ID

35046

Descripción

Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02481050

Link

https://clinicaltrials.gov/show/NCT02481050

Palabras clave

Versiones (1)
  1. 12/2/19 12/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de febrero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02481050

Inglés

Eligibility Breast Cancer NCT02481050

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological or cytological adenocarcinoma of the breast
Descripción

Breast adenocarcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0858252
2. females, aged greater than or equal to 18 years at time of informed consent
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. her2-negative as determined by fluorescence in situ hybridization (fish); or 0 or 1+
Descripción

HER2 Negative FISH

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0162789
by immunohistochemistry (ihc) staining
Descripción

HER2 Negative Immunohistochemistry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0021044
4. participants with metastatic breast cancer who have received at least 2 and not more than 5 prior chemotherapy regimens
Descripción

Secondary malignant neoplasm of female breast | Prior Chemotherapy Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
5. participants with at least one measurable lesion greater than or equal to 10 mm in the longest diameter for a non-lymph node or greater than or equal to 15 mm in the short-axis diameter for a lymph node as determined by investigator using response evaluation criteria in solid tumors version 1.1 (recist v1.1)
Descripción

Measurable lesion Quantity Longest Diameter | Exception Lymph node | Measurable lesion Lymph node Short axis Diameter

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0552406
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024204
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0024204
UMLS CUI [3,3]
C0522488
UMLS CUI [3,4]
C1301886
6. eastern cooperative oncology group (ecog) performance status less than or equal to 2
Descripción

ECOG performance status

Tipo de datos

boolean

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

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
8. any neuropathy must recover to grade less than or equal to 2 prior to enrollment
Descripción

Neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
9. adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dl or calculated creatinine clearance greater than or equal to 50 ml/minute according to the cockcroft and gault formula
Descripción

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
10. adequate bone marrow function as evidenced by absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 10.0 g/dl (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/l
Descripción

Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement | Hemoglobin measurement Growth Factor Corrected | Hemoglobin measurement Transfusion Corrected | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4,1]
C0518015
UMLS CUI [4,2]
C0018284
UMLS CUI [4,3]
C0205202
UMLS CUI [5,1]
C0518015
UMLS CUI [5,2]
C1879316
UMLS CUI [5,3]
C0205202
UMLS CUI [6]
C0032181
11. adequate liver function as evidenced by total bilirubin less than or equal to 1.5 x upper limit of normal (uln), alkaline phosphatase, alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln (less than or equal to 5 x uln in the case of liver metastases), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
Descripción

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Secondary malignant neoplasm of liver | Relationship Secondary malignant neoplasm of bone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0494165
UMLS CUI [7,1]
C0439849
UMLS CUI [7,2]
C0153690
12. are willing and able to comply with all aspects of the treatment protocol
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
13. provide written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment with eribulin
Descripción

Prior Therapy Eribulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2350866
2. hypersensitivity to eribulin/excipients or halichondrin b or known intolerance of eribulin
Descripción

Hypersensitivity Eribulin | Hypersensitivity Eribulin Pharmaceutical Excipient | Hypersensitivity Halichondrin B | Intolerance to eribulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2350866
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2350866
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0120715
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C2350866
3. current enrollment in another clinical study or used of any investigational drug or device within the past 28 days preceding informed consent
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
4. previous treatment with chemotherapy, radiation, biological, or targeted therapy within the last 2 weeks or 5 x half-life, whichever is longer, preceding informed consent
Descripción

Prior Chemotherapy | Prior radiation therapy | Biological treatment | Targeted Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
UMLS CUI [3]
C1531518
UMLS CUI [4]
C2985566
5. females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin ([b-hcg] test). a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Descripción

Breast Feeding | Pregnancy | Serum Beta-HCG Test Positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C1255526
UMLS CUI [3,2]
C1514241
6. all females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
Descripción

Childbearing Potential | Exception Postmenopausal state | Exception Amenorrhea | Exception Female Sterilization | Bilateral tubal ligation | Total hysterectomy | Bilateral oophorectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0232970
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002453
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015787
UMLS CUI [5]
C0589114
UMLS CUI [6]
C0677962
UMLS CUI [7]
C0278321
7. females of childbearing potential who had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
Descripción

Childbearing Potential Sexual intercourse | Childbearing Potential Contraceptive methods Unwilling | Total abstinence | Intrauterine Devices | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Contraceptive implant | Contraceptives, Oral | Partner had vasectomy | Partner Azoospermia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0009253
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0234008
UMLS CUI [4]
C0021900
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6]
C0221829
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0087145
UMLS CUI [9]
C1657106
UMLS CUI [10]
C0009905
UMLS CUI [11]
C0420842
UMLS CUI [12,1]
C0682323
UMLS CUI [12,2]
C0004509
females who are currently abstinent and do not agree to use a double barrier method as described above or to refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
Descripción

Gender Sexual Abstinence | Barrier Contraception Double Unwilling | Avoidance Sexual activity Rejected

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C0036864
UMLS CUI [3,3]
C1548437
females who are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
Descripción

Gender | Use of Hormonal Oral Contraceptives | Hormonal Oral Contraceptive Dose Stable Lacking | Rejection Use of Hormonal Oral Contraceptive Same

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0009907
UMLS CUI [3,1]
C0009907
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0332268
UMLS CUI [4,1]
C1548437
UMLS CUI [4,2]
C1524063
UMLS CUI [4,3]
C0009907
UMLS CUI [4,4]
C0445247
8. known central nervous system (cns) disease, except for those participants with treated brain metastasis who are stable for at least 1 month with no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids
Descripción

CNS disorder | Exception Metastatic malignant neoplasm to brain Treated | Exception Patient's condition stable | Exception Disease Progression Absent | Exception Hemorrhage Absent | Exception Adrenal Cortex Hormones Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1282982
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0242656
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0019080
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0001617
UMLS CUI [6,3]
C0332197
9. known human immunodeficiency virus (hiv) positive
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
10. existing anticancer, therapy-related toxicities of grades greater than or equal to 2, with the exception of alopecia
Descripción

Cancer treatment | Therapy-Related Toxicity CTCAE Grades | Exception Alopecia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1710382
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
11. a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated greater than 5 years previously with no subsequent evidence of recurrence
Descripción

Malignant Neoplasm Previous | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Malignant Neoplasms Treated | Exception Recurrence Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2825055
UMLS CUI [5,3]
C0332197
12. clinically significant cardiovascular impairment (congestive heart failure of new york heart association [nyha] classification greater than ii, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0848757
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205404
13. clinically significant ecg abnormality, including a marked baseline prolonged qt/qtc interval (ie, a repeated demonstration of a qtc interval greater than 500 milliseconds)
Descripción

ECG abnormal | Prolonged QT interval | Prolonged QTc interval

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0151878
UMLS CUI [3]
C1560305
14. pulmonary lymphangitic involvement that resulted in pulmonary dysfunction requiring active treatment, including the use of oxygen
Descripción

Lymphangitic metastasis to lung Resulting in Pulmonary Dysfunction | Requirement Therapeutic procedure | Requirement Use of supplemental oxygen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2062926
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C1709770
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0087111
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C4067893
15. history of concomitant medical condition(s) that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study
Descripción

Comorbidity compromises Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C2732579
16. the investigator's belief that the participant is medically unfit to receive eribulin or unsuitable for any other reason
Descripción

Study Subject Medically unfit Eribulin | Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C2350866
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
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Similar models

Eligibility Breast Cancer NCT02481050

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma
Item
1. histological or cytological adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
Gender | Age
Item
2. females, aged greater than or equal to 18 years at time of informed consent
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2 Negative FISH
Item
3. her2-negative as determined by fluorescence in situ hybridization (fish); or 0 or 1+
boolean
C2348908 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
HER2 Negative Immunohistochemistry
Item
by immunohistochemistry (ihc) staining
boolean
C2348908 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast | Prior Chemotherapy Quantity
Item
4. participants with metastatic breast cancer who have received at least 2 and not more than 5 prior chemotherapy regimens
boolean
C0346993 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Measurable lesion Quantity Longest Diameter | Exception Lymph node | Measurable lesion Lymph node Short axis Diameter
Item
5. participants with at least one measurable lesion greater than or equal to 10 mm in the longest diameter for a non-lymph node or greater than or equal to 15 mm in the short-axis diameter for a lymph node as determined by investigator using response evaluation criteria in solid tumors version 1.1 (recist v1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0552406 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0522488 (UMLS CUI [3,3])
C1301886 (UMLS CUI [3,4])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of greater than or equal to 3 months
boolean
C0023671 (UMLS CUI [1])
Neuropathy CTCAE Grades
Item
8. any neuropathy must recover to grade less than or equal to 2 prior to enrollment
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
9. adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dl or calculated creatinine clearance greater than or equal to 50 ml/minute according to the cockcroft and gault formula
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement | Hemoglobin measurement Growth Factor Corrected | Hemoglobin measurement Transfusion Corrected | Platelet Count measurement
Item
10. adequate bone marrow function as evidenced by absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 10.0 g/dl (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0518015 (UMLS CUI [4,1])
C0018284 (UMLS CUI [4,2])
C0205202 (UMLS CUI [4,3])
C0518015 (UMLS CUI [5,1])
C1879316 (UMLS CUI [5,2])
C0205202 (UMLS CUI [5,3])
C0032181 (UMLS CUI [6])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Secondary malignant neoplasm of liver | Relationship Secondary malignant neoplasm of bone
Item
11. adequate liver function as evidenced by total bilirubin less than or equal to 1.5 x upper limit of normal (uln), alkaline phosphatase, alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln (less than or equal to 5 x uln in the case of liver metastases), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0439849 (UMLS CUI [6,1])
C0494165 (UMLS CUI [6,2])
C0439849 (UMLS CUI [7,1])
C0153690 (UMLS CUI [7,2])
Protocol Compliance
Item
12. are willing and able to comply with all aspects of the treatment protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
13. provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Eribulin
Item
1. previous treatment with eribulin
boolean
C1514463 (UMLS CUI [1,1])
C2350866 (UMLS CUI [1,2])
Hypersensitivity Eribulin | Hypersensitivity Eribulin Pharmaceutical Excipient | Hypersensitivity Halichondrin B | Intolerance to eribulin
Item
2. hypersensitivity to eribulin/excipients or halichondrin b or known intolerance of eribulin
boolean
C0020517 (UMLS CUI [1,1])
C2350866 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2350866 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0120715 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C2350866 (UMLS CUI [4,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
3. current enrollment in another clinical study or used of any investigational drug or device within the past 28 days preceding informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Prior Chemotherapy | Prior radiation therapy | Biological treatment | Targeted Therapy
Item
4. previous treatment with chemotherapy, radiation, biological, or targeted therapy within the last 2 weeks or 5 x half-life, whichever is longer, preceding informed consent
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C2985566 (UMLS CUI [4])
Breast Feeding | Pregnancy | Serum Beta-HCG Test Positive
Item
5. females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin ([b-hcg] test). a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C1255526 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Childbearing Potential | Exception Postmenopausal state | Exception Amenorrhea | Exception Female Sterilization | Bilateral tubal ligation | Total hysterectomy | Bilateral oophorectomy
Item
6. all females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002453 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0015787 (UMLS CUI [4,2])
C0589114 (UMLS CUI [5])
C0677962 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
Childbearing Potential Sexual intercourse | Childbearing Potential Contraceptive methods Unwilling | Total abstinence | Intrauterine Devices | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Contraceptive implant | Contraceptives, Oral | Partner had vasectomy | Partner Azoospermia
Item
7. females of childbearing potential who had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
boolean
C3831118 (UMLS CUI [1,1])
C0009253 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0234008 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C0221829 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C1657106 (UMLS CUI [9])
C0009905 (UMLS CUI [10])
C0420842 (UMLS CUI [11])
C0682323 (UMLS CUI [12,1])
C0004509 (UMLS CUI [12,2])
Gender Sexual Abstinence | Barrier Contraception Double Unwilling | Avoidance Sexual activity Rejected
Item
females who are currently abstinent and do not agree to use a double barrier method as described above or to refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0036864 (UMLS CUI [3,2])
C1548437 (UMLS CUI [3,3])
Gender | Use of Hormonal Oral Contraceptives | Hormonal Oral Contraceptive Dose Stable Lacking | Rejection Use of Hormonal Oral Contraceptive Same
Item
females who are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
boolean
C0079399 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0009907 (UMLS CUI [2,2])
C0009907 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
C1548437 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
C0009907 (UMLS CUI [4,3])
C0445247 (UMLS CUI [4,4])
CNS disorder | Exception Metastatic malignant neoplasm to brain Treated | Exception Patient's condition stable | Exception Disease Progression Absent | Exception Hemorrhage Absent | Exception Adrenal Cortex Hormones Absent
Item
8. known central nervous system (cns) disease, except for those participants with treated brain metastasis who are stable for at least 1 month with no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids
boolean
C0007682 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1282982 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0019080 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0001617 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
HIV Seropositivity
Item
9. known human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Cancer treatment | Therapy-Related Toxicity CTCAE Grades | Exception Alopecia
Item
10. existing anticancer, therapy-related toxicities of grades greater than or equal to 2, with the exception of alopecia
boolean
C0920425 (UMLS CUI [1])
C1710382 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
Malignant Neoplasm Previous | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Malignant Neoplasms Treated | Exception Recurrence Absent
Item
11. a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated greater than 5 years previously with no subsequent evidence of recurrence
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C2825055 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Cardiovascular impairment | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Serious
Item
12. clinically significant cardiovascular impairment (congestive heart failure of new york heart association [nyha] classification greater than ii, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
boolean
C0848757 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
ECG abnormal | Prolonged QT interval | Prolonged QTc interval
Item
13. clinically significant ecg abnormality, including a marked baseline prolonged qt/qtc interval (ie, a repeated demonstration of a qtc interval greater than 500 milliseconds)
boolean
C0522055 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
Lymphangitic metastasis to lung Resulting in Pulmonary Dysfunction | Requirement Therapeutic procedure | Requirement Use of supplemental oxygen
Item
14. pulmonary lymphangitic involvement that resulted in pulmonary dysfunction requiring active treatment, including the use of oxygen
boolean
C2062926 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C1709770 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C4067893 (UMLS CUI [3,2])
Comorbidity compromises Completion of clinical trial
Item
15. history of concomitant medical condition(s) that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study
boolean
C0009488 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Study Subject Medically unfit Eribulin | Study Subject Participation Status Inappropriate
Item
16. the investigator's belief that the participant is medically unfit to receive eribulin or unsuitable for any other reason
boolean
C0681850 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C2350866 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
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