0 Ratings
ID

44056

Description

ODM derived from http://clinicaltrials.gov/show/NCT00932724

Link

http://clinicaltrials.gov/show/NCT00932724

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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Creative Commons BY 4.0
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    Eligibility NCT00932724 Metastatic Colorectal Cancer

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age at least 18 Years
    Description

    age at least 18 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or with 3 months after termination of standard chemotherapy (fluoropyrimidine-based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 1nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.
    Description

    Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or with 3 months after termination of standard chemotherapy (fluoropyrimidine-based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 1nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C1513040
    UMLS CUI 2011AA
    C0948380
    MedDRA 14.1
    10052358
    UMLS CUI 2011AA
    C1405978
    UMLS CUI 2011AA
    C0242656
    SNOMED CT 2011_0131
    246453008
    MedDRA 14.1
    10061818
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0596581
    UMLS CUI 2011AA
    C0796324
    UMLS CUI 2011AA
    C1710384
    MedDRA 14.1
    10066377
    UMLS CUI 2011AA
    CL415164
    HL7 V3 2006_05
    OINT
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    CL031856
    UMLS CUI 2011AA
    C0796392
    SNOMED CT 2011_0131
    409406007
    UMLS CUI 2011AA
    C1537502
    UMLS CUI 2011AA
    C0678926
    UMLS CUI 2011AA
    C0995188
    SNOMED CT 2011_0131
    409400001
    UMLS CUI 2011AA
    C0879427
    SNOMED CT 2011_0131
    424401006
    No chemotherapy within 4 weeks before treatment start
    Description

    No chemotherapy within 4 weeks before treatment start

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C3173309
    SNOMED CT 2011_0131
    413946009
    No residual significant toxicity (> NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC grade 4 within 4 weeks before treatment start.
    Description

    No residual significant toxicity (> NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC grade 4 within 4 weeks before treatment start.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C0040539
    UMLS CUI 2011AA
    C1513882
    UMLS CUI 2011AA
    C2826262
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0750557
    UMLS CUI 2011AA
    C0031117
    MedDRA 14.1
    10029331
    ICD-10-CM Version 2010
    G64
    ICD-9-CM Version 2011
    350-359.99
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C1557261
    CTCAE 1105E
    MTHU115776
    UMLS CUI 2011AA
    C1557256
    CTCAE 1105E
    MTHU115527
    No previous treatment with experimental therapies after standard therapies is allowed.
    Description

    No previous treatment with experimental therapies after standard therapies is allowed.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0949266
    Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating
    Description

    Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0035150
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C0027552
    SNOMED CT 2011_0131
    410525008
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0232973
    SNOMED CT 2011_0131
    60001007
    UMLS CUI 2011AA
    C2826207
    Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2
    Description

    Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1520224
    WBC >= 3,000/mm3, absolute neutrophil count (ANC) >= 1,500/mm3, platelet count >=100,000/mm3
    Description

    WBC >= 3,000/mm3, absolute neutrophil count (ANC) >= 1,500/mm3, platelet count >=100,000/mm3

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0023508
    SNOMED CT 2011_0131
    767002
    MedDRA 14.1
    10047939
    UMLS CUI 2011AA
    C0948762
    MedDRA 14.1
    10052033
    UMLS CUI 2011AA
    C1287267
    SNOMED CT 2011_0131
    365632008
    LOINC Version 232
    777-3
    Bilirubin <= 2.0 mg/dL (40 micromol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be <=3.5 mg/dL (59.86 micromol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) <= 5 x upper limit of normal (ULN). Hepatic alkaline phosphatase <= 3.0 x ULN (in case of liver metastases higher levels do not hinder inclusion of patients)
    Description

    Bilirubin <= 2.0 mg/dL (40 micromol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be <=3.5 mg/dL (59.86 micromol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) <= 5 x upper limit of normal (ULN). Hepatic alkaline phosphatase <= 3.0 x ULN (in case of liver metastases higher levels do not hinder inclusion of patients)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011221
    SNOMED CT 2011_0131
    79706000
    LOINC Version 232
    1975-2
    UMLS CUI 2011AA
    C0017551
    SNOMED CT 2011_0131
    27503000
    MedDRA 14.1
    10018267
    ICD-10-CM Version 2010
    E80.4
    UMLS CUI 2011AA
    C0004002
    SNOMED CT 2011_0131
    26091008
    LOINC Version 232
    MTHU004883
    UMLS CUI 2011AA
    C0001899
    SNOMED CT 2011_0131
    56935002
    LOINC Version 232
    MTHU006766
    UMLS CUI 2011AA
    C1519815
    UMLS CUI 2011AA
    C0855470
    MedDRA 14.1
    10005308
    Serum creatinine <= 2.0 mg/dL (180 micromol/L)or creatinine clearance >= 50 ml/min. , proteinuria < 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein
    Description

    Serum creatinine <= 2.0 mg/dL (180 micromol/L)or creatinine clearance >= 50 ml/min. , proteinuria < 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0201976
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    UMLS CUI 2011AA
    C0373595
    SNOMED CT 2011_0131
    167181009
    MedDRA 14.1
    10011371
    UMLS CUI 2011AA
    C0033687
    SNOMED CT 2011_0131
    29738008
    MedDRA 14.1
    10037032
    ICD-10-CM Version 2010
    R80
    ICD-9-CM Version 2011
    791.0
    CTCAE 1105E
    E13008
    UMLS CUI 2011AA
    C0456209
    SNOMED CT 2011_0131
    276833005
    UMLS CUI 2011AA
    C0430371
    SNOMED CT 2011_0131
    271346009
    UMLS CUI 2011AA
    CL415097
    Written informed consent according to ICH-GCP and national laws and regulations prior to receipt of any trial medication or beginning trial procedures
    Description

    Written informed consent according to ICH-GCP and national laws and regulations prior to receipt of any trial medication or beginning trial procedures

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Evidence of any other malignant disease (with the exception of tumors operatively cured >= 5 years prior to the trial)
    Description

    Evidence of any other malignant disease (with the exception of tumors operatively cured >= 5 years prior to the trial)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0543467
    SNOMED CT 2011_0131
    83578000
    MedDRA 14.1
    10051332
    LOINC Version 232
    MTHU000079
    UMLS CUI 2011AA
    C1880198
    Brain metastases
    Description

    Known brain metastases

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0220650
    MedDRA 14.1
    10006128
    Uncontrolled pleural effusions
    Description

    Uncontrolled pleural effusions

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205318
    SNOMED CT 2011_0131
    19032002
    UMLS CUI 2011AA
    C0032227
    SNOMED CT 2011_0131
    60046008
    MedDRA 14.1
    10035598
    ICD-10-CM Version 2010
    J90
    ICD-9-CM Version 2011
    511.9
    CTCAE 1105E
    E13486
    Interstitial pneumonitis or pulmonary fibrosis
    Description

    Interstitial pneumonitis or pulmonary fibrosis

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0206061
    SNOMED CT 2011_0131
    64667001
    MedDRA 14.1
    10022618
    ICD-10-CM Version 2010
    J84.9
    UMLS CUI 2011AA
    C0034069
    SNOMED CT 2011_0131
    51615001
    MedDRA 14.1
    10037383
    ICD-10-CM Version 2010
    J84.1
    CTCAE 1105E
    E13527
    Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g., alcoholism or substance abuse)
    Description

    Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g., alcoholism or substance abuse)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0443343
    SNOMED CT 2011_0131
    263922001
    UMLS CUI 2011AA
    C0442893
    SNOMED CT 2011_0131
    56019007, 264578000
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    257551009
    MedDRA 14.1
    10021789
    UMLS CUI 2011AA
    C0683578
    UMLS CUI 2011AA
    C1554075
    HL7 V3 2006_05
    NP
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0001973
    SNOMED CT 2011_0131
    284591009
    MedDRA 14.1
    10001639
    ICD-10-CM Version 2010
    F10.2
    ICD-9-CM Version 2011
    305.01
    UMLS CUI 2011AA
    C0740858
    SNOMED CT 2011_0131
    66214007
    MedDRA 14.1
    10066169
    LOINC Version 232
    MTHU019364
    Unstable cardiac disease in the last 6 months
    Description

    Unstable cardiac disease in the last 6 months

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0443343
    SNOMED CT 2011_0131
    263922001
    UMLS CUI 2011AA
    C0018799
    SNOMED CT 2011_0131
    56265001
    MedDRA 14.1
    10061024
    Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial - ongoing therapy with steroids is permitted if the dose is not > 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial
    Description

    Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial - ongoing therapy with steroids is permitted if the dose is not > 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C1166209
    UMLS CUI 2011AA
    CL414476
    UMLS CUI 2011AA
    C0003250
    SNOMED CT 2011_0131
    49616005
    UMLS CUI 2011AA
    C0521104
    SNOMED CT 2011_0131
    75554001
    UMLS CUI 2011AA
    C1708745
    UMLS CUI 2011AA
    C0149783
    SNOMED CT 2011_0131
    297279009
    MedDRA 14.1
    10062117
    Any evidence or history (elicited by the investigator) of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization
    Description

    Any evidence or history (elicited by the investigator) of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0231220
    SNOMED CT 2011_0131
    264931009
    UMLS CUI 2011AA
    C1880018
    UMLS CUI 2011AA
    C0441471
    SNOMED CT 2011_0131
    272379006
    LOINC Version 232
    MTHU019184
    UMLS CUI 2011AA
    C0038454
    SNOMED CT 2011_0131
    230690007
    MedDRA 14.1
    10042244
    ICD-10-CM Version 2010
    I63.9
    CTCAE 1105E
    E12826
    UMLS CUI 2011AA
    C0007787
    SNOMED CT 2011_0131
    266257000
    MedDRA 14.1
    10044390
    LOINC Version 232
    MTHU020810
    ICD-10-CM Version 2010
    G45.9
    ICD-9-CM Version 2011
    435.9
    CTCAE 1105E
    E12834
    Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)
    Description

    Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0034065
    SNOMED CT 2011_0131
    59282003
    MedDRA 14.1
    10037377
    ICD-10-CM Version 2010
    I26
    ICD-9-CM Version 2011
    415.1
    UMLS CUI 2011AA
    C0040046
    SNOMED CT 2011_0131
    64156001
    MedDRA 14.1
    10043570
    UMLS CUI 2011AA
    C0149871
    SNOMED CT 2011_0131
    128053003
    MedDRA 14.1
    10051055
    ICD-10-CM Version 2010
    I82.40
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0150457
    SNOMED CT 2011_0131
    182764009
    MedDRA 14.1
    10053468
    UMLS CUI 2011AA
    C0918269
    UMLS CUI 2011AA
    C0019134
    SNOMED CT 2011_0131
    372877000
    LOINC Version 232
    MTHU003766
    History of hypersensitivity to mistletoe
    Description

    History of hypersensitivity to mistletoe

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0042785
    SNOMED CT 2011_0131
    43601004
    History of primary immunodeficiency
    Description

    History of primary immunodeficiency

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0398686
    SNOMED CT 2011_0131
    58606001
    MedDRA 14.1
    10064859
    Known human immunodeficiency virus (HIV) or known active viral hepatic infections
    Description

    Known human immunodeficiency virus (HIV) or known active viral hepatic infections

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0019682
    SNOMED CT 2011_0131
    19030005
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0042721
    SNOMED CT 2011_0131
    3738000
    MedDRA 14.1
    10019799
    LOINC Version 232
    MTHU020837
    ICD-10-CM Version 2010
    B19
    ICD-9-CM Version 2011
    070
    CTCAE 1105E
    E11410
    Prior treatment with CY-503
    Description

    Prior treatment with CY-503

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C0013230
    A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent
    Description

    A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1699700
    HL7 V3 2006_05
    MEDCCAT
    UMLS CUI 2011AA
    C0423895
    SNOMED CT 2011_0131
    247571009
    UMLS CUI 2011AA
    C0038580
    SNOMED CT 2011_0131
    2403008
    UMLS CUI 2011AA
    C0740858
    SNOMED CT 2011_0131
    66214007
    MedDRA 14.1
    10066169
    LOINC Version 232
    MTHU019364
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1299582
    SNOMED CT 2011_0131
    371151008
    UMLS CUI 2011AA
    C1554962
    HL7 V3 2006_05
    C
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1519316
    UMLS CUI 2011AA
    C0021430
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    age at least 18 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or with 3 months after termination of standard chemotherapy (fluoropyrimidine-based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 1nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.
    Item
    Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or with 3 months after termination of standard chemotherapy (fluoropyrimidine-based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 1nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.
    boolean
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C1513040 (UMLS CUI 2011AA)
    C0948380 (UMLS CUI 2011AA)
    10052358 (MedDRA 14.1)
    C1405978 (UMLS CUI 2011AA)
    C0242656 (UMLS CUI 2011AA)
    246453008 (SNOMED CT 2011_0131)
    10061818 (MedDRA 14.1)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0596581 (UMLS CUI 2011AA)
    C0796324 (UMLS CUI 2011AA)
    C1710384 (UMLS CUI 2011AA)
    10066377 (MedDRA 14.1)
    CL415164 (UMLS CUI 2011AA)
    OINT (HL7 V3 2006_05)
    C0205269 (UMLS CUI 2011AA)
    20646008 (SNOMED CT 2011_0131)
    CL031856 (UMLS CUI 2011AA)
    C0796392 (UMLS CUI 2011AA)
    409406007 (SNOMED CT 2011_0131)
    C1537502 (UMLS CUI 2011AA)
    C0678926 (UMLS CUI 2011AA)
    C0995188 (UMLS CUI 2011AA)
    409400001 (SNOMED CT 2011_0131)
    C0879427 (UMLS CUI 2011AA)
    424401006 (SNOMED CT 2011_0131)
    No chemotherapy within 4 weeks before treatment start
    Item
    No chemotherapy within 4 weeks before treatment start
    boolean
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C3173309 (UMLS CUI 2011AA)
    413946009 (SNOMED CT 2011_0131)
    No residual significant toxicity (> NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC grade 4 within 4 weeks before treatment start.
    Item
    No residual significant toxicity (> NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC grade 4 within 4 weeks before treatment start.
    boolean
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C0040539 (UMLS CUI 2011AA)
    C1513882 (UMLS CUI 2011AA)
    C2826262 (UMLS CUI 2011AA)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0750557 (UMLS CUI 2011AA)
    C0031117 (UMLS CUI 2011AA)
    10029331 (MedDRA 14.1)
    G64 (ICD-10-CM Version 2010)
    350-359.99 (ICD-9-CM Version 2011)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C1557261 (UMLS CUI 2011AA)
    MTHU115776 (CTCAE 1105E)
    C1557256 (UMLS CUI 2011AA)
    MTHU115527 (CTCAE 1105E)
    No previous treatment with experimental therapies after standard therapies is allowed.
    Item
    No previous treatment with experimental therapies after standard therapies is allowed.
    boolean
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C1514463 (UMLS CUI 2011AA)
    C0949266 (UMLS CUI 2011AA)
    Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating
    Item
    Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating
    boolean
    C0035150 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C0027552 (UMLS CUI 2011AA)
    410525008 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0232973 (UMLS CUI 2011AA)
    60001007 (SNOMED CT 2011_0131)
    C2826207 (UMLS CUI 2011AA)
    Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2
    Item
    Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2
    boolean
    C1520224 (UMLS CUI 2011AA)
    WBC >= 3,000/mm3, absolute neutrophil count (ANC) >= 1,500/mm3, platelet count >=100,000/mm3
    Item
    WBC >= 3,000/mm3, absolute neutrophil count (ANC) >= 1,500/mm3, platelet count >=100,000/mm3
    boolean
    C0023508 (UMLS CUI 2011AA)
    767002 (SNOMED CT 2011_0131)
    10047939 (MedDRA 14.1)
    C0948762 (UMLS CUI 2011AA)
    10052033 (MedDRA 14.1)
    C1287267 (UMLS CUI 2011AA)
    365632008 (SNOMED CT 2011_0131)
    777-3 (LOINC Version 232)
    Bilirubin <= 2.0 mg/dL (40 micromol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be <=3.5 mg/dL (59.86 micromol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) <= 5 x upper limit of normal (ULN). Hepatic alkaline phosphatase <= 3.0 x ULN (in case of liver metastases higher levels do not hinder inclusion of patients)
    Item
    Bilirubin <= 2.0 mg/dL (40 micromol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be <=3.5 mg/dL (59.86 micromol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) <= 5 x upper limit of normal (ULN). Hepatic alkaline phosphatase <= 3.0 x ULN (in case of liver metastases higher levels do not hinder inclusion of patients)
    boolean
    C0011221 (UMLS CUI 2011AA)
    79706000 (SNOMED CT 2011_0131)
    1975-2 (LOINC Version 232)
    C0017551 (UMLS CUI 2011AA)
    27503000 (SNOMED CT 2011_0131)
    10018267 (MedDRA 14.1)
    E80.4 (ICD-10-CM Version 2010)
    C0004002 (UMLS CUI 2011AA)
    26091008 (SNOMED CT 2011_0131)
    MTHU004883 (LOINC Version 232)
    C0001899 (UMLS CUI 2011AA)
    56935002 (SNOMED CT 2011_0131)
    MTHU006766 (LOINC Version 232)
    C1519815 (UMLS CUI 2011AA)
    C0855470 (UMLS CUI 2011AA)
    10005308 (MedDRA 14.1)
    Serum creatinine <= 2.0 mg/dL (180 micromol/L)or creatinine clearance >= 50 ml/min. , proteinuria < 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein
    Item
    Serum creatinine <= 2.0 mg/dL (180 micromol/L)or creatinine clearance >= 50 ml/min. , proteinuria < 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein
    boolean
    C0201976 (UMLS CUI 2011AA)
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    C0373595 (UMLS CUI 2011AA)
    167181009 (SNOMED CT 2011_0131)
    10011371 (MedDRA 14.1)
    C0033687 (UMLS CUI 2011AA)
    29738008 (SNOMED CT 2011_0131)
    10037032 (MedDRA 14.1)
    R80 (ICD-10-CM Version 2010)
    791.0 (ICD-9-CM Version 2011)
    E13008 (CTCAE 1105E)
    C0456209 (UMLS CUI 2011AA)
    276833005 (SNOMED CT 2011_0131)
    C0430371 (UMLS CUI 2011AA)
    271346009 (SNOMED CT 2011_0131)
    CL415097 (UMLS CUI 2011AA)
    Written informed consent according to ICH-GCP and national laws and regulations prior to receipt of any trial medication or beginning trial procedures
    Item
    Written informed consent according to ICH-GCP and national laws and regulations prior to receipt of any trial medication or beginning trial procedures
    boolean
    C0021430 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    Evidence of any other malignant disease (with the exception of tumors operatively cured >= 5 years prior to the trial)
    Item
    Evidence of any other malignant disease (with the exception of tumors operatively cured >= 5 years prior to the trial)
    boolean
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0543467 (UMLS CUI 2011AA)
    83578000 (SNOMED CT 2011_0131)
    10051332 (MedDRA 14.1)
    MTHU000079 (LOINC Version 232)
    C1880198 (UMLS CUI 2011AA)
    Known brain metastases
    Item
    Brain metastases
    boolean
    C0220650 (UMLS CUI 2011AA)
    10006128 (MedDRA 14.1)
    Uncontrolled pleural effusions
    Item
    Uncontrolled pleural effusions
    boolean
    C0205318 (UMLS CUI 2011AA)
    19032002 (SNOMED CT 2011_0131)
    C0032227 (UMLS CUI 2011AA)
    60046008 (SNOMED CT 2011_0131)
    10035598 (MedDRA 14.1)
    J90 (ICD-10-CM Version 2010)
    511.9 (ICD-9-CM Version 2011)
    E13486 (CTCAE 1105E)
    Interstitial pneumonitis or pulmonary fibrosis
    Item
    Interstitial pneumonitis or pulmonary fibrosis
    boolean
    C0206061 (UMLS CUI 2011AA)
    64667001 (SNOMED CT 2011_0131)
    10022618 (MedDRA 14.1)
    J84.9 (ICD-10-CM Version 2010)
    C0034069 (UMLS CUI 2011AA)
    51615001 (SNOMED CT 2011_0131)
    10037383 (MedDRA 14.1)
    J84.1 (ICD-10-CM Version 2010)
    E13527 (CTCAE 1105E)
    Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g., alcoholism or substance abuse)
    Item
    Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g., alcoholism or substance abuse)
    boolean
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0443343 (UMLS CUI 2011AA)
    263922001 (SNOMED CT 2011_0131)
    C0442893 (UMLS CUI 2011AA)
    56019007, 264578000 (SNOMED CT 2011_0131)
    C0009450 (UMLS CUI 2011AA)
    257551009 (SNOMED CT 2011_0131)
    10021789 (MedDRA 14.1)
    C0683578 (UMLS CUI 2011AA)
    C1554075 (UMLS CUI 2011AA)
    NP (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0001973 (UMLS CUI 2011AA)
    284591009 (SNOMED CT 2011_0131)
    10001639 (MedDRA 14.1)
    F10.2 (ICD-10-CM Version 2010)
    305.01 (ICD-9-CM Version 2011)
    C0740858 (UMLS CUI 2011AA)
    66214007 (SNOMED CT 2011_0131)
    10066169 (MedDRA 14.1)
    MTHU019364 (LOINC Version 232)
    Unstable cardiac disease in the last 6 months
    Item
    Unstable cardiac disease in the last 6 months
    boolean
    C0443343 (UMLS CUI 2011AA)
    263922001 (SNOMED CT 2011_0131)
    C0018799 (UMLS CUI 2011AA)
    56265001 (SNOMED CT 2011_0131)
    10061024 (MedDRA 14.1)
    Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial - ongoing therapy with steroids is permitted if the dose is not > 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial
    Item
    Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial - ongoing therapy with steroids is permitted if the dose is not > 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial
    boolean
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C1166209 (UMLS CUI 2011AA)
    CL414476 (UMLS CUI 2011AA)
    C0003250 (UMLS CUI 2011AA)
    49616005 (SNOMED CT 2011_0131)
    C0521104 (UMLS CUI 2011AA)
    75554001 (SNOMED CT 2011_0131)
    C1708745 (UMLS CUI 2011AA)
    C0149783 (UMLS CUI 2011AA)
    297279009 (SNOMED CT 2011_0131)
    10062117 (MedDRA 14.1)
    Any evidence or history (elicited by the investigator) of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization
    Item
    Any evidence or history (elicited by the investigator) of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization
    boolean
    C0231220 (UMLS CUI 2011AA)
    264931009 (SNOMED CT 2011_0131)
    C1880018 (UMLS CUI 2011AA)
    C0441471 (UMLS CUI 2011AA)
    272379006 (SNOMED CT 2011_0131)
    MTHU019184 (LOINC Version 232)
    C0038454 (UMLS CUI 2011AA)
    230690007 (SNOMED CT 2011_0131)
    10042244 (MedDRA 14.1)
    I63.9 (ICD-10-CM Version 2010)
    E12826 (CTCAE 1105E)
    C0007787 (UMLS CUI 2011AA)
    266257000 (SNOMED CT 2011_0131)
    10044390 (MedDRA 14.1)
    MTHU020810 (LOINC Version 232)
    G45.9 (ICD-10-CM Version 2010)
    435.9 (ICD-9-CM Version 2011)
    E12834 (CTCAE 1105E)
    Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)
    Item
    Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)
    boolean
    C0034065 (UMLS CUI 2011AA)
    59282003 (SNOMED CT 2011_0131)
    10037377 (MedDRA 14.1)
    I26 (ICD-10-CM Version 2010)
    415.1 (ICD-9-CM Version 2011)
    C0040046 (UMLS CUI 2011AA)
    64156001 (SNOMED CT 2011_0131)
    10043570 (MedDRA 14.1)
    C0149871 (UMLS CUI 2011AA)
    128053003 (SNOMED CT 2011_0131)
    10051055 (MedDRA 14.1)
    I82.40 (ICD-10-CM Version 2010)
    C1514873 (UMLS CUI 2011AA)
    C0150457 (UMLS CUI 2011AA)
    182764009 (SNOMED CT 2011_0131)
    10053468 (MedDRA 14.1)
    C0918269 (UMLS CUI 2011AA)
    C0019134 (UMLS CUI 2011AA)
    372877000 (SNOMED CT 2011_0131)
    MTHU003766 (LOINC Version 232)
    History of hypersensitivity to mistletoe
    Item
    History of hypersensitivity to mistletoe
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0042785 (UMLS CUI 2011AA)
    43601004 (SNOMED CT 2011_0131)
    History of primary immunodeficiency
    Item
    History of primary immunodeficiency
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0398686 (UMLS CUI 2011AA)
    58606001 (SNOMED CT 2011_0131)
    10064859 (MedDRA 14.1)
    Known human immunodeficiency virus (HIV) or known active viral hepatic infections
    Item
    Known human immunodeficiency virus (HIV) or known active viral hepatic infections
    boolean
    C0019682 (UMLS CUI 2011AA)
    19030005 (SNOMED CT 2011_0131)
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0042721 (UMLS CUI 2011AA)
    3738000 (SNOMED CT 2011_0131)
    10019799 (MedDRA 14.1)
    MTHU020837 (LOINC Version 232)
    B19 (ICD-10-CM Version 2010)
    070 (ICD-9-CM Version 2011)
    E11410 (CTCAE 1105E)
    Prior treatment with CY-503
    Item
    Prior treatment with CY-503
    boolean
    C1514463 (UMLS CUI 2011AA)
    C0150312 (UMLS CUI 2011AA)
    52101004 (SNOMED CT 2011_0131)
    C0013230 (UMLS CUI 2011AA)
    A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent
    Item
    A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent
    boolean
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C0423895 (UMLS CUI 2011AA)
    247571009 (SNOMED CT 2011_0131)
    C0038580 (UMLS CUI 2011AA)
    2403008 (SNOMED CT 2011_0131)
    C0740858 (UMLS CUI 2011AA)
    66214007 (SNOMED CT 2011_0131)
    10066169 (MedDRA 14.1)
    MTHU019364 (LOINC Version 232)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1299582 (UMLS CUI 2011AA)
    371151008 (SNOMED CT 2011_0131)
    C1554962 (UMLS CUI 2011AA)
    C (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1519316 (UMLS CUI 2011AA)
    C0021430 (UMLS CUI 2011AA)
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