ID

39312

Description

Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01439282

Link

https://clinicaltrials.gov/show/NCT01439282

Keywords

  1. 12/18/19 12/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 18, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Estrogen Receptor Positive Tumor NCT01439282

Eligibility Estrogen Receptor Positive Tumor NCT01439282

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male subjects aged greater than or equal to 18 years and female subjects who must be postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal follicle-stimulating hormone [fsh] levels).
Description

Age | Postmenopausal state | Amenorrhea Duration | Bilateral oophorectomy | Hysterectomy | Both ovaries Intact | Follicle stimulating hormone level Postmenopausal

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
UMLS CUI [4]
C0278321
UMLS CUI [5]
C0020699
UMLS CUI [6,1]
C0227898
UMLS CUI [6,2]
C0205266
UMLS CUI [7,1]
C0202022
UMLS CUI [7,2]
C0232970
2. subject is a candidate for chemotherapy in the adjuvant setting.
Description

Patient Appropriate Adjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0085533
adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
Description

Start Adjuvant therapy | Operative Surgical Procedure Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0678222
3. histologically confirmed stage i to ii invasive breast cancer. subjects may have more than one synchronous primary breast tumor.
Description

Invasive carcinoma of breast TNM Breast tumor staging | Breast Carcinoma Synchronous Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0439580
UMLS CUI [2,3]
C1265611
4. receptor status:
Description

Receptor status

Data type

boolean

Alias
UMLS CUI [1]
C0449443
her2-normal as determined by a negative fluorescence in situ hybridization (fish) result or 0 to 1+ by immunohistochemistry (ihc) staining result
Description

HER2 Normal | HER2 FISH Negative | HER2 Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C0162789
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C0021044
er-positive, node-negative or er-positive grade 1 or 2 node-positive breast cancer
Description

Estrogen receptor positive | Negative Lymph Node | Breast Carcinoma TNM Breast tumor staging Estrogen receptor positive Lymph node positive

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0678034
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0474926
UMLS CUI [3,3]
C0279754
UMLS CUI [3,4]
C0746319
5. ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. 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/min per the cockcroft and gault formula
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
7. adequate bone marrow function as evidenced by anc greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 10.0 g/dl, and platelet count greater than or equal to 100 x 10^9/l
Description

Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
8. adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (uln) and alkaline phosphatase, alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln
Description

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
9. male subjects must have had a successful vasectomy (confirmed azoospermia), or their female partners must not be of childbearing potential, or male subjects must agree to use and have their female partners use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide] throughout the entire study period and for 30 days after study drug discontinuation..
Description

Gender | Vasectomy | Azoospermia | Partner Female infertility | Gender Contraceptive methods | Partner Contraceptive methods | Sexual Abstinence | Intrauterine Devices | Barrier Contraception Double | Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0042387
UMLS CUI [3]
C0004509
UMLS CUI [4,1]
C0682323
UMLS CUI [4,2]
C0021361
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [6,1]
C0682323
UMLS CUI [6,2]
C0700589
UMLS CUI [7]
C0036899
UMLS CUI [8]
C0021900
UMLS CUI [9,1]
C0004764
UMLS CUI [9,2]
C0205173
UMLS CUI [10]
C0677582
UMLS CUI [11]
C0042241
UMLS CUI [12]
C0087145
10. voluntary agreement to provide written informed consent and willingness and ability to comply with all aspects of the protocol
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. stage iii and iv invasive breast cancer
Description

Invasive carcinoma of breast TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
2. prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast cancer
Description

Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma | Prior Immunotherapy Breast Carcinoma | Biological treatment Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1514461
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0678222
3. nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would preclude any of the study therapy drugs
Description

Systemic disease Except Malignant Neoplasms | Cardiovascular Disease | Kidney Disease | Liver disease | Systemic disease Excludes Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0006826
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0013230
4. subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer
Description

Second Cancer | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
5. subjects with pre-existing neuropathy greater than grade 2
Description

Neuropathy Pre-existing CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
6. subjects with known positive human immunodeficiency virus (hiv) status
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
7. females of childbearing potential. females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal fsh levels).
Description

Childbearing Potential | Exception Postmenopausal state | Exception Amenorrhea Duration | Exception Bilateral oophorectomy | Exception Hysterectomy | Both ovaries Intact | Age | FSH level Postmenopausal

Data type

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 [3,3]
C0449238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0278321
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020699
UMLS CUI [6,1]
C0227898
UMLS CUI [6,2]
C0205266
UMLS CUI [7]
C0001779
UMLS CUI [8,1]
C0202022
UMLS CUI [8,2]
C0232970
8. subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications
Description

Gastrointestinal Disease Intake Oral medication Unable | Gastrointestinal Diseases Absorption Oral medication Unable | Condition Intake Oral medication Unable | Condition Absorption Oral medication Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0175795
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0237442
UMLS CUI [2,3]
C0175795
UMLS CUI [2,4]
C1299582
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0175795
UMLS CUI [3,4]
C1299582
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0237442
UMLS CUI [4,3]
C0175795
UMLS CUI [4,4]
C1299582
9. subjects with known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase [dpd] deficiency)
Description

Hypersensitivity Eribulin mesylate | Hypersensitivity Eribulin mesylate Excipient | Hypersensitivity Fluoropyrimidine | Dihydropyrimidine Dehydrogenase Deficiency | Dihydropyrimidine Dehydrogenase Deficiency Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2608038
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2608038
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0596581
UMLS CUI [4]
C1959620
UMLS CUI [5,1]
C1959620
UMLS CUI [5,2]
C0332197
10. a clinically significant electrocardiogram (ecg) abnormality, including a marked baseline prolongation of qt/qtc interval (time between the start of the q wave and the end of the t wave/qt interval corrected for heart rate) (e.g., repeated demonstration of a qtc interval greater than 500 ms)
Description

Electrocardiogram abnormal | Prolonged QT interval | Prolonged QTc interval

Data type

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0151878
UMLS CUI [3]
C1560305
11. any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
Description

Medical condition Study Subject Participation Status Excluded | Condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196

Similar models

Eligibility Estrogen Receptor Positive Tumor NCT01439282

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Postmenopausal state | Amenorrhea Duration | Bilateral oophorectomy | Hysterectomy | Both ovaries Intact | Follicle stimulating hormone level Postmenopausal
Item
1. male subjects aged greater than or equal to 18 years and female subjects who must be postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal follicle-stimulating hormone [fsh] levels).
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0278321 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0227898 (UMLS CUI [6,1])
C0205266 (UMLS CUI [6,2])
C0202022 (UMLS CUI [7,1])
C0232970 (UMLS CUI [7,2])
Patient Appropriate Adjuvant Chemotherapy
Item
2. subject is a candidate for chemotherapy in the adjuvant setting.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
Start Adjuvant therapy | Operative Surgical Procedure Breast Carcinoma
Item
adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
boolean
C0439659 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Invasive carcinoma of breast TNM Breast tumor staging | Breast Carcinoma Synchronous Quantity
Item
3. histologically confirmed stage i to ii invasive breast cancer. subjects may have more than one synchronous primary breast tumor.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0439580 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Receptor status
Item
4. receptor status:
boolean
C0449443 (UMLS CUI [1])
HER2 Normal | HER2 FISH Negative | HER2 Immunohistochemistry
Item
her2-normal as determined by a negative fluorescence in situ hybridization (fish) result or 0 to 1+ by immunohistochemistry (ihc) staining result
boolean
C0069515 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0069515 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0069515 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
Estrogen receptor positive | Negative Lymph Node | Breast Carcinoma TNM Breast tumor staging Estrogen receptor positive Lymph node positive
Item
er-positive, node-negative or er-positive grade 1 or 2 node-positive breast cancer
boolean
C0279754 (UMLS CUI [1])
C0678034 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0279754 (UMLS CUI [3,3])
C0746319 (UMLS CUI [3,4])
ECOG performance status
Item
5. ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
6. 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/min per 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 | Platelet Count measurement
Item
7. adequate bone marrow function as evidenced by anc greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 10.0 g/dl, 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])
C0032181 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
8. adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (uln) and alkaline phosphatase, alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Gender | Vasectomy | Azoospermia | Partner Female infertility | Gender Contraceptive methods | Partner Contraceptive methods | Sexual Abstinence | Intrauterine Devices | Barrier Contraception Double | Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides
Item
9. male subjects must have had a successful vasectomy (confirmed azoospermia), or their female partners must not be of childbearing potential, or male subjects must agree to use and have their female partners use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide] throughout the entire study period and for 30 days after study drug discontinuation..
boolean
C0079399 (UMLS CUI [1])
C0042387 (UMLS CUI [2])
C0004509 (UMLS CUI [3])
C0682323 (UMLS CUI [4,1])
C0021361 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0682323 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0036899 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0004764 (UMLS CUI [9,1])
C0205173 (UMLS CUI [9,2])
C0677582 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0087145 (UMLS CUI [12])
Informed Consent | Protocol Compliance
Item
10. voluntary agreement to provide written informed consent and willingness and ability to comply with all aspects of the protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast TNM Breast tumor staging
Item
1. stage iii and iv invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma | Prior Immunotherapy Breast Carcinoma | Biological treatment Breast Carcinoma
Item
2. prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1514461 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
Systemic disease Except Malignant Neoplasms | Cardiovascular Disease | Kidney Disease | Liver disease | Systemic disease Excludes Investigational New Drugs
Item
3. nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would preclude any of the study therapy drugs
boolean
C0442893 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0013230 (UMLS CUI [5,3])
Second Cancer | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
4. subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Neuropathy Pre-existing CTCAE Grades
Item
5. subjects with pre-existing neuropathy greater than grade 2
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
HIV Seropositivity
Item
6. subjects with known positive human immunodeficiency virus (hiv) status
boolean
C0019699 (UMLS CUI [1])
Childbearing Potential | Exception Postmenopausal state | Exception Amenorrhea Duration | Exception Bilateral oophorectomy | Exception Hysterectomy | Both ovaries Intact | Age | FSH level Postmenopausal
Item
7. females of childbearing potential. females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal fsh levels).
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])
C0449238 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0278321 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0020699 (UMLS CUI [5,2])
C0227898 (UMLS CUI [6,1])
C0205266 (UMLS CUI [6,2])
C0001779 (UMLS CUI [7])
C0202022 (UMLS CUI [8,1])
C0232970 (UMLS CUI [8,2])
Gastrointestinal Disease Intake Oral medication Unable | Gastrointestinal Diseases Absorption Oral medication Unable | Condition Intake Oral medication Unable | Condition Absorption Oral medication Unable
Item
8. subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications
boolean
C0017178 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0175795 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0237442 (UMLS CUI [4,2])
C0175795 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
Hypersensitivity Eribulin mesylate | Hypersensitivity Eribulin mesylate Excipient | Hypersensitivity Fluoropyrimidine | Dihydropyrimidine Dehydrogenase Deficiency | Dihydropyrimidine Dehydrogenase Deficiency Absent
Item
9. subjects with known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase [dpd] deficiency)
boolean
C0020517 (UMLS CUI [1,1])
C2608038 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2608038 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0596581 (UMLS CUI [3,2])
C1959620 (UMLS CUI [4])
C1959620 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Electrocardiogram abnormal | Prolonged QT interval | Prolonged QTc interval
Item
10. a clinically significant electrocardiogram (ecg) abnormality, including a marked baseline prolongation of qt/qtc interval (time between the start of the q wave and the end of the t wave/qt interval corrected for heart rate) (e.g., repeated demonstration of a qtc interval greater than 500 ms)
boolean
C0522055 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
Medical condition Study Subject Participation Status Excluded | Condition Study Subject Participation Status Excluded
Item
11. any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])

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