ID

22070

Descripción

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: 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

Palabras clave

Versiones (2)
  1. 18/5/17 18/5/17 -
  2. 29/5/17 29/5/17 -
Subido en

18 de mayo de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572

1 formularios  
Serious Adverse Events
Descripción

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse events during the study?
Descripción

If YES, indicate below:

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Sex

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

integer

Alias
UMLS CUI [1]
C0034510
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
Descripción

Serious adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Date of onset
Descripción

Date of onset

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
NCI-CTCAE toxicity
Descripción

NCI-CTCAE toxicity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3887242
UMLS CUI [1,2]
C1519255
Outcome
Descripción

Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Date of resolution or death
Descripción

Date of resolution or death

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Action taken with investigational product(s) as a result of the non-serious AE
Descripción

Action taken with investigational product

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did subject withdraw from study as a result of this serious AE?
Descripción

Withdrawal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
Descripción

Relationship to investigational product(s)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Does the AE meet the definition of serious?
Descripción

Seriousness

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Possible Causes of SAE other than Investigational Product(s), check all that apply:
Descripción

Cause of SAE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Please specify cause of SAE
Descripción

Cause of SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Seriousness, check all that apply
Descripción

Seriousness

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Seriousness, if other please specify
Descripción

Seriousness

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
If fatal, was an autopsy done/to be performed?
Descripción

autopsy

Tipo de datos

text

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
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Similar models

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Serious Adverse Events NCT00078572

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Withdrawal
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
American Hispanic (4)
CL Item
Other (5)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Serious adverse event
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1519255 (UMLS CUI [1])
Date of onset
Item
Date of onset
text
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
NCI-CTCAE toxicity
integer
C3887242 (UMLS CUI [1,1])
C1519255 (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
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved  (R)
CL Item
Resolved with sequelae  (S)
CL Item
Not resolved (N)
CL Item
Fatal (F)
Date of resolution or death
Item
Date of resolution or death
date
C0806020 (UMLS CUI [1,1])
C1519255 (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])
C1519255 (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 serious AE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of this serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Withdrawal
Code List
Is there a reasonable possibility that the SAE 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])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
Item
Possible Causes of SAE other than Investigational Product(s), check all that apply:
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Cause of SAE
Code List
Possible Causes of SAE other than Investigational Product(s), check all that apply:
CL Item
Disease under study (1)
CL Item
Treatment failure (2)
CL Item
Activity related to study participation (e.g., procedures) (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant disorder (5)
CL Item
Concomitant medication (6)
CL Item
Other (7)
Cause of SAE
Item
Please specify cause of SAE
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, check all that apply
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness, check all that apply
CL Item
Death (A)
CL Item
Life threatening (B)
CL Item
Hospitalization required or prolonged (C)
CL Item
Disabling or incapacitating (D)
CL Item
Congenital anomaly (E)
CL Item
Other (see definition) (F)
Seriousness
Item
Seriousness, if other please specify
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If fatal, was an autopsy done/to be performed?
text
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Withdrawal
Code List
If fatal, was an autopsy done/to be performed?
CL Item
Yes (Y)
CL Item
No (N)
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