English

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572

1 forms  
Current Medical Conditions / Baseline Signs and Symptoms
Description

Current Medical Conditions / Baseline Signs and Symptoms

Alias
UMLS CUI-1
C3899485
UMLS CUI-2
C1457887
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)?
Description

current medical conditions, baseline signs or symptoms

Data type

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C1457887
Current Medical Conditions or Baseline Signs and symptoms
Description

If YES, record all screening clinical signs and symptoms below according to the instructions on the facing page.

Data type

text

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C1457887
NCI CTCAE Grade
Description

Refer to the NCI CTCAE Common Toxicity Criteria version 3 in the study reference manual. If the condition is not found in the NCI CTCAE, assign a grade using one of the following: 1=Mild, 2=Moderate, 3=Severe, 4=Life Threatening

Data type

integer

Alias
UMLS CUI [1]
C3887242
Physical Exam (Vital Signs, Weight, Height)
Description

Physical Exam (Vital Signs, Weight, Height)

Alias
UMLS CUI-1
C0518766
Date Vital Signs
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
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
ECOG Performance Status
Description

ECOG Performance Status

Alias
UMLS CUI-1
C1520224
ECOG
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

integer

Alias
UMLS CUI [1]
C1520224
Cardiac Assessments Screening
Description

Cardiac Assessments Screening

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0013516
Was a 12-lead ECG performed?
Description

If NO, record details on the INVESTIGATOR COMMENT LOG page. If YES, record details below.

Data type

text

Alias
UMLS CUI [1]
C0430456
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1623258
Check the appropriate box to indicate ECG results.
Description

ECG results

Data type

text

Alias
UMLS CUI [1]
C1623258
If ABNORMAL, check to indicate if the abnormalities are clinically significant.
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
Was an Echocardiogram (ECHO) performed?
Description

If YES, record details below.

Data type

text

Alias
UMLS CUI [1]
C0013516
Institution name
Description

Institution name

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0013516
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013516
Left ventricular ejection fraction
Description

Left ventricular ejection fraction

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
%
Lower limit of normal
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
%
Was a Multi-gated acquisition (MUGA) scan performed?
Description

If YES, record details below.

Data type

text

Alias
UMLS CUI [1]
C0521317
Institution name
Description

Institution name

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0521317
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0521317
Left ventricular ejection fraction
Description

Left ventricular ejection fraction

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
%
Lower limit of normal
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
%
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Lab ID
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
Lab name
Description

Lab name

Data type

text

Alias
UMLS CUI [1]
C1882331
Date hematology sample taken
Description

Date hematology sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2]
C0474523
Units for differential, check one:
Description

Units

Data type

integer

Alias
UMLS CUI [1]
C1519795
UMLS CUI [2]
C0474523
Hemoglobin
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1]
C0518015
Hematocrit
Description

Hematocrit

Data type

float

Alias
UMLS CUI [1]
C0518014
RBC
Description

RBC

Data type

integer

Alias
UMLS CUI [1]
C0014772
Platelets
Description

Platelets

Data type

integer

Alias
UMLS CUI [1]
C0032181
Total WBC
Description

Total WBC

Data type

integer

Alias
UMLS CUI [1]
C0023508
Neutrophils
Description

Neutrophils

Data type

integer

Alias
UMLS CUI [1]
C0948762
Granulocytes
Description

Granulocytes

Data type

integer

Alias
UMLS CUI [1]
C0857490
Lymphocytes
Description

Lymphocytes

Data type

integer

Alias
UMLS CUI [1]
C0200635
Monocytes
Description

Monocytes

Data type

integer

Alias
UMLS CUI [1]
C0200637
Eosinophils
Description

Eosinophils

Data type

integer

Alias
UMLS CUI [1]
C0200638
Basophils
Description

Basophils

Data type

integer

Alias
UMLS CUI [1]
C0200641
Clinical Chemistry
Description

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C2347783
Lab ID
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
Lab name
Description

Lab name

Data type

text

Alias
UMLS CUI [1]
C1882331
Date clinical chemistry sample taken
Description

Date clinical chemistry sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2]
C0008000
Sodium
Description

Sodium

Data type

float

Alias
UMLS CUI [1]
C0337443
Potassium
Description

Potassium

Data type

float

Alias
UMLS CUI [1]
C0202194
Chloride
Description

Chloride

Data type

float

Alias
UMLS CUI [1]
C0201952
Bicarbonate
Description

Bicarbonate

Data type

float

Alias
UMLS CUI [1]
C0202059
Calcium
Description

Calcium

Data type

float

Alias
UMLS CUI [1]
C0201925
Glucose
Description

Glucose

Data type

float

Alias
UMLS CUI [1]
C0202042
Total Protein
Description

Total Protein

Data type

float

Alias
UMLS CUI [1]
C0555903
Albumin
Description

Albumin

Data type

float

Alias
UMLS CUI [1]
C0201838
Uric acid
Description

Uric acid

Data type

float

Alias
UMLS CUI [1]
C0202239
Creatinine
Description

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
BUN
Description

BUN

Data type

float

Alias
UMLS CUI [1]
C0005845
Urea
Description

Urea

Data type

float

Alias
UMLS CUI [1]
C0523961
Total bilirubin
Description

Total bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase
Description

Alkaline phosphatase

Data type

float

Alias
UMLS CUI [1]
C0201850
AST (SGOT)
Description

AST (SGOT)

Data type

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Description

ALT (SGPT)

Data type

float

Alias
UMLS CUI [1]
C0201836
Calculated Creatinine Clearance
Description

NOTE: Refer to the creatinine clearance worksheet for calculation.

Data type

float

Alias
UMLS CUI [1]
C0373595
Weight
Description

Creatinine Clearance Worksheet

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Creatinine Clearance Worksheet

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Age
Description

Creatinine Clearance Worksheet

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C0001779
years
Serum Creatinine
Description

Creatinine Clearance Worksheet

Data type

float

Alias
UMLS CUI [1]
C0201976
Serum Creatinine Units, check one:
Description

Creatinine Clearance Worksheet

Data type

integer

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519795
Response Assessment
Description

Response Assessment

Alias
UMLS CUI-1
C0871261
Date of lesion evaluation
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
Response assessment, check one:
Description

Response assessment

Data type

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0221198
If progressive disease is checked, indicate the primary method of evaluation.
Description

primary method of evaluation

Data type

text

Alias
UMLS CUI [1]
C2911685
Date of symptomatic progression of cancer
Description

Symptomatic progression of cancer, if checked, complete details below

Data type

date

Alias
UMLS CUI [1,1]
C0178874
UMLS CUI [1,2]
C0011008
Specify symptoms
Description

Specify symptoms

Data type

text

Alias
UMLS CUI [1]
C1457887
Confirmatory Scan
Description

Confirmatory Scan

Date of lesion evaluation
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
Response assessment, check one:
Description

Response assessment

Data type

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0221198
If progressive disease is checked, indicate the primary method of evaluation.
Description

primary method of evaluation

Data type

text

Alias
UMLS CUI [1]
C2911685
Date of symptomatic progression of cancer
Description

Symptomatic progression of cancer, if checked, complete details below

Data type

date

Alias
UMLS CUI [1,1]
C0178874
UMLS CUI [1,2]
C0011008
Specify symptoms
Description

Specify symptoms

Data type

text

Alias
UMLS CUI [1]
C1457887
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Week 24 NCT00078572

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Current Medical Conditions / Baseline Signs and Symptoms
C3899485 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
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])
signed informed consent
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])
Item
NCI CTCAE Grade
integer
C3887242 (UMLS CUI [1])
NCI CTCAE Grade
Code List
NCI CTCAE Grade
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])
Item Group
ECOG Performance Status
C1520224 (UMLS CUI-1)
ECOG
Item
ECOG
integer
C1520224 (UMLS CUI [1])
Item Group
Cardiac Assessments Screening
C1623258 (UMLS CUI-1)
C0013516 (UMLS CUI-2)
Item
Was a 12-lead ECG performed?
text
C0430456 (UMLS CUI [1])
signed informed consent
Code List
Was a 12-lead ECG performed?
CL Item
Yes (Y)
CL Item
No (N)
Date of assessment
Item
Date of assessment
date
C0011008 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Item
Check the appropriate box to indicate ECG results.
text
C1623258 (UMLS CUI [1])
ECG results
Code List
Check the appropriate box to indicate ECG results.
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])
signed informed consent
Code List
If ABNORMAL, check to indicate if the abnormalities are clinically significant.
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an Echocardiogram (ECHO) performed?
text
C0013516 (UMLS CUI [1])
signed informed consent
Code List
Was an Echocardiogram (ECHO) performed?
CL Item
Yes (Y)
CL Item
No (N)
Institution name
Item
Institution name
text
C1301943 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
integer
C0428772 (UMLS CUI [1])
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])
Item
Was a Multi-gated acquisition (MUGA) scan performed?
text
C0521317 (UMLS CUI [1])
signed informed consent
Code List
Was a Multi-gated acquisition (MUGA) scan performed?
CL Item
Yes (Y)
CL Item
No (N)
Institution name
Item
Institution name
text
C1301943 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
integer
C0428772 (UMLS CUI [1])
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])
Item Group
Hematology
C0474523 (UMLS CUI-1)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
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])
Item
Units for differential, check one:
integer
C1519795 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Units
Code List
Units for differential, check one:
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])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
C2347783 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
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])
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])
Serum Creatinine Units
Code List
Serum Creatinine Units, check one:
CL Item
mg/dL (1)
CL Item
μmol/L (2)
Item Group
Response Assessment
C0871261 (UMLS CUI-1)
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])
Item
Response assessment, check one:
text
C0521982 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Response assessment
Code List
Response assessment, check one:
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])
primary method of evaluation
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])
Specify symptoms
Item
Specify symptoms
text
C1457887 (UMLS CUI [1])
Item Group
Confirmatory Scan
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])
Item
Response assessment, check one:
text
C0521982 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Response assessment
Code List
Response assessment, check one:
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])
primary method of evaluation
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])
Specify symptoms
Item
Specify symptoms
text
C1457887 (UMLS CUI [1])
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