{
"info": {
"nct_id": "NCT04660760",
"official_title": "Ramucirumab Plus Trifluridine/Tipiracil (TAS-102) for Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: An Investigator-Initiated, Randomized Non-Inferiority Phase 2 Study",
"inclusion_criteria": "* Age >= 18 years\n* Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction\n* Have locally advanced unresectable or metastatic disease that has progressed =< 180 days since last treatment\n* One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors (RECIST)\n* Planned for second line treatment defined by failing or were intolerant to previous standard chemotherapies containing one or more of the following agents:\n\n * Fluoropyrimidine (IV 5-FU or capecitabine) and platinum (cisplatin or oxaliplatin)\n * Trastuzumab in case of HER2-positive disease\n * NOTE: For the patients whose disease recurred =< 168 days from the last dose of adjuvant anticancer chemotherapy, that adjuvant anticancer chemotherapy is counted as 1 prior chemotherapy line\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Ability to swallow oral medications\n* Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to registration)\n* Platelet count >= 100,000/mm^3 (obtained =< 7 days prior to registration)\n* Hemoglobin >= 9.0 g/dL (obtained =< 7 days prior to registration)\n* Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)\n* Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis) (obtained =< 7 days prior to registration)\n* International normalized ratio (INR) =< 1.5 x ULN, and a partial thromboplastin time (PTT) =< 5 seconds above the ULN (unless receiving anticoagulation therapy) (obtained =< 7 days prior to registration)\n\n * Note: Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy\n * Note: Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH)\n * Exception: If receiving warfarin, the patient must have an INR =< 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)\n* Urinary protein is =< 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate =< 1000 mg of protein in 24 hours to allow participation in this protocol) (obtained =< 7 days prior to registration)\n* Creatinine =< 1.5 times the ULN or creatinine clearance (measured via 24-hour urine collection) >= 50 mL/minute (that is, if serum creatinine is >= 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) (obtained =< 7 days prior to registration)\n* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide informed written consent =< 28 days prior to registration\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n* Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n * Pregnant women\n * Nursing women\n * Women of childbearing potential who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Previous treatment with TAS-102 or ramucirumab\n* Previous taxane therapy =< 180 days prior to registration\n* Any grade 3-4 gastrointestinal (GI) bleeding =< 90 days prior to registration\n* History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered \"significant\") =< 90 days prior to registration\n* Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration\n* Prior history of GI perforation/fistula =< 180 days of registration or risk factors for perforation\n* Serious or nonhealing wound, ulcer, or bone fracture =< 28 days prior to registration\n* Major surgery =< 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement =< 7 days prior to registration\n* Elective or planned major surgery to be performed during the course of the clinical trial\n* Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. NOTE: Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis\n* Uncontrolled or poorly-controlled hypertension (>= 150 mmHg systolic or >= 90 mmHg diastolic for >= 4 weeks) despite standard medical management\n* Immunocompromised and known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\n * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy =< 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. NOTE: Once-daily aspirin use (maximum dose 325 mg/day) is permitted",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age >= 18 years",
"criterions": [
{
"exact_snippets": "Age >= 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age >= 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction",
"criterions": [
{
"exact_snippets": "Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": [
"histological",
"cytological"
]
}
},
{
"exact_snippets": "Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "location",
"expected_value": [
"stomach",
"gastroesophageal junction"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": [
"histological",
"cytological"
]
}
},
{
"exact_snippets": "Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "location",
"expected_value": [
"stomach",
"gastroesophageal junction"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Have locally advanced unresectable or metastatic disease that has progressed =< 180 days since last treatment",
"criterions": [
{
"exact_snippets": "locally advanced unresectable or metastatic disease",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced unresectable",
"metastatic"
]
}
},
{
"exact_snippets": "disease that has progressed =< 180 days since last treatment",
"criterion": "disease progression",
"requirement": {
"requirement_type": "progression time",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "locally advanced unresectable or metastatic disease",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced unresectable",
"metastatic"
]
}
},
{
"exact_snippets": "disease that has progressed =< 180 days since last treatment",
"criterion": "disease progression",
"requirement": {
"requirement_type": "progression time",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors (RECIST)",
"criterions": [
{
"exact_snippets": "One or more measurable or nonmeasurable evaluable lesions",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesions"
}
}
},
{
"exact_snippets": "One or more measurable or nonmeasurable evaluable lesions",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": [
"measurable",
"nonmeasurable"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "One or more measurable or nonmeasurable evaluable lesions",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesions"
}
}
},
{
"exact_snippets": "One or more measurable or nonmeasurable evaluable lesions",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": [
"measurable",
"nonmeasurable"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Trastuzumab in case of HER2-positive disease",
"criterions": [
{
"exact_snippets": "HER2-positive disease",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "HER2-positive disease",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
"then_criteria": {
"exact_snippets": "Trastuzumab in case of HER2-positive disease",
"criterion": "Trastuzumab",
"requirement": {
"requirement_type": "treatment",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* NOTE: For the patients whose disease recurred =< 168 days from the last dose of adjuvant anticancer chemotherapy, that adjuvant anticancer chemotherapy is counted as 1 prior chemotherapy line",
"criterions": [
{
"exact_snippets": "disease recurred =< 168 days from the last dose of adjuvant anticancer chemotherapy",
"criterion": "disease recurrence time",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 168,
"unit": "days"
}
]
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "disease recurred =< 168 days from the last dose of adjuvant anticancer chemotherapy",
"criterion": "disease recurrence time",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 168,
"unit": "days"
}
]
}
}
},
"then_criteria": {
"exact_snippets": "disease recurred =< 168 days from the last dose of adjuvant anticancer chemotherapy",
"criterion": "adjuvant anticancer chemotherapy",
"requirement": {
"requirement_type": "counted as prior chemotherapy line",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Ability to swallow oral medications",
"criterions": [
{
"exact_snippets": "Ability to swallow oral medications",
"criterion": "ability to swallow oral medications",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ability to swallow oral medications",
"criterion": "ability to swallow oral medications",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count (ANC) >= 1500/mm^3",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count (ANC) >= 1500/mm^3",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "ANC test date",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count >= 100,000/mm^3 (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "Platelet count >= 100,000/mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "platelet count",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelet count >= 100,000/mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "platelet count",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin >= 9.0 g/dL (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "Hemoglobin >= 9.0 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9.0,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "hemoglobin test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin >= 9.0 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9.0,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "hemoglobin test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "Total bilirubin =< 1.5 x upper limit of normal (ULN)",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "time of bilirubin test",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total bilirubin =< 1.5 x upper limit of normal (ULN)",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "time of bilirubin test",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis) (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "Aspartate transaminase (AST) ... =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "Aspartate transaminase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
]
}
}
},
{
"exact_snippets": "Aspartate transaminase (AST) ... =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "Aspartate transaminase (AST)",
"requirement": {
"requirement_type": "level with liver metastasis",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5.0,
"unit": "x UNL"
}
]
}
}
},
{
"exact_snippets": "alanine transaminase (ALT) =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "alanine transaminase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
]
}
}
},
{
"exact_snippets": "alanine transaminase (ALT) =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "alanine transaminase (ALT)",
"requirement": {
"requirement_type": "level with liver metastasis",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5.0,
"unit": "x UNL"
}
]
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Aspartate transaminase (AST) ... =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "Aspartate transaminase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
]
}
}
},
{
"exact_snippets": "alanine transaminase (ALT) =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "alanine transaminase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Aspartate transaminase (AST) ... =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "Aspartate transaminase (AST)",
"requirement": {
"requirement_type": "level with liver metastasis",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5.0,
"unit": "x UNL"
}
]
}
}
},
{
"exact_snippets": "alanine transaminase (ALT) =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis)",
"criterion": "alanine transaminase (ALT)",
"requirement": {
"requirement_type": "level with liver metastasis",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5.0,
"unit": "x UNL"
}
]
}
}
}
]
}
]
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Note: Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy",
"criterions": [
{
"exact_snippets": "Patients receiving warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must be switched to low molecular weight heparin",
"criterion": "anticoagulant medication",
"requirement": {
"requirement_type": "type",
"expected_value": "low molecular weight heparin"
}
},
{
"exact_snippets": "have achieved stable coagulation profile",
"criterion": "coagulation profile",
"requirement": {
"requirement_type": "stability",
"expected_value": "stable"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Patients receiving warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "must be switched to low molecular weight heparin",
"criterion": "anticoagulant medication",
"requirement": {
"requirement_type": "type",
"expected_value": "low molecular weight heparin"
}
},
{
"exact_snippets": "have achieved stable coagulation profile",
"criterion": "coagulation profile",
"requirement": {
"requirement_type": "stability",
"expected_value": "stable"
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Note: Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH)",
"criterions": [
{
"exact_snippets": "Patients on full-dose anticoagulation",
"criterion": "full-dose anticoagulation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must be on a stable dose",
"criterion": "stable dose of anticoagulation",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
},
{
"exact_snippets": "minimum duration 14 days",
"criterion": "duration of stable dose",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
},
{
"exact_snippets": "oral anticoagulant or low molecular weight heparin (LMWH)",
"criterion": "type of anticoagulant",
"requirement": {
"requirement_type": "type",
"expected_value": [
"oral anticoagulant",
"low molecular weight heparin (LMWH)"
]
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Patients on full-dose anticoagulation",
"criterion": "full-dose anticoagulation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "must be on a stable dose",
"criterion": "stable dose of anticoagulation",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
},
{
"exact_snippets": "minimum duration 14 days",
"criterion": "duration of stable dose",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
},
{
"exact_snippets": "oral anticoagulant or low molecular weight heparin (LMWH)",
"criterion": "type of anticoagulant",
"requirement": {
"requirement_type": "type",
"expected_value": [
"oral anticoagulant",
"low molecular weight heparin (LMWH)"
]
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Exception: If receiving warfarin, the patient must have an INR =< 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)",
"criterions": [
{
"exact_snippets": "receiving warfarin ... INR =< 3.0",
"criterion": "INR level",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 3.0,
"unit": "N/A"
}
}
},
{
"exact_snippets": "heparin and LMWH ... no active bleeding",
"criterion": "active bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no bleeding within 14 days prior to first dose of protocol therapy",
"criterion": "bleeding within 14 days",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pathological condition ... high risk of bleeding",
"criterion": "pathological condition with high risk of bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "tumor involving major vessels",
"criterion": "tumor involving major vessels",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "known varices",
"criterion": "known varices",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "receiving warfarin ... INR =< 3.0",
"criterion": "INR level",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 3.0,
"unit": "N/A"
}
}
},
"then_criteria": null,
"else_criteria": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "heparin and LMWH ... no active bleeding",
"criterion": "active bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no bleeding within 14 days prior to first dose of protocol therapy",
"criterion": "bleeding within 14 days",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "pathological condition ... high risk of bleeding",
"criterion": "pathological condition with high risk of bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "tumor involving major vessels",
"criterion": "tumor involving major vessels",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "known varices",
"criterion": "known varices",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
}
},
{
"identified_line": {
"line": "* Creatinine =< 1.5 times the ULN or creatinine clearance (measured via 24-hour urine collection) >= 50 mL/minute (that is, if serum creatinine is >= 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "Creatinine =< 1.5 times the ULN",
"criterion": "creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times the ULN"
}
}
},
{
"exact_snippets": "creatinine clearance (measured via 24-hour urine collection) >= 50 mL/minute",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "mL/minute"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Creatinine =< 1.5 times the ULN",
"criterion": "creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times the ULN"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "creatinine clearance (measured via 24-hour urine collection) >= 50 mL/minute",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "mL/minute"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only",
"criterions": [
{
"exact_snippets": "Negative pregnancy test ... for women of childbearing potential only",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "Negative pregnancy test ... for women of childbearing potential only",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "applicability",
"expected_value": "women of childbearing potential"
}
},
{
"exact_snippets": "Negative pregnancy test done =< 7 days prior to registration",
"criterion": "pregnancy test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Negative pregnancy test ... for women of childbearing potential only",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "applicability",
"expected_value": "women of childbearing potential"
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "Negative pregnancy test ... for women of childbearing potential only",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "Negative pregnancy test done =< 7 days prior to registration",
"criterion": "pregnancy test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Ability to complete questionnaire(s) by themselves or with assistance",
"criterions": [
{
"exact_snippets": "Ability to complete questionnaire(s) by themselves or with assistance",
"criterion": "ability to complete questionnaire",
"requirement": {
"requirement_type": "assistance",
"expected_value": [
"by themselves",
"with assistance"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ability to complete questionnaire(s) by themselves or with assistance",
"criterion": "ability to complete questionnaire",
"requirement": {
"requirement_type": "assistance",
"expected_value": [
"by themselves",
"with assistance"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Provide informed written consent =< 28 days prior to registration",
"criterions": [
{
"exact_snippets": "Provide informed written consent",
"criterion": "informed written consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
},
{
"exact_snippets": "=< 28 days prior to registration",
"criterion": "timeframe for consent",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Provide informed written consent",
"criterion": "informed written consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
},
{
"exact_snippets": "=< 28 days prior to registration",
"criterion": "timeframe for consent",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)",
"criterions": [
{
"exact_snippets": "Willing to return to enrolling institution for follow-up",
"criterion": "willingness to return for follow-up",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Willing to return to enrolling institution for follow-up",
"criterion": "willingness to return for follow-up",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)",
"criterions": [
{
"exact_snippets": "teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
},
{
"exact_snippets": "teratogenicity of ramucirumab is not known, the patient, if sexually active, must be ... surgically sterile",
"criterion": "surgical sterility",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "teratogenicity of ramucirumab is not known, the patient, if sexually active, must be ... using effective contraception (hormonal or barrier methods)",
"criterion": "contraception use",
"requirement": {
"requirement_type": "method",
"expected_value": [
"hormonal",
"barrier"
]
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
},
"then_criteria": {
"or_criteria": [
{
"exact_snippets": "teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
},
{
"exact_snippets": "teratogenicity of ramucirumab is not known, the patient, if sexually active, must be ... surgically sterile",
"criterion": "surgical sterility",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "teratogenicity of ramucirumab is not known, the patient, if sexually active, must be ... using effective contraception (hormonal or barrier methods)",
"criterion": "contraception use",
"requirement": {
"requirement_type": "method",
"expected_value": [
"hormonal",
"barrier"
]
}
}
]
},
"else_criteria": null
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Nursing women",
"criterions": [
{
"exact_snippets": "Nursing women",
"criterion": "nursing status",
"requirement": {
"requirement_type": "status",
"expected_value": "nursing"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Nursing women",
"criterion": "nursing status",
"requirement": {
"requirement_type": "status",
"expected_value": "nursing"
}
}
}
},
{
"identified_line": {
"line": "* Women of childbearing potential who are unwilling to employ adequate contraception",
"criterions": [
{
"exact_snippets": "Women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unwilling to employ adequate contraception",
"criterion": "contraception use",
"requirement": {
"requirement_type": "willingness",
"expected_value": false
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unwilling to employ adequate contraception",
"criterion": "contraception use",
"requirement": {
"requirement_type": "willingness",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Previous treatment with TAS-102 or ramucirumab",
"criterions": [
{
"exact_snippets": "Previous treatment with TAS-102",
"criterion": "TAS-102 treatment",
"requirement": {
"requirement_type": "previous treatment",
"expected_value": true
}
},
{
"exact_snippets": "Previous treatment with ... ramucirumab",
"criterion": "ramucirumab treatment",
"requirement": {
"requirement_type": "previous treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Previous treatment with TAS-102",
"criterion": "TAS-102 treatment",
"requirement": {
"requirement_type": "previous treatment",
"expected_value": true
}
},
{
"exact_snippets": "Previous treatment with ... ramucirumab",
"criterion": "ramucirumab treatment",
"requirement": {
"requirement_type": "previous treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Previous taxane therapy =< 180 days prior to registration",
"criterions": [
{
"exact_snippets": "Previous taxane therapy =< 180 days prior to registration",
"criterion": "previous taxane therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previous taxane therapy =< 180 days prior to registration",
"criterion": "previous taxane therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days"
}
}
}
}
},
{
"identified_line": {
"line": "* Any grade 3-4 gastrointestinal (GI) bleeding =< 90 days prior to registration",
"criterions": [
{
"exact_snippets": "Any grade 3-4 gastrointestinal (GI) bleeding",
"criterion": "gastrointestinal bleeding",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "grade"
},
{
"operator": "<=",
"value": 4,
"unit": "grade"
}
]
}
}
},
{
"exact_snippets": "Any grade 3-4 gastrointestinal (GI) bleeding",
"criterion": "gastrointestinal bleeding",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 90,
"unit": "days"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Any grade 3-4 gastrointestinal (GI) bleeding",
"criterion": "gastrointestinal bleeding",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "grade"
},
{
"operator": "<=",
"value": 4,
"unit": "grade"
}
]
}
}
},
{
"exact_snippets": "Any grade 3-4 gastrointestinal (GI) bleeding",
"criterion": "gastrointestinal bleeding",
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"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 90,
"unit": "days"
}
]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered \"significant\") =< 90 days prior to registration",
"criterions": [
{
"exact_snippets": "History of deep vein thrombosis (DVT) ... =< 90 days prior to registration",
"criterion": "deep vein thrombosis (DVT)",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days prior to registration"
}
}
},
{
"exact_snippets": "History of ... pulmonary embolism (PE) ... =< 90 days prior to registration",
"criterion": "pulmonary embolism (PE)",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days prior to registration"
}
}
},
{
"exact_snippets": "History of ... any other significant thromboembolism ... =< 90 days prior to registration",
"criterion": "significant thromboembolism",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days prior to registration"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of deep vein thrombosis (DVT) ... =< 90 days prior to registration",
"criterion": "deep vein thrombosis (DVT)",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days prior to registration"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "History of ... pulmonary embolism (PE) ... =< 90 days prior to registration",
"criterion": "pulmonary embolism (PE)",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days prior to registration"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "History of ... any other significant thromboembolism ... =< 90 days prior to registration",
"criterion": "significant thromboembolism",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days prior to registration"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration",
"criterions": [
{
"exact_snippets": "Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration",
"criterion": "arterial thromboembolic events",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days prior to registration"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration",
"criterion": "arterial thromboembolic events",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days prior to registration"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days prior to registration"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration",
"criterion": "transient ischemic attack",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days prior to registration"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration",
"criterion": "cerebrovascular accident",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days prior to registration"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days prior to registration"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Prior history of GI perforation/fistula =< 180 days of registration or risk factors for perforation",
"criterions": [
{
"exact_snippets": "Prior history of GI perforation/fistula =< 180 days of registration",
"criterion": "GI perforation/fistula history",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days"
}
}
},
{
"exact_snippets": "risk factors for perforation",
"criterion": "risk factors for perforation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior history of GI perforation/fistula =< 180 days of registration",
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}
},
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{
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"line": "* Fluoropyrimidine (IV 5-FU or capecitabine) and platinum (cisplatin or oxaliplatin)",
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{
"exact_snippets": "Fluoropyrimidine (IV 5-FU or capecitabine)",
"criterion": "fluoropyrimidine treatment",
"requirement": {
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"capecitabine"
]
}
},
{
"exact_snippets": "platinum (cisplatin or oxaliplatin)",
"criterion": "platinum treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"cisplatin",
"oxaliplatin"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Fluoropyrimidine (IV 5-FU or capecitabine)",
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"requirement": {
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"expected_value": "IV 5-FU"
}
},
{
"exact_snippets": "Fluoropyrimidine (IV 5-FU or capecitabine)",
"criterion": "fluoropyrimidine treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "capecitabine"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "platinum (cisplatin or oxaliplatin)",
"criterion": "platinum treatment",
"requirement": {
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"expected_value": "cisplatin"
}
},
{
"exact_snippets": "platinum (cisplatin or oxaliplatin)",
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"requirement": {
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "0"
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "1"
}
}
]
}
},
{
"identified_line": {
"line": "* International normalized ratio (INR) =< 1.5 x ULN, and a partial thromboplastin time (PTT) =< 5 seconds above the ULN (unless receiving anticoagulation therapy) (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "International normalized ratio (INR) =< 1.5 x ULN",
"criterion": "International normalized ratio (INR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "partial thromboplastin time (PTT) =< 5 seconds above the ULN",
"criterion": "partial thromboplastin time (PTT)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "seconds above the ULN"
}
}
},
{
"exact_snippets": "unless receiving anticoagulation therapy",
"criterion": "receiving anticoagulation therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days prior to registration"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Urinary protein is =< 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate =< 1000 mg of protein in 24 hours to allow participation in this protocol) (obtained =< 7 days prior to registration)",
"criterions": [
{
"exact_snippets": "Urinary protein is =< 1+ on dipstick or routine urinalysis (UA)",
"criterion": "urinary protein",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "+"
}
}
},
{
"exact_snippets": "if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate =< 1000 mg of protein in 24 hours",
"criterion": "urinary protein",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "+"
}
}
},
{
"exact_snippets": "if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate =< 1000 mg of protein in 24 hours",
"criterion": "urinary protein",
"requirement": {
"requirement_type": "24-hour urine protein",
"expected_value": {
"operator": "<=",
"value": 1000,
"unit": "mg"
}
}
},
{
"exact_snippets": "obtained =< 7 days prior to registration",
"criterion": "urinary protein test timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:",
"criterions": [
{
"exact_snippets": "genotoxic, mutagenic and teratogenic effects",
"criterion": "effects on fetus and newborn",
"requirement": {
"requirement_type": "types",
"expected_value": [
"genotoxic",
"mutagenic",
"teratogenic"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Pregnant women",
"criterions": [
{
"exact_snippets": "Pregnant women",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens",
"criterions": [
{
"exact_snippets": "Co-morbid systemic illnesses or other severe concurrent disease",
"criterion": "co-morbid systemic illnesses or other severe concurrent disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Co-morbid systemic illnesses or other severe concurrent disease",
"criterion": "co-morbid systemic illnesses or other severe concurrent disease",
"requirement": {
"requirement_type": "impact on study",
"expected_value": "make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Co-morbid systemic illnesses or other severe concurrent disease",
"criterion": "co-morbid systemic illnesses or other severe concurrent disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Co-morbid systemic illnesses or other severe concurrent disease",
"criterion": "co-morbid systemic illnesses or other severe concurrent disease",
"requirement": {
"requirement_type": "impact on study",
"expected_value": "make the patient inappropriate for entry into this study"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Co-morbid systemic illnesses or other severe concurrent disease",
"criterion": "co-morbid systemic illnesses or other severe concurrent disease",
"requirement": {
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"expected_value": "severe"
}
},
{
"exact_snippets": "Co-morbid systemic illnesses or other severe concurrent disease",
"criterion": "co-morbid systemic illnesses or other severe concurrent disease",
"requirement": {
"requirement_type": "impact on study",
"expected_value": "interfere significantly with the proper assessment of safety and toxicity"
}
}
]
}
]
}
}
],
"failed_miscellaneous": []
}