age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
ECOG Performance Status of 0 to 2
Item
ECOG Performance Status of 0 to 2
boolean
C1520224 (UMLS CUI 2011AA)
Life expectancy of at least 12 weeks.
Item
Life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI 2011AA)
At least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy
Item
Subjects with at least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently. Lesions must be measured by CT-scan or MRI.
boolean
49755003 (SNOMED CT 2011_0131)
10011603 (MedDRA 14.1)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
10052358 (MedDRA 14.1)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
150415003 (SNOMED CT 2011_0131)
409406007 (SNOMED CT 2011_0131)
C1513041 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2045825 (UMLS CUI [1,3])
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Item
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
Hemoglobin > 9.0 g/dl
Item
Hemoglobin
boolean
C0518015 (UMLS CUI 2011AA)
Absolute neutrophil count (ANC) >1,500/mm3
Item
Absolute Neutrophil Count, ANC
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal
Item
Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
Item
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0441932 (UMLS CUI 2011AA)
258322007 (SNOMED CT 2011_0131)
Alkaline phosphatase < 4 x upper limit of normal
Item
Alkaline phosphatase < 4 x upper limit of normal
boolean
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
PT-INR/PTT < 1.5 x ULN
Item
PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
boolean
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
182764009 (SNOMED CT 2011_0131)
10053468 (MedDRA 14.1)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C0525032 (UMLS CUI [1,1])
C0030605 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
Serum creatinine < 1.5 x upper limit of normal
Item
Serum creatinine < 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI 2011AA)
Signed and dated informed consent before the start of specific protocol procedures
Item
Signed and dated informed consent before the start of specific protocol procedures
boolean
C0021430 (UMLS CUI 2011AA)
History of cardiac disease
Item
History of cardiac disease: congestive heart failure >NYHA class 2. Active CAD (MI more than 6 mo prior to study entry is allowed). Cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
boolean
392521001 (SNOMED CT 2011_0131)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
67507000 (SNOMED CT 2011_0131)
10066860 (MedDRA 14.1)
C0559157 (UMLS CUI [1])
History of HIV infection or chronic hepatitis B or C
Item
History of HIV infection or chronic hepatitis B or C
boolean
392521001 (SNOMED CT 2011_0131)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
61977001 (SNOMED CT 2011_0131)
10008910 (MedDRA 14.1)
B18.1 (ICD-10-CM Version 2010)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
C0262926 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
C0524910 (UMLS CUI [1,4])
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
Item
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1560948 (UMLS CUI 2011AA)
MTHU114619 (CTCAE 1105E)
C1560949 (UMLS CUI 2011AA)
MTHU115603 (CTCAE 1105E)
C1560950 (UMLS CUI 2011AA)
MTHU116429 (CTCAE 1105E)
Symptomatic metastatic brain or meningeal tumors
Item
Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
boolean
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
126952004 (SNOMED CT 2011_0131)
10061019 (MedDRA 14.1)
239.6 (ICD-9-CM Version 2011)
C0036525 (UMLS CUI [1,1])
C0006118 (UMLS CUI [1,2])
C1334722 (UMLS CUI [1,3])
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Item
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
boolean
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
History of organ allograft
Item
History of organ allograft
boolean
392521001 (SNOMED CT 2011_0131)
MTHU020170 (LOINC Version 232)
C0262926 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
Patients with evidence or history of bleeding diathesis
Item
Bleeding tendency, Bleeding Disorders
boolean
C0005779 (UMLS CUI 2011AA)
Patients undergoing renal dialysis
Item
Kidney dialysis
boolean
C0917873 (UMLS CUI 2011AA)
265764009 (SNOMED CT 2011_0131)
10049051 (MedDRA 14.1)
Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
Item
Dihydropyrimidine Dehydrogenase Deficiency
boolean
C1959620 (UMLS CUI 2011AA)
77365006 (SNOMED CT 2011_0131)
10052622 (MedDRA 14.1)
Contraindications for the use of atropine in patients receiving FOLFIRI
Item
Contraindications for the use of atropine in patients receiving FOLFIRI
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0004259 (UMLS CUI 2011AA)
73949004 (SNOMED CT 2011_0131)
MTHU002117 (LOINC Version 232)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1880658 (UMLS CUI 2011AA)
Previous or concurrent cancer
Item
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
boolean
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
E (HL7 V3 2006_05)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
425231005 (SNOMED CT 2011_0131)
261663004 (SNOMED CT 2011_0131)
44401000 (SNOMED CT 2011_0131)
23351008 (SNOMED CT 2011_0131)
C0205420 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Peripheral sensory neuropathy > CTC grade 2
Item
Peripheral sensory neuropathy > CTC grade 2
boolean
C0151313 (UMLS CUI 2011AA)
95662005 (SNOMED CT 2011_0131)
10034620 (MedDRA 14.1)
E12768 (CTCAE 1105E)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
Item
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
boolean
C1856359 (UMLS CUI 2011AA)
C1258215 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10021328 (MedDRA 14.1)
E10812 (CTCAE 1105E)
C0016751 (UMLS CUI 2011AA)
20052008 (SNOMED CT 2011_0131)
10019878 (MedDRA 14.1)
E74.12 (ICD-10-CM Version 2010)
271.2 (ICD-9-CM Version 2011)
Pregnant or breast-feeding patients.
Item
Pregnant or breast-feeding patients.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
No pregnancy
Item
Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.
boolean
224526002 (SNOMED CT 2011_0131)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
224526002 (SNOMED CT 2011_0131)
339947000 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
10062577 (MedDRA 14.1)
268464009 (SNOMED CT 2011_0131)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
268457007 (SNOMED CT 2011_0131)
C0232973 (UMLS CUI [1])
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Item
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C0683954 (UMLS CUI 2011AA)
Unstable condition
Item
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
boolean
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
263922001 (SNOMED CT 2011_0131)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
45704003 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI [1])
Patients unable to swallow oral medications.
Item
Patients unable to swallow oral medications.
boolean
C0221470 (UMLS CUI 2011AA)
249486008 (SNOMED CT 2011_0131)
10049866 (MedDRA 14.1)
R13.0 (ICD-10-CM Version 2010)
C0304289 (UMLS CUI 2011AA)
40461009 (SNOMED CT 2011_0131)
Other anticancer chemotherapy or immunotherapy past 4 weeks
Item
Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
boolean
74964007 (SNOMED CT 2011_0131)
150415003 (SNOMED CT 2011_0131)
146638005 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI [1,1])
C0021083 (UMLS CUI [1,2])
C3828653 (UMLS CUI [1,3])
Radiotherapy past 3 weeks
Item
Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
boolean
75554001 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI [1])
Major surgery within 4 weeks of start of study
Item
major surgery
boolean
C0679637 (UMLS CUI 2011AA)
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
Item
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
boolean
C0194037 (UMLS CUI 2011AA)
58776007 (SNOMED CT 2011_0131)
C2825926 (UMLS CUI 2011AA)
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry
Item
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
boolean
260676000 (SNOMED CT 2011_0131)
80572003 (SNOMED CT 2011_0131)
MTHU031847 (LOINC Version 232)
C1524063 (UMLS CUI [1,1])
C0005525 (UMLS CUI [1,2])
C0079459 (UMLS CUI [1,3])
Other trial
Item
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
boolean
52101004 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI [1])
Prior exposure to the study drug.
Item
Prior exposure to the study drug.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Any St. John´s wort containing remedy
Item
Any St. John´s wort containing remedy
boolean
C0936242 (UMLS CUI 2011AA)
51621002 (SNOMED CT 2011_0131)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)