ID

30557

Beskrivning

Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01015248

Länk

https://clinicaltrials.gov/show/NCT01015248

Nyckelord

Versioner (1)
  1. 2018-06-14 2018-06-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility MALT LYMPHOMA NCT01015248

Engelsk

Eligibility MALT LYMPHOMA NCT01015248

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven diagnosis of cd20-positive marginal zone b-cell lymphoma of malt type arisen at any extranodal site (who classification)
Beskrivning

Marginal Zone B-Cell Lymphoma MALT Lymphoma CD20 antigen positive WHO tumor classification | Origin Site Extranodal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1367654
UMLS CUI [1,2]
C0242647
UMLS CUI [1,3]
C3888518
UMLS CUI [1,4]
C1301142
UMLS CUI [2,1]
C0439659
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C1517067
2. any stage (ann arbor i-iv)
Beskrivning

Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1]
C0432516
3. the novo disease en any extranodal site. for primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:
Beskrivning

Disease de novo | Origin Site Extranodal | Prior Therapy Gastric lymphoma | Prior Therapy Cutaneous lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0439659
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C1517067
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0349532
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1276146
1. cutaneous lymphoma: recurrent lymphoma after local therapy
Beskrivning

Cutaneous lymphoma | Recurrent Lymphoma Post Local Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1276146
UMLS CUI [2,1]
C4525062
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1517925
2. gastric lymphoma:
Beskrivning

Gastric lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0349532
b1. h. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).
Beskrivning

Disease Helicobacter pylori Negative | Disease de novo Untreated | Recurrent disease Post Local Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Antibiotics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0079488
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1515568
UMLS CUI [2,3]
C0332155
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1517925
UMLS CUI [4]
C0543467
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0003232
b2. h. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post h. pylori eradication; stable disease with persistent lymphoma at 1 year post h. pylori eradication; relapse (without h. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy)
Beskrivning

Disease Helicobacter pylori Positive | Antibiotics failed | Disease Progression Post Helicobacter eradication therapy | Lymphoma Persistent Post Helicobacter eradication therapy | Recurrent disease Post Remission | Reinfection Helicobacter pylori Absent | First line treatment Antibiotics failed | Local Therapy Additional failed | Operative Surgical Procedures | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0079488
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0559761
UMLS CUI [4,1]
C0024299
UMLS CUI [4,2]
C0205322
UMLS CUI [4,3]
C0687676
UMLS CUI [4,4]
C0559761
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0544452
UMLS CUI [6,1]
C0205339
UMLS CUI [6,2]
C0079488
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C1708063
UMLS CUI [7,2]
C0003232
UMLS CUI [7,3]
C0231175
UMLS CUI [8,1]
C1517925
UMLS CUI [8,2]
C1524062
UMLS CUI [8,3]
C0231175
UMLS CUI [9]
C0543467
UMLS CUI [10]
C1522449
4. no evidence of histologic transformation to a high grade lymphoma
Beskrivning

Absence Transformation High Grade Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1536010
UMLS CUI [1,3]
C0079740
5. measurable or evaluable disease
Beskrivning

Measurable Disease | Evaluable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
6. age >18 and <85
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
7. ecog performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. life expectancy of at least 1 year
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
9. written informed consent given according to national/local regulations
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior chemotherapy or prior immunotherapy with any anti-cd20 monoclonal antibody
Beskrivning

Prior Chemotherapy | Prior Immunotherapy | Anti-CD20 Antibody

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1514461
UMLS CUI [3]
C3891557
2. prior radiotherapy in the last 6 weeks
Beskrivning

Prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
3. corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
Beskrivning

Adrenal Cortex Hormones | Exception Prednisone U/day chronic | Exclusion Indication Lymphoma | Exclusion Indication Lymphoma Symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0456683
UMLS CUI [2,4]
C0205191
UMLS CUI [3,1]
C2828389
UMLS CUI [3,2]
C3146298
UMLS CUI [3,3]
C0024299
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C3146298
UMLS CUI [4,3]
C0024299
UMLS CUI [4,4]
C1457887
4. major impairment of renal function (serum creatinine > 2,5 x upper normal) or liver function (asat/alat <2,5 x upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement.
Beskrivning

Renal Insufficiency Major | Serum creatinine raised | Liver Dysfunction Major | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Etiology Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0700225
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0205164
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C1278039
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0015127
UMLS CUI [7,3]
C0024299
5. impairment of bone marrow function (wbc <3.0x109/l, anc <1.5x109/l, plt <100x109/l), unless due to lymphoma involvement
Beskrivning

Bone Marrow function Impairment | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Etiology Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0221099
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0015127
UMLS CUI [5,3]
C0024299
6. evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement
Beskrivning

Heart Diseases | Nervous system disorder | Metabolic Diseases | Exception Etiology Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0025517
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015127
UMLS CUI [4,3]
C0024299
7. evidence of symptomatic central nervous system (cns) disease
Beskrivning

CNS disorder Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0231220
8. active hbv and/or hcv infection
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
9. known hiv infection
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
10. prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (cin1) or localized non-melanomatous skin cancer
Beskrivning

Malignant Neoplasms | Exception Cervical Intraepithelial Neoplasia Grade | Exception Skin carcinoma Localized

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0206708
UMLS CUI [2,3]
C0441800
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C0392752
11. any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule
Beskrivning

Mental disorder Interferes with Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
12. potential to attend regular visits to the hospital, on an outpatient regimen
Beskrivning

Hospital visit Regular | Outpatient Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545092
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0029921
UMLS CUI [2,2]
C0040808
13. hypersensibility to any compound of the study medication.
Beskrivning

Hypersensitivity Investigational New Drugs Compound

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1706082
14. non appropriate contraceptive method in women of childbearing potential or men
Beskrivning

Childbearing Potential Contraceptive methods Inappropriate | Gender Contraceptive methods Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1548788
15. treatment with any drug under research within 30 days previous to start the study medication.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility MALT LYMPHOMA NCT01015248

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Marginal Zone B-Cell Lymphoma MALT Lymphoma CD20 antigen positive WHO tumor classification | Origin Site Extranodal
Item
1. histologically proven diagnosis of cd20-positive marginal zone b-cell lymphoma of malt type arisen at any extranodal site (who classification)
boolean
C1367654 (UMLS CUI [1,1])
C0242647 (UMLS CUI [1,2])
C3888518 (UMLS CUI [1,3])
C1301142 (UMLS CUI [1,4])
C0439659 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1517067 (UMLS CUI [2,3])
Ann Arbor lymphoma staging system
Item
2. any stage (ann arbor i-iv)
boolean
C0432516 (UMLS CUI [1])
Disease de novo | Origin Site Extranodal | Prior Therapy Gastric lymphoma | Prior Therapy Cutaneous lymphoma
Item
3. the novo disease en any extranodal site. for primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:
boolean
C0012634 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0439659 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1517067 (UMLS CUI [2,3])
C1514463 (UMLS CUI [3,1])
C0349532 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C1276146 (UMLS CUI [4,2])
Cutaneous lymphoma | Recurrent Lymphoma Post Local Therapy
Item
1. cutaneous lymphoma: recurrent lymphoma after local therapy
boolean
C1276146 (UMLS CUI [1])
C4525062 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1517925 (UMLS CUI [2,3])
Gastric lymphoma
Item
2. gastric lymphoma:
boolean
C0349532 (UMLS CUI [1])
Disease Helicobacter pylori Negative | Disease de novo Untreated | Recurrent disease Post Local Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Antibiotics
Item
b1. h. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).
boolean
C0012634 (UMLS CUI [1,1])
C0079488 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1517925 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0003232 (UMLS CUI [6])
Disease Helicobacter pylori Positive | Antibiotics failed | Disease Progression Post Helicobacter eradication therapy | Lymphoma Persistent Post Helicobacter eradication therapy | Recurrent disease Post Remission | Reinfection Helicobacter pylori Absent | First line treatment Antibiotics failed | Local Therapy Additional failed | Operative Surgical Procedures | Therapeutic radiology procedure
Item
b2. h. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post h. pylori eradication; stable disease with persistent lymphoma at 1 year post h. pylori eradication; relapse (without h. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy)
boolean
C0012634 (UMLS CUI [1,1])
C0079488 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0559761 (UMLS CUI [3,3])
C0024299 (UMLS CUI [4,1])
C0205322 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C0559761 (UMLS CUI [4,4])
C0277556 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0544452 (UMLS CUI [5,3])
C0205339 (UMLS CUI [6,1])
C0079488 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1708063 (UMLS CUI [7,1])
C0003232 (UMLS CUI [7,2])
C0231175 (UMLS CUI [7,3])
C1517925 (UMLS CUI [8,1])
C1524062 (UMLS CUI [8,2])
C0231175 (UMLS CUI [8,3])
C0543467 (UMLS CUI [9])
C1522449 (UMLS CUI [10])
Absence Transformation High Grade Lymphoma
Item
4. no evidence of histologic transformation to a high grade lymphoma
boolean
C0332197 (UMLS CUI [1,1])
C1536010 (UMLS CUI [1,2])
C0079740 (UMLS CUI [1,3])
Measurable Disease | Evaluable Disease
Item
5. measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Age
Item
6. age >18 and <85
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
8. life expectancy of at least 1 year
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
9. written informed consent given according to national/local regulations
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy | Prior Immunotherapy | Anti-CD20 Antibody
Item
1. prior chemotherapy or prior immunotherapy with any anti-cd20 monoclonal antibody
boolean
C1514457 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
C3891557 (UMLS CUI [3])
Prior radiation therapy
Item
2. prior radiotherapy in the last 6 weeks
boolean
C0279134 (UMLS CUI [1])
Adrenal Cortex Hormones | Exception Prednisone U/day chronic | Exclusion Indication Lymphoma | Exclusion Indication Lymphoma Symptoms
Item
3. corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
boolean
C0001617 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
C2828389 (UMLS CUI [3,1])
C3146298 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
C2828389 (UMLS CUI [4,1])
C3146298 (UMLS CUI [4,2])
C0024299 (UMLS CUI [4,3])
C1457887 (UMLS CUI [4,4])
Renal Insufficiency Major | Serum creatinine raised | Liver Dysfunction Major | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Etiology Lymphoma
Item
4. major impairment of renal function (serum creatinine > 2,5 x upper normal) or liver function (asat/alat <2,5 x upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement.
boolean
C1565489 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0015127 (UMLS CUI [7,2])
C0024299 (UMLS CUI [7,3])
Bone Marrow function Impairment | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Etiology Lymphoma
Item
5. impairment of bone marrow function (wbc <3.0x109/l, anc <1.5x109/l, plt <100x109/l), unless due to lymphoma involvement
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0015127 (UMLS CUI [5,2])
C0024299 (UMLS CUI [5,3])
Heart Diseases | Nervous system disorder | Metabolic Diseases | Exception Etiology Lymphoma
Item
6. evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement
boolean
C0018799 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0015127 (UMLS CUI [4,2])
C0024299 (UMLS CUI [4,3])
CNS disorder Symptomatic
Item
7. evidence of symptomatic central nervous system (cns) disease
boolean
C0007682 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C
Item
8. active hbv and/or hcv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
9. known hiv infection
boolean
C0019693 (UMLS CUI [1])
Malignant Neoplasms | Exception Cervical Intraepithelial Neoplasia Grade | Exception Skin carcinoma Localized
Item
10. prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (cin1) or localized non-melanomatous skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0206708 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
Mental disorder Interferes with Protocol Compliance
Item
11. any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Hospital visit Regular | Outpatient Regimen
Item
12. potential to attend regular visits to the hospital, on an outpatient regimen
boolean
C0545092 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0029921 (UMLS CUI [2,1])
C0040808 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs Compound
Item
13. hypersensibility to any compound of the study medication.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods Inappropriate | Gender Contraceptive methods Inappropriate
Item
14. non appropriate contraceptive method in women of childbearing potential or men
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Investigational New Drugs
Item
15. treatment with any drug under research within 30 days previous to start the study medication.
boolean
C0013230 (UMLS CUI [1])
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