ID

42633

Beschreibung

To Determine the Objective Response Rate of 4 Cycles of Docetaxel + Anthracycline (Epirubicin or Doxorubicine) Followed by 4 Cycles of Docetaxel Single Agent; ODM derived from: https://clinicaltrials.gov/show/NCT00620100

Link

https://clinicaltrials.gov/show/NCT00620100

Stichworte

Versionen (2)
  1. 19.07.16 19.07.16 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00620100

Englisch

Eligibility Breast Neoplasms NCT00620100

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patient with histologically or cytologically documented breast adenocarcinoma
Beschreibung

Gender | Breast adenocarcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0858252
2. first local or metastatic relapse
Beschreibung

Relapse Local First | Relapse Metastatic First

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1279901
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0036525
UMLS CUI [2,3]
C1279901
3. patients must have received a prior neoadjuvant or adjuvant taxotere®-based chemotherapy regimen, provided this chemotherapy was completed > than or = to 12 months prior to enrollment date
Beschreibung

Taxotere | Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0699967
UMLS CUI [2]
C0085533
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0392920
4. prior hormone or immune therapy is allowed. antitumoral adjuvant hormone therapy may be continued during the study period, provided it was started > 12 months prior to study enrollment
Beschreibung

Prior Hormone Therapy | Prior Immunotherapy | Hormone Therapy Adjuvant Antitumor

Datentyp

boolean

Alias
UMLS CUI [1]
C1514460
UMLS CUI [2]
C1514461
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C1522673
UMLS CUI [3,3]
C2986475
5. her2/neu negative tumor demonstrated by immunohistochemistry (ihc 0 or 1+) or by fluorescence in situ hybridation (fish -). a patient with tumor assessed as 2+ by ihc can be enrolled if the tumor is negative by fish.
Beschreibung

Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization

Datentyp

boolean

Alias
UMLS CUI [1]
C2316304
UMLS CUI [2]
C0021044
UMLS CUI [3]
C0162789
6. ecog performance status of 0 to 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
7. normal cardiac function confirmed by lvef or shortening fraction (muga scan or echocardiography, respectively, within normal limits for the institution) assessed within 3 months prior to study entry. an ecg must be obtained within 4 weeks prior study entry and must demonstrate no clinically significant abnormality.
Beschreibung

Cardiac function | Left ventricular ejection fraction | Shortening Fraction | Multiple gated acquisition scanning | Echocardiography | ECG abnormality Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C1335957
UMLS CUI [4]
C0521317
UMLS CUI [5]
C0013516
UMLS CUI [6,1]
C0522055
UMLS CUI [6,2]
C2826293
8. patients are required to have at least one measurable lesion according to recist guidelines
Beschreibung

Measurable Disease Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
9. adequate organ function defined by:
Beschreibung

organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
1. hematology: neutrophils > than or = to 2.0 109/l, platelets > than or = to 100 109/l, hemoglobin > than or = to 10 g/dl
Beschreibung

Hematology | Absolute neutrophil count | Blood Platelets | Hemoglobin

Datentyp

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0019046
2. hepatic function: total bilirubin within normal limits, ast (sgot) and alt (sgpt) < than or = to 1.5 unl, alkaline phosphatase < than or = to 2.5 unl (unless accompanied by extensive bone metastases)
Beschreibung

Liver function | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone Extensive

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6,1]
C0153690
UMLS CUI [6,2]
C0205231
10. negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential
Beschreibung

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
11. written informed consent prior to beginning specific protocol procedures must be obtained and documented according to the local regulatory requirements
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior therapy for advanced or recurrent disease
Beschreibung

Prior Therapy advanced disease | Prior Therapy Recurrent disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0679246
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0277556
2. previous cumulative exposure to epirubicin > 600 mg/m² or to doxorubicin > 300 mg/m²
Beschreibung

Cumulative Exposure Epirubicin | Cumulative Exposure Doxorubicin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986588
UMLS CUI [1,2]
C0014582
UMLS CUI [2,1]
C2986588
UMLS CUI [2,2]
C0013089
3. previous radiation therapy having involved more than 25% of bone marrow; incomplete recovery from toxicity of radiation therapy
Beschreibung

prior radiation therapy Involved Bone Marrow | Therapeutic radiology procedure Toxicity Recovery Incomplete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0005953
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600688
UMLS CUI [2,3]
C2004454
UMLS CUI [2,4]
C0205257
4. symptomatic brain metastases and clinically diagnosed leptomeningeal metastases
Beschreibung

Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1704231
5. isolated unmeasurable bone lesions, serous pleural effusion or pulmonary lymphangiitis (i.e., unmeasurable disease according to the recist guidelines)
Beschreibung

Bone lesion Measurable Isolated | serous pleural effusion | Lymphangitis Pulmonary | Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0238792
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C0205409
UMLS CUI [2]
C2082495
UMLS CUI [3,1]
C0024225
UMLS CUI [3,2]
C2709248
UMLS CUI [4]
C1513041
6. pre-existing motor or sensory neurologic toxicity of a severity > than or = to grade 2 according to nci-ctc ae criteria version 3.0
Beschreibung

Toxicity Motor nerve Pre-existing | Toxicity Sensory nerve Pre-existing | CTCAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0501384
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0501385
UMLS CUI [2,3]
C2347662
UMLS CUI [3]
C1516728
7. pregnant or lactating women or women of childbearing potential not using adequate contraception
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
8. other serious illness or medical conditions, including:
Beschreibung

Illness Serious | Other medical condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3843040
1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
Beschreibung

Congestive heart failure | Angina, Unstable | Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia Uncontrolled High risk

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C0332167
2. history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent.
Beschreibung

nervous system disorder Significant | Mental disorders Significant | Psychotic Disorders | Dementia | Seizures | Comorbidity Informed Consent Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0036572
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0021430
UMLS CUI [6,3]
C0439801
3. active uncontrolled infection
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
4. active peptic ulcer, uncontrolled diabetes mellitus
Beschreibung

Peptic Ulcer | DIABETES MELLITUS NOS UNCONTROLLED

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0743131
9. past or current history of neoplasm other than breast carcinoma, except:
Beschreibung

Neoplasms | Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2]
C0678222
1. curatively treated non-melanoma skin cancer.
Beschreibung

curative treatment Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C0699893
2. in situ carcinoma of the cervix.
Beschreibung

Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C0851140
3. other cancer curatively treated and with no evidence of disease for at least 10 years
Beschreibung

curative treatment Malignant Neoplasm | Disease Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332120
10. chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< than or = to 20 mg methylprednisolone per day or equivalent)
Beschreibung

Adrenal Cortex Hormones | Methylprednisolone Low dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0025815
UMLS CUI [2,2]
C0445550
11. definite contraindications for the use of corticosteroids
Beschreibung

Medical contraindication Definite Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0439544
UMLS CUI [1,3]
C0001617
12. likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see section 6.2)
Beschreibung

Illicit Drugs Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C2348563
13. concurrent treatment with other investigational drugs. active treatment as part of another clinical therapeutic trial within 30 days prior to study entry
Beschreibung

Investigational New Drugs | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
14. concurrent treatment with any other anti-cancer therapy, except adjuvant hormone therapy started > than or = to 12 months prior to study enrollment. bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed
Beschreibung

cancer treatment | Hormone Therapy Adjuvant | Diphosphonates | Secondary malignant neoplasm of bone | Osteoporosis | Osteopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1522673
UMLS CUI [3]
C0012544
UMLS CUI [4]
C0153690
UMLS CUI [5]
C0029456
UMLS CUI [6]
C0029453
15. history of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80), epirubicin or doxorubicin
Beschreibung

Hypersensitivity docetaxel | Hypersensitivity Polysorbate 80 | Hypersensitivity Epirubicin | Hypersensitivity Doxorubicin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032601
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0014582
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013089
16. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Beschreibung

Mental condition Study Protocol Comprehension Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C1299582
17. subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Beschreibung

Compliance behavior Limited | uncooperative attitude | Clinical Study Follow-up Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C2188045
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1299582
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Breast Neoplasms NCT00620100

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast adenocarcinoma
Item
1. female patient with histologically or cytologically documented breast adenocarcinoma
boolean
C0079399 (UMLS CUI [1])
C0858252 (UMLS CUI [2])
Relapse Local First | Relapse Metastatic First
Item
2. first local or metastatic relapse
boolean
C0035020 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1279901 (UMLS CUI [1,3])
C0035020 (UMLS CUI [2,1])
C0036525 (UMLS CUI [2,2])
C1279901 (UMLS CUI [2,3])
Taxotere | Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy
Item
3. patients must have received a prior neoadjuvant or adjuvant taxotere®-based chemotherapy regimen, provided this chemotherapy was completed > than or = to 12 months prior to enrollment date
boolean
C0699967 (UMLS CUI [1])
C0085533 (UMLS CUI [2])
C0600558 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
Prior Hormone Therapy | Prior Immunotherapy | Hormone Therapy Adjuvant Antitumor
Item
4. prior hormone or immune therapy is allowed. antitumoral adjuvant hormone therapy may be continued during the study period, provided it was started > 12 months prior to study enrollment
boolean
C1514460 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C2986475 (UMLS CUI [3,3])
Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization
Item
5. her2/neu negative tumor demonstrated by immunohistochemistry (ihc 0 or 1+) or by fluorescence in situ hybridation (fish -). a patient with tumor assessed as 2+ by ihc can be enrolled if the tumor is negative by fish.
boolean
C2316304 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
ECOG performance status
Item
6. ecog performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Cardiac function | Left ventricular ejection fraction | Shortening Fraction | Multiple gated acquisition scanning | Echocardiography | ECG abnormality Clinical Significance
Item
7. normal cardiac function confirmed by lvef or shortening fraction (muga scan or echocardiography, respectively, within normal limits for the institution) assessed within 3 months prior to study entry. an ecg must be obtained within 4 weeks prior study entry and must demonstrate no clinically significant abnormality.
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C1335957 (UMLS CUI [3])
C0521317 (UMLS CUI [4])
C0013516 (UMLS CUI [5])
C0522055 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
Measurable Disease Quantity
Item
8. patients are required to have at least one measurable lesion according to recist guidelines
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
organ function
Item
9. adequate organ function defined by:
boolean
C0678852 (UMLS CUI [1])
Hematology | Absolute neutrophil count | Blood Platelets | Hemoglobin
Item
1. hematology: neutrophils > than or = to 2.0 109/l, platelets > than or = to 100 109/l, hemoglobin > than or = to 10 g/dl
boolean
C0200627 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Liver function | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone Extensive
Item
2. hepatic function: total bilirubin within normal limits, ast (sgot) and alt (sgpt) < than or = to 1.5 unl, alkaline phosphatase < than or = to 2.5 unl (unless accompanied by extensive bone metastases)
boolean
C0232741 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0153690 (UMLS CUI [6,1])
C0205231 (UMLS CUI [6,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
10. negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Informed consent
Item
11. written informed consent prior to beginning specific protocol procedures must be obtained and documented according to the local regulatory requirements
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy advanced disease | Prior Therapy Recurrent disease
Item
1. prior therapy for advanced or recurrent disease
boolean
C1514463 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
Cumulative Exposure Epirubicin | Cumulative Exposure Doxorubicin
Item
2. previous cumulative exposure to epirubicin > 600 mg/m² or to doxorubicin > 300 mg/m²
boolean
C2986588 (UMLS CUI [1,1])
C0014582 (UMLS CUI [1,2])
C2986588 (UMLS CUI [2,1])
C0013089 (UMLS CUI [2,2])
prior radiation therapy Involved Bone Marrow | Therapeutic radiology procedure Toxicity Recovery Incomplete
Item
3. previous radiation therapy having involved more than 25% of bone marrow; incomplete recovery from toxicity of radiation therapy
boolean
C0279134 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C2004454 (UMLS CUI [2,3])
C0205257 (UMLS CUI [2,4])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges
Item
4. symptomatic brain metastases and clinically diagnosed leptomeningeal metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2])
Bone lesion Measurable Isolated | serous pleural effusion | Lymphangitis Pulmonary | Measurable Disease
Item
5. isolated unmeasurable bone lesions, serous pleural effusion or pulmonary lymphangiitis (i.e., unmeasurable disease according to the recist guidelines)
boolean
C0238792 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0205409 (UMLS CUI [1,3])
C2082495 (UMLS CUI [2])
C0024225 (UMLS CUI [3,1])
C2709248 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4])
Toxicity Motor nerve Pre-existing | Toxicity Sensory nerve Pre-existing | CTCAE
Item
6. pre-existing motor or sensory neurologic toxicity of a severity > than or = to grade 2 according to nci-ctc ae criteria version 3.0
boolean
C0600688 (UMLS CUI [1,1])
C0501384 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0501385 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C1516728 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
7. pregnant or lactating women or women of childbearing potential not using adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Illness Serious | Other medical condition
Item
8. other serious illness or medical conditions, including:
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2])
Congestive heart failure | Angina, Unstable | Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia Uncontrolled High risk
Item
1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0332167 (UMLS CUI [5,3])
nervous system disorder Significant | Mental disorders Significant | Psychotic Disorders | Dementia | Seizures | Comorbidity Informed Consent Limited
Item
2. history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent.
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0036572 (UMLS CUI [5])
C0009488 (UMLS CUI [6,1])
C0021430 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
Communicable Disease Uncontrolled
Item
3. active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Peptic Ulcer | DIABETES MELLITUS NOS UNCONTROLLED
Item
4. active peptic ulcer, uncontrolled diabetes mellitus
boolean
C0030920 (UMLS CUI [1])
C0743131 (UMLS CUI [2])
Neoplasms | Breast Carcinoma
Item
9. past or current history of neoplasm other than breast carcinoma, except:
boolean
C0027651 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
curative treatment Skin carcinoma
Item
1. curatively treated non-melanoma skin cancer.
boolean
C1273390 (UMLS CUI [1,1])
C0699893 (UMLS CUI [1,2])
Carcinoma in situ of uterine cervix
Item
2. in situ carcinoma of the cervix.
boolean
C0851140 (UMLS CUI [1])
curative treatment Malignant Neoplasm | Disease Evidence of
Item
3. other cancer curatively treated and with no evidence of disease for at least 10 years
boolean
C1273390 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Adrenal Cortex Hormones | Methylprednisolone Low dose
Item
10. chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< than or = to 20 mg methylprednisolone per day or equivalent)
boolean
C0001617 (UMLS CUI [1])
C0025815 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
Medical contraindication Definite Adrenal Cortex Hormones
Item
11. definite contraindications for the use of corticosteroids
boolean
C1301624 (UMLS CUI [1,1])
C0439544 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
Illicit Drugs Study Protocol
Item
12. likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see section 6.2)
boolean
C0086190 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Investigational New Drugs | Study Subject Participation Status
Item
13. concurrent treatment with other investigational drugs. active treatment as part of another clinical therapeutic trial within 30 days prior to study entry
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
cancer treatment | Hormone Therapy Adjuvant | Diphosphonates | Secondary malignant neoplasm of bone | Osteoporosis | Osteopenia
Item
14. concurrent treatment with any other anti-cancer therapy, except adjuvant hormone therapy started > than or = to 12 months prior to study enrollment. bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed
boolean
C0920425 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0012544 (UMLS CUI [3])
C0153690 (UMLS CUI [4])
C0029456 (UMLS CUI [5])
C0029453 (UMLS CUI [6])
Hypersensitivity docetaxel | Hypersensitivity Polysorbate 80 | Hypersensitivity Epirubicin | Hypersensitivity Doxorubicin
Item
15. history of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80), epirubicin or doxorubicin
boolean
C0020517 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0014582 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0013089 (UMLS CUI [4,2])
Mental condition Study Protocol Comprehension Unable
Item
16. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
boolean
C3840291 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Compliance behavior Limited | uncooperative attitude | Clinical Study Follow-up Unable
Item
17. subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C2188045 (UMLS CUI [2])
C3274571 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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