{
"info": {
"nct_id": "NCT04838548",
"official_title": "An Open-Label, Multi-Cohort, Multi-center, Non-Randomized, Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer",
"inclusion_criteria": "* Willing to sign the ICF and follow the requirements specified in the protocol.\n* Age: ≥18 years,both genders.\n* Expected survival time≥6 months.\n* Patients with histologically confirmed advanced non-small cell lung cancer, and without histologically confirmed small cell lung cancer (SCLC).\n* Positive EGFR expression in tumor specimen.\n* Failed in the prior second-line or above standard of care therapies.\n* Archival or biopsy tumor specimens should be provided.\n* Patients must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).\n* ECOG performance score 0 or 1.\n* AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).\n* No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.\n* Organ functions and coagulation function must meet the basic requirements.\n* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* History of hypersensitivity to any component of the investigational product.\n* No documented progression after prior treatment, or recurrence during or after prior treatment.\n* Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.\n* Presence of central nervous system metastasis.\n* Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug.\n* Any severe or uncontrolled systemic disease judged by the investigator.\n* Patients with poorly controlled heart diseases.\n* Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.\n* Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy.\n* Prior history of other primary malignancies.\n* History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.\n* History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy.\n* History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.\n* Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.\n* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.\n* Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.\n* History of allogeneic tissue or solid organ transplant.\n* Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.\n* Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent.\n* Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Willing to sign the ICF and follow the requirements specified in the protocol.",
"criterions": [
{
"exact_snippets": "Willing to sign the ICF",
"criterion": "informed consent form (ICF)",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "follow the requirements specified in the protocol",
"criterion": "protocol adherence",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Willing to sign the ICF",
"criterion": "informed consent form (ICF)",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "follow the requirements specified in the protocol",
"criterion": "protocol adherence",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Age: ≥18 years,both genders.",
"criterions": [
{
"exact_snippets": "Age: ≥18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "both genders",
"criterion": "gender",
"requirement": {
"requirement_type": "allowed genders",
"expected_value": [
"male",
"female"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age: ≥18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "both genders",
"criterion": "gender",
"requirement": {
"requirement_type": "allowed genders",
"expected_value": [
"male",
"female"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Expected survival time≥6 months.",
"criterions": [
{
"exact_snippets": "Expected survival time≥6 months.",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Expected survival time≥6 months.",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with histologically confirmed advanced non-small cell lung cancer, and without histologically confirmed small cell lung cancer (SCLC).",
"criterions": [
{
"exact_snippets": "histologically confirmed advanced non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "histologically confirmed advanced non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
},
{
"exact_snippets": "without histologically confirmed small cell lung cancer (SCLC)",
"criterion": "small cell lung cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "not histologically confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "histologically confirmed advanced non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "histologically confirmed advanced non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
}
]
},
{
"exact_snippets": "without histologically confirmed small cell lung cancer (SCLC)",
"criterion": "small cell lung cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "not histologically confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "* Positive EGFR expression in tumor specimen.",
"criterions": [
{
"exact_snippets": "Positive EGFR expression in tumor specimen.",
"criterion": "EGFR expression",
"requirement": {
"requirement_type": "presence",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Positive EGFR expression in tumor specimen.",
"criterion": "EGFR expression",
"requirement": {
"requirement_type": "presence",
"expected_value": "positive"
}
}
]
}
},
{
"identified_line": {
"line": "* Failed in the prior second-line or above standard of care therapies.",
"criterions": [
{
"exact_snippets": "Failed in the prior second-line or above standard of care therapies.",
"criterion": "prior standard of care therapies",
"requirement": {
"requirement_type": "outcome",
"expected_value": "failed"
}
},
{
"exact_snippets": "Failed in the prior second-line or above standard of care therapies.",
"criterion": "prior standard of care therapies",
"requirement": {
"requirement_type": "line of therapy",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "line"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Failed in the prior second-line or above standard of care therapies.",
"criterion": "prior standard of care therapies",
"requirement": {
"requirement_type": "outcome",
"expected_value": "failed"
}
},
{
"exact_snippets": "Failed in the prior second-line or above standard of care therapies.",
"criterion": "prior standard of care therapies",
"requirement": {
"requirement_type": "line of therapy",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "line"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Archival or biopsy tumor specimens should be provided.",
"criterions": [
{
"exact_snippets": "Archival or biopsy tumor specimens should be provided.",
"criterion": "tumor specimens",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Archival or biopsy tumor specimens should be provided.",
"criterion": "tumor specimens",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).",
"criterions": [
{
"exact_snippets": "measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1)",
"criterion": "lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": "according to RECIST v1.1"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1)",
"criterion": "lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": "according to RECIST v1.1"
}
}
]
}
},
{
"identified_line": {
"line": "* AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
"criterions": [
{
"exact_snippets": "AEs related to prior systemic chemotherapy ... have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
"criterion": "AEs related to prior systemic chemotherapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
},
{
"exact_snippets": "AEs related to ... radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
"criterion": "AEs related to radical/extensive radiotherapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "AEs related to prior systemic chemotherapy ... have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
"criterion": "AEs related to prior systemic chemotherapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
},
{
"exact_snippets": "AEs related to ... radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
"criterion": "AEs related to radical/extensive radiotherapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.",
"criterions": [
{
"exact_snippets": "No severe cardiac dysfunction",
"criterion": "cardiac dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "not severe"
}
},
{
"exact_snippets": "left ventricular ejection fraction (LVEF) ≥ 50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No severe cardiac dysfunction",
"criterion": "cardiac dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "not severe"
}
},
{
"exact_snippets": "left ventricular ejection fraction (LVEF) ≥ 50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Organ functions and coagulation function must meet the basic requirements.",
"criterions": [
{
"exact_snippets": "Organ functions ... must meet the basic requirements.",
"criterion": "organ functions",
"requirement": {
"requirement_type": "condition",
"expected_value": "must meet the basic requirements"
}
},
{
"exact_snippets": "coagulation function must meet the basic requirements.",
"criterion": "coagulation function",
"requirement": {
"requirement_type": "condition",
"expected_value": "must meet the basic requirements"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Organ functions ... must meet the basic requirements.",
"criterion": "organ functions",
"requirement": {
"requirement_type": "condition",
"expected_value": "must meet the basic requirements"
}
},
{
"exact_snippets": "coagulation function must meet the basic requirements.",
"criterion": "coagulation function",
"requirement": {
"requirement_type": "condition",
"expected_value": "must meet the basic requirements"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.",
"criterions": [
{
"exact_snippets": "Patients with childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must use effective contraception during the treatment and for 6 months after the last dose of treatment",
"criterion": "contraception use",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the treatment and for 6 months after the last dose of treatment"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Patients with childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "must use effective contraception during the treatment and for 6 months after the last dose of treatment",
"criterion": "contraception use",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the treatment and for 6 months after the last dose of treatment"
}
},
"else_criteria": null
}
},
{
"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": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"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": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* History of hypersensitivity to any component of the investigational product.",
"criterions": [
{
"exact_snippets": "History of hypersensitivity to any component of the investigational product.",
"criterion": "hypersensitivity",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "History of hypersensitivity to any component of the investigational product.",
"criterion": "hypersensitivity",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No documented progression after prior treatment, or recurrence during or after prior treatment.",
"criterions": [
{
"exact_snippets": "No documented progression after prior treatment",
"criterion": "disease progression",
"requirement": {
"requirement_type": "documentation",
"expected_value": false
}
},
{
"exact_snippets": "recurrence during or after prior treatment",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "timing",
"expected_value": [
"during prior treatment",
"after prior treatment"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No documented progression after prior treatment",
"criterion": "disease progression",
"requirement": {
"requirement_type": "documentation",
"expected_value": false
}
},
{
"exact_snippets": "recurrence during or after prior treatment",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "timing",
"expected_value": [
"during prior treatment",
"after prior treatment"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.",
"criterions": [
{
"exact_snippets": "Received radiotherapy ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... chemotherapy ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... biologicals ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "biologicals",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... immunotherapy ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.",
"criterion": "other anti-tumor drugs",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Received radiotherapy ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... chemotherapy ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... biologicals ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "biologicals",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... immunotherapy ... within 4 weeks prior to the first dose of study treatment.",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Received ... other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.",
"criterion": "other anti-tumor drugs",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Presence of central nervous system metastasis.",
"criterions": [
{
"exact_snippets": "Presence of central nervous system metastasis",
"criterion": "central nervous system metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Presence of central nervous system metastasis",
"criterion": "central nervous system metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug.",
"criterions": [
{
"exact_snippets": "pleural, abdominal or pericardial effusion",
"criterion": "effusion",
"requirement": {
"requirement_type": "location",
"expected_value": [
"pleural",
"abdominal",
"pericardial"
]
}
},
{
"exact_snippets": "requiring puncture drainage",
"criterion": "effusion",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "puncture drainage"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "pleural, abdominal or pericardial effusion",
"criterion": "effusion",
"requirement": {
"requirement_type": "location",
"expected_value": [
"pleural",
"abdominal",
"pericardial"
]
}
},
{
"exact_snippets": "requiring puncture drainage",
"criterion": "effusion",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "puncture drainage"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Any severe or uncontrolled systemic disease judged by the investigator.",
"criterions": [
{
"exact_snippets": "severe or uncontrolled systemic disease",
"criterion": "systemic disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "severe or uncontrolled systemic disease",
"criterion": "systemic disease",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "severe or uncontrolled systemic disease",
"criterion": "systemic disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "severe or uncontrolled systemic disease",
"criterion": "systemic disease",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
}
]
},
{
"exact_snippets": "severe or uncontrolled systemic disease",
"criterion": "investigator judgment",
"requirement": {
"requirement_type": "judgment",
"expected_value": "unfavorable"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with poorly controlled heart diseases.",
"criterions": [
{
"exact_snippets": "poorly controlled heart diseases",
"criterion": "heart diseases",
"requirement": {
"requirement_type": "control",
"expected_value": "poorly controlled"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "poorly controlled heart diseases",
"criterion": "heart diseases",
"requirement": {
"requirement_type": "control",
"expected_value": "poorly controlled"
}
}
}
},
{
"identified_line": {
"line": "* Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.",
"criterions": [
{
"exact_snippets": "active infections",
"criterion": "active infections",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Hepatitis B",
"criterion": "Hepatitis B infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Hepatitis C",
"criterion": "Hepatitis C infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "human immunodeficiency virus (HIV) infection",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "active infections",
"criterion": "active infections",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "Hepatitis B",
"criterion": "Hepatitis B infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Hepatitis C",
"criterion": "Hepatitis C infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "human immunodeficiency virus (HIV) infection",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
},
{
"exact_snippets": "Hepatitis B",
"criterion": "Hepatitis B infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Hepatitis C",
"criterion": "Hepatitis C infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "human immunodeficiency virus (HIV) infection",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy.",
"criterions": [
{
"exact_snippets": "Active bacterial ... infection requiring systemic therapy.",
"criterion": "bacterial infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active bacterial ... infection requiring systemic therapy.",
"criterion": "bacterial infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
},
{
"exact_snippets": "Active ... viral ... infection requiring systemic therapy.",
"criterion": "viral infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... viral ... infection requiring systemic therapy.",
"criterion": "viral infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
},
{
"exact_snippets": "Active ... fungal ... infection requiring systemic therapy.",
"criterion": "fungal infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... fungal ... infection requiring systemic therapy.",
"criterion": "fungal infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
},
{
"exact_snippets": "Active ... rickettsial ... infection requiring systemic therapy.",
"criterion": "rickettsial infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... rickettsial ... infection requiring systemic therapy.",
"criterion": "rickettsial infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
},
{
"exact_snippets": "Active ... parasitic infection requiring systemic therapy.",
"criterion": "parasitic infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... parasitic infection requiring systemic therapy.",
"criterion": "parasitic infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Active bacterial ... infection requiring systemic therapy.",
"criterion": "bacterial infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active bacterial ... infection requiring systemic therapy.",
"criterion": "bacterial infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Active ... viral ... infection requiring systemic therapy.",
"criterion": "viral infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... viral ... infection requiring systemic therapy.",
"criterion": "viral infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Active ... fungal ... infection requiring systemic therapy.",
"criterion": "fungal infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... fungal ... infection requiring systemic therapy.",
"criterion": "fungal infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Active ... rickettsial ... infection requiring systemic therapy.",
"criterion": "rickettsial infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... rickettsial ... infection requiring systemic therapy.",
"criterion": "rickettsial infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Active ... parasitic infection requiring systemic therapy.",
"criterion": "parasitic infection",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "Active ... parasitic infection requiring systemic therapy.",
"criterion": "parasitic infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Prior history of other primary malignancies.",
"criterions": [
{
"exact_snippets": "Prior history of other primary malignancies",
"criterion": "other primary malignancies",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior history of other primary malignancies",
"criterion": "other primary malignancies",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.",
"criterions": [
{
"exact_snippets": "History of the following ophthalmologic abnormalities: severve dry eye syndrome",
"criterion": "severe dry eye syndrome",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of the following ophthalmologic abnormalities: ... keratoconjunctivitis sicca",
"criterion": "keratoconjunctivitis sicca",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of the following ophthalmologic abnormalities: ... severe exposure keratitis",
"criterion": "severe exposure keratitis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of the following ophthalmologic abnormalities: ... any other condition that may increase the risk of corneal epithelial damage",
"criterion": "condition that may increase the risk of corneal epithelial damage",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of the following ophthalmologic abnormalities: severve dry eye syndrome",
"criterion": "severe dry eye syndrome",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of the following ophthalmologic abnormalities: ... keratoconjunctivitis sicca",
"criterion": "keratoconjunctivitis sicca",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of the following ophthalmologic abnormalities: ... severe exposure keratitis",
"criterion": "severe exposure keratitis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of the following ophthalmologic abnormalities: ... any other condition that may increase the risk of corneal epithelial damage",
"criterion": "condition that may increase the risk of corneal epithelial damage",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy.",
"criterions": [
{
"exact_snippets": "History of severe skin disease requiring interruption of previous EGFR targeted therapy",
"criterion": "severe skin disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of severe skin disease requiring interruption of previous EGFR targeted therapy",
"criterion": "severe skin disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "History of severe skin disease requiring interruption of previous EGFR targeted therapy",
"criterion": "severe skin disease",
"requirement": {
"requirement_type": "treatment_interruption",
"expected_value": true
}
},
{
"exact_snippets": "chronic skin disease requiring oral or intravenous therapy",
"criterion": "chronic skin disease",
"requirement": {
"requirement_type": "chronicity",
"expected_value": true
}
},
{
"exact_snippets": "chronic skin disease requiring oral or intravenous therapy",
"criterion": "chronic skin disease",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"oral",
"intravenous"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of severe skin disease requiring interruption of previous EGFR targeted therapy",
"criterion": "severe skin disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of severe skin disease requiring interruption of previous EGFR targeted therapy",
"criterion": "severe skin disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
{
"exact_snippets": "History of severe skin disease requiring interruption of previous EGFR targeted therapy",
"criterion": "severe skin disease",
"requirement": {
"requirement_type": "treatment_interruption",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "chronic skin disease requiring oral or intravenous therapy",
"criterion": "chronic skin disease",
"requirement": {
"requirement_type": "chronicity",
"expected_value": true
}
},
{
"exact_snippets": "chronic skin disease requiring oral or intravenous therapy",
"criterion": "chronic skin disease",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"oral",
"intravenous"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.",
"criterions": [
{
"exact_snippets": "History of interstitial lung disease (ILD)",
"criterion": "interstitial lung disease (ILD)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... pneumonitis",
"criterion": "pneumonitis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "severe chronic obstructive pulmonary disease",
"criterion": "chronic obstructive pulmonary disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "severe pulmonary insufficiency",
"criterion": "pulmonary insufficiency",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "symptomatic bronchospasm",
"criterion": "bronchospasm",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of interstitial lung disease (ILD)",
"criterion": "interstitial lung disease (ILD)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... pneumonitis",
"criterion": "pneumonitis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "severe chronic obstructive pulmonary disease",
"criterion": "chronic obstructive pulmonary disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "severe pulmonary insufficiency",
"criterion": "pulmonary insufficiency",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "symptomatic bronchospasm",
"criterion": "bronchospasm",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.",
"criterions": [
{
"exact_snippets": "Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.",
"criterion": "pulmonary radiotherapy",
"requirement": {
"requirement_type": "dose",
"expected_value": {
"operator": ">",
"value": 30,
"unit": "Gy"
}
}
},
{
"exact_snippets": "Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.",
"criterion": "pulmonary radiotherapy",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 6 months prior to first dose of study drug"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.",
"criterion": "pulmonary radiotherapy",
"requirement": {
"requirement_type": "dose",
"expected_value": {
"operator": ">",
"value": 30,
"unit": "Gy"
}
}
},
{
"exact_snippets": "Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.",
"criterion": "pulmonary radiotherapy",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 6 months prior to first dose of study drug"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.",
"criterions": [
{
"exact_snippets": "Pulmonary embolism ... within 3 months prior to the first dose of study drug.",
"criterion": "pulmonary embolism",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "deep vein thrombosis within 3 months prior to the first dose of study drug.",
"criterion": "deep vein thrombosis",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pulmonary embolism ... within 3 months prior to the first dose of study drug.",
"criterion": "pulmonary embolism",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "deep vein thrombosis within 3 months prior to the first dose of study drug.",
"criterion": "deep vein thrombosis",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.",
"criterions": [
{
"exact_snippets": "Patients with active autoimmune disease",
"criterion": "active autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of autoimmune disease",
"criterion": "history of autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "using immunosuppressive agents",
"criterion": "use of immunosuppressive agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "systemic hormone therapy",
"criterion": "use of systemic hormone therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "still receiving within 2 weeks prior to enrollment",
"criterion": "time since last use of immunosuppressive agents or systemic hormone therapy",
"requirement": {
"requirement_type": "time since last use",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients with active autoimmune disease",
"criterion": "active autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"or_criteria": [
{
"exact_snippets": "using immunosuppressive agents",
"criterion": "use of immunosuppressive agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "systemic hormone therapy",
"criterion": "use of systemic hormone therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "still receiving within 2 weeks prior to enrollment",
"criterion": "time since last use of immunosuppressive agents or systemic hormone therapy",
"requirement": {
"requirement_type": "time since last use",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "history of autoimmune disease",
"criterion": "history of autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"or_criteria": [
{
"exact_snippets": "using immunosuppressive agents",
"criterion": "use of immunosuppressive agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "systemic hormone therapy",
"criterion": "use of systemic hormone therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "still receiving within 2 weeks prior to enrollment",
"criterion": "time since last use of immunosuppressive agents or systemic hormone therapy",
"requirement": {
"requirement_type": "time since last use",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* History of allogeneic tissue or solid organ transplant.",
"criterions": [
{
"exact_snippets": "History of allogeneic tissue or solid organ transplant.",
"criterion": "allogeneic tissue transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of allogeneic tissue or solid organ transplant.",
"criterion": "solid organ transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of allogeneic tissue or solid organ transplant.",
"criterion": "allogeneic tissue transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of allogeneic tissue or solid organ transplant.",
"criterion": "solid organ transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.",
"criterions": [
{
"exact_snippets": "Female patients",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
},
{
"exact_snippets": "positive serum pregnancy test",
"criterion": "pregnancy test result",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "positive"
}
},
{
"exact_snippets": "breast feeding",
"criterion": "breastfeeding status",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "breastfeeding"
}
},
{
"exact_snippets": "do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment",
"criterion": "contraceptive agreement",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "do not agree"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Female patients",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
},
{
"or_criteria": [
{
"exact_snippets": "positive serum pregnancy test",
"criterion": "pregnancy test result",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "positive"
}
},
{
"exact_snippets": "breast feeding",
"criterion": "breastfeeding status",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "breastfeeding"
}
},
{
"exact_snippets": "do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment",
"criterion": "contraceptive agreement",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "do not agree"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent.",
"criterions": [
{
"exact_snippets": "Active uncontrolled concomitant diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Active uncontrolled concomitant diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
},
{
"exact_snippets": "limit patient's compliance with study requirements",
"criterion": "compliance with study requirements",
"requirement": {
"requirement_type": "limitation",
"expected_value": true
}
},
{
"exact_snippets": "compromise patient's ability to provide written informed consent",
"criterion": "ability to provide written informed consent",
"requirement": {
"requirement_type": "compromise",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Active uncontrolled concomitant diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Active uncontrolled concomitant diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
}
]
},
{
"exact_snippets": "limit patient's compliance with study requirements",
"criterion": "compliance with study requirements",
"requirement": {
"requirement_type": "limitation",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Active uncontrolled concomitant diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Active uncontrolled concomitant diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
}
]
},
{
"exact_snippets": "compromise patient's ability to provide written informed consent",
"criterion": "ability to provide written informed consent",
"requirement": {
"requirement_type": "compromise",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.",
"criterions": [
{
"exact_snippets": "Other conditions inappropriate for participation ... at the discretion of the investigator.",
"criterion": "other conditions",
"requirement": {
"requirement_type": "appropriateness for participation",
"expected_value": "at the discretion of the investigator"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Other conditions inappropriate for participation ... at the discretion of the investigator.",
"criterion": "other conditions",
"requirement": {
"requirement_type": "appropriateness for participation",
"expected_value": "at the discretion of the investigator"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* ECOG performance score 0 or 1.",
"criterions": [
{
"exact_snippets": "ECOG performance score 0 or 1",
"criterion": "ECOG performance score",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "ECOG performance score 0 or 1",
"criterion": "ECOG performance score",
"requirement": {
"requirement_type": "value",
"expected_value": "0"
}
},
{
"exact_snippets": "ECOG performance score 0 or 1",
"criterion": "ECOG performance score",
"requirement": {
"requirement_type": "value",
"expected_value": "1"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}