ID

38342

Description

Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01961544

Link

https://clinicaltrials.gov/show/NCT01961544

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01961544

English

Eligibility Breast Neoplasms NCT01961544

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female, age greater or equal to 20 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. patients with histologically or cytologically confirmed carcinoma of the breast
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
3. patients with locally advance or metastatic carcinoma of the breast
Description

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
4. patients who have received two to five prior chemotherapeutic regimens including an antracycline and a taxane and 2 or more regimens for locally recurrent and/or metastatic disease
Description

Prior Chemotherapy Quantity | Anthracyclines | taxane | Therapeutic regimen Quantity Recurrent disease Locally | Therapeutic regimen Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0282564
UMLS CUI [3]
C0215136
UMLS CUI [4,1]
C1276413
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0277556
UMLS CUI [4,4]
C1517927
UMLS CUI [5,1]
C1276413
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0027627
5. patients must have proved refractory to the most recent chemotherapy on or within six (6) months of therapy
Description

Unresponsive to Chemotherapy Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0332185
6. patients who have assessable lesion according to recist v 1.1
Description

Lesion Evaluable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1516986
7. adequately maintained bone marrow function
Description

Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9 /l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin greater than or equal to 10.0 g/dl (a hemoglobin less than 10.0 g/dl is acceptable if it is corrected by erythropoietin or transfusion)
Description

Hemoglobin measurement | Hemoglobin measurement Corrected Erythropoietin | Hemoglobin measurement Corrected Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0518015
UMLS CUI [2,2]
C0205202
UMLS CUI [2,3]
C0014822
UMLS CUI [3,1]
C0518015
UMLS CUI [3,2]
C0205202
UMLS CUI [3,3]
C0005841
platelet count greater than or equal to 100 x 10^9 /l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
8. adequately maintained liver function
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
total bilirubin: less than or equal to 1.5 times the upper limits of normal (uln) and
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
alkaline phosphatase(alp), alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln (in the case of liver metastases less than or equal to 5 x uln)
Description

Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0494165
9. adequately maintained renal function
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
serum creatinine less than or equal to 2.0 mg/dl or
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
calculated creatinine clearance greater than or equal to 40 ml/min (cockcroft and gault formula)
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
10. resolution of all chemotherapy or radiation-related toxicities to grade 1 severity or lower, except for
Description

Toxicity Chemotherapy Related | Toxicity Radiotherapy Related | Resolution CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C1514893
UMLS CUI [3,2]
C1516728
alopecia
Description

Exception Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0002170
stable sensory neuropathy less than or equal to grade 2
Description

Sensory neuropathy Stable CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1516728
11. eastern cooperative oncology group (ecog) performance status of 0 to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
12. life expectancy of greater than or equal to 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
13. patients willing and able to comply with the study protocol for the duration of the study
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
14. patients who have provided written consent to participate in this study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have received a chemotherapy, radiation, biologics, immunotherapy or hormonal therapy within three weeks before treatment start (but, palliative radiation can be enrolled)
Description

Chemotherapy | Therapeutic radiology procedure | Biological Factors | Immunotherapy | Hormone Therapy | Palliative Radiation Therapy allowed

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0005515
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0279025
UMLS CUI [6,1]
C3898008
UMLS CUI [6,2]
C0683607
2. pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
Description

Lymphangitic metastasis to lung | Treatment required for Pulmonary Dysfunction | Use of supplemental oxygen

Data type

boolean

Alias
UMLS CUI [1]
C2062926
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C1709770
UMLS CUI [3]
C4067893
3. patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment in this study. any signs and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment
Description

Metastatic malignant neoplasm to brain | Neoplasm Metastasis Subdural | Exception Local Therapy Completed | Exception Corticosteroid use Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0038541
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1517925
UMLS CUI [3,3]
C0205197
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0239126
UMLS CUI [4,3]
C1444662
4. patients with meningeal carcinomatosis
Description

Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
5. significant cardiovascular impairment
Description

Cardiovascular impairment

Data type

boolean

Alias
UMLS CUI [1]
C0848757
myocardial infarction within the past six months, unstable angina, history of congestive heart failure nyha class iii or iv, or serious cardiac arrhythmia
Description

Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205404
qtc prolongation (bazett's formula greater than 480 msec) or congenital long qt syndrome
Description

Prolonged QTc Bazett formula | Congenital long QT syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C1969409
UMLS CUI [1,2]
C4038411
UMLS CUI [2]
C1141890
6. severe/uncontrolled intercurrent illness/infection required administration of antibiotic injection
Description

Comorbidity Severe | Comorbidity Uncontrolled | Communicable Disease Requirement Antibiotic Injection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0003232
UMLS CUI [3,4]
C1533685
7. patients who have processed a major surgery within four weeks before participation in this clinical trial
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
8. patients who have had a prior malignancy within the past five years other than breast cancer (but, treated non-melanoma skin cancer and carcinoma in situ of the cervix will not be excluded)
Description

Malignant Neoplasms | Exception Breast Carcinoma | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
9. patients with known positive hiv status
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
10. patients who have received genetic therapy or other investigational drug within 4 weeks before treatment start or expected to receive prohibited medication
Description

Gene therapy | Investigational New Drugs | Illicit medication use Expected

Data type

boolean

Alias
UMLS CUI [1]
C0017296
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0281875
UMLS CUI [3,2]
C1517001
11. patients with prior allergies to halichondrin b, its derivatives, active ingredient, or other diluting agent
Description

Hypersensitivity Halichondrin B | Hypersensitivity Halichondrin B Derivative | Hypersensitivity Halichondrin B Ingredient | Hypersensitivity Anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0120715
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0120715
UMLS CUI [2,3]
C1527240
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0120715
UMLS CUI [3,3]
C1550600
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0003280
12. patients who have received this investigational product before registration for this study
Description

halichondrin B

Data type

boolean

Alias
UMLS CUI [1]
C0120715
13. patients who are pregnant, who may possibly be pregnant, or are lactating
Description

Pregnancy | Possible pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
UMLS CUI [3]
C0006147
14. patients who do not agree to practice contraception for the study periods
Description

Patients Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
15. patients who have participated in other clinical trial within 4 weeks before screening
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
16. patients otherwise judged by investigator or sub investigator to be unsuitable for inclusion
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Breast Neoplasms NCT01961544

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female, age greater or equal to 20 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
2. patients with histologically or cytologically confirmed carcinoma of the breast
boolean
C0678222 (UMLS CUI [1])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
3. patients with locally advance or metastatic carcinoma of the breast
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Prior Chemotherapy Quantity | Anthracyclines | taxane | Therapeutic regimen Quantity Recurrent disease Locally | Therapeutic regimen Quantity Neoplasm Metastasis
Item
4. patients who have received two to five prior chemotherapeutic regimens including an antracycline and a taxane and 2 or more regimens for locally recurrent and/or metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
C1276413 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0277556 (UMLS CUI [4,3])
C1517927 (UMLS CUI [4,4])
C1276413 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0027627 (UMLS CUI [5,3])
Unresponsive to Chemotherapy Recent
Item
5. patients must have proved refractory to the most recent chemotherapy on or within six (6) months of therapy
boolean
C0205269 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Lesion Evaluable
Item
6. patients who have assessable lesion according to recist v 1.1
boolean
C0221198 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
Bone Marrow function
Item
7. adequately maintained bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9 /l
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement | Hemoglobin measurement Corrected Erythropoietin | Hemoglobin measurement Corrected Transfusion
Item
hemoglobin greater than or equal to 10.0 g/dl (a hemoglobin less than 10.0 g/dl is acceptable if it is corrected by erythropoietin or transfusion)
boolean
C0518015 (UMLS CUI [1])
C0518015 (UMLS CUI [2,1])
C0205202 (UMLS CUI [2,2])
C0014822 (UMLS CUI [2,3])
C0518015 (UMLS CUI [3,1])
C0205202 (UMLS CUI [3,2])
C0005841 (UMLS CUI [3,3])
Platelet Count measurement
Item
platelet count greater than or equal to 100 x 10^9 /l
boolean
C0032181 (UMLS CUI [1])
Liver function
Item
8. adequately maintained liver function
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin: less than or equal to 1.5 times the upper limits of normal (uln) and
boolean
C1278039 (UMLS CUI [1])
Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alkaline phosphatase(alp), alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln (in the case of liver metastases less than or equal to 5 x uln)
boolean
C0201850 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
Renal function
Item
9. adequately maintained renal function
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine less than or equal to 2.0 mg/dl or
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance greater than or equal to 40 ml/min (cockcroft and gault formula)
boolean
C2711451 (UMLS CUI [1])
Toxicity Chemotherapy Related | Toxicity Radiotherapy Related | Resolution CTCAE Grades
Item
10. resolution of all chemotherapy or radiation-related toxicities to grade 1 severity or lower, except for
boolean
C0600688 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1514893 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Exception Alopecia
Item
alopecia
boolean
C1705847 (UMLS CUI [1,1])
C0002170 (UMLS CUI [1,2])
Sensory neuropathy Stable CTCAE Grades
Item
stable sensory neuropathy less than or equal to grade 2
boolean
C0151313 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
ECOG performance status
Item
11. eastern cooperative oncology group (ecog) performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
12. life expectancy of greater than or equal to 3 months
boolean
C0023671 (UMLS CUI [1])
Protocol Compliance
Item
13. patients willing and able to comply with the study protocol for the duration of the study
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
14. patients who have provided written consent to participate in this study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Biological Factors | Immunotherapy | Hormone Therapy | Palliative Radiation Therapy allowed
Item
1. patients who have received a chemotherapy, radiation, biologics, immunotherapy or hormonal therapy within three weeks before treatment start (but, palliative radiation can be enrolled)
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C3898008 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Lymphangitic metastasis to lung | Treatment required for Pulmonary Dysfunction | Use of supplemental oxygen
Item
2. pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
boolean
C2062926 (UMLS CUI [1])
C0332121 (UMLS CUI [2,1])
C1709770 (UMLS CUI [2,2])
C4067893 (UMLS CUI [3])
Metastatic malignant neoplasm to brain | Neoplasm Metastasis Subdural | Exception Local Therapy Completed | Exception Corticosteroid use Discontinued
Item
3. patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment in this study. any signs and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment
boolean
C0220650 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0038541 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1517925 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0239126 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
Meningeal Carcinomatosis
Item
4. patients with meningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Cardiovascular impairment
Item
5. significant cardiovascular impairment
boolean
C0848757 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious
Item
myocardial infarction within the past six months, unstable angina, history of congestive heart failure nyha class iii or iv, or serious cardiac arrhythmia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Prolonged QTc Bazett formula | Congenital long QT syndrome
Item
qtc prolongation (bazett's formula greater than 480 msec) or congenital long qt syndrome
boolean
C1969409 (UMLS CUI [1,1])
C4038411 (UMLS CUI [1,2])
C1141890 (UMLS CUI [2])
Comorbidity Severe | Comorbidity Uncontrolled | Communicable Disease Requirement Antibiotic Injection
Item
6. severe/uncontrolled intercurrent illness/infection required administration of antibiotic injection
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003232 (UMLS CUI [3,3])
C1533685 (UMLS CUI [3,4])
Major surgery
Item
7. patients who have processed a major surgery within four weeks before participation in this clinical trial
boolean
C0679637 (UMLS CUI [1])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
8. patients who have had a prior malignancy within the past five years other than breast cancer (but, treated non-melanoma skin cancer and carcinoma in situ of the cervix will not be excluded)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
HIV Seropositivity
Item
9. patients with known positive hiv status
boolean
C0019699 (UMLS CUI [1])
Gene therapy | Investigational New Drugs | Illicit medication use Expected
Item
10. patients who have received genetic therapy or other investigational drug within 4 weeks before treatment start or expected to receive prohibited medication
boolean
C0017296 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0281875 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Hypersensitivity Halichondrin B | Hypersensitivity Halichondrin B Derivative | Hypersensitivity Halichondrin B Ingredient | Hypersensitivity Anticoagulants
Item
11. patients with prior allergies to halichondrin b, its derivatives, active ingredient, or other diluting agent
boolean
C0020517 (UMLS CUI [1,1])
C0120715 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0120715 (UMLS CUI [2,2])
C1527240 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0120715 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0003280 (UMLS CUI [4,2])
halichondrin B
Item
12. patients who have received this investigational product before registration for this study
boolean
C0120715 (UMLS CUI [1])
Pregnancy | Possible pregnancy | Breast Feeding
Item
13. patients who are pregnant, who may possibly be pregnant, or are lactating
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Patients Contraceptive methods Unwilling
Item
14. patients who do not agree to practice contraception for the study periods
boolean
C0030705 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Study Subject Participation Status
Item
15. patients who have participated in other clinical trial within 4 weeks before screening
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
16. patients otherwise judged by investigator or sub investigator to be unsuitable for inclusion
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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