Chemotherapy Containing Oxaliplatin Completed | Complete excision Colon tumor primary
Item
have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
boolean
C0392920 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0069717 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0015250 (UMLS CUI [2,1])
C0009375 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
Peripheral sensory neuropathy CTCAE Grades
Item
have grade ≥ 1 psn, as defined by the nci-ctcae version 3.0
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
ECOG performance status
Item
have an ecog performance status ≤2;
boolean
C1520224 (UMLS CUI [1])
Hematologic Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Glucohemoglobin measurement | Neutrophil count | Platelet Count measurement | Fibrin D dimer normal
Item
blood tests within 14 days prior to randomization: (a) ast (sgot) and alt (sgpt) ≤2 uln; (b) serum creatinine ≤1.5xunl; (c)hba1c ≤7%; (d) neutrophils ≥1.5x10^9/l ; (e) platelets ≥50x10^9/l; (f) serum d-dimer within normal limits
boolean
C0018941 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0202054 (UMLS CUI [5])
C0200633 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
C0855431 (UMLS CUI [8])
Peripheral Neuropathy Pre-existing
Item
pre-existing peripheral neuropathy prior to treatment with oxaliplatin
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Cancer treatment Additional
Item
receiving any further anti-cancer treatment
boolean
C0920425 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Thromboembolism
Item
history of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
boolean
C0040038 (UMLS CUI [1])
Heart Disease Unstable
Item
unstable cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Nervous system disorder | Mental disorders | Dementia | Seizures
Item
history of significant neurological or psychiatric disorders including dementia or seizures,
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Disseminated Intravascular Coagulation
Item
active disseminated intravascular coagulation
boolean
C0012739 (UMLS CUI [1])
Comorbidity Serious Study Subject Participation Status Impaired
Item
other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
Antidepressive Agents Peripheral sensory neuropathy | Antiepileptic Agents Peripheral sensory neuropathy
Item
use of antidepressant/antiepileptic medication (for the treatment of psn), unless commenced before informed consent form signed. the addition of these medications (for the treatment of psn) once the patient has consented is not allowed
boolean
C0003289 (UMLS CUI [1,1])
C0151313 (UMLS CUI [1,2])
C0003299 (UMLS CUI [2,1])
C0151313 (UMLS CUI [2,2])
Investigational New Drugs
Item
concurrent treatment with any other experimental drugs
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Postmenopausal state Amenorrhea Duration
Item
women of childbearing potential must be protected by effective contraceptive methods of birth control. post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0002453 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Psychological Factors Preventing Protocol Compliance | Factor Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance
Item
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. those conditions should be assessed with the patient before registration in the trial.
boolean
C0033898 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])