{
"info": {
"nct_id": "NCT06561620",
"official_title": "A Prospective Study of Befotertinib Adjuvant Therapy in Patients With Postoperative MRD-positive Non-small Cell Lung Cancer in Stage IA2-IB With High Risk Factors",
"inclusion_criteria": "1. Age: 18-75 years old.\n2. Gender: both men and women are acceptable, as balanced as possible.\n3. Patients with lung adenocarcinoma who underwent R0 resection and were clinically confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical tissue samples tested positive for EGFR-sensitive mutations and positive for MRD after surgery.\n4. Accompanied by arbitrary ≥ 2 high-risk factors; High risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, pathological micropapillary composition ≥ 15%, complex glandular composition ≥ 20%, etc.\n\n4. Achieve R0 resection: For CTR < 50% ground glass nodules, wedge resection is acceptable and the margin is negative, and 3 groups of lymph node biopsies are negative; for CTR ≥ 50% or pure solid nodules, at least segmental resection is undergone, and lymph node dissection is systematically performed; if there is no clear evidence of metastasis, if it cannot be judged, it can be determined by an independent review committee for pathological consultation.\n\n5. The ECOG behavioral status score is 0 to 1, and the expected survival time is > 1 year.\n\n6. Voluntary MRD screening and voluntary befortinib adjuvant therapy; 7. Have a certain organ system function, defined as follows, based on the researcher's experience A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L B. Platelets ≥ 100 x 109/L; C. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Note that in order to achieve the required hemoglobin level, blood transfusion is allowed; D. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); E. If there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastasis, ≤ 5 × ULN; F. Creatinine ≤ 1.5 x ULN. Patients are still eligible for inclusion if the creatinine clearance value calculated by the Cockcroft-Gault method is ≥ 50 mL/min (0.83 mL/s).\n\n8. Female subjects of childbearing age must have a serum pregnancy test within 3 days before the start of the study drug, and the result is negative, and they are willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug; for significant other male subjects who are women of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose.\n\n9. Voluntary and capable of following the test and follow-up procedures. 10. Sign the informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "1. There is any other treatment before the operation, and no informed consent is signed;\n2. The patient has been diagnosed with cancer within 2 years;\n3. Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence; CT scan at baseline revealed idiopathic pulmonary fibrosis.\n4. Patients who are known to be allergic to any component of befortinib or similar drugs;\n5. Pregnant or lactating women;\n6. Situations considered unsuitable for inclusion by other researchers.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Age: 18-75 years old.",
"criterions": [
{
"exact_snippets": "Age: 18-75 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
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{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
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"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age: 18-75 years old.",
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"requirement": {
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{
"operator": ">=",
"value": 18,
"unit": "years"
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},
{
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"criterions": [
{
"exact_snippets": "Gender: both men and women are acceptable",
"criterion": "gender",
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"expected_value": [
"men",
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]
}
},
{
"exact_snippets": "as balanced as possible",
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"expected_value": "as balanced as possible"
}
}
]
},
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]
}
},
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{
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"line": "3. Patients with lung adenocarcinoma who underwent R0 resection and were clinically confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical tissue samples tested positive for EGFR-sensitive mutations and positive for MRD after surgery.",
"criterions": [
{
"exact_snippets": "Patients with lung adenocarcinoma",
"criterion": "lung adenocarcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
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"criterion": "R0 resection",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
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"criterion": "cancer stage",
"requirement": {
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"expected_value": [
"IA2",
"IB"
]
}
},
{
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"criterion": "tumor size",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "cm"
},
{
"operator": "<=",
"value": 4,
"unit": "cm"
}
]
}
}
},
{
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"criterion": "EGFR-sensitive mutations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for MRD after surgery",
"criterion": "MRD (Minimal Residual Disease)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"requirement": {
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"expected_value": true
}
},
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"requirement": {
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"expected_value": true
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},
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"IA2",
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"operator": ">=",
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"unit": "cm"
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"unit": "cm"
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]
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"criterion": "EGFR-sensitive mutations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for MRD after surgery",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
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{
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"criterion": "ECOG behavioral status score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "expected survival time is > 1 year",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
}
]
},
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"exact_snippets": "ECOG behavioral status score is 0 to 1",
"criterion": "ECOG behavioral status score",
"requirement": {
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"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
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"value": 1,
"unit": "N/A"
}
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}
},
{
"exact_snippets": "expected survival time is > 1 year",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "year"
}
}
}
]
}
},
{
"identified_line": {
"line": "8. Female subjects of childbearing age must have a serum pregnancy test within 3 days before the start of the study drug, and the result is negative, and they are willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug; for significant other male subjects who are women of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose.",
"criterions": [
{
"exact_snippets": "Female subjects of childbearing age",
"criterion": "gender and reproductive status",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "Female subjects of childbearing age",
"criterion": "gender and reproductive status",
"requirement": {
"requirement_type": "reproductive status",
"expected_value": "childbearing age"
}
},
{
"exact_snippets": "serum pregnancy test within 3 days before the start of the study drug, and the result is negative",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 3 days before the start of the study drug"
}
},
{
"exact_snippets": "serum pregnancy test within 3 days before the start of the study drug, and the result is negative",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "method",
"expected_value": [
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"contraceptives",
"condoms"
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}
},
{
"exact_snippets": "willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug",
"criterion": "contraceptive use",
"requirement": {
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}
},
{
"exact_snippets": "significant other male subjects who are women of childbearing age",
"criterion": "significant other gender and reproductive status",
"requirement": {
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"expected_value": "male"
}
},
{
"exact_snippets": "significant other male subjects who are women of childbearing age",
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"requirement": {
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}
},
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"criterion": "contraceptive or sterilization status",
"requirement": {
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"expected_value": "surgically sterilized"
}
},
{
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"criterion": "contraceptive or sterilization status",
"requirement": {
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"expected_value": "agree to use effective methods of contraception"
}
},
{
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"criterion": "contraceptive or sterilization status",
"requirement": {
"requirement_type": "duration",
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}
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"and_criteria": [
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"and_criteria": [
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"expected_value": "female"
}
},
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}
},
{
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"exact_snippets": "serum pregnancy test within 3 days before the start of the study drug, and the result is negative",
"criterion": "serum pregnancy test",
"requirement": {
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}
},
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"exact_snippets": "serum pregnancy test within 3 days before the start of the study drug, and the result is negative",
"criterion": "serum pregnancy test",
"requirement": {
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"expected_value": "negative"
}
}
]
},
{
"and_criteria": [
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"criterion": "contraceptive use",
"requirement": {
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"expected_value": true
}
},
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"criterion": "contraceptive use",
"requirement": {
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"expected_value": [
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"condoms"
]
}
},
{
"exact_snippets": "willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug",
"criterion": "contraceptive use",
"requirement": {
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}
}
]
}
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"criterion": "significant other gender and reproductive status",
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"expected_value": "male"
}
},
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"requirement": {
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}
},
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"requirement": {
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"expected_value": "surgically sterilized"
}
},
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"exact_snippets": "surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose",
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"expected_value": "agree to use effective methods of contraception"
}
},
{
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"criterion": "contraceptive or sterilization status",
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}
}
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]
}
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}
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}
},
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"line": "9. Voluntary and capable of following the test and follow-up procedures. 10. Sign the informed consent form.",
"criterions": [
{
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"criterion": "voluntary participation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
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"expected_value": true
}
},
{
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"expected_value": true
}
}
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{
"and_criteria": [
{
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"expected_value": true
}
},
{
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"expected_value": true
}
}
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"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
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"expected_value": "healthy"
}
}
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
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"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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},
{
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{
"exact_snippets": "maximum age of 75 Years",
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"unit": "Years"
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"unit": "Years"
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"criterion": "prior treatment",
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"expected_value": false
}
},
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}
},
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},
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"line": "2. The patient has been diagnosed with cancer within 2 years;",
"criterions": [
{
"exact_snippets": "The patient has been diagnosed with cancer within 2 years",
"criterion": "cancer diagnosis",
"requirement": {
"requirement_type": "time since diagnosis",
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"comparisons": [
{
"operator": "<=",
"value": 2,
"unit": "years"
}
]
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"exact_snippets": "The patient has been diagnosed with cancer within 2 years",
"criterion": "cancer diagnosis",
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"requirement_type": "time since diagnosis",
"expected_value": {
"comparisons": [
{
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"value": 2,
"unit": "years"
}
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}
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}
},
{
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"criterions": [
{
"exact_snippets": "history of interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "drug-induced interstitial disease",
"criterion": "drug-induced interstitial disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "any active interstitial lung disease with clinical evidence",
"criterion": "active interstitial lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "CT scan at baseline revealed idiopathic pulmonary fibrosis",
"criterion": "idiopathic pulmonary fibrosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"exact_snippets": "history of interstitial lung disease",
"criterion": "interstitial lung disease",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "drug-induced interstitial disease",
"criterion": "drug-induced interstitial disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "any active interstitial lung disease with clinical evidence",
"criterion": "active interstitial lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "CT scan at baseline revealed idiopathic pulmonary fibrosis",
"criterion": "idiopathic pulmonary fibrosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "4. Patients who are known to be allergic to any component of befortinib or similar drugs;",
"criterions": [
{
"exact_snippets": "Patients who are known to be allergic to any component of befortinib",
"criterion": "allergy to befortinib components",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "allergic to ... similar drugs",
"criterion": "allergy to similar drugs",
"requirement": {
"requirement_type": "presence",
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}
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