ID

43415

Description

A Controlled Randomized Double-blind Multi-center Phase II Study of FOLFOX6 or FOLFIRI Combined With Sorafenib Versus Placebo in Second-line Metastatic Colorectal Carcinoma NCT00889343 ODM derived from http://clinicaltrials.gov/show/NCT00889343

Link

http://clinicaltrials.gov/show/NCT00889343

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/29/15 9/29/15 - Martin Dugas
  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 Metastatic Colorectal Carcinoma FOLFOX6 or FOLFIRI Combined With Sorafenib NCT00889343

German English

Eligibility Metastatic Colorectal Carcinoma FOLFOX6 or FOLFIRI Combined With Sorafenib NCT00889343

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
ECOG Performance Status of 0 to 2
Description

ECOG Performance Status of 0 to 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
Life expectancy of at least 12 weeks.
Description

Life expectancy of at least 12 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
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.
Description

At least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy

Data type

boolean

Alias
SNOMED CT 2011_0131
49755003
MedDRA 14.1
10011603
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
MedDRA 14.1
10052358
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
SNOMED CT 2011_0131
150415003
SNOMED CT 2011_0131
409406007
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2045825
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Description

Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
Hemoglobin
Description

Hemoglobin > 9.0 g/dl

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
Absolute Neutrophil Count, ANC
Description

Absolute neutrophil count (ANC) >1,500/mm3

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal
Description

Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
Description

ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0441932
SNOMED CT 2011_0131
258322007
Alkaline phosphatase < 4 x upper limit of normal
Description

Alkaline phosphatase < 4 x upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C1519815
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.]
Description

PT-INR/PTT < 1.5 x ULN

Data type

boolean

Alias
SNOMED CT 2011_0131
42525009
MedDRA 14.1
10000630
SNOMED CT 2011_0131
182764009
MedDRA 14.1
10053468
SNOMED CT 2011_0131
372877000
LOINC Version 232
MTHU003766
UMLS CUI [1,1]
C0525032
UMLS CUI [1,2]
C0030605
UMLS CUI [1,3]
C1519815
Serum creatinine < 1.5 x upper limit of normal
Description

Serum creatinine < 1.5 x upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
Signed and dated informed consent before the start of specific protocol procedures
Description

Signed and dated informed consent before the start of specific protocol procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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
Description

History of cardiac disease

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
SNOMED CT 2011_0131
67507000
MedDRA 14.1
10066860
UMLS CUI [1]
C0559157
History of HIV infection or chronic hepatitis B or C
Description

History of HIV infection or chronic hepatitis B or C

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
SNOMED CT 2011_0131
61977001
MedDRA 14.1
10008910
ICD-10-CM Version 2010
B18.1
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019693
UMLS CUI [1,3]
C0524909
UMLS CUI [1,4]
C0524910
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
Description

Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1560948
CTCAE 1105E
MTHU114619
UMLS CUI 2011AA
C1560949
CTCAE 1105E
MTHU115603
UMLS CUI 2011AA
C1560950
CTCAE 1105E
MTHU116429
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)
Description

Symptomatic metastatic brain or meningeal tumors

Data type

boolean

Alias
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
SNOMED CT 2011_0131
126952004
MedDRA 14.1
10061019
ICD-9-CM Version 2011
239.6
UMLS CUI [1,1]
C0036525
UMLS CUI [1,2]
C0006118
UMLS CUI [1,3]
C1334722
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Description

Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)

Data type

boolean

Alias
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
History of organ allograft
Description

History of organ allograft

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
LOINC Version 232
MTHU020170
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0029216
Bleeding tendency, Bleeding Disorders
Description

Patients with evidence or history of bleeding diathesis

Data type

boolean

Alias
UMLS CUI 2011AA
C0005779
Kidney dialysis
Description

Patients undergoing renal dialysis

Data type

boolean

Alias
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
265764009
MedDRA 14.1
10049051
Dihydropyrimidine Dehydrogenase Deficiency
Description

Known deficit in Dihydropyrimidine Deshydrogenase (DPD)

Data type

boolean

Alias
UMLS CUI 2011AA
C1959620
SNOMED CT 2011_0131
77365006
MedDRA 14.1
10052622
Contraindications for the use of atropine in patients receiving FOLFIRI
Description

Contraindications for the use of atropine in patients receiving FOLFIRI

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0004259
SNOMED CT 2011_0131
73949004
LOINC Version 232
MTHU002117
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1880658
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.
Description

Previous or concurrent cancer

Data type

boolean

Alias
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
HL7 V3 2006_05
E
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
SNOMED CT 2011_0131
425231005
SNOMED CT 2011_0131
261663004
SNOMED CT 2011_0131
44401000
SNOMED CT 2011_0131
23351008
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0006826
Peripheral sensory neuropathy > CTC grade 2
Description

Peripheral sensory neuropathy > CTC grade 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0151313
SNOMED CT 2011_0131
95662005
MedDRA 14.1
10034620
CTCAE 1105E
E12768
UMLS CUI 2011AA
C1557260
CTCAE 1105E
MTHU114803
UMLS CUI 2011AA
C1557261
CTCAE 1105E
MTHU115776
UMLS CUI 2011AA
C1557262
CTCAE 1105E
MTHU116556
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
Description

Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance

Data type

boolean

Alias
UMLS CUI 2011AA
C1856359
UMLS CUI 2011AA
C1258215
SNOMED CT 2011_0131
81060008
MedDRA 14.1
10021328
CTCAE 1105E
E10812
UMLS CUI 2011AA
C0016751
SNOMED CT 2011_0131
20052008
MedDRA 14.1
10019878
ICD-10-CM Version 2010
E74.12
ICD-9-CM Version 2011
271.2
Pregnant or breast-feeding patients.
Description

Pregnant or breast-feeding patients.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
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.
Description

No pregnancy

Data type

boolean

Alias
SNOMED CT 2011_0131
224526002
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
SNOMED CT 2011_0131
224526002
SNOMED CT 2011_0131
339947000
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
MedDRA 14.1
10062577
SNOMED CT 2011_0131
268464009
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
SNOMED CT 2011_0131
268457007
UMLS CUI [1]
C0232973
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Description

Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Data type

boolean

Alias
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C2348568
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0683954
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Description

Unstable condition

Data type

boolean

Alias
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
SNOMED CT 2011_0131
263922001
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
SNOMED CT 2011_0131
45704003
SNOMED CT 2011_0131
110465008
UMLS CUI [1]
C0443343
Patients unable to swallow oral medications.
Description

Patients unable to swallow oral medications.

Data type

boolean

Alias
UMLS CUI 2011AA
C0221470
SNOMED CT 2011_0131
249486008
MedDRA 14.1
10049866
ICD-10-CM Version 2010
R13.0
UMLS CUI 2011AA
C0304289
SNOMED CT 2011_0131
40461009
Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
Description

Other anticancer chemotherapy or immunotherapy past 4 weeks

Data type

boolean

Alias
SNOMED CT 2011_0131
74964007
SNOMED CT 2011_0131
150415003
SNOMED CT 2011_0131
146638005
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0021083
UMLS CUI [1,3]
C3828653
Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
Description

Radiotherapy past 3 weeks

Data type

boolean

Alias
SNOMED CT 2011_0131
75554001
UMLS CUI [1]
C0034619
major surgery
Description

Major surgery within 4 weeks of start of study

Data type

boolean

Alias
UMLS CUI 2011AA
C0679637
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
Description

Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0194037
SNOMED CT 2011_0131
58776007
UMLS CUI 2011AA
C2825926
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]
Description

Use of biologic response modifiers, such as G-CSF, within 3 week of study entry

Data type

boolean

Alias
SNOMED CT 2011_0131
260676000
SNOMED CT 2011_0131
80572003
LOINC Version 232
MTHU031847
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0005525
UMLS CUI [1,3]
C0079459
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Description

Other trial

Data type

boolean

Alias
SNOMED CT 2011_0131
52101004
SNOMED CT 2011_0131
110465008
UMLS CUI [1]
C2348568
Prior exposure to the study drug.
Description

Prior exposure to the study drug.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Any St. John´s wort containing remedy
Description

Any St. John´s wort containing remedy

Data type

boolean

Alias
UMLS CUI 2011AA
C0936242
SNOMED CT 2011_0131
51621002
UMLS CUI 2011AA
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
C0013227
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Similar models

Eligibility Metastatic Colorectal Carcinoma FOLFOX6 or FOLFIRI Combined With Sorafenib NCT00889343

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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)
C0009450 (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
C0011946 (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)
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