ID

30883

Beskrivning

Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01029054

Länk

https://clinicaltrials.gov/show/NCT01029054

Nyckelord

Versioner (1)
  1. 2018-07-01 2018-07-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01029054

Engelsk

Eligibility Multiple Myeloma NCT01029054

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. newly diagnosed, histologically confirmed, previously untreated stage i, ii, or iii multiple myeloma requiring systemic chemotherapy
Beskrivning

Multiple Myeloma untreated Durie/Salmon Stage | Systemic Chemotherapy Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C4528204
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C1514873
2. diagnosis of symptomatic multiple myeloma per imwg uniform criteria within the past 90 days
Beskrivning

Multiple Myeloma Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
3. measurable disease, per imwg (international myeloma working group) criteria (>= one of the following) within the past 4 weeks:
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
monoclonal protein >= 0.5 g/dl by serum protein electrophoresis
Beskrivning

Monoclonal Protein Measurement Serum protein electrophoresis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2984963
UMLS CUI [1,2]
C0201720
monoclonal light chain >= 200 mg by 24-hour urine protein electrophoresis
Beskrivning

Monoclonal free light chain present 24-hour urine protein electrophoresis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1532998
UMLS CUI [1,2]
C2321676
if serum protein electrophoresis is felt to be unreliable for routine m-protein measurement, then quantitative immunoglobulin levels are acceptable
Beskrivning

Serum protein electrophoresis unreliable Monoclonal Protein Measurement | Immunoglobulin level Quantitative Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201720
UMLS CUI [1,2]
C0749770
UMLS CUI [1,3]
C2984963
UMLS CUI [2,1]
C0428536
UMLS CUI [2,2]
C0392762
UMLS CUI [2,3]
C1879533
4. life expectancy > 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
5. eastern cooperative oncology group (ecog) performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate hepatic function, with bilirubin < 1.5 x the uln, and ast (aspartate aminotransferase) and alt (alanine transaminase) < 2.5 x uln
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
7. absolute neutrophil count (anc) >=1.0 x 109/l, hemoglobin >= 8 g/dl, platelet count >= 75 x 109/l
Beskrivning

Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
8. calculated creatinine clearance (by cockroft-gault) >= 60 ml/min
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
9. written informed consent in accordance with federal, local, and institutional guidelines.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
10. subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring.
Beskrivning

Protocol Compliance | Contraceptive methods | Pregnancy Tests | Monitoring of laboratory results

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0032976
UMLS CUI [4]
C3165364
11. must be able to take either 81 mg or 325 mg aspirin daily as prophylactic anticoagulation.
Beskrivning

Aspirin U/day | Anticoagulation Prophylactic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0199176
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non-secretory or hyposecretory multiple myeloma, defined as <0.5 g/dl m-protein in serum, <200 mg/24 hr urine m-protein, or disease only measured by serum free light chain
Beskrivning

Non-secretory myeloma | Multiple Myeloma M Protein Very low | Serum Monoclonal Protein Measurement | Monoclonal Protein Measurement 24 Hour Urine Test | Serum Free Immunoglobulin Light Chain Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0442811
UMLS CUI [3,1]
C0229671
UMLS CUI [3,2]
C2984963
UMLS CUI [4,1]
C2984963
UMLS CUI [4,2]
C1255149
UMLS CUI [5,1]
C2827352
UMLS CUI [5,2]
C0242485
2. poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome
Beskrivning

POEMS Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0085404
3. plasma cell leukemia
Beskrivning

Leukemia, Plasma Cell

Datatyp

boolean

Alias
UMLS CUI [1]
C0023484
4. waldenström's macroglobulinemia or igm myeloma
Beskrivning

Waldenstrom Macroglobulinemia | Multiple Myeloma-IgM

Datatyp

boolean

Alias
UMLS CUI [1]
C0024419
UMLS CUI [2]
C2347304
5. radiotherapy to multiple sites or immunotherapy within 2 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
Beskrivning

Therapeutic radiology procedure Site Multiple | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0439064
UMLS CUI [2]
C0021083
6. patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
Beskrivning

Systemic therapy Multiple Myeloma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0026764
prior treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)
Beskrivning

Steroid therapy Hypercalcemia allowed | Steroid therapy Compression of spinal cord allowed | Steroid therapy Multiple Myeloma Progressive allowed | Dexamethasone Dosage Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0020437
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0037926
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0026764
UMLS CUI [3,3]
C0205329
UMLS CUI [3,4]
C0683607
UMLS CUI [4,1]
C0011777
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205163
bisphosphonates are permitted
Beskrivning

Diphosphonates

Datatyp

boolean

Alias
UMLS CUI [1]
C0012544
7. participation in an investigational therapeutic study within 3 weeks or within 5 drug halflives (t1/2) prior to first dose, whichever time is greater
Beskrivning

Study Subject Participation Status | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
8. pregnant or lactating females
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. history of allergy to mannitol
Beskrivning

Mannitol allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571922
10. major surgery within 3 weeks prior to first dose
Beskrivning

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
11. myocardial infarction within 3 months prior to enrollment, nyha (new york heart association) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Beskrivning

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Cardiac conduction abnormality Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
UMLS CUI [6,1]
C1842820
UMLS CUI [6,2]
C1623258
12. uncontrolled hypertension or diabetes
Beskrivning

Uncontrolled hypertension | Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421258
13. acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
Beskrivning

Communicable Disease Requirement Antibiotics for systemic use | Communicable Disease Requirement ANTIVIRALS FOR SYSTEMIC USE | Communicable Disease Requirement ANTIFUNGALS FOR SYSTEMIC USE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3540704
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3653777
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C3653743
14. known or suspected hiv infection, known hiv seropositivity
Beskrivning

HIV Infection | HIV Infection Suspected | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0019699
15. active hepatitis infection
Beskrivning

Hepatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0019158
16. non-hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < gleason grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
Beskrivning

Non-Hematologic Malignancy | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Thyroid carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Prostate carcinoma Gleason Grading System | Exception Prostate carcinoma Prostate-Specific Antigen Stable | Exception Malignant Neoplasm Cured Excision

Datatyp

boolean

Alias
UMLS CUI [1]
C0935681
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0549473
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [6,3]
C0332326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0600139
UMLS CUI [7,3]
C0138741
UMLS CUI [7,4]
C0205360
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0006826
UMLS CUI [8,3]
C1880198
UMLS CUI [8,4]
C0728940
17. any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Beskrivning

Disease Interferes with Protocol Compliance | Medical condition Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Medical condition Interferes with Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
18. significant neuropathy (grade >2) at the time of the first dose and/or within 14 days before enrollment
Beskrivning

Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
19. contraindication to any of the required concomitant drugs
Beskrivning

Medical contraindication Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
20. subjects in whom the required program of po and iv fluid hydration is contraindicated
Beskrivning

Medical contraindication Fluid Hydration per os | Medical contraindication Fluid Hydration Intravenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0302908
UMLS CUI [1,3]
C4520800
UMLS CUI [1,4]
C1527415
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0302908
UMLS CUI [2,3]
C4520800
UMLS CUI [2,4]
C0348016
21. subjects with known or suspected amyloidosis of any organ
Beskrivning

Amyloidosis Organ Any | Suspicion Amyloidosis Organ Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002726
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0002726
UMLS CUI [2,3]
C0178784
UMLS CUI [2,4]
C1552551
22. subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
Beskrivning

Pleural effusion Requirement Thoracentesis | Ascites Requirement Paracentesis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0189477
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0034115
Tillbaka till toppen

Similar models

Eligibility Multiple Myeloma NCT01029054

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma untreated Durie/Salmon Stage | Systemic Chemotherapy Required
Item
1. newly diagnosed, histologically confirmed, previously untreated stage i, ii, or iii multiple myeloma requiring systemic chemotherapy
boolean
C0026764 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C4528204 (UMLS CUI [1,3])
C1883256 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Multiple Myeloma Symptomatic
Item
2. diagnosis of symptomatic multiple myeloma per imwg uniform criteria within the past 90 days
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Measurable Disease
Item
3. measurable disease, per imwg (international myeloma working group) criteria (>= one of the following) within the past 4 weeks:
boolean
C1513041 (UMLS CUI [1])
Monoclonal Protein Measurement Serum protein electrophoresis
Item
monoclonal protein >= 0.5 g/dl by serum protein electrophoresis
boolean
C2984963 (UMLS CUI [1,1])
C0201720 (UMLS CUI [1,2])
Monoclonal free light chain present 24-hour urine protein electrophoresis
Item
monoclonal light chain >= 200 mg by 24-hour urine protein electrophoresis
boolean
C1532998 (UMLS CUI [1,1])
C2321676 (UMLS CUI [1,2])
Serum protein electrophoresis unreliable Monoclonal Protein Measurement | Immunoglobulin level Quantitative Acceptable
Item
if serum protein electrophoresis is felt to be unreliable for routine m-protein measurement, then quantitative immunoglobulin levels are acceptable
boolean
C0201720 (UMLS CUI [1,1])
C0749770 (UMLS CUI [1,2])
C2984963 (UMLS CUI [1,3])
C0428536 (UMLS CUI [2,1])
C0392762 (UMLS CUI [2,2])
C1879533 (UMLS CUI [2,3])
Life Expectancy
Item
4. life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
6. adequate hepatic function, with bilirubin < 1.5 x the uln, and ast (aspartate aminotransferase) and alt (alanine transaminase) < 2.5 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
7. absolute neutrophil count (anc) >=1.0 x 109/l, hemoglobin >= 8 g/dl, platelet count >= 75 x 109/l
boolean
C0948762 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
8. calculated creatinine clearance (by cockroft-gault) >= 60 ml/min
boolean
C2711451 (UMLS CUI [1])
Informed Consent
Item
9. written informed consent in accordance with federal, local, and institutional guidelines.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance | Contraceptive methods | Pregnancy Tests | Monitoring of laboratory results
Item
10. subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring.
boolean
C0525058 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0032976 (UMLS CUI [3])
C3165364 (UMLS CUI [4])
Aspirin U/day | Anticoagulation Prophylactic
Item
11. must be able to take either 81 mg or 325 mg aspirin daily as prophylactic anticoagulation.
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Non-secretory myeloma | Multiple Myeloma M Protein Very low | Serum Monoclonal Protein Measurement | Monoclonal Protein Measurement 24 Hour Urine Test | Serum Free Immunoglobulin Light Chain Measurement
Item
1. non-secretory or hyposecretory multiple myeloma, defined as <0.5 g/dl m-protein in serum, <200 mg/24 hr urine m-protein, or disease only measured by serum free light chain
boolean
C0456845 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0442811 (UMLS CUI [2,3])
C0229671 (UMLS CUI [3,1])
C2984963 (UMLS CUI [3,2])
C2984963 (UMLS CUI [4,1])
C1255149 (UMLS CUI [4,2])
C2827352 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
POEMS Syndrome
Item
2. poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome
boolean
C0085404 (UMLS CUI [1])
Leukemia, Plasma Cell
Item
3. plasma cell leukemia
boolean
C0023484 (UMLS CUI [1])
Waldenstrom Macroglobulinemia | Multiple Myeloma-IgM
Item
4. waldenström's macroglobulinemia or igm myeloma
boolean
C0024419 (UMLS CUI [1])
C2347304 (UMLS CUI [2])
Therapeutic radiology procedure Site Multiple | Immunotherapy
Item
5. radiotherapy to multiple sites or immunotherapy within 2 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
boolean
C1522449 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0021083 (UMLS CUI [2])
Systemic therapy Multiple Myeloma
Item
6. patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
boolean
C1515119 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
Steroid therapy Hypercalcemia allowed | Steroid therapy Compression of spinal cord allowed | Steroid therapy Multiple Myeloma Progressive allowed | Dexamethasone Dosage Equivalent
Item
prior treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)
boolean
C0149783 (UMLS CUI [1,1])
C0020437 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0149783 (UMLS CUI [2,1])
C0037926 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0149783 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C0205329 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
C0011777 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
Diphosphonates
Item
bisphosphonates are permitted
boolean
C0012544 (UMLS CUI [1])
Study Subject Participation Status | Therapy, Investigational
Item
7. participation in an investigational therapeutic study within 3 weeks or within 5 drug halflives (t1/2) prior to first dose, whichever time is greater
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
8. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mannitol allergy
Item
9. history of allergy to mannitol
boolean
C0571922 (UMLS CUI [1])
Major surgery
Item
10. major surgery within 3 weeks prior to first dose
boolean
C0679637 (UMLS CUI [1])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Cardiac conduction abnormality Electrocardiography
Item
11. myocardial infarction within 3 months prior to enrollment, nyha (new york heart association) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C1842820 (UMLS CUI [6,1])
C1623258 (UMLS CUI [6,2])
Uncontrolled hypertension | Diabetic - poor control
Item
12. uncontrolled hypertension or diabetes
boolean
C1868885 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
Communicable Disease Requirement Antibiotics for systemic use | Communicable Disease Requirement ANTIVIRALS FOR SYSTEMIC USE | Communicable Disease Requirement ANTIFUNGALS FOR SYSTEMIC USE
Item
13. acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3540704 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3653777 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3653743 (UMLS CUI [3,3])
HIV Infection | HIV Infection Suspected | HIV Seropositivity
Item
14. known or suspected hiv infection, known hiv seropositivity
boolean
C0019693 (UMLS CUI [1])
C0019693 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
Hepatitis
Item
15. active hepatitis infection
boolean
C0019158 (UMLS CUI [1])
Non-Hematologic Malignancy | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Thyroid carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Prostate carcinoma Gleason Grading System | Exception Prostate carcinoma Prostate-Specific Antigen Stable | Exception Malignant Neoplasm Cured Excision
Item
16. non-hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < gleason grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
boolean
C0935681 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0549473 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C0332326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0600139 (UMLS CUI [7,2])
C0138741 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
C1705847 (UMLS CUI [8,1])
C0006826 (UMLS CUI [8,2])
C1880198 (UMLS CUI [8,3])
C0728940 (UMLS CUI [8,4])
Disease Interferes with Protocol Compliance | Medical condition Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Medical condition Interferes with Informed Consent
Item
17. any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
Neuropathy CTCAE Grades
Item
18. significant neuropathy (grade >2) at the time of the first dose and/or within 14 days before enrollment
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Medical contraindication Investigational New Drugs
Item
19. contraindication to any of the required concomitant drugs
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Medical contraindication Fluid Hydration per os | Medical contraindication Fluid Hydration Intravenous
Item
20. subjects in whom the required program of po and iv fluid hydration is contraindicated
boolean
C1301624 (UMLS CUI [1,1])
C0302908 (UMLS CUI [1,2])
C4520800 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
C1301624 (UMLS CUI [2,1])
C0302908 (UMLS CUI [2,2])
C4520800 (UMLS CUI [2,3])
C0348016 (UMLS CUI [2,4])
Amyloidosis Organ Any | Suspicion Amyloidosis Organ Any
Item
21. subjects with known or suspected amyloidosis of any organ
boolean
C0002726 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0242114 (UMLS CUI [2,1])
C0002726 (UMLS CUI [2,2])
C0178784 (UMLS CUI [2,3])
C1552551 (UMLS CUI [2,4])
Pleural effusion Requirement Thoracentesis | Ascites Requirement Paracentesis
Item
22. subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
boolean
C0032227 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0189477 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0034115 (UMLS CUI [2,3])
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