ID

22071

Beschrijving

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Non-serious Adverse Events Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Trefwoorden

Versies (1)
  1. 18-05-17 18-05-17 -
Geüploaded op

18 mei 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-serious Adverse Events NCT00078572

Engels

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-serious Adverse Events NCT00078572

1 Formulieren  
Non-serious Adverse Events
Beschrijving

Non-serious Adverse Events

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

If YES, indicate below:

Datatype

text

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

Non-serious adverse event

Datatype

text

Alias
UMLS CUI [1]
C1518404
Date of onset
Beschrijving

Date of onset

Datatype

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
NCI-CTCAE toxicity
Beschrijving

NCI-CTCAE toxicity

Datatype

integer

Alias
UMLS CUI [1,1]
C3887242
UMLS CUI [1,2]
C1518404
Outcome
Beschrijving

Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Date of resolution
Beschrijving

Date of resolution

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Action taken with investigational product(s) as a result of the non-serious AE
Beschrijving

Action taken with investigational product

Datatype

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?
Beschrijving

Withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Beschrijving

Relationship to investigational product(s)

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Does the AE meet the definition of serious?
Beschrijving

Seriousness

Datatype

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
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Similar models

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-serious Adverse Events NCT00078572

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Non-serious adverse event
Item
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1518404 (UMLS CUI [1])
Date of onset
Item
Date of onset
text
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
NCI-CTCAE toxicity
integer
C3887242 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
NCI-CTCAE toxicity
Code List
NCI-CTCAE toxicity
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Not applicable (4)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved  (R)
CL Item
Resolved with sequelae  (S)
CL Item
Not resolved (N)
Date of resolution
Item
Date of resolution
date
C0806020 (UMLS CUI [1,1])
C1518404 (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
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (4)
Item
Did subject withdraw from study as a result of this non-serious AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of this non-serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Withdrawal
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
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