ID

41726

Descripción

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.

Palabras clave

Versiones (3)
  1. 19/12/20 19/12/20 -
  2. 9/1/21 9/1/21 -
  3. 23/1/21 23/1/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de enero de 2021

DOI

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Licencia

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

Inglés

Adverse events

1 formularios  
  1. StudyEvent: ODM
    1. Adverse events
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
subject ID
Descripción

subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Adverse events
Descripción

Adverse events

Alias
UMLS CUI-1
C0877248
sequence number
Descripción

adverse event, sequence number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348184
event, diagnosis only (if known) otherwise sign/symptom
Descripción

adverse event, diagnosis or sign/symptom

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C3540840
modified term
Descripción

adverse event; modified reported term

Tipo de datos

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Descripción

MedDRA synonym

Tipo de datos

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Descripción

MedDRA lower level term code

Tipo de datos

text

Alias
UMLS CUI [1]
C3898442
failed coding
Descripción

failed coding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
start date and time
Descripción

adverse event start date and time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826806
outcome
Descripción

adverse event outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
recovered/resolved, provide end date and time
Descripción

recovered or resolved, adverse event end date and time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2826793
UMLS CUI [1,2]
C1709863
recovered/resolved with sequelae, provide end date and time.
Descripción

recovered/resolved with sequelae, adverse event end date and time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2826793
UMLS CUI [1,2]
C1709862
fatal, record Date and Time of Death
Descripción

adverse event fatal, date and time of death

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2826793
UMLS CUI [1,2]
C1148348
UMLS CUI [2,1]
C2826793
UMLS CUI [2,2]
C1301931
frequency
Descripción

adverse event, frequency

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C0877248
maximum intensity
Descripción

severity of adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C1710066
action taken with investigational product(s) as a result of the AE
Descripción

action taken with investigational product

Tipo de datos

text

Alias
UMLS CUI [1]
C1704758
did the subject withdraw from study as a result of this AE?
Descripción

subject withdawal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0422727
is there a reasonable possibility that the AE may have been caused by the investigational product
Descripción

possibility that AE was caused by investigational product

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0877248
does this adverse event meet the definition of serious?
Descripción

if Yes, complete paper SAE form and fax to GSK safety within 24hr

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
serious adverse event resulting in death
Descripción

please check all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1705232
serious adverse event, life threatening
Descripción

please check all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517874
serious adverse event, requiring hospitalisation or prolongation of existing hospitalisation
Descripción

please check all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
serious adverse event, resulting in disability/incapacity
Descripción

please check all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3176592
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0231170
serious adverse event, causing congenital anomaly/birth defect
Descripción

please check all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0000768
serious adverse event, other
Descripción

please check all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
if other, please specify:
Descripción

serious adverse event, other specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
if it was a serious adverse event, was this caused by an activity related to study participation (e.g., procedures)?
Descripción

serious adverse event, caused by activity related to study participation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
serious flag
Descripción

serious flag

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C1708067
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Similar models

Adverse events

1 formularios
  1. StudyEvent: ODM
    1. Adverse events
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Adverse events
C0877248 (UMLS CUI-1)
adverse event, sequence number
Item
sequence number
text
C0877248 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
adverse event, diagnosis or sign/symptom
Item
event, diagnosis only (if known) otherwise sign/symptom
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
adverse event; modified reported term
Item
modified term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
failed coding
Item
failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
adverse event start date and time
Item
start date and time
datetime
C2826806 (UMLS CUI [1])
Item
outcome
text
C1705586 (UMLS CUI [1])
adverse event outcome
Code List
outcome
CL Item
recovert/resolved (1)
CL Item
recovering/resolving (2)
CL Item
not recovert/notresolved (3)
CL Item
recovered/resolved with sequelae (4)
CL Item
fatal (5)
recovered or resolved, adverse event end date and time
Item
recovered/resolved, provide end date and time
datetime
C2826793 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
recovered/resolved with sequelae, adverse event end date and time
Item
recovered/resolved with sequelae, provide end date and time.
datetime
C2826793 (UMLS CUI [1,1])
C1709862 (UMLS CUI [1,2])
adverse event fatal, date and time of death
Item
fatal, record Date and Time of Death
datetime
C2826793 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
C2826793 (UMLS CUI [2,1])
C1301931 (UMLS CUI [2,2])
Item
frequency
text
C0439603 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
frequency
Code List
frequency
CL Item
single episode (1)
CL Item
intermittent (2)
Item
maximum intensity
text
C1710066 (UMLS CUI [1])
severity of adverse event
Code List
maximum intensity
CL Item
mild (1)
CL Item
moderate  (2)
CL Item
severe (3)
CL Item
not applicable (4)
Item
action taken with investigational product(s) as a result of the AE
text
C1704758 (UMLS CUI [1])
action taken with investigational product
Code List
action taken with investigational product(s) as a result of the AE
CL Item
investigational product(s) withdrawn  (1)
CL Item
dose reduced  (2)
CL Item
dose increased (3)
CL Item
dose not changed (4)
CL Item
dose interrupted  (5)
CL Item
not applicable (6)
subject withdawal
Item
did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
possibility that AE was caused by investigational product
Item
is there a reasonable possibility that the AE may have been caused by the investigational product
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
serious adverse event
Item
does this adverse event meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])
serious adverse event, results in death
Item
serious adverse event resulting in death
boolean
C1705232 (UMLS CUI [1])
serious adverse event, life threatening
Item
serious adverse event, life threatening
boolean
C1517874 (UMLS CUI [1])
serious adverse event, requiring hospitalisation or prolongation of existing hospitalisation
Item
serious adverse event, requiring hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
serious adverse event, resulting in disability/incapacity
Item
serious adverse event, resulting in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C3176592 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0231170 (UMLS CUI [2,2])
serious adverse event, causing congenital anomaly/birth defect
Item
serious adverse event, causing congenital anomaly/birth defect
boolean
C1519255 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
serious adverse event, other
Item
serious adverse event, other
boolean
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
serious adverse event, other specification
Item
if other, please specify:
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
serious adverse event, caused by activity related to study participation
Item
if it was a serious adverse event, was this caused by an activity related to study participation (e.g., procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
serious flag
Item
serious flag
text
C0205404 (UMLS CUI [1,1])
C1708067 (UMLS CUI [1,2])
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