa  (IB)
CL Item
Inhalation  (IH)
CL Item
Intramuscular  (IM)
CL Item
Intranasal  (IN)
CL Item
Injection  (INJ)
CL Item
Intraocular (IO)
CL Item
Intraosteal  (IOS)
CL Item
Intrathecal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous  (IV)
CL Item
Nasal  (NS)
CL Item
Both eyes (OU)
CL Item
Oral  (PO)
CL Item
Rectal  (PR)
CL Item
Subcutaneous  (SC)
CL Item
Sublingual  (SL)
CL Item
Transdermal  (TD)
CL Item
Topical  (TP)
CL Item
Unknown  (UNK)
CL Item
Vaginal  (VG)
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date and Time of concomitant medication
Item
Start Date and time
datetime
C2826734 (UMLS CUI [1])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Concomitant medication prior to study
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant medication ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitat medication end date and time
Item
If no, please specify end date and time
datetime
C2826744 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
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