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Erreur:
ID
22073
Description
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: Withdrawal / Study Conclusion 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
Lien
https://clinicaltrials.gov/ct2/show/NCT00078572
Mots-clés
Versions (2)
- 18/05/2017 18/05/2017 -
- 18/05/2017 18/05/2017 -
Téléchargé le
18 mai 2017
DOI
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Licence
Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572
Similar models
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Withdrawal / Study Conclusion
C2349954 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C1707478 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Item
Does the subject have any current medical conditions, baseline signs or symptoms when assessed at screening (i.e., within 2 weeks prior to the first dose of investigational product)?
text
C3899485 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Code List
Does the subject have any current medical conditions, baseline signs or symptoms when assessed at screening (i.e., within 2 weeks prior to the first dose of investigational product)?
CL Item
Yes (Y)
CL Item
No (N)
Current Medical Conditions or Baseline Signs and symptoms
Item
Current Medical Conditions or Baseline Signs and symptoms
text
C3899485 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life Threatening (4)
Item Group
Physical Exam (Vital Signs, Weight, Height)
C0518766 (UMLS CUI-1)
Date Vital Signs
Item
Date Vital Signs
date
C0011008 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
ECOG
Item
ECOG
integer
C1520224 (UMLS CUI [1])
Item Group
Cardiac Assessments Screening
C1827871 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0013516 (UMLS CUI-3)
C1623258 (UMLS CUI-2)
C0013516 (UMLS CUI-3)
CL Item
Yes (Y)
CL Item
No (N)
Date of assessment
Item
Date of assessment
date
C0011008 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (N)
CL Item
Abnormal (A)
Item
If ABNORMAL, check to indicate if the abnormalities are clinically significant.
text
C1623258 (UMLS CUI [1])
Code List
If ABNORMAL, check to indicate if the abnormalities are clinically significant.
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Yes (Y)
CL Item
No (N)
Institution name
Item
Institution name
text
C1301943 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
integer
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0013516 (UMLS CUI [2])
Lower limit of normal
Item
Lower limit of normal
integer
C1518030 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
C0428772 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
Item
Was a Multi-gated acquisition (MUGA) scan performed?
text
C0521317 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Institution name
Item
Institution name
text
C1301943 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0521317 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0521317 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
integer
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0521317 (UMLS CUI [2])
Lower limit of normal
Item
Lower limit of normal
integer
C1518030 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
C0428772 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Lab name
Item
Lab name
text
C1882331 (UMLS CUI [1])
Date hematology sample taken
Item
Date hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2])
Item
Units for differential, check one:
integer
C1519795 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
CL Item
Percent % (1)
CL Item
Absolute Count (2)
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
RBC
Item
RBC
integer
C0014772 (UMLS CUI [1])
Platelets
Item
Platelets
integer
C0032181 (UMLS CUI [1])
Total WBC
Item
Total WBC
integer
C0023508 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
integer
C0948762 (UMLS CUI [1])
Granulocytes
Item
Granulocytes
integer
C0857490 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
integer
C0200641 (UMLS CUI [1])
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Lab name
Item
Lab name
text
C1882331 (UMLS CUI [1])
Date clinical chemistry sample taken
Item
Date clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [2])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Bicarbonate
Item
Bicarbonate
float
C0202059 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Uric acid
Item
Uric acid
float
C0202239 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Calculated Creatinine Clearance
Item
Calculated Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
Item
Serum Creatinine Units, check one:
integer
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
mg/dL (1)
CL Item
μmol/L (2)
Date of lesion evaluation
Item
Date of lesion evaluation
date
C0221198 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Item
Response assessment, check one:
text
C0521982 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
Complete response (CR)
CL Item
Partial response (PR)
CL Item
Stable disease (SD)
CL Item
Progressive disease (PD)
CL Item
Unknown (U)
Item
If progressive disease is checked, indicate the primary method of evaluation.
text
C2911685 (UMLS CUI [1])
Code List
If progressive disease is checked, indicate the primary method of evaluation.
CL Item
Progressive disease by lesion evaluation (PLE)
CL Item
Symptomatic progression of cancer (SPC)
Date of symptomatic progression of cancer
Item
Date of symptomatic progression of cancer
date
C0178874 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Specify symptoms
Item
Specify symptoms
text
C1457887 (UMLS CUI [1])
Item Group
Confirmatory Scan
C0011923 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
C0521982 (UMLS CUI-3)
C0750484 (UMLS CUI-2)
C0521982 (UMLS CUI-3)
Date of lesion evaluation
Item
Date of lesion evaluation
date
C0221198 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Item
Response assessment, check one:
text
C0521982 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
Complete response (CR)
CL Item
Partial response (PR)
CL Item
Stable disease (SD)
CL Item
Progressive disease (PD)
CL Item
Unknown (U)
Item
If progressive disease is checked, indicate the primary method of evaluation.
text
C2911685 (UMLS CUI [1])
Code List
If progressive disease is checked, indicate the primary method of evaluation.
CL Item
Progressive disease by lesion evaluation (PLE)
CL Item
Symptomatic progression of cancer (SPC)
Date of symptomatic progression of cancer
Item
Date of symptomatic progression of cancer
date
C0178874 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Specify symptoms
Item
Specify symptoms
text
C1457887 (UMLS CUI [1])
Item Group
Endpoint Evaluation : Investigator
C0220825 (UMLS CUI-1)
C0521982 (UMLS CUI-2)
C0521982 (UMLS CUI-2)
CL Item
Complete response (CR)
CL Item
Partial response (PR)
CL Item
Stable disease (SD)
CL Item
Progressive disease (PD)
CL Item
Unknown (U)
Date of response
Item
Date of response
date
C0011008 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,2])
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