ID
41823
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 document is to be filled out if and whenever an adverse event occurs during the study period.
Trefwoorden
Versies (3)
- 19-12-20 19-12-20 -
- 09-01-21 09-01-21 -
- 23-01-21 23-01-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 januari 2021
DOI
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Licentie
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Adverse events
- StudyEvent: ODM
Beschrijving
Adverse events
Alias
- UMLS CUI-1
- C0877248
Beschrijving
adverse event, sequence number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348184
Beschrijving
adverse event, diagnosis or sign/symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C3540840
Beschrijving
adverse event; modified reported term
Datatype
text
Alias
- UMLS CUI [1]
- C2826798
Beschrijving
MedDRA synonym
Datatype
text
Alias
- UMLS CUI [1]
- C1140263
Beschrijving
MedDRA lower level term code
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
failed coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
adverse event start date and time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschrijving
adverse event outcome
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
recovered or resolved, adverse event end date and time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2826793
- UMLS CUI [1,2]
- C1709863
Beschrijving
recovered/resolved with sequelae, adverse event end date and time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2826793
- UMLS CUI [1,2]
- C1709862
Beschrijving
adverse event fatal, date and time of death
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2826793
- UMLS CUI [1,2]
- C1148348
- UMLS CUI [2,1]
- C2826793
- UMLS CUI [2,2]
- C1301931
Beschrijving
adverse event, frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C0877248
Beschrijving
severity of adverse event
Datatype
text
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
action taken with investigational product
Datatype
text
Alias
- UMLS CUI [1]
- C1704758
Beschrijving
subject withdawal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
possibility that AE was caused by investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0877248
Beschrijving
if Yes, complete paper SAE form and fax to GSK safety within 24hr
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
please check all that apply
Datatype
boolean
Alias
- UMLS CUI [1]
- C1705232
Beschrijving
please check all that apply
Datatype
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschrijving
please check all that apply
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Beschrijving
please check all that apply
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3176592
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0231170
Beschrijving
please check all that apply
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826727
Beschrijving
please check all that apply
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
Beschrijving
serious adverse event, other specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
serious adverse event, caused by activity related to study participation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beschrijving
serious flag
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205404
- UMLS CUI [1,2]
- C1708067
Similar models
Adverse events
- StudyEvent: ODM
C2348184 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C0231175 (UMLS CUI [1,2])
C1709863 (UMLS CUI [1,2])
C1709862 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,2])
C2826793 (UMLS CUI [2,1])
C1301931 (UMLS CUI [2,2])
C0085978 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C3176592 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0231170 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1708067 (UMLS CUI [1,2])