Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
Age
Item
Alter >= 18 Jahre
boolean
follicular B-NHL, subtypes follicular lymphoma (FL) (Grades 1 and 2
Item
Diagnosis of follicular B-NHL of the following subtypes (World Health Organization [WHO] classification 1997): follicular lymphoma (FL) (Grades 1 and 2).
boolean
relapse or progression following prior anti-neoplastic treatment
Item
Documented relapse or progression following prior antineoplastic treatment. New lesions or objective evidence of progression of existing lesions must document relapse or progression following the previous therapy.
boolean
If any prior regimen included rituximab, the subject must have responded.
Item
If any prior regimen included rituximab, the subject must have responded (complete response [CR], unconfirmed complete response [CRu], partial response [PR]), and the time to progression (TTP) from the first dose of rituximab must have been 6 months or more.
boolean
At least 1 measurable tumor mass
Item
At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation
boolean
the decision to initiate treatment is justified to manage the subject's lymphoma
Item
In the opinion of the investigator the decision to initiate treatment is justified to manage the subject's lymphoma
boolean
No active central nervous system lymphoma
Item
No active central nervous system lymphoma
boolean
ECOG status ? 2
Item
Eastern Cooperative Oncology Group [ECOG] status ? 2
boolean
Female subjects must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control; and have a negative pregnancy test at screening.
Item
Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum beta-human chorionic gonadotropin (?-hCG) pregnancy test at screening.
boolean
informed consent
Item
Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
boolean
If health authorities have approved the pharmacogenomic testing, subjects must have signed a separate informed consent.
Item
In countries where health authorities have approved the pharmacogenomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for pharmacogenomics testing, but optional for serum protein testing and future testing.
boolean
Item Group
Ausschlusskriterien
malignancy other than NHL
Item
Diagnosed or treated for a malignancy other than NHL within 1 year of randomization, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
boolean
transformation from indolent NHL to a more aggressive form of NHL
Item
Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL.
boolean
disallowed therapies
Item
Prior treatment with VELCADE; Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization; Nitrosoureas within 6 weeks before randomization; Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization; Stem cell transplant within 6 months before randomization; Major surgery within 2 weeks before randomization.
boolean
Residual toxic effects of previous therapy or surgery
Item
Residual toxic effects of previous therapy or surgery of Grade 3 or worse
boolean
Peripheral neuropathy or neuropathic pain
Item
Peripheral neuropathy or neuropathic pain of Grade 2 or worse
boolean
Have received an experimental drug or used an experimental medical device.
Item
Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
boolean
allergic reaction attributable to compounds containing boron or mannitol
Item
History of allergic reaction attributable to compounds containing boron or mannitol
boolean
hypersensitivity to murine proteins or to any component of rituximab
Item
Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate
boolean
treatment with another investigational agent
Item
Concurrent treatment with another investigational agent
boolean
Female subject is pregnant or breast-feeding
Item
Female subject who is pregnant or breast-feeding
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
man
Item
Mann
string
C0025266 (UMLS CUI)
339947000 (SNOMED CT 2010_0731)
Woman
Item
Frau
string
C0043210 (UMLS CUI)
224526002 (SNOMED CT 2010_0731)
NHL
Item
Lymphoma, Non-Hodgkin (Non-Hodgkins lymphoma)
string
C0024305 (UMLS CUI)
118601006 (SNOMED CT 2010_0731)
10029547 (MedDRA 13.1)
C85.9 (ICD-10-CM Version 2010)
Lymphoma, Follicular
Item
Follicular low grade B-cell lymphoma, Follicular non-Hodgkin lymphoma
string
C0024301 (UMLS CUI)
277618009, 308121000 (SNOMED CT 2010_0731)
10061170 (MedDRA 13.1)
C82 (ICD-10-CM Version 2010)
202.0 (ICD-9-CM Version 2011)
FL grade I
Item
Follicular lymphoma grade I, unspecified site
string
C2853785 (UMLS CUI)
C82.00 (ICD-10-CM Version 2010)
FL grade II
Item
Follicular lymphoma grade II, unspecified site
string
C2853795 (UMLS CUI)
C82.10 (ICD-10-CM Version 2010)
WHO classification
Item
WHO-Klassifikation
string
C0451584 (UMLS CUI)
273931002 (SNOMED CT 2010_0731)
Relapse
Item
Rezidiv
string
C0277556 (UMLS CUI)
58184002 (SNOMED CT 2010_0731)
Documented
Item
Documented (qualifier value)
string
C1301725 (UMLS CUI)
397934002 (SNOMED CT 2010_0731)
Progression
Item
Krankheitsverlauf
string
C0242656 (UMLS CUI)
246453008 (SNOMED CT 2010_0731)
10061818 (MedDRA 13.1)
Antineoplastic Drug/Agent Therapy
Item
Antineoplastic Drug/Agent Therapy
string
CL378288 (UMLS CUI)
Therapy
Item
Therapie
string
C0087111 (UMLS CUI)
Previous
Item
Previous (qualifier value)
string
C0205156 (UMLS CUI)
9130008 (SNOMED CT 2010_0731)
Lesion
Item
Läsion
string
C0221198 (UMLS CUI)
49755003 (SNOMED CT 2010_0731)
Evidence
Item
Evidence of
string
C0332120 (UMLS CUI)
18669006 (SNOMED CT 2010_0731)
Regimen
Item
Treatment Regimen
string
CL031856 (UMLS CUI)
Rituxan
Item
Rituximab
string
C0732355 (UMLS CUI)
386919002 (SNOMED CT 2010_0731)
In complete remission
Item
Complete Response (CR)
string
C0677874 (UMLS CUI)
103338009 (SNOMED CT 2010_0731)
PR
Item
partial response (partial remission)
string
C1521726 (UMLS CUI)
103337004 (SNOMED CT 2010_0731)
TTP
Item
Time to Progression
string
CL425094 (UMLS CUI)
Mass
Item
Mass of body structure, Mass (morphologic abnormality), Tumor Mass
string
C0577559 (UMLS CUI)
4147007 (SNOMED CT 2010_0731)
10026865 (MedDRA 13.1)
Irradiation
Item
Irradiation
string
C1522449 (UMLS CUI)
108290001 (SNOMED CT 2010_0731)
10037794 (MedDRA 13.1)
Lymphoma
Item
Lymphom
string
C0024299 (UMLS CUI)
21964009 (SNOMED CT 2010_0731)
10025310 (MedDRA 13.1)
C85.9 (ICD-10-CM Version 2010)
CNS Lymphoma
Item
Central Nervous System Lymphoma
string
C0280803 (UMLS CUI)
307649006 (SNOMED CT 2010_0731)
10007953 (MedDRA 13.1)
200.5 (ICD-9-CM Version 2011)
Active
Item
aktiv
string
C0205177 (UMLS CUI)
55561003 (SNOMED CT 2010_0731)
ECOG
Item
ECOG Status
string
C1520224 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
female
Item
weiblich
string
C0015780 (UMLS CUI)
248152002 (SNOMED CT 2010_0731)
F (HL7 V3 02-34)
Postmenopause
Item
Postmenopause
string
C0206159 (UMLS CUI)
10051775 (MedDRA 13.1)
Surgical
Item
Operative Surgical Procedures
string
C0543467 (UMLS CUI)
83578000 (SNOMED CT 2010_0731)
10051332 (MedDRA 13.1)
MTHU000079 (LOINC Version 232)
Sterile
Item
Steril
string
C0232920 (UMLS CUI)
261029002 (SNOMED CT 2010_0731)
Abstinent
Item
Abstinent
string
C0457801 (UMLS CUI)
105542008 (SNOMED CT 2010_0731)
10043185 (MedDRA 13.1)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Contraceptives, Oral
Item
orales Kontrazeptivum
string
C0009905 (UMLS CUI)
59261009 (SNOMED CT 2010_0731)
Prescriptions
Item
Prescription (procedure)
string
C0033080 (UMLS CUI)
16076005 (SNOMED CT 2010_0731)
Contraceptive
Item
Kontrazeptivum
string
C0009871 (UMLS CUI)
417122000 (SNOMED CT 2010_0731)
Injection
Item
Injektion
string
C1533685 (UMLS CUI)
59108006 (SNOMED CT 2010_0731)
10052995 (MedDRA 13.1)
Intrauterine Devices
Item
Intrauterine contraceptive device
string
C0021900 (UMLS CUI)
268460000 (SNOMED CT 2010_0731)
10022745 (MedDRA 13.1)
Contraception, Barrier
Item
Barrier contraception method
string
C0004764 (UMLS CUI)
225370004 (SNOMED CT 2010_0731)
Double
Item
Double (qualifier value)
string
C0205173 (UMLS CUI)
1305003 (SNOMED CT 2010_0731)
Contraceptive Patch
Item
Contraceptive Patch
string
C2985284 (UMLS CUI)
Male sterilization
Item
Male sterilization (procedure)
string
C0024559 (UMLS CUI)
399141000 (SNOMED CT 2010_0731)
10065591 (MedDRA 13.1)
63.70 (ICD-9-CM Version 2011)
Entry
Item
Entry
string
C1705654 (UMLS CUI)
Study
Item
Studie
string
C0008976 (UMLS CUI)
110465008 (SNOMED CT 2010_0731)
Serum pregnancy test
Item
Schwangerschaftstest (B-HCG im Serum)
string
C0430060 (UMLS CUI)
166434005 (SNOMED CT 2010_0731)
Negative Pregnancy Test
Item
negativer Schwangerschaftstest
string
C0427780 (UMLS CUI)
250425007 (SNOMED CT 2010_0731)
10036574 (MedDRA 13.1)
Screening
Item
Screening
string
C1409616 (UMLS CUI)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Pharmacogenomic Test
Item
Pharmacogenomic Test
string
C2347501 (UMLS CUI)
Procurement of patient informed consent, investigational study
Item
Procurement of patient informed consent, investigational study
string
C0021430 (UMLS CUI)
55149002 (SNOMED CT 2010_0731)
Study Subject Participation Status
Item
Subject Participation Status in Clinical Study
string
C2348568 (UMLS CUI)
Genetic test
Item
Genetischer Test
string
C0679560 (UMLS CUI)
405824009 (SNOMED CT 2010_0731)
Serum/plasma protein test
Item
Serum/plasma protein test
string
C0428486 (UMLS CUI)
166776003 (SNOMED CT 2010_0731)
Testing
Item
Testing
string
C0039593 (UMLS CUI)
Future
Item
Future
string
C0016884 (UMLS CUI)
Mandatory Testing
Item
Mandatory Testing
string
C0242803 (UMLS CUI)
Optional
Item
Optional
string
C1518600 (UMLS CUI)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Randomization
Item
Random Allocation
string
C0034656 (UMLS CUI)
Biochemical Markers
Item
Biochemischer Marker
string
C0206015 (UMLS CUI)
Marker
Item
Marker, Biomarker
string
C0005516 (UMLS CUI)
Radiographic
Item
Radiographisch
string
C0444708 (UMLS CUI)
258106000 (SNOMED CT 2010_0731)
Basal cell carcinoma
Item
Basalzellenkarzinom
string
C0007117 (UMLS CUI)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
Squamous cell carcinoma
Item
Plattenepithelkarzinom
string
C0007137 (UMLS CUI)
28899001 (SNOMED CT 2010_0731)
10041823 (MedDRA 13.1)
In situ cancer
Item
In situ cancer
string
C0851135 (UMLS CUI)
10021570 (MedDRA 13.1)
Clinical
Item
klinisch
string
C0205210 (UMLS CUI)
58147004 (SNOMED CT 2010_0731)
Transformation
Item
Transformation
string
C1510411 (UMLS CUI)
Indolent NHL
Item
Indolent Non-Hodgkin Lymphoma
string
C1334170 (UMLS CUI)
Aggressive NHL
Item
Aggressive Non-Hodgkin Lymphoma
string
C0852469 (UMLS CUI)
10029608 (MedDRA 13.1)
Bortezomib
Item
Velcade
string
C1176309 (UMLS CUI)
407097007 (SNOMED CT 2010_0731)
antineoplastic Immunotherapy
Item
Immunotherapy, antineoplastic
string
C0864561 (UMLS CUI)
Antibodies
Item
Antikörper
string
C0003241 (UMLS CUI)
68498002 (SNOMED CT 2010_0731)
MTHU003502 (LOINC Version 232)
Unconjugated
Item
nicht konjugiert
string
C0522530 (UMLS CUI)
103396006 (SNOMED CT 2010_0731)
Antibody Therapy
Item
Antikörpertherapie
string
C0281176 (UMLS CUI)
THER (HL7 V3 02-34)
Experimental Therapies
Item
Therapies, Investigational
string
C0949266 (UMLS CUI)
radiotherapy
Item
Radiotherapie, Strahlentherapie
string
C0034619 (UMLS CUI)
Nitrosoureas
Item
Nitroharnstoff
string
C0028210 (UMLS CUI)
372610009 (SNOMED CT 2010_0731)
Radioimmunoconjugate
Item
Radioimmunoconjugate
string
C0243019 (UMLS CUI)
Immunoconjugates
Item
Immunoconjugates
string
C0243020 (UMLS CUI)
Toxin
Item
Toxin
string
C0040549 (UMLS CUI)
80917008 (SNOMED CT 2010_0731)
Stem cell transplant
Item
stem cell transplantation
string
C1504389 (UMLS CUI)
10063581 (MedDRA 13.1)
surgery
Item
operative procedures
string
C0038895 (UMLS CUI)
Major
Item
Major (qualifier value)
string
C0205164 (UMLS CUI)
255603008 (SNOMED CT 2010_0731)
Residual
Item
Residual
string
C1609982 (UMLS CUI)
65320000 (SNOMED CT 2010_0731)
Toxic
Item
Toxisch
string
CL034921 (UMLS CUI)
poisonous effects
Item
poisonous effects
string
C0243147 (UMLS CUI)
Previous
Item
Previous (qualifier value)
string
C0205156 (UMLS CUI)
9130008 (SNOMED CT 2010_0731)
Grade 3
Item
Grade 3
string
C0450094 (UMLS CUI)
Peripheral Neuropathy
Item
Disorders of the peripheral nervous system
string
C0031117 (UMLS CUI)
10029331 (MedDRA 13.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
Neuropathic Pain
Item
Neuropathic Pain
string
CL428997 (UMLS CUI)
Grade 2
Item
Grade 2
string
C1522446 (UMLS CUI)
Investigational Drug
Item
Investigational New Drug
string
C0013230 (UMLS CUI)
Investigational Device
Item
Investigational Medical Device
string
C2346570 (UMLS CUI)
Allergic Reaction
Item
allergische Reaktion
string
C1527304 (UMLS CUI)
421668005 (SNOMED CT 2010_0731)
10001718 (MedDRA 13.1)
T78.40 (ICD-10-CM Version 2010)
Boron
Item
Bor
string
C0006030 (UMLS CUI)
70597009 (SNOMED CT 2010_0731)
MTHU014128 (LOINC Version 232)
Mannitol
Item
Mannitol
string
C0024730 (UMLS CUI)
387168006 (SNOMED CT 2010_0731)
MTHU015736 (LOINC Version 232)
anaphylaxis
Item
Anaphylaxie, anaphylaktischer Schock
string
C0002792 (UMLS CUI)
39579001 (SNOMED CT 2010_0731)
10002199 (MedDRA 13.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE Version 4.03)
Immediate hypersensitivity
Item
IgE-mediated hypersensitivity disorder
string
C0020523 (UMLS CUI)
422076005 (SNOMED CT 2010_0731)
10021413 (MedDRA 13.1)
Mus
Item
Murine
string
C0026809 (UMLS CUI)
447482001 (SNOMED CT 2010_0731)
Proteins
Item
Protein, Eiweiß
string
C0033684 (UMLS CUI)
88878007 (SNOMED CT 2010_0731)
MTHU001951 (LOINC Version 232)
Polysorbate 80
Item
Polyoxethylenesorbitan oleate
string
C0032601 (UMLS CUI)
255899003 (SNOMED CT 2010_0731)
sodium citrate dihydrate
Item
sodium citrate dihydrate
string
C0724696 (UMLS CUI)
concurrent therapy
Item
kombinierte Therapie
string
C0009429 (UMLS CUI)
Investigational Drug
Item
Investigational New Drug, Experimental Drug
string
C0013230 (UMLS CUI)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
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