ID
22317
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT00078572
Nyckelord
Versioner (1)
- 2017-05-29 2017-05-29 -
Uppladdad den
29 maj 2017
DOI
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Licens
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
Beskrivning
Physical Exam (Vital Signs, Weight, Height)
Alias
- UMLS CUI-1
- C0518766
Beskrivning
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
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Blood pressure systolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure diastolic
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
ECOG Performance Status
Alias
- UMLS CUI-1
- C1520224
Beskrivning
Cardiac Assessments Screening
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C0013516
Beskrivning
If NO, record details on the INVESTIGATOR COMMENT LOG page. If YES, record details below.
Datatyp
text
Alias
- UMLS CUI [1]
- C0430456
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1623258
Beskrivning
ECG results
Datatyp
text
Alias
- UMLS CUI [1]
- C1623258
Beskrivning
If YES, record the abnormality on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page at Screening.
Datatyp
text
Alias
- UMLS CUI [1]
- C1623258
Beskrivning
If YES, record details below.
Datatyp
text
Alias
- UMLS CUI [1]
- C0013516
Beskrivning
Institution name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0013516
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013516
Beskrivning
Left ventricular ejection fraction
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1]
- C0428772
- UMLS CUI [2]
- C0013516
Beskrivning
Lower limit of normal
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C1518030
- UMLS CUI [1,2]
- C0428772
- UMLS CUI [2]
- C0013516
Beskrivning
If YES, record details below.
Datatyp
text
Alias
- UMLS CUI [1]
- C0521317
Beskrivning
Institution name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0521317
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0521317
Beskrivning
Left ventricular ejection fraction
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1]
- C0428772
- UMLS CUI [2]
- C0521317
Beskrivning
NOTE: If left ventricular ejection fraction is not within institutional range of normal, the subject must not enter the study.
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C1518030
- UMLS CUI [1,2]
- C0428772
- UMLS CUI [2]
- C0521317
Beskrivning
Hematology
Alias
- UMLS CUI-1
- C0474523
Beskrivning
Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Beskrivning
Lab name
Datatyp
text
Alias
- UMLS CUI [1]
- C1882331
Beskrivning
Date hematology sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2]
- C0474523
Beskrivning
Units
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519795
- UMLS CUI [2]
- C0474523
Beskrivning
Hemoglobin
Datatyp
float
Alias
- UMLS CUI [1]
- C0518015
Beskrivning
Hematocrit
Datatyp
float
Alias
- UMLS CUI [1]
- C0518014
Beskrivning
RBC
Datatyp
integer
Alias
- UMLS CUI [1]
- C0014772
Beskrivning
Platelets
Datatyp
integer
Alias
- UMLS CUI [1]
- C0032181
Beskrivning
Total WBC
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
Neutrophils
Datatyp
integer
Alias
- UMLS CUI [1]
- C0948762
Beskrivning
Granulocytes
Datatyp
integer
Alias
- UMLS CUI [1]
- C0857490
Beskrivning
Lymphocytes
Datatyp
integer
Alias
- UMLS CUI [1]
- C0200635
Beskrivning
Monocytes
Datatyp
integer
Alias
- UMLS CUI [1]
- C0200637
Beskrivning
Eosinophils
Datatyp
integer
Alias
- UMLS CUI [1]
- C0200638
Beskrivning
Basophils
Datatyp
integer
Alias
- UMLS CUI [1]
- C0200641
Beskrivning
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C2347783
Beskrivning
Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Beskrivning
Lab name
Datatyp
text
Alias
- UMLS CUI [1]
- C1882331
Beskrivning
Date clinical chemistry sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2]
- C0008000
Beskrivning
Sodium
Datatyp
float
Alias
- UMLS CUI [1]
- C0337443
Beskrivning
Potassium
Datatyp
float
Alias
- UMLS CUI [1]
- C0202194
Beskrivning
Chloride
Datatyp
float
Alias
- UMLS CUI [1]
- C0201952
Beskrivning
Bicarbonate
Datatyp
float
Alias
- UMLS CUI [1]
- C0202059
Beskrivning
Calcium
Datatyp
float
Alias
- UMLS CUI [1]
- C0201925
Beskrivning
Glucose
Datatyp
float
Alias
- UMLS CUI [1]
- C0202042
Beskrivning
Total Protein
Datatyp
float
Alias
- UMLS CUI [1]
- C0555903
Beskrivning
Albumin
Datatyp
float
Alias
- UMLS CUI [1]
- C0201838
Beskrivning
Uric acid
Datatyp
float
Alias
- UMLS CUI [1]
- C0202239
Beskrivning
Creatinine
Datatyp
float
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
BUN
Datatyp
float
Alias
- UMLS CUI [1]
- C0005845
Beskrivning
Urea
Datatyp
float
Alias
- UMLS CUI [1]
- C0523961
Beskrivning
Total bilirubin
Datatyp
float
Alias
- UMLS CUI [1]
- C0201913
Beskrivning
Alkaline phosphatase
Datatyp
float
Alias
- UMLS CUI [1]
- C0201850
Beskrivning
AST (SGOT)
Datatyp
float
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
ALT (SGPT)
Datatyp
float
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
NOTE: Refer to the creatinine clearance worksheet for calculation.
Datatyp
float
Alias
- UMLS CUI [1]
- C0373595
Beskrivning
Creatinine Clearance Worksheet
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Creatinine Clearance Worksheet
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Creatinine Clearance Worksheet
Datatyp
integer
Måttenheter
- years
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
Creatinine Clearance Worksheet
Datatyp
float
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
Creatinine Clearance Worksheet
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1519795
Beskrivning
Response Assessment
Alias
- UMLS CUI-1
- C0871261
Beskrivning
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.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0220825
Beskrivning
Response assessment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0221198
Beskrivning
primary method of evaluation
Datatyp
text
Alias
- UMLS CUI [1]
- C2911685
Beskrivning
Symptomatic progression of cancer, if checked, complete details below
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0178874
- UMLS CUI [1,2]
- C0011008
Beskrivning
Specify symptoms
Datatyp
text
Alias
- UMLS CUI [1]
- C1457887
Beskrivning
Confirmatory Scan
Beskrivning
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.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0220825
Beskrivning
Response assessment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0221198
Beskrivning
primary method of evaluation
Datatyp
text
Alias
- UMLS CUI [1]
- C2911685
Beskrivning
Symptomatic progression of cancer, if checked, complete details below
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0178874
- UMLS CUI [1,2]
- C0011008
Beskrivning
Specify symptoms
Datatyp
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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