ID
22317
Description
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: Week 24 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
Keywords
Versions (1)
- 5/29/17 5/29/17 -
Uploaded on
May 29, 2017
DOI
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License
Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572
Description
Physical Exam (Vital Signs, Weight, Height)
Alias
- UMLS CUI-1
- C0518766
Description
NOTE: Record Vital Signs within 2 weeks prior to first dose of medication NOTE: Blood pressure and heart rate must be taken after 5 minutes of sitting
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Blood pressure systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure diastolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
ECOG Performance Status
Alias
- UMLS CUI-1
- C1520224
Description
Cardiac Assessments Screening
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C0013516
Description
If NO, record details on the INVESTIGATOR COMMENT LOG page. If YES, record details below.
Data type
text
Alias
- UMLS CUI [1]
- C0430456
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1623258
Description
ECG results
Data type
text
Alias
- UMLS CUI [1]
- C1623258
Description
If YES, record the abnormality on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page at Screening.
Data type
text
Alias
- UMLS CUI [1]
- C1623258
Description
If YES, record details below.
Data type
text
Alias
- UMLS CUI [1]
- C0013516
Description
Institution name
Data type
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0013516
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013516
Description
Left ventricular ejection fraction
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0428772
- UMLS CUI [2]
- C0013516
Description
Lower limit of normal
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1518030
- UMLS CUI [1,2]
- C0428772
- UMLS CUI [2]
- C0013516
Description
If YES, record details below.
Data type
text
Alias
- UMLS CUI [1]
- C0521317
Description
Institution name
Data type
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0521317
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0521317
Description
Left ventricular ejection fraction
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0428772
- UMLS CUI [2]
- C0521317
Description
NOTE: If left ventricular ejection fraction is not within institutional range of normal, the subject must not enter the study.
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1518030
- UMLS CUI [1,2]
- C0428772
- UMLS CUI [2]
- C0521317
Description
Hematology
Alias
- UMLS CUI-1
- C0474523
Description
Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Lab name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Date hematology sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2]
- C0474523
Description
Units
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
- UMLS CUI [2]
- C0474523
Description
Hemoglobin
Data type
float
Alias
- UMLS CUI [1]
- C0518015
Description
Hematocrit
Data type
float
Alias
- UMLS CUI [1]
- C0518014
Description
RBC
Data type
integer
Alias
- UMLS CUI [1]
- C0014772
Description
Platelets
Data type
integer
Alias
- UMLS CUI [1]
- C0032181
Description
Total WBC
Data type
integer
Alias
- UMLS CUI [1]
- C0023508
Description
Neutrophils
Data type
integer
Alias
- UMLS CUI [1]
- C0948762
Description
Granulocytes
Data type
integer
Alias
- UMLS CUI [1]
- C0857490
Description
Lymphocytes
Data type
integer
Alias
- UMLS CUI [1]
- C0200635
Description
Monocytes
Data type
integer
Alias
- UMLS CUI [1]
- C0200637
Description
Eosinophils
Data type
integer
Alias
- UMLS CUI [1]
- C0200638
Description
Basophils
Data type
integer
Alias
- UMLS CUI [1]
- C0200641
Description
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C2347783
Description
Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Lab name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Date clinical chemistry sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2]
- C0008000
Description
Sodium
Data type
float
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium
Data type
float
Alias
- UMLS CUI [1]
- C0202194
Description
Chloride
Data type
float
Alias
- UMLS CUI [1]
- C0201952
Description
Bicarbonate
Data type
float
Alias
- UMLS CUI [1]
- C0202059
Description
Calcium
Data type
float
Alias
- UMLS CUI [1]
- C0201925
Description
Glucose
Data type
float
Alias
- UMLS CUI [1]
- C0202042
Description
Total Protein
Data type
float
Alias
- UMLS CUI [1]
- C0555903
Description
Albumin
Data type
float
Alias
- UMLS CUI [1]
- C0201838
Description
Uric acid
Data type
float
Alias
- UMLS CUI [1]
- C0202239
Description
Creatinine
Data type
float
Alias
- UMLS CUI [1]
- C0201976
Description
BUN
Data type
float
Alias
- UMLS CUI [1]
- C0005845
Description
Urea
Data type
float
Alias
- UMLS CUI [1]
- C0523961
Description
Total bilirubin
Data type
float
Alias
- UMLS CUI [1]
- C0201913
Description
Alkaline phosphatase
Data type
float
Alias
- UMLS CUI [1]
- C0201850
Description
AST (SGOT)
Data type
float
Alias
- UMLS CUI [1]
- C0201899
Description
ALT (SGPT)
Data type
float
Alias
- UMLS CUI [1]
- C0201836
Description
NOTE: Refer to the creatinine clearance worksheet for calculation.
Data type
float
Alias
- UMLS CUI [1]
- C0373595
Description
Creatinine Clearance Worksheet
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Creatinine Clearance Worksheet
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Creatinine Clearance Worksheet
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1]
- C0001779
Description
Creatinine Clearance Worksheet
Data type
float
Alias
- UMLS CUI [1]
- C0201976
Description
Creatinine Clearance Worksheet
Data type
integer
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1519795
Description
Response Assessment
Alias
- UMLS CUI-1
- C0871261
Description
Response assessments are required at Week 24. If the subject had a complete response or partial response a confirmatory scan should be performed no less than 4 weeks later.
Data type
date
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0220825
Description
Response assessment
Data type
text
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0221198
Description
primary method of evaluation
Data type
text
Alias
- UMLS CUI [1]
- C2911685
Description
Symptomatic progression of cancer, if checked, complete details below
Data type
date
Alias
- UMLS CUI [1,1]
- C0178874
- UMLS CUI [1,2]
- C0011008
Description
Specify symptoms
Data type
text
Alias
- UMLS CUI [1]
- C1457887
Description
Confirmatory Scan
Description
Response assessments are required at Week 24. If the subject had a complete response or partial response a confirmatory scan should be performed no less than 4 weeks later.
Data type
date
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0220825
Description
Response assessment
Data type
text
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0221198
Description
primary method of evaluation
Data type
text
Alias
- UMLS CUI [1]
- C2911685
Description
Symptomatic progression of cancer, if checked, complete details below
Data type
date
Alias
- UMLS CUI [1,1]
- C0178874
- UMLS CUI [1,2]
- C0011008
Description
Specify symptoms
Data type
text
Alias
- UMLS CUI [1]
- C1457887
Similar models
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572
C1457887 (UMLS CUI-2)
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C0013516 (UMLS CUI-2)
C1623258 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
C0428772 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [1,2])
C0521317 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
C0428772 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
C0600091 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
C0600091 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [2])
C1519795 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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