ID

29424

Description

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Non-Serious Adverse Event

Keywords

Versions (1)
  1. 3/22/18 3/22/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 22, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587

English

Non-Serious Adverse Event

1 forms  
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

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

Non-Serious Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Non-serious adverse event: Diagnosis only (if known) or signs / symptoms (list one per line)
Description

Non-serious adverse events

Data type

text

Alias
UMLS CUI [1]
C1518404
Date of onset Non-Serious Adverse Event
Description

Date of onset Non-Serious Adverse Event

Data type

date

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C1518404
Time of onset Non-Serious Adverse Event
Description

Time of onset Non-Serious Adverse Event

Data type

time

Alias
UMLS CUI [1,1]
C2697889
UMLS CUI [1,2]
C1518404
Maximum Toxicity Non-Serious Adverse Event
Description

Maximum Toxicity Non-Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1518404
Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End date Non-Serious Adverse Event
Description

End date Non-Serious Adverse Event

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697886
End time Non-Serious Adverse Event
Description

End time Non-Serious Adverse Event

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826658
Action taken with investigational product(s) as a result of the non-serious AE
Description

Action taken with investigational product

Data type

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did subject withdraw from study as a result of this non-serious AE?
Description

subject withdraw from study

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to Investigational Product

Data type

boolean

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

Non-Serious Adverse Event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious adverse events
Item
Non-serious adverse event: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1518404 (UMLS CUI [1])
Date of onset Non-Serious Adverse Event
Item
Date of onset Non-Serious Adverse Event
date
C2985916 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of onset Non-Serious Adverse Event
Item
Time of onset Non-Serious Adverse Event
time
C2697889 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Toxicity Non-Serious Adverse Event
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Toxicity Non-Serious Adverse Event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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)
End date Non-Serious Adverse Event
Item
End date Non-Serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
End time Non-Serious Adverse Event
Item
End time Non-Serious Adverse Event
time
C1518404 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Investigationalproduct(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 withdraw from study
Item
Did subject withdraw from study as a result of this non-serious AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to 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])
C1518404 (UMLS CUI [1,3])
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