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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License

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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