ID

22072

Beschreibung

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

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Stichworte

Versionen (2)
  1. 18-05-17 18-05-17 -
  2. 18-05-17 18-05-17 -
Hochgeladen am

18 mei 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study ConclusionNCT00078572

Englisch

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572

1 Formulare  
Current Medical Conditions / Baseline Signs and Symptoms
Beschreibung

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)?
Beschreibung

current medical conditions, baseline signs or symptoms

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

integer

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

Physical Exam (Vital Signs, Weight, Height)

Alias
UMLS CUI-1
C0518766
Date Vital Signs
Beschreibung

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

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Blood pressure systolic
Beschreibung

Blood pressure systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Beschreibung

Blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
ECOG Performance Status
Beschreibung

ECOG Performance Status

Alias
UMLS CUI-1
C1520224
ECOG
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C1520224
Cardiac Assessments Screening
Beschreibung

Cardiac Assessments Screening

Alias
UMLS CUI-1
C1827871
UMLS CUI-2
C1623258
UMLS CUI-3
C0013516
Was a 12-lead ECG performed?
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0430456
Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0430456
Check the appropriate box to indicate ECG results.
Beschreibung

ECG results

Datentyp

text

Alias
UMLS CUI [1]
C1623258
If ABNORMAL, check to indicate if the abnormalities are clinically significant.
Beschreibung

If YES, record the abnormality on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page at Screening.

Datentyp

text

Alias
UMLS CUI [1]
C1623258
Was an Echocardiogram (ECHO) performed?
Beschreibung

If YES, record details below.

Datentyp

text

Alias
UMLS CUI [1]
C0013516
Institution name
Beschreibung

Institution name

Datentyp

text

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

Date

Datentyp

date

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

Left ventricular ejection fraction

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
%
Lower limit of normal
Beschreibung

Lower limit of normal

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C1518030
UMLS CUI [1,2]
C0428772
UMLS CUI [2]
C0013516
%
Was a Multi-gated acquisition (MUGA) scan performed?
Beschreibung

If YES, record details below.

Datentyp

text

Alias
UMLS CUI [1]
C0521317
Institution name
Beschreibung

Institution name

Datentyp

text

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

Date

Datentyp

date

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

Left ventricular ejection fraction

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
%
Lower limit of normal
Beschreibung

NOTE: If left ventricular ejection fraction is not within institutional range of normal, the subject must not enter the study.

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C1518030
UMLS CUI [1,2]
C0428772
UMLS CUI [2]
C0521317
%
Hematology
Beschreibung

Hematology

Alias
UMLS CUI-1
C0474523
Lab ID
Beschreibung

Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Lab name
Beschreibung

Lab name

Datentyp

text

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

Date hematology sample taken

Datentyp

date

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

Units

Datentyp

integer

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

Hemoglobin

Datentyp

float

Alias
UMLS CUI [1]
C0518015
Hematocrit
Beschreibung

Hematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0518014
RBC
Beschreibung

RBC

Datentyp

integer

Alias
UMLS CUI [1]
C0014772
Platelets
Beschreibung

Platelets

Datentyp

integer

Alias
UMLS CUI [1]
C0032181
Total WBC
Beschreibung

Total WBC

Datentyp

integer

Alias
UMLS CUI [1]
C0023508
Neutrophils
Beschreibung

Neutrophils

Datentyp

integer

Alias
UMLS CUI [1]
C0948762
Granulocytes
Beschreibung

Granulocytes

Datentyp

integer

Alias
UMLS CUI [1]
C0857490
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

integer

Alias
UMLS CUI [1]
C0200635
Monocytes
Beschreibung

Monocytes

Datentyp

integer

Alias
UMLS CUI [1]
C0200637
Eosinophils
Beschreibung

Eosinophils

Datentyp

integer

Alias
UMLS CUI [1]
C0200638
Basophils
Beschreibung

Basophils

Datentyp

integer

Alias
UMLS CUI [1]
C0200641
Clinical Chemistry
Beschreibung

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C2347783
Lab ID
Beschreibung

Any clinically significant laboratory abnormalities must be recorded on the CURRENT MEDICAL CONDITIONS / BASELINE SIGNS AND SYMPTOMS page

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Lab name
Beschreibung

Lab name

Datentyp

text

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

Date clinical chemistry sample taken

Datentyp

date

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

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Potassium
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1]
C0202194
Chloride
Beschreibung

Chloride

Datentyp

float

Alias
UMLS CUI [1]
C0201952
Bicarbonate
Beschreibung

Bicarbonate

Datentyp

float

Alias
UMLS CUI [1]
C0202059
Calcium
Beschreibung

Calcium

Datentyp

float

Alias
UMLS CUI [1]
C0201925
Glucose
Beschreibung

Glucose

Datentyp

float

Alias
UMLS CUI [1]
C0202042
Total Protein
Beschreibung

Total Protein

Datentyp

float

Alias
UMLS CUI [1]
C0555903
Albumin
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Uric acid
Beschreibung

Uric acid

Datentyp

float

Alias
UMLS CUI [1]
C0202239
Creatinine
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
BUN
Beschreibung

BUN

Datentyp

float

Alias
UMLS CUI [1]
C0005845
Urea
Beschreibung

Urea

Datentyp

float

Alias
UMLS CUI [1]
C0523961
Total bilirubin
Beschreibung

Total bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

float

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

AST (SGOT)

Datentyp

float

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

ALT (SGPT)

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Calculated Creatinine Clearance
Beschreibung

NOTE: Refer to the creatinine clearance worksheet for calculation.

Datentyp

float

Alias
UMLS CUI [1]
C0373595
Weight
Beschreibung

Creatinine Clearance Worksheet

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschreibung

Creatinine Clearance Worksheet

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Age
Beschreibung

Creatinine Clearance Worksheet

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1]
C0001779
years
Serum Creatinine
Beschreibung

Creatinine Clearance Worksheet

Datentyp

float

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

Creatinine Clearance Worksheet

Datentyp

integer

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

Response Assessment

Alias
UMLS CUI-1
C0871261
UMLS CUI-2
C0521982
Date of lesion evaluation
Beschreibung

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.

Datentyp

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0220825
Response assessment, check one:
Beschreibung

Response assessment

Datentyp

text

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

primary method of evaluation

Datentyp

text

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

Symptomatic progression of cancer, if checked, complete details below

Datentyp

date

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

Specify symptoms

Datentyp

text

Alias
UMLS CUI [1]
C1457887
Confirmatory Scan
Beschreibung

Confirmatory Scan

Alias
UMLS CUI-1
C0011923
UMLS CUI-2
C0750484
UMLS CUI-3
C0521982
Date of lesion evaluation
Beschreibung

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.

Datentyp

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0220825
Response assessment, check one:
Beschreibung

Response assessment

Datentyp

text

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

primary method of evaluation

Datentyp

text

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

Symptomatic progression of cancer, if checked, complete details below

Datentyp

date

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

Specify symptoms

Datentyp

text

Alias
UMLS CUI [1]
C1457887
Endpoint Evaluation : Investigator
Beschreibung

Endpoint Evaluation : Investigator

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0521982
Best response, check one:
Beschreibung

Best response

Datentyp

text

Alias
UMLS CUI [1]
C0521982
Date of response
Beschreibung

If partial response or complete response is ✔, complete below:

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0521982
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Ähnliche Modelle

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C1827871 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0013516 (UMLS CUI-3)
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])
C0430456 (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)
C0521982 (UMLS CUI-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])
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
C0011923 (UMLS CUI-1)
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])
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
Endpoint Evaluation : Investigator
C0220825 (UMLS CUI-1)
C0521982 (UMLS CUI-2)
Item
Best response, check one:
text
C0521982 (UMLS CUI [1])
Response assessment
Code List
Best response, 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)
Date of response
Item
Date of response
date
C0011008 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
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