ID

34634

Beskrivning

TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia

Nyckelord

Versioner (1)
  1. 2019-01-21 2019-01-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Engelsk

Non-Serious Adverse Event Form

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beskrivning

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Beskrivning

Non-Serious Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1]
C1518404
Event
Beskrivning

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatyp

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beskrivning

Non-Serious Adverse Event, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Start Time
Beskrivning

Non-Serious Adverse Event, Start Time

Datatyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Outcome
Beskrivning

Non-Serious Adverse Event, Adverse Event Outcome

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date
Beskrivning

Non-Serious Adverse Event, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
End Time
Beskrivning

Non-Serious Adverse Event, End Time

Datatyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Frequency
Beskrivning

Non-Serious Adverse Event, Frequencies

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Beskrivning

Non-Serious Adverse Event, Symptom Intensity, Maximum

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beskrivning

Non-Serious Adverse Event, Action Taken with Study Treatment

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Beskrivning

Non-Serious Adverse Event, Withdraw

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

Non-Serious Adverse Event, Experimental drug, Causations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
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Similar models

Non-Serious Adverse Event Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event
Item
Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event, Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event, Start Time
Item
Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
Non-Serious Adverse Event, End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event, End Time
Item
End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Non-Serious Adverse Event, Frequencies
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event, Symptom Intensity, Maximum
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 Non-Serious AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-Serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious 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)
Non-Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-Serious Adverse Event, Experimental drug, Causations
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
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