ID

43936

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: Screening 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 (2)
  1. 5/29/17 5/29/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Screening NCT00078572

English

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Screening NCT00078572

1 forms  
Pharmacogenetic Research - Blood - Informed Consent
Description

Pharmacogenetic Research - Blood - Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0005767
Has informed consent been obtained for Pharmacogenetic Research?
Description

informed consent

Data type

text

Alias
UMLS CUI [1]
C0021430
Date informed consent obtained for Pharmacogenetic Research
Description

Date informed consent obtained

Data type

date

Alias
UMLS CUI [1,1]
C0514044
UMLS CUI [1,2]
C0011008
If NO, specify reason below, check one:
Description

reason informed consent was not obtained

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [1,3]
C0392360
Has a blood sample been collected for Pharmacogenetic Research?
Description

blood sample

Data type

text

Alias
UMLS CUI [1]
C0005834
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0005834
Has this subject withdrawn consent for Pharmacogenetic Research?
Description

withdraw consent

Data type

text

Alias
UMLS CUI [1]
C2349954
Has a request been made for sample destruction?
Description

sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If YES, check one reason:
Description

reason for sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Pharmacogenetic Research - Tumor - Informed Consent
Description

Pharmacogenetic Research - Tumor - Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0006826
Has informed consent been obtained for Pharmacogenetic Research?
Description

informed consent

Data type

text

Alias
UMLS CUI [1]
C0021430
Date informed consent obtained for Pharmacogenetic Research
Description

Date informed consent obtained

Data type

date

Alias
UMLS CUI [1,1]
C0514044
UMLS CUI [1,2]
C0011008
If NO, specify reason below, check one:
Description

reason informed consent was not obtained

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
UMLS CUI [1,3]
C0392360
Has a tumor sample been collected for Pharmacogenetic Research?
Description

tumor sample

Data type

text

Alias
UMLS CUI [1]
C0475358
Date tumor sample taken
Description

Date tumor sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0475358
Has this subject withdrawn consent for Pharmacogenetic Research?
Description

withdraw consent

Data type

text

Alias
UMLS CUI [1]
C2349954
Inclusion Criteria Worksheet
Description

Inclusion Criteria Worksheet

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Has the subject provided signed informed consent?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0021430
Does the subject have histologically or cytologically confirmed invasive breast cancer with stage IIIb, stage IIIc with T4 lesion, or stage IV disease?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0278488
Does the subject have documentation of ErbB2 overexpression (IHC 3+ or IHC 2+ with FISH confirmation) based on local, central laboratory or initial diagnostic results?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1,1]
C1515559
UMLS CUI [1,2]
C0587081
UMLS CUI [2]
C0853879
Does the subject have documented progressive advanced or metastatic breast cancer?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study. NOTE: Progression for entry is defined as appearance of any new lesion not previously identified or increase of 25% or more in existent lesions and must be documented.

Data type

text

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C0853879
Subjects must have refractory breast cancer defined as progression in the metastatic setting after prior therapy which must include: At least 4 cycles of anthracycline- and taxane-containing regimens (concurrently or sequentially) At least 2 cycles, provided disease progresssion occurred while on the respective anthracycline or taxane containing chemotherapy regimen(s) Subjects who relapse > 6 months after completion of adjuvant anthracycline- containing chemotherapy, and for whom further anthracycline therapy is not indicated, are eligible for the study if the remaining inclusion criteria are met. Check YES if this is applicable for the subject. NOTE: Prior treatment with capecitabine is not permitted.
Description

Check YES if this is applicable for the subject.

Data type

text

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205269
Prior treatment must contain trastuzumab (Herceptin®) alone or in combination with other chemotherapy for at least 6 weeks of standard doses unless the trastuzumab local label requirements indicate the subject is not eligible for trastuzumab treatment.
Description

Check YES if this is applicable for the subject.

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0728747
Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.
Description

Check YES if this is applicable for the subject, otherwise check NO.

Data type

text

Alias
UMLS CUI [1]
C1563119
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0279025
Subject has no CNS metastases or has stable CNS metastases (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are eligible.
Description

Check YES if this is applicable for the subject

Data type

text

Alias
UMLS CUI [1]
C0686377
Is the subject female 18 years of age or older?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0681850
Does the subject have an ECOG Performance status of 0 or 1?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C1520224
Does the subject have measurable disease according to RECIST (Response Evaluation Criteria in Solid Tumors)?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1709926
Does the subject have archived tumor tissue available to re-evaluate intra- tumoral expression levels of ErbB1 and ErbB2 by IHC and FISH testing performed by the study central laboratory? NOTE: Central laboratory results will not be used to determine subject eligibility for the study, unless testing is being used for required documentation of ErbB2 overexpression.
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1,1]
C0003738
UMLS CUI [1,2]
C0475358
Does the subject have a life expectancy of ≥12 weeks?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0023671
Has the subject recovered from clinically significant side effects associated with prior radiotherapy and chemotherapy?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C2004454
UMLS CUI [2,1]
C0001688
UMLS CUI [2,2]
C1522449
UMLS CUI [3,1]
C0001688
UMLS CUI [3,2]
C0392920
Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.
Description

Check YES if this is applicable for the subject

Data type

text

Alias
UMLS CUI [1]
C1522449
Does the subject have a cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (or MUGA if echocardiogram is not available)?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0232174
Is the subject able to swallow and retain oral medication?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C2712086
Has the subject completed all screening assessments as outlined in the protocol?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C1710477
Does the subject have adequate Renal Function defined as a Creatinine Clearance ≥50mL/min, determined by calculated creatinine clearance using Cockcroft and Gault Method and normalized to Body Surface Area (BSA)?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0232804
Does the subject have adequate hematologic and hepatic function as defined below?
Description

Inclusion Criteria check one box for each question: If any INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
Exclusion Criteria Worksheet
Description

Exclusion Criteria Worksheet

Alias
UMLS CUI-1
C0680251
Is the subject pregnant, or a lactating female, or planning to become pregnant during the study?
Description

Exclusion Criteria check one box for each question: If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this study.

Data type

text

Alias
UMLS CUI [1]
C0549206
Does the subject have Malabsorption Syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis?
Description

Malabsorption Syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis

Data type

text

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0017178
Does the subject have a history of other malignancy? NOTE: A subject who has been disease-free for 5 years, or has a history of completely resected non-melanoma skin cancer or has been successfully treated for in situ carcinoma is eligible.
Description

history of other malignancy

Data type

text

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0262926
Does the subject have a concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject’s safety?
Description

concurrent disease or condition

Data type

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
Does the subject have unresolved or unstable, serious toxicity from prior administration of another investigational drug?
Description

unresolved or unstable, serious toxicity

Data type

text

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C0013230
Does the subject have active or uncontrolled infection?
Description

active or uncontrolled infection

Data type

text

Alias
UMLS CUI [1]
C0009450
Does the subject have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent?
Description

dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Does the subject have a known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure?
Description

history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

Data type

text

Alias
UMLS CUI [1]
C0018799
Is the subject taking coumarin-derivative anticoagulants such as warfarin and phenprocoumon?
Description

coumarin-derivative anticoagulants

Data type

text

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0010207
Does the subject have a known history of, or clinical evidence of leptomeningeal carcinomatosis?
Description

history of, or clinical evidence of leptomeningeal carcinomatosis

Data type

text

Alias
UMLS CUI [1]
C0220654
Is the subject receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine?
Description

concurrent anti-cancer therapy other than capecitabine

Data type

text

Alias
UMLS CUI [1]
C0920425
Bisphosphonates should not be initiated following first dose of study medication for the treatment of bone metastases. Additionally, bisphosphonates for prophylactic use in subjects without bone disease is not permitted.
Description

Check NO if this is applicable for the subject

Data type

text

Alias
UMLS CUI [1]
C0012544
Is the subject receiving concurrent treatment with an investigational agent or participating in another clinical trial?
Description

concurrent treatment with an investigational agent or participating in another clinical trial

Data type

text

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
Has the subject used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy?
Description

used an investigational drug

Data type

text

Alias
UMLS CUI [1]
C0013230
Does the subject have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GW572016 or excipients of GW572016?
Description

immediate or delayed hypersensitivity reaction or idiosyncrasy

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1384663
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C1384663
Does the subject have known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients?
Description

immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients?

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0231191
UMLS CUI [2,1]
C0671970
UMLS CUI [2,2]
C0016360
UMLS CUI [2,3]
C0015237
Does the subject have known dihydropyrimidine dehydrogenase (DPD) deficiency? Yes No
Description

dihydropyrimidine dehydrogenase (DPD) deficiency

Data type

text

Alias
UMLS CUI [1]
C1959620
Inclusion and Exclusion Criteria
Description

Inclusion and Exclusion Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1512693
UMLS CUI-3
C1516637
Protocol code
Description

Protocol code

Data type

text

Alias
UMLS CUI [1,1]
C1507394
UMLS CUI [1,2]
C0600091
Session number
Description

Session number

Data type

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)? See INCLUSION / EXCLUSION CRITERIA WORKSHEET.
Description

meet all entry criteria

Data type

text

Alias
UMLS CUI [1]
C0013893
Check all boxes that represent a violation of the inclusion criteria:
Description

violation of the inclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1512693
UMLS CUI [2]
C1516637
Check all boxes that represent a violation of the exclusion criteria:
Description

violation of the exclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C0680251
UMLS CUI [2]
C1516637
Current Medical Conditions / Baseline Signs and Symptoms
Description

Current Medical Conditions / Baseline Signs and Symptoms

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0012634
UMLS CUI-3
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]
C0012634
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]
C0012634
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 [1,1]
C3887242
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1457887
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 - Local Lab Screening
Description

Hematology - Local Lab Screening

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
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 - Local Lab Screening
Description

Clinical Chemistry - Local Lab Screening

Alias
UMLS CUI-1
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]
C2347783
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
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Similar models

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Screening NCT00078572

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pharmacogenetic Research - Blood - Informed Consent
C0021430 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Has informed consent been obtained for Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1])
signed informed consent
Code List
Has informed consent been obtained for Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
Date informed consent obtained
Item
Date informed consent obtained for Pharmacogenetic Research
date
C0514044 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If NO, specify reason below, check one:
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason informed consent was not obtained
Code List
If NO, specify reason below, check one:
CL Item
Subject declined (SD)
CL Item
Subject not asked by investigator (SI)
CL Item
Other (X)
Item
Has a blood sample been collected for Pharmacogenetic Research?
text
C0005834 (UMLS CUI [1])
signed informed consent
Code List
Has a blood sample been collected for Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
text
C2349954 (UMLS CUI [1])
signed informed consent
Code List
Has this subject withdrawn consent for Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
signed informed consent
Code List
Has a request been made for sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If YES, check one reason:
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for sample destruction
Code List
If YES, check one reason:
CL Item
Subject’s request (R)
CL Item
Screen failure (F)
CL Item
Other (X)
Item Group
Pharmacogenetic Research - Tumor - Informed Consent
C0021430 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
Item
Has informed consent been obtained for Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1])
signed informed consent
Code List
Has informed consent been obtained for Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
Date informed consent obtained
Item
Date informed consent obtained for Pharmacogenetic Research
date
C0514044 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If NO, specify reason below, check one:
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason informed consent was not obtained
Code List
If NO, specify reason below, check one:
CL Item
Subject declined (SD)
CL Item
Subject not asked by investigator (SI)
CL Item
Other (X)
Item
Has a tumor sample been collected for Pharmacogenetic Research?
text
C0475358 (UMLS CUI [1])
signed informed consent
Code List
Has a tumor sample been collected for Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
Date tumor sample taken
Item
Date tumor sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
text
C2349954 (UMLS CUI [1])
signed informed consent
Code List
Has this subject withdrawn consent for Pharmacogenetic Research?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion Criteria Worksheet
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Item
Has the subject provided signed informed consent?
text
C0021430 (UMLS CUI [1])
signed informed consent
Code List
Has the subject provided signed informed consent?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have histologically or cytologically confirmed invasive breast cancer with stage IIIb, stage IIIc with T4 lesion, or stage IV disease?
text
C0853879 (UMLS CUI [1])
C0278488 (UMLS CUI [2])
signed informed consent
Code List
Does the subject have histologically or cytologically confirmed invasive breast cancer with stage IIIb, stage IIIc with T4 lesion, or stage IV disease?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have documentation of ErbB2 overexpression (IHC 3+ or IHC 2+ with FISH confirmation) based on local, central laboratory or initial diagnostic results?
text
C1515559 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2])
signed informed consent
Code List
Does the subject have documentation of ErbB2 overexpression (IHC 3+ or IHC 2+ with FISH confirmation) based on local, central laboratory or initial diagnostic results?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have documented progressive advanced or metastatic breast cancer?
text
C0278488 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
signed informed consent
Code List
Does the subject have documented progressive advanced or metastatic breast cancer?
CL Item
Yes (Y)
CL Item
No (N)
Item
Subjects must have refractory breast cancer defined as progression in the metastatic setting after prior therapy which must include: At least 4 cycles of anthracycline- and taxane-containing regimens (concurrently or sequentially) At least 2 cycles, provided disease progresssion occurred while on the respective anthracycline or taxane containing chemotherapy regimen(s) Subjects who relapse > 6 months after completion of adjuvant anthracycline- containing chemotherapy, and for whom further anthracycline therapy is not indicated, are eligible for the study if the remaining inclusion criteria are met. Check YES if this is applicable for the subject. NOTE: Prior treatment with capecitabine is not permitted.
text
C0678222 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
signed informed consent
Code List
Subjects must have refractory breast cancer defined as progression in the metastatic setting after prior therapy which must include: At least 4 cycles of anthracycline- and taxane-containing regimens (concurrently or sequentially) At least 2 cycles, provided disease progresssion occurred while on the respective anthracycline or taxane containing chemotherapy regimen(s) Subjects who relapse > 6 months after completion of adjuvant anthracycline- containing chemotherapy, and for whom further anthracycline therapy is not indicated, are eligible for the study if the remaining inclusion criteria are met. Check YES if this is applicable for the subject. NOTE: Prior treatment with capecitabine is not permitted.
CL Item
Yes (Y)
CL Item
No (N)
Item
Prior treatment must contain trastuzumab (Herceptin®) alone or in combination with other chemotherapy for at least 6 weeks of standard doses unless the trastuzumab local label requirements indicate the subject is not eligible for trastuzumab treatment.
text
C1514463 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
signed informed consent
Code List
Prior treatment must contain trastuzumab (Herceptin®) alone or in combination with other chemotherapy for at least 6 weeks of standard doses unless the trastuzumab local label requirements indicate the subject is not eligible for trastuzumab treatment.
CL Item
Yes (Y)
CL Item
No (N)
Item
Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.
text
C1563119 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
signed informed consent
Code List
Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.
CL Item
Yes (Y)
CL Item
No (N)
Item
Subject has no CNS metastases or has stable CNS metastases (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are eligible.
text
C0686377 (UMLS CUI [1])
signed informed consent
Code List
Subject has no CNS metastases or has stable CNS metastases (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are eligible.
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the subject female 18 years of age or older?
text
C0001779 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
signed informed consent
Code List
Is the subject female 18 years of age or older?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have an ECOG Performance status of 0 or 1?
text
C1520224 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have an ECOG Performance status of 0 or 1?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have measurable disease according to RECIST (Response Evaluation Criteria in Solid Tumors)?
text
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
signed informed consent
Code List
Does the subject have measurable disease according to RECIST (Response Evaluation Criteria in Solid Tumors)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have archived tumor tissue available to re-evaluate intra- tumoral expression levels of ErbB1 and ErbB2 by IHC and FISH testing performed by the study central laboratory? NOTE: Central laboratory results will not be used to determine subject eligibility for the study, unless testing is being used for required documentation of ErbB2 overexpression.
text
C0003738 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
signed informed consent
Code List
Does the subject have archived tumor tissue available to re-evaluate intra- tumoral expression levels of ErbB1 and ErbB2 by IHC and FISH testing performed by the study central laboratory? NOTE: Central laboratory results will not be used to determine subject eligibility for the study, unless testing is being used for required documentation of ErbB2 overexpression.
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have a life expectancy of ≥12 weeks?
text
C0023671 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have a life expectancy of ≥12 weeks?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has the subject recovered from clinically significant side effects associated with prior radiotherapy and chemotherapy?
text
C2004454 (UMLS CUI [1])
C0001688 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0001688 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
signed informed consent
Code List
Has the subject recovered from clinically significant side effects associated with prior radiotherapy and chemotherapy?
CL Item
Yes (Y)
CL Item
No (N)
Item
Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.
text
C1522449 (UMLS CUI [1])
signed informed consent
Code List
Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have a cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (or MUGA if echocardiogram is not available)?
text
C0232174 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have a cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (or MUGA if echocardiogram is not available)?
CL Item
Yes (Y)
CL Item
No (N)
swallow and retain oral medication
Item
Is the subject able to swallow and retain oral medication?
text
C0175795 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
Item
Has the subject completed all screening assessments as outlined in the protocol?
text
C1710477 (UMLS CUI [1])
signed informed consent
Code List
Has the subject completed all screening assessments as outlined in the protocol?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have adequate Renal Function defined as a Creatinine Clearance ≥50mL/min, determined by calculated creatinine clearance using Cockcroft and Gault Method and normalized to Body Surface Area (BSA)?
text
C0232804 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have adequate Renal Function defined as a Creatinine Clearance ≥50mL/min, determined by calculated creatinine clearance using Cockcroft and Gault Method and normalized to Body Surface Area (BSA)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have adequate hematologic and hepatic function as defined below?
text
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
signed informed consent
Code List
Does the subject have adequate hematologic and hepatic function as defined below?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Exclusion Criteria Worksheet
C0680251 (UMLS CUI-1)
Item
Is the subject pregnant, or a lactating female, or planning to become pregnant during the study?
text
C0549206 (UMLS CUI [1])
signed informed consent
Code List
Is the subject pregnant, or a lactating female, or planning to become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have Malabsorption Syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis?
text
C0024523 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
signed informed consent
Code List
Does the subject have Malabsorption Syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have a history of other malignancy? NOTE: A subject who has been disease-free for 5 years, or has a history of completely resected non-melanoma skin cancer or has been successfully treated for in situ carcinoma is eligible.
text
C0027651 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
signed informed consent
Code List
Does the subject have a history of other malignancy? NOTE: A subject who has been disease-free for 5 years, or has a history of completely resected non-melanoma skin cancer or has been successfully treated for in situ carcinoma is eligible.
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have a concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject’s safety?
text
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
signed informed consent
Code List
Does the subject have a concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject’s safety?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have unresolved or unstable, serious toxicity from prior administration of another investigational drug?
text
C0013221 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
signed informed consent
Code List
Does the subject have unresolved or unstable, serious toxicity from prior administration of another investigational drug?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have active or uncontrolled infection?
text
C0009450 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have active or uncontrolled infection?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent?
text
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
signed informed consent
Code List
Does the subject have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have a known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure?
text
C0018799 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have a known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the subject taking coumarin-derivative anticoagulants such as warfarin and phenprocoumon?
text
C0003280 (UMLS CUI [1])
C0010207 (UMLS CUI [2])
signed informed consent
Code List
Is the subject taking coumarin-derivative anticoagulants such as warfarin and phenprocoumon?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have a known history of, or clinical evidence of leptomeningeal carcinomatosis?
text
C0220654 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have a known history of, or clinical evidence of leptomeningeal carcinomatosis?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the subject receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine?
text
C0920425 (UMLS CUI [1])
signed informed consent
Code List
Is the subject receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine?
CL Item
Yes (Y)
CL Item
No (N)
Item
Bisphosphonates should not be initiated following first dose of study medication for the treatment of bone metastases. Additionally, bisphosphonates for prophylactic use in subjects without bone disease is not permitted.
text
C0012544 (UMLS CUI [1])
signed informed consent
Code List
Bisphosphonates should not be initiated following first dose of study medication for the treatment of bone metastases. Additionally, bisphosphonates for prophylactic use in subjects without bone disease is not permitted.
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the subject receiving concurrent treatment with an investigational agent or participating in another clinical trial?
text
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
signed informed consent
Code List
Is the subject receiving concurrent treatment with an investigational agent or participating in another clinical trial?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has the subject used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy?
text
C0013230 (UMLS CUI [1])
signed informed consent
Code List
Has the subject used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GW572016 or excipients of GW572016?
text
C0020517 (UMLS CUI [1,1])
C1384663 (UMLS CUI [1,2])
C0231191 (UMLS CUI [2,1])
C1384663 (UMLS CUI [2,2])
signed informed consent
Code List
Does the subject have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GW572016 or excipients of GW572016?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients?
text
C0020517 (UMLS CUI [1,1])
C0231191 (UMLS CUI [1,2])
C0671970 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
signed informed consent
Code List
Does the subject have known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject have known dihydropyrimidine dehydrogenase (DPD) deficiency? Yes No
text
C1959620 (UMLS CUI [1])
signed informed consent
Code List
Does the subject have known dihydropyrimidine dehydrogenase (DPD) deficiency? Yes No
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion and Exclusion Criteria
C0680251 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
C1516637 (UMLS CUI-3)
Protocol code
Item
Protocol code
text
C1507394 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Session number
Item
Session number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)? See INCLUSION / EXCLUSION CRITERIA WORKSHEET.
text
C0013893 (UMLS CUI [1])
signed informed consent
Code List
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)? See INCLUSION / EXCLUSION CRITERIA WORKSHEET.
CL Item
Yes (Y)
CL Item
No (N)
Item
Check all boxes that represent a violation of the inclusion criteria:
integer
C1709750 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [2])
violation of the inclusion criteria
Code List
Check all boxes that represent a violation of the inclusion criteria:
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
Item
Check all boxes that represent a violation of the exclusion criteria:
integer
C1709750 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1516637 (UMLS CUI [2])
undefined item
Code List
Check all boxes that represent a violation of the exclusion criteria:
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
Item Group
Current Medical Conditions / Baseline Signs and Symptoms
C0262926 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C1457887 (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
C0012634 (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
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Item
NCI CTCAE Grade
integer
C3887242 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
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 - Local Lab Screening
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])
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 - Local Lab Screening
C2347783 (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 clinical chemistry sample taken
Item
Date clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C2347783 (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)
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