ID

37429

Descrizione

Trial of Afatinib With Paclitaxel for Neoadjuvant Therapy of TNBC and Research of Biomarkers of Afatinib; ODM derived from: https://clinicaltrials.gov/show/NCT02511847

collegamento

https://clinicaltrials.gov/show/NCT02511847

Keywords

versioni (1)
  1. 25/07/19 25/07/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

25 luglio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Triple Negative Breast Cancer NCT02511847

Inglese

Eligibility Triple Negative Breast Cancer NCT02511847

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patients, age ≥20 years
Descrizione

Gender | Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologically confirmed invasive er-, pr-, and her2-negative (triple-negative) adenocarcinoma of the breast
Descrizione

Breast adenocarcinoma Triple Negative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C3539878
3. triple-negative tumors are defined as:
Descrizione

Triple Negative Breast Neoplasms

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3539878
i. for her2-negative: fluorescence in situ hybridization (fish)-negative (defined by ratio <2.0) or immunohistochemical (ihc) 0, ihc 1+, or ihc 2+ or ihc 3+and fish-negative (defined by ratio <2.0) ii. for er- and pr-negative: < 5% tumor staining by immunohistochemistry (ihc)
Descrizione

HER2/Neu Negative | FISH Negative | Immunohistochemistry | Estrogen receptor negative | Progesterone receptor negative | Neoplasm Staining Percentage Immunohistochemistry

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348908
UMLS CUI [2,1]
C0162789
UMLS CUI [2,2]
C1513916
UMLS CUI [3]
C0021044
UMLS CUI [4]
C0279756
UMLS CUI [5]
C0279766
UMLS CUI [6,1]
C0027651
UMLS CUI [6,2]
C1704680
UMLS CUI [6,3]
C0439165
UMLS CUI [6,4]
C0021044
4. the first tnbc 20 patients with or without egfr expression or mutation are eligible. interim analysis of response rate will be calculated to determine the criteria of 21 to 40 patients.
Descrizione

Triple Negative Breast Neoplasms | EGFR Gene Expression | EGFR Gene Expression Absent | EGFR gene mutation | EGFR gene mutation Absent | Analysis Frequency of Responses

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3539878
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C0017262
UMLS CUI [3,1]
C0034802
UMLS CUI [3,2]
C0017262
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C3266992
UMLS CUI [5,1]
C3266992
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0936012
UMLS CUI [6,2]
C0237629
5. all of the newly diagnosed tnbc patients should be met the following criteria: clinical node-positive with any t stage patents or clinical node-negative patients with ct2-4. ct1n0m0 lesions are excluded. patients with metastatic disease are excluded. the measurement method of tumor size can be by physical exam and/or image study.
Descrizione

Triple Negative Breast Neoplasms | Lymph node positive TNM Breast tumor staging | Negative Lymph Node TNM Breast tumor staging | Lesion TNM Breast tumor staging Excluded | Neoplasm Metastasis Excluded | Tumor size Physical Examination | Tumor size Image study

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3539878
UMLS CUI [2,1]
C0746319
UMLS CUI [2,2]
C0474926
UMLS CUI [3,1]
C0678034
UMLS CUI [3,2]
C0474926
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0474926
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0332196
UMLS CUI [6,1]
C0475440
UMLS CUI [6,2]
C0031809
UMLS CUI [7,1]
C0475440
UMLS CUI [7,2]
C1881134
6. eastern cooperative oncology group performance status (ecog ps) 0-1.
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
7. within 2 weeks prior randomization:
Descrizione

Status pre- Randomization

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C0034656
i. adequate bone marrow function, hepatic function, and renal function. ii. controlled blood pressure with or without antihypertensive treatment iii. normal prothrombin time (pt) and partial thromboplastin time (ptt) iv. adequate cardiac function assessed by 12-lead ecg and if clinically indicated echocardiography to document lvef
Descrizione

Bone Marrow function | Liver function | Renal function | Blood Pressure Controlled | Antihypertensive therapy | Antihypertensive therapy Absent | Prothrombin time normal | Partial prothrombin time Normal | Cardiac function 12 lead ECG | Cardiac function Echocardiography | Left ventricular ejection fraction

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C0005823
UMLS CUI [4,2]
C2587213
UMLS CUI [5]
C0585941
UMLS CUI [6,1]
C0585941
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C0580551
UMLS CUI [8,1]
C0853653
UMLS CUI [8,2]
C0205307
UMLS CUI [9,1]
C0232164
UMLS CUI [9,2]
C0430456
UMLS CUI [10,1]
C0232164
UMLS CUI [10,2]
C0013516
UMLS CUI [11]
C0428772
8. bilateral, synchronous breast cancer is allowed if one primary tumor meets the inclusion criteria.
Descrizione

Bilateral breast cancer Synchronous

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0439580
9. adequate bone marrow function defined as wbc ≥3.5 x 109/l, anc ≥1.5 x 109/l, platelets ≥lln, and hemoglobin ≥10 g/dl.
Descrizione

Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
10. adequate liver function defined as total serum bilirubin ≤1.5x uln and serum transaminases ≤2.5x uln
Descrizione

Liver function | Serum total bilirubin measurement | Transaminase Assay

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0919834
11. adequate renal function defined as creatinine ≤1.5x uln
Descrizione

Renal function | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
12. able and willing to give informed consent and comply with the protocol
Descrizione

Informed Consent Willing | Protocol Compliance Willing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0600109
13. written informed consent obtained prior to any screening/baseline procedures
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
14. knowledge of the investigational nature of the study and ability to provide consent for study participation; and ability and willingness to comply with study visits, treatment, testing, and other study procedures
Descrizione

Knowledge Study Protocol | Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0376554
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. er+ (>5%) or pr+ (>5%) or her-2 overexpression
Descrizione

Estrogen receptor positive | Progesterone receptor positive | HER2 Protein Overexpression

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
UMLS CUI [3]
C1515560
2. active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix.
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
3. prior chemotherapy, radiotherapy or targeted therapy including afatinib or her-2 or egfr inhibitors.
Descrizione

Prior Chemotherapy | Prior radiation therapy | Targeted Therapy | Afatinib | HER-2 inhibitors | EGFR inhibitors

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
UMLS CUI [3]
C2985566
UMLS CUI [4]
C2987648
UMLS CUI [5]
C2916795
UMLS CUI [6]
C1443775
4. participation in another interventional clinical trial in the preceding 30 days prior to trial.
Descrizione

Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
5. patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study
Descrizione

Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Communicable Disease Severe compromises Study Subject Participation Status | Communicable Disease Uncontrolled compromises Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C2348568
6. prior hypersensitivity reactions to a taxane or to cremophor® el (polyoxyethylated castor oil)
Descrizione

Allergic Reaction Taxane | Allergic Reaction Cremophor EL

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0215136
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0056476
7. pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive β-hcg laboratory test (serum > 5 miu/ml)
Descrizione

Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0430060
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
8. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 180 days after study treatment. highly effective contraception methods include:
Descrizione

Childbearing Potential | Exception Use of Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
true abstinence in line with the preferred and usual lifestyle of the subject
Descrizione

Sexual Abstinence

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0036899
female subject or male partner sterilization or
Descrizione

Female Sterilization | Partner had vasectomy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0420842
combination of any two of the following (a+b or a+c, or b+c):
Descrizione

Contraceptive methods Combination

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205195
1. use of oral, injected or implanted hormonal methods of contraception
Descrizione

Hormonal contraception | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2985296
UMLS CUI [2]
C0009907
UMLS CUI [3]
C1656586
UMLS CUI [4]
C1657106
2. placement of an intrauterine device (iud) or intrauterine system (ius)
Descrizione

Intrauterine Devices | Intrauterine System Contraceptive Devices

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021900
UMLS CUI [2,1]
C4293370
UMLS CUI [2,2]
C0009886
3. barrier methods of contraception: condom for male partner or occlusive cap
Descrizione

Contraception, Barrier | Male Condoms Partner

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004764
UMLS CUI [2,1]
C0009653
UMLS CUI [2,2]
C0682323
4. (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Descrizione

Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0042241
UMLS CUI [2]
C0493327
UMLS CUI [3]
C3843415
9. patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Descrizione

Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factor Interferes with Protocol Compliance | Geographic Factor Interferes with Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
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Similar models

Eligibility Triple Negative Breast Cancer NCT02511847

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female patients, age ≥20 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast adenocarcinoma Triple Negative
Item
2. histologically confirmed invasive er-, pr-, and her2-negative (triple-negative) adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C3539878 (UMLS CUI [1,2])
Triple Negative Breast Neoplasms
Item
3. triple-negative tumors are defined as:
boolean
C3539878 (UMLS CUI [1])
HER2/Neu Negative | FISH Negative | Immunohistochemistry | Estrogen receptor negative | Progesterone receptor negative | Neoplasm Staining Percentage Immunohistochemistry
Item
i. for her2-negative: fluorescence in situ hybridization (fish)-negative (defined by ratio <2.0) or immunohistochemical (ihc) 0, ihc 1+, or ihc 2+ or ihc 3+and fish-negative (defined by ratio <2.0) ii. for er- and pr-negative: < 5% tumor staining by immunohistochemistry (ihc)
boolean
C2348908 (UMLS CUI [1])
C0162789 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0021044 (UMLS CUI [3])
C0279756 (UMLS CUI [4])
C0279766 (UMLS CUI [5])
C0027651 (UMLS CUI [6,1])
C1704680 (UMLS CUI [6,2])
C0439165 (UMLS CUI [6,3])
C0021044 (UMLS CUI [6,4])
Triple Negative Breast Neoplasms | EGFR Gene Expression | EGFR Gene Expression Absent | EGFR gene mutation | EGFR gene mutation Absent | Analysis Frequency of Responses
Item
4. the first tnbc 20 patients with or without egfr expression or mutation are eligible. interim analysis of response rate will be calculated to determine the criteria of 21 to 40 patients.
boolean
C3539878 (UMLS CUI [1])
C0034802 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0034802 (UMLS CUI [3,1])
C0017262 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3266992 (UMLS CUI [4])
C3266992 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0936012 (UMLS CUI [6,1])
C0237629 (UMLS CUI [6,2])
Triple Negative Breast Neoplasms | Lymph node positive TNM Breast tumor staging | Negative Lymph Node TNM Breast tumor staging | Lesion TNM Breast tumor staging Excluded | Neoplasm Metastasis Excluded | Tumor size Physical Examination | Tumor size Image study
Item
5. all of the newly diagnosed tnbc patients should be met the following criteria: clinical node-positive with any t stage patents or clinical node-negative patients with ct2-4. ct1n0m0 lesions are excluded. patients with metastatic disease are excluded. the measurement method of tumor size can be by physical exam and/or image study.
boolean
C3539878 (UMLS CUI [1])
C0746319 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C0678034 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0027627 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0475440 (UMLS CUI [6,1])
C0031809 (UMLS CUI [6,2])
C0475440 (UMLS CUI [7,1])
C1881134 (UMLS CUI [7,2])
ECOG performance status
Item
6. eastern cooperative oncology group performance status (ecog ps) 0-1.
boolean
C1520224 (UMLS CUI [1])
Status pre- Randomization
Item
7. within 2 weeks prior randomization:
boolean
C0332152 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function | Blood Pressure Controlled | Antihypertensive therapy | Antihypertensive therapy Absent | Prothrombin time normal | Partial prothrombin time Normal | Cardiac function 12 lead ECG | Cardiac function Echocardiography | Left ventricular ejection fraction
Item
i. adequate bone marrow function, hepatic function, and renal function. ii. controlled blood pressure with or without antihypertensive treatment iii. normal prothrombin time (pt) and partial thromboplastin time (ptt) iv. adequate cardiac function assessed by 12-lead ecg and if clinically indicated echocardiography to document lvef
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0005823 (UMLS CUI [4,1])
C2587213 (UMLS CUI [4,2])
C0585941 (UMLS CUI [5])
C0585941 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0580551 (UMLS CUI [7])
C0853653 (UMLS CUI [8,1])
C0205307 (UMLS CUI [8,2])
C0232164 (UMLS CUI [9,1])
C0430456 (UMLS CUI [9,2])
C0232164 (UMLS CUI [10,1])
C0013516 (UMLS CUI [10,2])
C0428772 (UMLS CUI [11])
Bilateral breast cancer Synchronous
Item
8. bilateral, synchronous breast cancer is allowed if one primary tumor meets the inclusion criteria.
boolean
C0281267 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
9. adequate bone marrow function defined as wbc ≥3.5 x 109/l, anc ≥1.5 x 109/l, platelets ≥lln, and hemoglobin ≥10 g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Liver function | Serum total bilirubin measurement | Transaminase Assay
Item
10. adequate liver function defined as total serum bilirubin ≤1.5x uln and serum transaminases ≤2.5x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0919834 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
11. adequate renal function defined as creatinine ≤1.5x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Informed Consent Willing | Protocol Compliance Willing
Item
12. able and willing to give informed consent and comply with the protocol
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed Consent
Item
13. written informed consent obtained prior to any screening/baseline procedures
boolean
C0021430 (UMLS CUI [1])
Knowledge Study Protocol | Protocol Compliance
Item
14. knowledge of the investigational nature of the study and ability to provide consent for study participation; and ability and willingness to comply with study visits, treatment, testing, and other study procedures
boolean
C0376554 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Estrogen receptor positive | Progesterone receptor positive | HER2 Protein Overexpression
Item
1. er+ (>5%) or pr+ (>5%) or her-2 overexpression
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
C1515560 (UMLS CUI [3])
Second Primary Cancer | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
2. active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix.
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Prior Chemotherapy | Prior radiation therapy | Targeted Therapy | Afatinib | HER-2 inhibitors | EGFR inhibitors
Item
3. prior chemotherapy, radiotherapy or targeted therapy including afatinib or her-2 or egfr inhibitors.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C2985566 (UMLS CUI [3])
C2987648 (UMLS CUI [4])
C2916795 (UMLS CUI [5])
C1443775 (UMLS CUI [6])
Study Subject Participation Status
Item
4. participation in another interventional clinical trial in the preceding 30 days prior to trial.
boolean
C2348568 (UMLS CUI [1])
Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Communicable Disease Severe compromises Study Subject Participation Status | Communicable Disease Uncontrolled compromises Study Subject Participation Status
Item
5. patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
Allergic Reaction Taxane | Allergic Reaction Cremophor EL
Item
6. prior hypersensitivity reactions to a taxane or to cremophor® el (polyoxyethylated castor oil)
boolean
C1527304 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0056476 (UMLS CUI [2,2])
Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding
Item
7. pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive β-hcg laboratory test (serum > 5 miu/ml)
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Childbearing Potential | Exception Use of Contraceptive methods
Item
8. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 180 days after study treatment. highly effective contraception methods include:
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Sexual Abstinence
Item
true abstinence in line with the preferred and usual lifestyle of the subject
boolean
C0036899 (UMLS CUI [1])
Female Sterilization | Partner had vasectomy
Item
female subject or male partner sterilization or
boolean
C0015787 (UMLS CUI [1])
C0420842 (UMLS CUI [2])
Contraceptive methods Combination
Item
combination of any two of the following (a+b or a+c, or b+c):
boolean
C0700589 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
Hormonal contraception | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant
Item
1. use of oral, injected or implanted hormonal methods of contraception
boolean
C2985296 (UMLS CUI [1])
C0009907 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
Intrauterine Devices | Intrauterine System Contraceptive Devices
Item
2. placement of an intrauterine device (iud) or intrauterine system (ius)
boolean
C0021900 (UMLS CUI [1])
C4293370 (UMLS CUI [2,1])
C0009886 (UMLS CUI [2,2])
Contraception, Barrier | Male Condoms Partner
Item
3. barrier methods of contraception: condom for male partner or occlusive cap
boolean
C0004764 (UMLS CUI [1])
C0009653 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository
Item
4. (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
boolean
C0042241 (UMLS CUI [1])
C0493327 (UMLS CUI [2])
C3843415 (UMLS CUI [3])
Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factor Interferes with Protocol Compliance | Geographic Factor Interferes with Protocol Compliance
Item
9. patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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