{
"info": {
"nct_id": "NCT03353831",
"official_title": "Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial",
"inclusion_criteria": "1. Patients with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer\n2. Relapsed disease\n3. Patients with up to three prior therapies. In patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months; in addition patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines are also eligible\n4. Measurable disease, evaluable disease in combination with GCIG CA-125 criteria, or histologically proven relapse/progression\n5. Mandatory de novo tumor biopsy (not older than 3 months) sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of PDL1 status prior to randomization for stratification.\n6. Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)\n7. Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line\n8. Patients previously treated with bevacizumab are eligible, with the exclusion of those patients that has suspended bevacizumab for more than 2 subsequent cycles or permanently discontinued bevacizumab during their previous treatment due to toxicity.\n9. Females aged ≥ 18 years at signing at time of signing informed consent form\n10. Signed written informed consent and ability to comply with the study protocol, in the investigator's judgement\n11. Adequate hematological, renal and hepatic function within 28 days prior to first administration of study treatment:\n\n * Hemoglobin ≥ 9.0 g/dL\n * Absolute neutrophil count (ANC) ≥ 1.5 x 10xE^9/L\n * Platelet count ≥ 100 x 10xE^9/L\n * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n * Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN\n * Serum creatinine ≤ 1.5 x institutional ULN\n * Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization\n * Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24-hours urine must demonstrate ≤ 1 g of protein in 24 hours.\n12. Patients must have adequately controlled blood pressure (BP), with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study.\n13. Estimated life expectancy of at least 3 months\n14. ECOG performance status 0 - 1\n15. Negative urine or serum pregnancy test within 7 days of study treatment in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1\n16. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later.\n17. For countries where this will apply to: a patient will be eligible for randomization in this study only, if either affiliated to, or a beneficiary of a social security category.\n18. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, that include the completion of patient-reported outcomes questionnaires.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors)\n2. Ovarian tumors of low malignant potential (e.g. borderline tumors)\n3. Malignancies other than ovarian cancer within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer)\n4. More than three prior systemic anticancer regimens; maintenance therapies (e.g. with bevacizumab, olaparib or niraparib) are not calculated as separate line.\n5. Prior systemic anticancer therapy within 28 days before randomization (except bevacizumab: 20 days).\n6. Prior radiotherapy to the pelvis or the abdomen.\n7. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement thera-py is permitted).\n8. Prior treatment with anti-CD137 or immune checkpoint blockade therapies, anti-PD1, or anti-PD-L1 therapeutic antibodies or anti-CTLA 4\n9. Prior randomization in AGO-OVAR 2.29.\n10. Treatment with systemic immunostimulatory agents (in-cluding but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to cycle 1, day 1.\n11. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophos-phamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.\n\n The use of inhaled corticosteroids for chronic obstruc-tive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.\n12. Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have screening and subsequent tumor assessments performed using magnetic resonance imaging (MRI).\n13. Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1, day 1 or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab/placebo. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination\n14. Major surgery within 4 weeks of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.\n15. Previous allogeneic bone marrow transplant or previous solid organ transplantation.\n16. Current treatment with anti-viral therapy for HBV.\n17. History of idiopathic pulmonary fibrosis (including pneumonitis), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evi-dence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted\n18. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization\n19. History or evidence hemorrhagic disorders within 6 months prior to randomization\n20. Patients are excluded if having a history or evidence of thrombosis as follows:\n\n * Any Grade 4 thrombosis\n * Arterial thrombosis within 6 months prior to ran-domization\n * Grade ≤ 3 venous thrombosis within 3 months prior to randomization Patients with central venous access thrombosis are eligi-ble.\n21. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of sus-pected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of sus-pected spinal cord compression\n22. History of autoimmune disease, including but not limited to dermatomyositis, myasthenia gravis, myositis, auto-immune hepatitis, systemic lupus erythematosus, rheu-matoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guil-lain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Except patients with:\n\n * a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone\n * controlled type 1 diabetes mellitus on a stable insulin regimen\n\n Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n * Rash must cover < 10% of body surface area\n * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months\n23. Any prior history of hypertensive crisis (CTCAE grade 4) or hypertensive encephalopathy.\n24. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.\n\n Patients with past hepatitis B virus (HBV) infection or re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n25. Persistent toxicities (≥ CTCAE grade 2) with the exception of alopecia, caused by previous cancer treatment. Neurotoxicity CTCAE grade 2 is permitted in case the patient is planned for PLD treatment.\n26. Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization, including but not limited to active tuberculosis or hospitalization for complications of infection, bacteremia, or severe pneumonia. Patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n27. Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.\n28. Clinically significant (e.g. active) cardiovascular disease, including:\n\n * Myocardial infarction or unstable angina pectoris within ≤ 6 months of randomization\n * New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF)\n * Poorly controlled cardiac arrhythmia despite medica-tion (patients with rate controlled atrial fibrillation are eligible)\n * Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision)\n * Resting ECG with QTc >470 msec or family history of long QT syndrome\n29. For patients with PLD treatment: Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal\n30. Evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation).\n31. Non-healing wound, active ulcer or bone fracture.\n32. History of bowel obstruction (including subocclusive disease) related to underlying disease, a history of ab-dominal fistula, GI perforation, or intra-abdominal abscess, or evidence of deep infiltration of the bowel by pelvic examination or on computed tomography, or clinical symptoms of bowel obstruction.\n33. Patients with evidence of abdominal free air.\n34. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications\n35. Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n36. Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab, paclitaxel, pegylated liposomal doxorubicin, or their excipients that contra-indicates the subject's participation.\n37. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent.\n38. Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo as well as breastfeeding women or intended to breastfeed during the study and up to 6 months after treatment with paclitaxel, bevacizumab and pegylated liposomal doxorubicin (PLD).\n39. For France only: Patients deprived of their liberty by judicial or administrative decision and patients under a legal protection measure or unable to express their consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer",
"criterions": [
{
"exact_snippets": "histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": [
"ovarian",
"fallopian tube",
"primary peritoneal"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": [
"ovarian",
"fallopian tube",
"primary peritoneal"
]
}
}
]
}
},
{
"identified_line": {
"line": "2. Relapsed disease",
"criterions": [
{
"exact_snippets": "Relapsed disease",
"criterion": "disease status",
"requirement": {
"requirement_type": "status",
"expected_value": "relapsed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Relapsed disease",
"criterion": "disease status",
"requirement": {
"requirement_type": "status",
"expected_value": "relapsed"
}
}
]
}
},
{
"identified_line": {
"line": "3. Patients with up to three prior therapies. In patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months; in addition patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines are also eligible",
"criterions": [
{
"exact_snippets": "Patients with up to three prior therapies",
"criterion": "prior therapies",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months",
"criterion": "treatment free interval after platinum",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 6,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines",
"criterion": "consideration for platinum-containing chemotherapy",
"requirement": {
"requirement_type": "consideration",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients with up to three prior therapies",
"criterion": "prior therapies",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
},
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months",
"criterion": "prior therapies",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months",
"criterion": "treatment free interval after platinum",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines",
"criterion": "prior therapies",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "=",
"value": 3,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines",
"criterion": "consideration for platinum-containing chemotherapy",
"requirement": {
"requirement_type": "consideration",
"expected_value": false
}
}
]
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "4. Measurable disease, evaluable disease in combination with GCIG CA-125 criteria, or histologically proven relapse/progression",
"criterions": [
{
"exact_snippets": "Measurable disease",
"criterion": "disease",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
},
{
"exact_snippets": "evaluable disease in combination with GCIG CA-125 criteria",
"criterion": "disease",
"requirement": {
"requirement_type": "evaluability",
"expected_value": true
}
},
{
"exact_snippets": "evaluable disease in combination with GCIG CA-125 criteria",
"criterion": "disease",
"requirement": {
"requirement_type": "GCIG CA-125 criteria",
"expected_value": true
}
},
{
"exact_snippets": "histologically proven relapse/progression",
"criterion": "relapse/progression",
"requirement": {
"requirement_type": "histological proof",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "evaluable disease in combination with GCIG CA-125 criteria",
"criterion": "disease",
"requirement": {
"requirement_type": "evaluability",
"expected_value": true
}
},
{
"exact_snippets": "evaluable disease in combination with GCIG CA-125 criteria",
"criterion": "disease",
"requirement": {
"requirement_type": "GCIG CA-125 criteria",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Measurable disease",
"criterion": "disease",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
},
{
"exact_snippets": "histologically proven relapse/progression",
"criterion": "relapse/progression",
"requirement": {
"requirement_type": "histological proof",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Mandatory de novo tumor biopsy (not older than 3 months) sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of PDL1 status prior to randomization for stratification.",
"criterions": [
{
"exact_snippets": "Mandatory de novo tumor biopsy",
"criterion": "tumor biopsy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "not older than 3 months",
"criterion": "tumor biopsy age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "sent to central laboratory",
"criterion": "tumor biopsy submission",
"requirement": {
"requirement_type": "destination",
"expected_value": "central laboratory"
}
},
{
"exact_snippets": "formalin-fixed, paraffin-embedded (FFPE) sample",
"criterion": "tumor biopsy preparation",
"requirement": {
"requirement_type": "method",
"expected_value": "formalin-fixed, paraffin-embedded (FFPE)"
}
},
{
"exact_snippets": "determination of PDL1 status",
"criterion": "PDL1 status",
"requirement": {
"requirement_type": "determination",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Mandatory de novo tumor biopsy",
"criterion": "tumor biopsy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "not older than 3 months",
"criterion": "tumor biopsy age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "sent to central laboratory",
"criterion": "tumor biopsy submission",
"requirement": {
"requirement_type": "destination",
"expected_value": "central laboratory"
}
},
{
"exact_snippets": "formalin-fixed, paraffin-embedded (FFPE) sample",
"criterion": "tumor biopsy preparation",
"requirement": {
"requirement_type": "method",
"expected_value": "formalin-fixed, paraffin-embedded (FFPE)"
}
},
{
"exact_snippets": "determination of PDL1 status",
"criterion": "PDL1 status",
"requirement": {
"requirement_type": "determination",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)",
"criterions": [
{
"exact_snippets": "Availability of a representative archival FFPE tumor sample",
"criterion": "archival FFPE tumor sample",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "preferable from primary diagnosis",
"criterion": "source of tumor sample",
"requirement": {
"requirement_type": "preference",
"expected_value": "primary diagnosis"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Availability of a representative archival FFPE tumor sample",
"criterion": "archival FFPE tumor sample",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "preferable from primary diagnosis",
"criterion": "source of tumor sample",
"requirement": {
"requirement_type": "preference",
"expected_value": "primary diagnosis"
}
}
]
}
},
{
"identified_line": {
"line": "7. Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line",
"criterions": [
{
"exact_snippets": "Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel)",
"criterion": "progression on chemotherapy",
"requirement": {
"requirement_type": "progression",
"expected_value": false
}
},
{
"exact_snippets": "in any prior line",
"criterion": "prior line of chemotherapy",
"requirement": {
"requirement_type": "progression",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel)",
"criterion": "progression on chemotherapy",
"requirement": {
"requirement_type": "progression",
"expected_value": false
}
},
{
"exact_snippets": "in any prior line",
"criterion": "prior line of chemotherapy",
"requirement": {
"requirement_type": "progression",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "9. Females aged ≥ 18 years at signing at time of signing informed consent form",
"criterions": [
{
"exact_snippets": "Females",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "aged ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Females",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "aged ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "10. Signed written informed consent and ability to comply with the study protocol, in the investigator's judgement",
"criterions": [
{
"exact_snippets": "Signed written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "ability to comply with the study protocol",
"criterion": "compliance with study protocol",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Signed written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "ability to comply with the study protocol",
"criterion": "compliance with study protocol",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "11. Adequate hematological, renal and hepatic function within 28 days prior to first administration of study treatment:",
"criterions": [
{
"exact_snippets": "Adequate hematological ... function",
"criterion": "hematological function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hepatic function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate hematological ... function",
"criterion": "hematological function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hepatic function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin ≥ 9.0 g/dL",
"criterions": [
{
"exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9.0,
"unit": "g/dL"
}
}
}
]
},
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count (ANC) ≥ 1.5 x 10xE^9/L",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10xE^9/L",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "x 10xE^9/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10xE^9/L",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "x 10xE^9/L"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count ≥ 100 x 10xE^9/L",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 100 x 10xE^9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x 10xE^9/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelet count ≥ 100 x 10xE^9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x 10xE^9/L"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)",
"criterions": [
{
"exact_snippets": "Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional upper limit of normal (ULN)"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional upper limit of normal (ULN)"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN",
"criterions": [
{
"exact_snippets": "Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) ... ≤ 2.5 x ULN",
"criterion": "ASAT/SGOT levels",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ... ≤ 2.5 x ULN",
"criterion": "ALAT/SGPT levels",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "liver metastases are present ... values must be ≤ 5 x ULN",
"criterion": "ASAT/SGOT and ALAT/SGPT levels with liver metastases",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "x ULN"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "liver metastases are present ... values must be ≤ 5 x ULN",
"criterion": "liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "liver metastases are present ... values must be ≤ 5 x ULN",
"criterion": "ASAT/SGOT and ALAT/SGPT levels with liver metastases",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "x ULN"
}
}
}
]
},
"else_criteria": {
"and_criteria": [
{
"exact_snippets": "Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) ... ≤ 2.5 x ULN",
"criterion": "ASAT/SGOT levels",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ... ≤ 2.5 x ULN",
"criterion": "ALAT/SGPT levels",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
}
]
}
}
},
{
"identified_line": {
"line": "* Serum creatinine ≤ 1.5 x institutional ULN",
"criterions": [
{
"exact_snippets": "Serum creatinine ≤ 1.5 x institutional ULN",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Serum creatinine ≤ 1.5 x institutional ULN",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization",
"criterions": [
{
"exact_snippets": "Patient not receiving anticoagulant medication",
"criterion": "anticoagulant medication",
"requirement": {
"requirement_type": "receiving",
"expected_value": false
}
},
{
"exact_snippets": "International Normalized Ratio (INR) ≤ 1.5",
"criterion": "International Normalized Ratio (INR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN",
"criterion": "Activated ProThrombin Time (aPTT)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "use of full-dose oral or parenteral anticoagulants is permitted ... INR or aPTT is within therapeutic limits",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "permitted",
"expected_value": true
}
},
{
"exact_snippets": "use of full-dose oral or parenteral anticoagulants is permitted ... INR or aPTT is within therapeutic limits",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "INR or aPTT within therapeutic limits",
"expected_value": true
}
},
{
"exact_snippets": "If the patient is on oral anticoagulants, dose has to be stable for at least two weeks",
"criterion": "oral anticoagulant dose stability",
"requirement": {
"requirement_type": "stability duration",
"expected_value": "at least two weeks"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patient not receiving anticoagulant medication",
"criterion": "anticoagulant medication",
"requirement": {
"requirement_type": "receiving",
"expected_value": false
}
},
{
"exact_snippets": "International Normalized Ratio (INR) ≤ 1.5",
"criterion": "International Normalized Ratio (INR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN",
"criterion": "Activated ProThrombin Time (aPTT)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "use of full-dose oral or parenteral anticoagulants is permitted ... INR or aPTT is within therapeutic limits",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "permitted",
"expected_value": true
}
},
{
"exact_snippets": "use of full-dose oral or parenteral anticoagulants is permitted ... INR or aPTT is within therapeutic limits",
"criterion": "anticoagulant use",
"requirement": {
"requirement_type": "INR or aPTT within therapeutic limits",
"expected_value": true
}
},
{
"exact_snippets": "If the patient is on oral anticoagulants, dose has to be stable for at least two weeks",
"criterion": "oral anticoagulant dose stability",
"requirement": {
"requirement_type": "stability duration",
"expected_value": "at least two weeks"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24-hours urine must demonstrate ≤ 1 g of protein in 24 hours.",
"criterions": [
{
"exact_snippets": "Urine dipstick for proteinuria < 2+",
"criterion": "urine dipstick proteinuria",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "+"
}
}
},
{
"exact_snippets": "If urine dipstick is ≥ 2+ ... 24-hours urine must demonstrate ≤ 1 g of protein in 24 hours",
"criterion": "24-hour urine protein",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "g"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Urine dipstick for proteinuria < 2+",
"criterion": "urine dipstick proteinuria",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "+"
}
}
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "If urine dipstick is ≥ 2+ ... 24-hours urine must demonstrate ≤ 1 g of protein in 24 hours",
"criterion": "24-hour urine protein",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "g"
}
}
}
}
},
{
"identified_line": {
"line": "12. Patients must have adequately controlled blood pressure (BP), with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study.",
"criterions": [
{
"exact_snippets": "adequately controlled blood pressure (BP)",
"criterion": "blood pressure",
"requirement": {
"requirement_type": "control",
"expected_value": "adequately controlled"
}
},
{
"exact_snippets": "systolic BP of ≤ 140 mmHg",
"criterion": "systolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 140,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "diastolic BP of ≤ 90 mmHg",
"criterion": "diastolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study",
"criterion": "blood pressure measurement",
"requirement": {
"requirement_type": "setting",
"expected_value": "clinic"
}
},
{
"exact_snippets": "BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study",
"criterion": "blood pressure measurement",
"requirement": {
"requirement_type": "professional",
"expected_value": "medical professional"
}
},
{
"exact_snippets": "BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study",
"criterion": "blood pressure measurement",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 2 weeks prior to starting study"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "adequately controlled blood pressure (BP)",
"criterion": "blood pressure",
"requirement": {
"requirement_type": "control",
"expected_value": "adequately controlled"
}
},
{
"exact_snippets": "systolic BP of ≤ 140 mmHg",
"criterion": "systolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 140,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "diastolic BP of ≤ 90 mmHg",
"criterion": "diastolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "mmHg"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study",
"criterion": "blood pressure measurement",
"requirement": {
"requirement_type": "setting",
"expected_value": "clinic"
}
},
{
"exact_snippets": "BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study",
"criterion": "blood pressure measurement",
"requirement": {
"requirement_type": "professional",
"expected_value": "medical professional"
}
},
{
"exact_snippets": "BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study",
"criterion": "blood pressure measurement",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 2 weeks prior to starting study"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "13. Estimated life expectancy of at least 3 months",
"criterions": [
{
"exact_snippets": "Estimated life expectancy of at least 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Estimated life expectancy of at least 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "14. ECOG performance status 0 - 1",
"criterions": [
{
"exact_snippets": "ECOG performance status 0 - 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG performance status 0 - 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "15. Negative urine or serum pregnancy test within 7 days of study treatment in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1",
"criterions": [
{
"exact_snippets": "Negative urine or serum pregnancy test ... in women of childbearing potential (WOCBP)",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "women of childbearing potential (WOCBP)",
"criterion": "women of childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "women of childbearing potential (WOCBP)",
"criterion": "women of childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Negative urine or serum pregnancy test ... in women of childbearing potential (WOCBP)",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "16. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later.",
"criterions": [
{
"exact_snippets": "women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "agreement to remain abstinent (refrain from heterosexual intercourse)",
"criterion": "abstinence",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "use a contraceptive method with a failure rate of < 1% per year",
"criterion": "contraceptive method",
"requirement": {
"requirement_type": "failure rate",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "% per year"
}
}
},
{
"exact_snippets": "during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later",
"criterion": "duration of contraceptive use",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "agreement to remain abstinent (refrain from heterosexual intercourse)",
"criterion": "abstinence",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "use a contraceptive method with a failure rate of < 1% per year",
"criterion": "contraceptive method",
"requirement": {
"requirement_type": "failure rate",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "% per year"
}
}
},
{
"exact_snippets": "during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later",
"criterion": "duration of contraceptive use",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later"
}
}
]
}
]
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "17. For countries where this will apply to: a patient will be eligible for randomization in this study only, if either affiliated to, or a beneficiary of a social security category.",
"criterions": [
{
"exact_snippets": "affiliated to ... a social security category",
"criterion": "social security affiliation",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
},
{
"exact_snippets": "beneficiary of a social security category",
"criterion": "social security beneficiary",
"requirement": {
"requirement_type": "beneficiary status",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "For countries where this will apply to",
"criterion": "country applicability",
"requirement": {
"requirement_type": "applicability",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "a patient will be eligible for randomization in this study only",
"criterion": "randomization eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "affiliated to ... a social security category",
"criterion": "social security affiliation",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
},
{
"exact_snippets": "beneficiary of a social security category",
"criterion": "social security beneficiary",
"requirement": {
"requirement_type": "beneficiary status",
"expected_value": true
}
}
]
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "18. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, that include the completion of patient-reported outcomes questionnaires.",
"criterions": [
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plans",
"criterion": "compliance with treatment plans",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plans",
"criterion": "compliance with treatment plans",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... completion of patient-reported outcomes questionnaires",
"criterion": "completion of patient-reported outcomes questionnaires",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... completion of patient-reported outcomes questionnaires",
"criterion": "completion of patient-reported outcomes questionnaires",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plans",
"criterion": "compliance with treatment plans",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plans",
"criterion": "compliance with treatment plans",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... completion of patient-reported outcomes questionnaires",
"criterion": "completion of patient-reported outcomes questionnaires",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... completion of patient-reported outcomes questionnaires",
"criterion": "completion of patient-reported outcomes questionnaires",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"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 be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"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": "1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors)",
"criterions": [
{
"exact_snippets": "Non-epithelial tumor origin of the ovary",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "location",
"expected_value": "ovary"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of the ovary",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of ... the fallopian tube",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "location",
"expected_value": "fallopian tube"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of ... the fallopian tube",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of ... the peritoneum",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "location",
"expected_value": "peritoneum"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of ... the peritoneum",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Non-epithelial tumor origin of the ovary",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "location",
"expected_value": "ovary"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of the ovary",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Non-epithelial tumor origin of ... the fallopian tube",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "location",
"expected_value": "fallopian tube"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of ... the fallopian tube",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Non-epithelial tumor origin of ... the peritoneum",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "location",
"expected_value": "peritoneum"
}
},
{
"exact_snippets": "Non-epithelial tumor origin of ... the peritoneum",
"criterion": "tumor origin",
"requirement": {
"requirement_type": "type",
"expected_value": "non-epithelial"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Ovarian tumors of low malignant potential (e.g. borderline tumors)",
"criterions": [
{
"exact_snippets": "Ovarian tumors of low malignant potential (e.g. borderline tumors)",
"criterion": "ovarian tumors",
"requirement": {
"requirement_type": "malignant potential",
"expected_value": "low"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Ovarian tumors of low malignant potential (e.g. borderline tumors)",
"criterion": "ovarian tumors",
"requirement": {
"requirement_type": "malignant potential",
"expected_value": "low"
}
}
}
},
{
"identified_line": {
"line": "4. More than three prior systemic anticancer regimens; maintenance therapies (e.g. with bevacizumab, olaparib or niraparib) are not calculated as separate line.",
"criterions": [
{
"exact_snippets": "More than three prior systemic anticancer regimens",
"criterion": "prior systemic anticancer regimens",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "N/A"
}
}
},
{
"exact_snippets": "maintenance therapies (e.g. with bevacizumab, olaparib or niraparib) are not calculated as separate line",
"criterion": "maintenance therapies",
"requirement": {
"requirement_type": "calculation as separate line",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "More than three prior systemic anticancer regimens",
"criterion": "prior systemic anticancer regimens",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "N/A"
}
}
},
{
"not_criteria": {
"exact_snippets": "maintenance therapies (e.g. with bevacizumab, olaparib or niraparib) are not calculated as separate line",
"criterion": "maintenance therapies",
"requirement": {
"requirement_type": "calculation as separate line",
"expected_value": false
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "5. Prior systemic anticancer therapy within 28 days before randomization (except bevacizumab: 20 days).",
"criterions": [
{
"exact_snippets": "Prior systemic anticancer therapy within 28 days before randomization",
"criterion": "prior systemic anticancer therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
},
{
"exact_snippets": "(except bevacizumab: 20 days)",
"criterion": "prior bevacizumab therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 20,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior systemic anticancer therapy within 28 days before randomization",
"criterion": "prior systemic anticancer therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
},
{
"not_criteria": {
"exact_snippets": "(except bevacizumab: 20 days)",
"criterion": "prior bevacizumab therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 20,
"unit": "days"
}
}
}
}
]
},
{
"exact_snippets": "(except bevacizumab: 20 days)",
"criterion": "prior bevacizumab therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 20,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "6. Prior radiotherapy to the pelvis or the abdomen.",
"criterions": [
{
"exact_snippets": "Prior radiotherapy to the pelvis",
"criterion": "prior radiotherapy to the pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Prior radiotherapy to ... the abdomen",
"criterion": "prior radiotherapy to the abdomen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Prior radiotherapy to the pelvis",
"criterion": "prior radiotherapy to the pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Prior radiotherapy to ... the abdomen",
"criterion": "prior radiotherapy to the abdomen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "7. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement thera-py is permitted).",
"criterions": [
{
"exact_snippets": "Administration of other simultaneous chemotherapy drugs",
"criterion": "simultaneous chemotherapy drugs",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
},
{
"exact_snippets": "any other anticancer therapy",
"criterion": "anticancer therapy",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
},
{
"exact_snippets": "anti-neoplastic hormonal therapy",
"criterion": "anti-neoplastic hormonal therapy",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
},
{
"exact_snippets": "simultaneous radiotherapy during the trial treatment period",
"criterion": "simultaneous radiotherapy",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Administration of other simultaneous chemotherapy drugs",
"criterion": "simultaneous chemotherapy drugs",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
},
{
"exact_snippets": "simultaneous radiotherapy during the trial treatment period",
"criterion": "simultaneous radiotherapy",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
}
]
},
{
"exact_snippets": "any other anticancer therapy",
"criterion": "anticancer therapy",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
},
{
"exact_snippets": "anti-neoplastic hormonal therapy",
"criterion": "anti-neoplastic hormonal therapy",
"requirement": {
"requirement_type": "administration",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "8. Prior treatment with anti-CD137 or immune checkpoint blockade therapies, anti-PD1, or anti-PD-L1 therapeutic antibodies or anti-CTLA 4",
"criterions": [
{
"exact_snippets": "Prior treatment with anti-CD137",
"criterion": "prior treatment with anti-CD137",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "immune checkpoint blockade therapies",
"criterion": "prior treatment with immune checkpoint blockade therapies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "anti-PD1",
"criterion": "prior treatment with anti-PD1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "anti-PD-L1 therapeutic antibodies",
"criterion": "prior treatment with anti-PD-L1 therapeutic antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "anti-CTLA 4",
"criterion": "prior treatment with anti-CTLA 4",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior treatment with anti-CD137",
"criterion": "prior treatment with anti-CD137",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "immune checkpoint blockade therapies",
"criterion": "prior treatment with immune checkpoint blockade therapies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "anti-PD1",
"criterion": "prior treatment with anti-PD1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "anti-PD-L1 therapeutic antibodies",
"criterion": "prior treatment with anti-PD-L1 therapeutic antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "anti-CTLA 4",
"criterion": "prior treatment with anti-CTLA 4",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "9. Prior randomization in AGO-OVAR 2.29.",
"criterions": [
{
"exact_snippets": "Prior randomization in AGO-OVAR 2.29",
"criterion": "randomization in AGO-OVAR 2.29",
"requirement": {
"requirement_type": "prior",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior randomization in AGO-OVAR 2.29",
"criterion": "randomization in AGO-OVAR 2.29",
"requirement": {
"requirement_type": "prior",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "10. Treatment with systemic immunostimulatory agents (in-cluding but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to cycle 1, day 1.",
"criterions": [
{
"exact_snippets": "Treatment with systemic immunostimulatory agents (in-cluding but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to cycle 1, day 1.",
"criterion": "treatment with systemic immunostimulatory agents",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 4,
"unit": "weeks"
}
]
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Treatment with systemic immunostimulatory agents (in-cluding but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to cycle 1, day 1.",
"criterion": "treatment with systemic immunostimulatory agents",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 4,
"unit": "weeks"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "11. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophos-phamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.",
"criterions": [
{
"exact_snippets": "Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophos-phamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1",
"criterion": "systemic corticosteroids or other systemic immunosuppressive medications",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
},
{
"exact_snippets": "anticipated requirement for systemic immunosuppressive medications during the trial",
"criterion": "systemic immunosuppressive medications",
"requirement": {
"requirement_type": "anticipated requirement",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophos-phamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1",
"criterion": "systemic corticosteroids or other systemic immunosuppressive medications",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "anticipated requirement for systemic immunosuppressive medications during the trial",
"criterion": "systemic immunosuppressive medications",
"requirement": {
"requirement_type": "anticipated requirement",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "12. Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have screening and subsequent tumor assessments performed using magnetic resonance imaging (MRI).",
"criterions": [
{
"exact_snippets": "history of allergic reaction to IV contrast",
"criterion": "allergic reaction to IV contrast",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "requiring steroid pre-treatment",
"criterion": "steroid pre-treatment",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "history of allergic reaction to IV contrast",
"criterion": "allergic reaction to IV contrast",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "requiring steroid pre-treatment",
"criterion": "steroid pre-treatment",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "13. Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1, day 1 or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab/placebo. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination",
"criterions": [
{
"exact_snippets": "Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1, day 1",
"criterion": "live, attenuated vaccine administration",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "live, attenuated vaccine requirement",
"requirement": {
"requirement_type": "time frame",
"expected_value": "during the study or within 5 months after the last dose of atezolizumab/placebo"
}
},
{
"exact_snippets": "Influenza vaccination should be given during influenza season only",
"criterion": "influenza vaccination timing",
"requirement": {
"requirement_type": "season",
"expected_value": "influenza season only"
}
},
{
"exact_snippets": "Patients must not receive live, attenuated influenza vaccination",
"criterion": "live, attenuated influenza vaccination",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1, day 1",
"criterion": "live, attenuated vaccine administration",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "live, attenuated vaccine requirement",
"requirement": {
"requirement_type": "time frame",
"expected_value": "during the study or within 5 months after the last dose of atezolizumab/placebo"
}
}
]
},
{
"exact_snippets": "Patients must not receive live, attenuated influenza vaccination",
"criterion": "live, attenuated influenza vaccination",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Influenza vaccination should be given during influenza season only",
"criterion": "influenza vaccination timing",
"requirement": {
"requirement_type": "season",
"expected_value": "influenza season only"
}
}
]
}
},
{
"identified_line": {
"line": "15. Previous allogeneic bone marrow transplant or previous solid organ transplantation.",
"criterions": [
{
"exact_snippets": "Previous allogeneic bone marrow transplant",
"criterion": "allogeneic bone marrow transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "previous solid organ transplantation",
"criterion": "solid organ transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Previous allogeneic bone marrow transplant",
"criterion": "allogeneic bone marrow transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "previous solid organ transplantation",
"criterion": "solid organ transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "16. Current treatment with anti-viral therapy for HBV.",
"criterions": [
{
"exact_snippets": "Current treatment with anti-viral therapy for HBV",
"criterion": "anti-viral therapy for HBV",
"requirement": {
"requirement_type": "current treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Current treatment with anti-viral therapy for HBV",
"criterion": "anti-viral therapy for HBV",
"requirement": {
"requirement_type": "current treatment",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "18. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization",
"criterions": [
{
"exact_snippets": "Previous Cerebro-Vascular Accident (CVA) ... within 6 months prior to randomization",
"criterion": "Cerebro-Vascular Accident (CVA)",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "Previous ... Transient Ischemic Attack (TIA) ... within 6 months prior to randomization",
"criterion": "Transient Ischemic Attack (TIA)",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "Previous ... Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization",
"criterion": "Sub-Arachnoids Hemorrhage (SAH)",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Previous Cerebro-Vascular Accident (CVA) ... within 6 months prior to randomization",
"criterion": "Cerebro-Vascular Accident (CVA)",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Previous ... Transient Ischemic Attack (TIA) ... within 6 months prior to randomization",
"criterion": "Transient Ischemic Attack (TIA)",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Previous ... Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization",
"criterion": "Sub-Arachnoids Hemorrhage (SAH)",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "20. Patients are excluded if having a history or evidence of thrombosis as follows:",
"criterions": [
{
"exact_snippets": "history or evidence of thrombosis",
"criterion": "thrombosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "history or evidence of thrombosis",
"criterion": "thrombosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Any Grade 4 thrombosis",
"criterions": [
{
"exact_snippets": "Any Grade 4 thrombosis",
"criterion": "thrombosis",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 4"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Any Grade 4 thrombosis",
"criterion": "thrombosis",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 4"
}
}
}
},
{
"identified_line": {
"line": "* Arterial thrombosis within 6 months prior to ran-domization",
"criterions": [
{
"exact_snippets": "Arterial thrombosis within 6 months prior to ran-domization",
"criterion": "arterial thrombosis",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 6 months prior to randomization"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Arterial thrombosis within 6 months prior to ran-domization",
"criterion": "arterial thrombosis",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 6 months prior to randomization"
}
}
}
},
{
"identified_line": {
"line": "* Grade ≤ 3 venous thrombosis within 3 months prior to randomization Patients with central venous access thrombosis are eligi-ble.",
"criterions": [
{
"exact_snippets": "Grade ≤ 3 venous thrombosis",
"criterion": "venous thrombosis",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "grade"
}
}
},
{
"exact_snippets": "within 3 months prior to randomization",
"criterion": "venous thrombosis",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 3 months prior to randomization"
}
},
{
"exact_snippets": "central venous access thrombosis",
"criterion": "central venous access thrombosis",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Grade ≤ 3 venous thrombosis",
"criterion": "venous thrombosis",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "grade"
}
}
},
{
"exact_snippets": "within 3 months prior to randomization",
"criterion": "venous thrombosis",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "within 3 months prior to randomization"
}
}
]
},
{
"not_criteria": {
"exact_snippets": "central venous access thrombosis",
"criterion": "central venous access thrombosis",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
}
]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "21. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of sus-pected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of sus-pected spinal cord compression",
"criterions": [
{
"exact_snippets": "History or clinical suspicion of brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "history or suspicion",
"expected_value": true
}
},
{
"exact_snippets": "History or clinical suspicion of ... spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "history or suspicion",
"expected_value": true
}
},
{
"exact_snippets": "CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of sus-pected brain metastases",
"criterion": "CT/MRI of the brain",
"requirement": {
"requirement_type": "mandatory",
"expected_value": true
}
},
{
"exact_snippets": "CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of sus-pected brain metastases",
"criterion": "CT/MRI of the brain",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of sus-pected spinal cord compression",
"criterion": "Spinal MRI",
"requirement": {
"requirement_type": "mandatory",
"expected_value": true
}
},
{
"exact_snippets": "Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of sus-pected spinal cord compression",
"criterion": "Spinal MRI",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History or clinical suspicion of brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "history or suspicion",
"expected_value": true
}
},
{
"condition": {
"exact_snippets": "History or clinical suspicion of brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "history or suspicion",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of sus-pected brain metastases",
"criterion": "CT/MRI of the brain",
"requirement": {
"requirement_type": "mandatory",
"expected_value": true
}
},
{
"exact_snippets": "CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of sus-pected brain metastases",
"criterion": "CT/MRI of the brain",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"else_criteria": null
}
]
},
{
"and_criteria": [
{
"exact_snippets": "History or clinical suspicion of ... spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "history or suspicion",
"expected_value": true
}
},
{
"condition": {
"exact_snippets": "History or clinical suspicion of ... spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "history or suspicion",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of sus-pected spinal cord compression",
"criterion": "Spinal MRI",
"requirement": {
"requirement_type": "mandatory",
"expected_value": true
}
},
{
"exact_snippets": "Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of sus-pected spinal cord compression",
"criterion": "Spinal MRI",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"else_criteria": null
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "22. History of autoimmune disease, including but not limited to dermatomyositis, myasthenia gravis, myositis, auto-immune hepatitis, systemic lupus erythematosus, rheu-matoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guil-lain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Except patients with:",
"criterions": [
{
"exact_snippets": "History of autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "dermatomyositis",
"criterion": "dermatomyositis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myasthenia gravis",
"criterion": "myasthenia gravis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myositis",
"criterion": "myositis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "auto-immune hepatitis",
"criterion": "auto-immune hepatitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "systemic lupus erythematosus",
"criterion": "systemic lupus erythematosus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "rheu-matoid arthritis",
"criterion": "rheumatoid arthritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "vascular thrombosis associated with anti-phospholipid syndrome",
"criterion": "vascular thrombosis associated with anti-phospholipid syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Wegener's granulomatosis",
"criterion": "Wegener's granulomatosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Sjögren's syndrome",
"criterion": "Sjögren's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Guil-lain-Barré syndrome",
"criterion": "Guillain-Barré syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "multiple sclerosis",
"criterion": "multiple sclerosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "vasculitis",
"criterion": "vasculitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "glomerulonephritis",
"criterion": "glomerulonephritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "History of autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "dermatomyositis",
"criterion": "dermatomyositis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myasthenia gravis",
"criterion": "myasthenia gravis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myositis",
"criterion": "myositis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "auto-immune hepatitis",
"criterion": "auto-immune hepatitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "systemic lupus erythematosus",
"criterion": "systemic lupus erythematosus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "rheu-matoid arthritis",
"criterion": "rheumatoid arthritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "vascular thrombosis associated with anti-phospholipid syndrome",
"criterion": "vascular thrombosis associated with anti-phospholipid syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Wegener's granulomatosis",
"criterion": "Wegener's granulomatosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Sjögren's syndrome",
"criterion": "Sjögren's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Guil-lain-Barré syndrome",
"criterion": "Guillain-Barré syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "multiple sclerosis",
"criterion": "multiple sclerosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "vasculitis",
"criterion": "vasculitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "glomerulonephritis",
"criterion": "glomerulonephritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"not_criteria": {
"or_criteria": [
{
"exact_snippets": "dermatomyositis",
"criterion": "dermatomyositis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myasthenia gravis",
"criterion": "myasthenia gravis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myositis",
"criterion": "myositis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "auto-immune hepatitis",
"criterion": "auto-immune hepatitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "systemic lupus erythematosus",
"criterion": "systemic lupus erythematosus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "rheu-matoid arthritis",
"criterion": "rheumatoid arthritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "vascular thrombosis associated with anti-phospholipid syndrome",
"criterion": "vascular thrombosis associated with anti-phospholipid syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Wegener's granulomatosis",
"criterion": "Wegener's granulomatosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Sjögren's syndrome",
"criterion": "Sjögren's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Guil-lain-Barré syndrome",
"criterion": "Guillain-Barré syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "multiple sclerosis",
"criterion": "multiple sclerosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "vasculitis",
"criterion": "vasculitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "glomerulonephritis",
"criterion": "glomerulonephritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone",
"criterions": [
{
"exact_snippets": "a history of autoimmune hypothyroidism",
"criterion": "autoimmune hypothyroidism",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "a stable dose of thyroid replacement hormone",
"criterion": "thyroid replacement hormone",
"requirement": {
"requirement_type": "dose stability",
"expected_value": "stable"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "a history of autoimmune hypothyroidism",
"criterion": "autoimmune hypothyroidism",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "a stable dose of thyroid replacement hormone",
"criterion": "thyroid replacement hormone",
"requirement": {
"requirement_type": "dose stability",
"expected_value": "stable"
}
}
]
}
},
{
"identified_line": {
"line": "* controlled type 1 diabetes mellitus on a stable insulin regimen",
"criterions": [
{
"exact_snippets": "controlled type 1 diabetes mellitus",
"criterion": "type 1 diabetes mellitus",
"requirement": {
"requirement_type": "control",
"expected_value": "controlled"
}
},
{
"exact_snippets": "stable insulin regimen",
"criterion": "insulin regimen",
"requirement": {
"requirement_type": "stability",
"expected_value": "stable"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "controlled type 1 diabetes mellitus",
"criterion": "type 1 diabetes mellitus",
"requirement": {
"requirement_type": "control",
"expected_value": "controlled"
}
},
{
"exact_snippets": "stable insulin regimen",
"criterion": "insulin regimen",
"requirement": {
"requirement_type": "stability",
"expected_value": "stable"
}
}
]
}
},
{
"identified_line": {
"line": "Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:",
"criterions": [
{
"exact_snippets": "eczema",
"criterion": "eczema",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "psoriasis",
"criterion": "psoriasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "lichen simplex chronicus",
"criterion": "lichen simplex chronicus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "vitiligo",
"criterion": "vitiligo",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dermatologic manifestations only",
"criterion": "dermatologic manifestations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients with psoriatic arthritis are excluded",
"criterion": "psoriatic arthritis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "eczema",
"criterion": "eczema",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dermatologic manifestations only",
"criterion": "dermatologic manifestations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "psoriasis",
"criterion": "psoriasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dermatologic manifestations only",
"criterion": "dermatologic manifestations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "lichen simplex chronicus",
"criterion": "lichen simplex chronicus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dermatologic manifestations only",
"criterion": "dermatologic manifestations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "vitiligo",
"criterion": "vitiligo",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "dermatologic manifestations only",
"criterion": "dermatologic manifestations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
},
{
"exact_snippets": "patients with psoriatic arthritis are excluded",
"criterion": "psoriatic arthritis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Rash must cover < 10% of body surface area",
"criterions": [
{
"exact_snippets": "Rash must cover < 10% of body surface area",
"criterion": "rash coverage",
"requirement": {
"requirement_type": "coverage",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "% of body surface area"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Rash must cover < 10% of body surface area",
"criterion": "rash coverage",
"requirement": {
"requirement_type": "coverage",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "% of body surface area"
}
}
}
}
},
{
"identified_line": {
"line": "* Disease is well controlled at baseline and requires only low-potency topical corticosteroids",
"criterions": [
{
"exact_snippets": "Disease is well controlled at baseline",
"criterion": "disease control",
"requirement": {
"requirement_type": "status",
"expected_value": "well controlled"
}
},
{
"exact_snippets": "requires only low-potency topical corticosteroids",
"criterion": "corticosteroid requirement",
"requirement": {
"requirement_type": "potency",
"expected_value": "low"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease is well controlled at baseline",
"criterion": "disease control",
"requirement": {
"requirement_type": "status",
"expected_value": "well controlled"
}
},
{
"exact_snippets": "requires only low-potency topical corticosteroids",
"criterion": "corticosteroid requirement",
"requirement": {
"requirement_type": "potency",
"expected_value": "low"
}
}
]
}
},
{
"identified_line": {
"line": "23. Any prior history of hypertensive crisis (CTCAE grade 4) or hypertensive encephalopathy.",
"criterions": [
{
"exact_snippets": "prior history of hypertensive crisis (CTCAE grade 4)",
"criterion": "hypertensive crisis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "prior history of hypertensive crisis (CTCAE grade 4)",
"criterion": "hypertensive crisis",
"requirement": {
"requirement_type": "severity",
"expected_value": "CTCAE grade 4"
}
},
{
"exact_snippets": "prior history of ... hypertensive encephalopathy",
"criterion": "hypertensive encephalopathy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "prior history of hypertensive crisis (CTCAE grade 4)",
"criterion": "hypertensive crisis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "prior history of hypertensive crisis (CTCAE grade 4)",
"criterion": "hypertensive crisis",
"requirement": {
"requirement_type": "severity",
"expected_value": "CTCAE grade 4"
}
}
]
},
{
"exact_snippets": "prior history of ... hypertensive encephalopathy",
"criterion": "hypertensive encephalopathy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "24. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.",
"criterions": [
{
"exact_snippets": "Immunocompromised patients",
"criterion": "immunocompromised status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "serologically positive for human immunodeficiency virus (HIV)",
"criterion": "HIV status",
"requirement": {
"requirement_type": "serological positivity",
"expected_value": true
}
},
{
"exact_snippets": "active hepatitis B ... positive hepatitis B surface antigen [HBsAg] test at screening",
"criterion": "hepatitis B status",
"requirement": {
"requirement_type": "active infection",
"expected_value": true
}
},
{
"exact_snippets": "active hepatitis B ... positive hepatitis B surface antigen [HBsAg] test at screening",
"criterion": "hepatitis B status",
"requirement": {
"requirement_type": "HBsAg test result",
"expected_value": "positive"
}
},
{
"exact_snippets": "hepatitis C",
"criterion": "hepatitis C status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Immunocompromised patients",
"criterion": "immunocompromised status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "serologically positive for human immunodeficiency virus (HIV)",
"criterion": "HIV status",
"requirement": {
"requirement_type": "serological positivity",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "active hepatitis B ... positive hepatitis B surface antigen [HBsAg] test at screening",
"criterion": "hepatitis B status",
"requirement": {
"requirement_type": "active infection",
"expected_value": true
}
},
{
"exact_snippets": "active hepatitis B ... positive hepatitis B surface antigen [HBsAg] test at screening",
"criterion": "hepatitis B status",
"requirement": {
"requirement_type": "HBsAg test result",
"expected_value": "positive"
}
}
]
},
{
"exact_snippets": "hepatitis C",
"criterion": "hepatitis C status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "25. Persistent toxicities (≥ CTCAE grade 2) with the exception of alopecia, caused by previous cancer treatment. Neurotoxicity CTCAE grade 2 is permitted in case the patient is planned for PLD treatment.",
"criterions": [
{
"exact_snippets": "Persistent toxicities (≥ CTCAE grade 2) ... caused by previous cancer treatment",
"criterion": "persistent toxicities",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "CTCAE grade"
}
}
},
{
"exact_snippets": "alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Neurotoxicity CTCAE grade 2",
"criterion": "neurotoxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "=",
"value": 2,
"unit": "CTCAE grade"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Persistent toxicities (≥ CTCAE grade 2) ... caused by previous cancer treatment",
"criterion": "persistent toxicities",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "CTCAE grade"
}
}
},
{
"not_criteria": {
"exact_snippets": "alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
]
}
},
{
"not_criteria": {
"exact_snippets": "Neurotoxicity CTCAE grade 2",
"criterion": "neurotoxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "=",
"value": 2,
"unit": "CTCAE grade"
}
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "26. Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization, including but not limited to active tuberculosis or hospitalization for complications of infection, bacteremia, or severe pneumonia. Patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.",
"criterions": [
{
"exact_snippets": "Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization",
"criterion": "severe infection",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization",
"criterion": "severe infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"oral antibiotics",
"IV antibiotics"
]
}
},
{
"exact_snippets": "Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization",
"criterion": "severe infection",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 weeks prior to randomization"
}
},
{
"exact_snippets": "active tuberculosis",
"criterion": "active tuberculosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hospitalization for complications of infection",
"criterion": "hospitalization for complications of infection",
"requirement": {
"requirement_type": "hospitalization",
"expected_value": true
}
},
{
"exact_snippets": "bacteremia",
"criterion": "bacteremia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe pneumonia",
"criterion": "severe pneumonia",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study",
"criterion": "prophylactic antibiotics",
"requirement": {
"requirement_type": "treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization",
"criterion": "severe infection",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization",
"criterion": "severe infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"oral antibiotics",
"IV antibiotics"
]
}
}
]
},
{
"exact_snippets": "Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization",
"criterion": "severe infection",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 weeks prior to randomization"
}
}
]
},
{
"not_criteria": {
"exact_snippets": "Patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study",
"criterion": "prophylactic antibiotics",
"requirement": {
"requirement_type": "treatment",
"expected_value": true
}
}
}
]
},
{
"exact_snippets": "active tuberculosis",
"criterion": "active tuberculosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hospitalization for complications of infection",
"criterion": "hospitalization for complications of infection",
"requirement": {
"requirement_type": "hospitalization",
"expected_value": true
}
},
{
"exact_snippets": "bacteremia",
"criterion": "bacteremia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe pneumonia",
"criterion": "severe pneumonia",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
}
},
{
"identified_line": {
"line": "27. Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.",
"criterions": [
{
"exact_snippets": "Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "chronic use",
"expected_value": true
}
},
{
"exact_snippets": "Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "dosage",
"expected_value": {
"operator": ">",
"value": 325,
"unit": "mg/day"
}
}
},
{
"exact_snippets": "Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "chronic use",
"expected_value": true
}
},
{
"exact_snippets": "Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "days"
}
}
}
]
},
{
"exact_snippets": "Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "dosage",
"expected_value": {
"operator": ">",
"value": 325,
"unit": "mg/day"
}
}
}
]
}
},
{
"identified_line": {
"line": "28. Clinically significant (e.g. active) cardiovascular disease, including:",
"criterions": [
{
"exact_snippets": "Clinically significant (e.g. active) cardiovascular disease",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "Clinically significant (e.g. active) cardiovascular disease",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Clinically significant (e.g. active) cardiovascular disease",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "Clinically significant (e.g. active) cardiovascular disease",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF)",
"criterions": [
{
"exact_snippets": "New York Heart Association (NYHA) ≥ grade 2",
"criterion": "NYHA grade",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "grade"
}
}
},
{
"exact_snippets": "congestive heart failure (CHF)",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "New York Heart Association (NYHA) ≥ grade 2",
"criterion": "NYHA grade",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "grade"
}
}
},
{
"exact_snippets": "congestive heart failure (CHF)",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Poorly controlled cardiac arrhythmia despite medica-tion (patients with rate controlled atrial fibrillation are eligible)",
"criterions": [
{
"exact_snippets": "Poorly controlled cardiac arrhythmia despite medica-tion",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "control",
"expected_value": "poorly controlled despite medication"
}
},
{
"exact_snippets": "rate controlled atrial fibrillation",
"criterion": "atrial fibrillation",
"requirement": {
"requirement_type": "control",
"expected_value": "rate controlled"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Poorly controlled cardiac arrhythmia despite medica-tion",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "control",
"expected_value": "poorly controlled despite medication"
}
},
"then_criteria": {
"not_criteria": {
"exact_snippets": "rate controlled atrial fibrillation",
"criterion": "atrial fibrillation",
"requirement": {
"requirement_type": "control",
"expected_value": "rate controlled"
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision)",
"criterions": [
{
"exact_snippets": "Peripheral vascular disease grade ≥ 3",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "grade",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "N/A"
}
}
},
{
"exact_snippets": "symptomatic and interfering with activities of daily living [ADL]",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "symptoms",
"expected_value": "interfering with activities of daily living"
}
},
{
"exact_snippets": "requiring repair or revision",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "repair or revision"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Peripheral vascular disease grade ≥ 3",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "grade",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "N/A"
}
}
},
{
"exact_snippets": "symptomatic and interfering with activities of daily living [ADL]",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "symptoms",
"expected_value": "interfering with activities of daily living"
}
}
]
},
{
"exact_snippets": "requiring repair or revision",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "repair or revision"
}
}
]
}
},
{
"identified_line": {
"line": "* Resting ECG with QTc >470 msec or family history of long QT syndrome",
"criterions": [
{
"exact_snippets": "Resting ECG with QTc >470 msec",
"criterion": "QTc interval",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 470,
"unit": "msec"
}
}
},
{
"exact_snippets": "family history of long QT syndrome",
"criterion": "family history of long QT syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Resting ECG with QTc >470 msec",
"criterion": "QTc interval",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 470,
"unit": "msec"
}
}
},
{
"exact_snippets": "family history of long QT syndrome",
"criterion": "family history of long QT syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "29. For patients with PLD treatment: Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal",
"criterions": [
{
"exact_snippets": "Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal",
"criterion": "left ventricular ejection fraction",
"requirement": {
"requirement_type": "measurement",
"expected_value": "below the institutional lower limit of normal"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "For patients with PLD treatment",
"criterion": "PLD treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal",
"criterion": "left ventricular ejection fraction",
"requirement": {
"requirement_type": "measurement",
"expected_value": "below the institutional lower limit of normal"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "30. Evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation).",
"criterions": [
{
"exact_snippets": "Evidence of bleeding diathesis",
"criterion": "bleeding diathesis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "significant coagulopathy (in the absence of anticoagulation)",
"criterion": "significant coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Evidence of bleeding diathesis",
"criterion": "bleeding diathesis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"and_criteria": [
{
"exact_snippets": "significant coagulopathy (in the absence of anticoagulation)",
"criterion": "significant coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "significant coagulopathy (in the absence of anticoagulation)",
"criterion": "anticoagulation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "31. Non-healing wound, active ulcer or bone fracture.",
"criterions": [
{
"exact_snippets": "Non-healing wound",
"criterion": "wound",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "active ulcer",
"criterion": "ulcer",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
},
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Non-healing wound",
"criterion": "wound",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "active ulcer",
"criterion": "ulcer",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
},
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "33. Patients with evidence of abdominal free air.",
"criterions": [
{
"exact_snippets": "evidence of abdominal free air",
"criterion": "abdominal free air",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "evidence of abdominal free air",
"criterion": "abdominal free air",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "34. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications",
"criterions": [
{
"exact_snippets": "Evidence of any other disease",
"criterion": "other disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "metabolic dysfunction",
"criterion": "metabolic dysfunction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "physical examination finding",
"criterion": "physical examination finding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "laboratory finding",
"criterion": "laboratory finding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Evidence of any other disease",
"criterion": "other disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications",
"criterion": "reasonable suspicion of contraindication or high risk",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "metabolic dysfunction",
"criterion": "metabolic dysfunction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications",
"criterion": "reasonable suspicion of contraindication or high risk",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "physical examination finding",
"criterion": "physical examination finding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications",
"criterion": "reasonable suspicion of contraindication or high risk",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "laboratory finding",
"criterion": "laboratory finding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications",
"criterion": "reasonable suspicion of contraindication or high risk",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "35. Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins",
"criterions": [
{
"exact_snippets": "Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells",
"criterion": "hypersensitivity or allergy to CHO ovary cell drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins",
"criterion": "severe allergic, anaphylactic, or hypersensitivity reactions to antibodies or fusion proteins",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells",
"criterion": "hypersensitivity or allergy to CHO ovary cell drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins",
"criterion": "severe allergic, anaphylactic, or hypersensitivity reactions to antibodies or fusion proteins",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "37. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent.",
"criterions": [
{
"exact_snippets": "poor medical risk due to a serious, uncontrolled medical disorder",
"criterion": "serious, uncontrolled medical disorder",
"requirement": {
"requirement_type": "risk",
"expected_value": "poor"
}
},
{
"exact_snippets": "poor medical risk due to a ... non-malignant systemic disease",
"criterion": "non-malignant systemic disease",
"requirement": {
"requirement_type": "risk",
"expected_value": "poor"
}
},
{
"exact_snippets": "poor medical risk due to a ... active, uncontrolled infection",
"criterion": "active, uncontrolled infection",
"requirement": {
"requirement_type": "risk",
"expected_value": "poor"
}
},
{
"exact_snippets": "psychiatric disorder that prohibits obtaining informed consent",
"criterion": "psychiatric disorder",
"requirement": {
"requirement_type": "prohibits obtaining informed consent",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "poor medical risk due to a serious, uncontrolled medical disorder",
"criterion": "serious, uncontrolled medical disorder",
"requirement": {
"requirement_type": "risk",
"expected_value": "poor"
}
},
{
"exact_snippets": "poor medical risk due to a ... non-malignant systemic disease",
"criterion": "non-malignant systemic disease",
"requirement": {
"requirement_type": "risk",
"expected_value": "poor"
}
},
{
"exact_snippets": "poor medical risk due to a ... active, uncontrolled infection",
"criterion": "active, uncontrolled infection",
"requirement": {
"requirement_type": "risk",
"expected_value": "poor"
}
}
]
},
{
"exact_snippets": "psychiatric disorder that prohibits obtaining informed consent",
"criterion": "psychiatric disorder",
"requirement": {
"requirement_type": "prohibits obtaining informed consent",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "38. Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo as well as breastfeeding women or intended to breastfeed during the study and up to 6 months after treatment with paclitaxel, bevacizumab and pegylated liposomal doxorubicin (PLD).",
"criterions": [
{
"exact_snippets": "Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "intention to become pregnant",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding women or intended to breastfeed during the study and up to 6 months after treatment with paclitaxel, bevacizumab and pegylated liposomal doxorubicin (PLD)",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding women or intended to breastfeed during the study and up to 6 months after treatment with paclitaxel, bevacizumab and pegylated liposomal doxorubicin (PLD)",
"criterion": "intention to breastfeed",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "intention to become pregnant",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "breastfeeding women or intended to breastfeed during the study and up to 6 months after treatment with paclitaxel, bevacizumab and pegylated liposomal doxorubicin (PLD)",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding women or intended to breastfeed during the study and up to 6 months after treatment with paclitaxel, bevacizumab and pegylated liposomal doxorubicin (PLD)",
"criterion": "intention to breastfeed",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "39. For France only: Patients deprived of their liberty by judicial or administrative decision and patients under a legal protection measure or unable to express their consent.",
"criterions": [
{
"exact_snippets": "Patients deprived of their liberty by judicial or administrative decision",
"criterion": "deprivation of liberty",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients under a legal protection measure",
"criterion": "legal protection measure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients ... unable to express their consent",
"criterion": "ability to express consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients deprived of their liberty by judicial or administrative decision",
"criterion": "deprivation of liberty",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patients under a legal protection measure",
"criterion": "legal protection measure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "patients ... unable to express their consent",
"criterion": "ability to express consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "The use of inhaled corticosteroids for chronic obstruc-tive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.",
"criterions": [
{
"exact_snippets": "inhaled corticosteroids for chronic obstructive pulmonary disease",
"criterion": "inhaled corticosteroids",
"requirement": {
"requirement_type": "condition",
"expected_value": "chronic obstructive pulmonary disease"
}
},
{
"exact_snippets": "mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension",
"criterion": "mineralocorticoids",
"requirement": {
"requirement_type": "condition",
"expected_value": "orthostatic hypotension"
}
},
{
"exact_snippets": "low-dose supplemental corticosteroids for adrenocortical insufficiency",
"criterion": "low-dose supplemental corticosteroids",
"requirement": {
"requirement_type": "condition",
"expected_value": "adrenocortical insufficiency"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "inhaled corticosteroids for chronic obstructive pulmonary disease",
"criterion": "inhaled corticosteroids",
"requirement": {
"requirement_type": "condition",
"expected_value": "chronic obstructive pulmonary disease"
}
}
]
}
]
}
},
{
"not_criteria": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension",
"criterion": "mineralocorticoids",
"requirement": {
"requirement_type": "condition",
"expected_value": "orthostatic hypotension"
}
}
]
}
]
}
},
{
"not_criteria": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "low-dose supplemental corticosteroids for adrenocortical insufficiency",
"criterion": "low-dose supplemental corticosteroids",
"requirement": {
"requirement_type": "condition",
"expected_value": "adrenocortical insufficiency"
}
}
]
}
]
}
}
]
}
},
{
"identified_line": {
"line": "17. History of idiopathic pulmonary fibrosis (including pneumonitis), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evi-dence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted",
"criterions": [
{
"exact_snippets": "History of idiopathic pulmonary fibrosis",
"criterion": "idiopathic pulmonary fibrosis",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "History of ... organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia)",
"criterion": "organizing pneumonia",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "evidence of active pneumonitis on screening chest CT scan",
"criterion": "active pneumonitis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of idiopathic pulmonary fibrosis",
"criterion": "idiopathic pulmonary fibrosis",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "History of ... organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia)",
"criterion": "organizing pneumonia",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
]
},
{
"exact_snippets": "evidence of active pneumonitis on screening chest CT scan",
"criterion": "active pneumonitis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Patients with past hepatitis B virus (HBV) infection or re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.",
"criterions": [
{
"exact_snippets": "past hepatitis B virus (HBV) infection",
"criterion": "past HBV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test)",
"criterion": "resolved HBV infection",
"requirement": {
"requirement_type": "HBsAg test result",
"expected_value": "negative"
}
},
{
"exact_snippets": "re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test)",
"criterion": "resolved HBV infection",
"requirement": {
"requirement_type": "anti-HBc antibody test result",
"expected_value": "positive"
}
},
{
"exact_snippets": "positive for hepatitis C virus (HCV) antibody ... PCR is negative for HCV RNA",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "HCV antibody test result",
"expected_value": "positive"
}
},
{
"exact_snippets": "positive for hepatitis C virus (HCV) antibody ... PCR is negative for HCV RNA",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "HCV RNA PCR test result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "past hepatitis B virus (HBV) infection",
"criterion": "past HBV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test)",
"criterion": "resolved HBV infection",
"requirement": {
"requirement_type": "HBsAg test result",
"expected_value": "negative"
}
},
{
"exact_snippets": "re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test)",
"criterion": "resolved HBV infection",
"requirement": {
"requirement_type": "anti-HBc antibody test result",
"expected_value": "positive"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "positive for hepatitis C virus (HCV) antibody ... PCR is negative for HCV RNA",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "HCV antibody test result",
"expected_value": "positive"
}
},
{
"exact_snippets": "positive for hepatitis C virus (HCV) antibody ... PCR is negative for HCV RNA",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "HCV RNA PCR test result",
"expected_value": "negative"
}
}
]
}
]
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "8. Patients previously treated with bevacizumab are eligible, with the exclusion of those patients that has suspended bevacizumab for more than 2 subsequent cycles or permanently discontinued bevacizumab during their previous treatment due to toxicity.",
"criterions": [
{
"exact_snippets": "Patients previously treated with bevacizumab",
"criterion": "previous bevacizumab treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "suspended bevacizumab for more than 2 subsequent cycles",
"criterion": "bevacizumab suspension duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "cycles"
}
}
},
{
"exact_snippets": "permanently discontinued bevacizumab during their previous treatment due to toxicity",
"criterion": "permanent bevacizumab discontinuation due to toxicity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients previously treated with bevacizumab",
"criterion": "previous bevacizumab treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"or_criteria": [
{
"exact_snippets": "suspended bevacizumab for more than 2 subsequent cycles",
"criterion": "bevacizumab suspension duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "cycles"
}
}
},
{
"exact_snippets": "permanently discontinued bevacizumab during their previous treatment due to toxicity",
"criterion": "permanent bevacizumab discontinuation due to toxicity",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
]
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "3. Malignancies other than ovarian cancer within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer)",
"criterions": [
{
"exact_snippets": "Malignancies other than ovarian cancer within 5 years prior to randomisation",
"criterion": "other malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%)",
"criterion": "risk of metastasis or death",
"requirement": {
"requirement_type": "risk",
"expected_value": "negligible"
}
},
{
"exact_snippets": "treated with expected curative outcome",
"criterion": "treatment outcome",
"requirement": {
"requirement_type": "outcome",
"expected_value": "curative"
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Malignancies other than ovarian cancer within 5 years prior to randomisation",
"criterion": "other malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%)",
"criterion": "risk of metastasis or death",
"requirement": {
"requirement_type": "risk",
"expected_value": "negligible"
}
},
{
"exact_snippets": "treated with expected curative outcome",
"criterion": "treatment outcome",
"requirement": {
"requirement_type": "outcome",
"expected_value": "curative"
}
}
]
}
]
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "Malignancies other than ovarian cancer within 5 years prior to randomisation",
"criterion": "other malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "14. Major surgery within 4 weeks of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.",
"criterions": [
{
"exact_snippets": "Major surgery within 4 weeks of starting study treatment",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since surgery",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "patient who has not completely recovered from the effects of any major surgery",
"criterion": "recovery from major surgery",
"requirement": {
"requirement_type": "recovery status",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Major surgery within 4 weeks of starting study treatment",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since surgery",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "patient who has not completely recovered from the effects of any major surgery",
"criterion": "recovery from major surgery",
"requirement": {
"requirement_type": "recovery status",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Major surgery within 4 weeks of starting study treatment",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since surgery",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "19. History or evidence hemorrhagic disorders within 6 months prior to randomization",
"criterions": [
{
"exact_snippets": "History or evidence hemorrhagic disorders",
"criterion": "hemorrhagic disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "within 6 months prior to randomization",
"criterion": "time since hemorrhagic disorder",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "History or evidence hemorrhagic disorders",
"criterion": "hemorrhagic disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "within 6 months prior to randomization",
"criterion": "time since hemorrhagic disorder",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months",
"criterions": [
{
"exact_snippets": "No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months",
"criterion": "acute exacerbations of the underlying condition",
"requirement": {
"requirement_type": "occurrence",
"expected_value": false
}
},
{
"exact_snippets": "No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months",
"criterion": "acute exacerbations of the underlying condition",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"psoralen plus ultraviolet A radiation",
"methotrexate",
"retinoids",
"biologic agents",
"oral calcineurin inhibitors",
"high potency or oral corticosteroids"
]
}
},
{
"exact_snippets": "No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months",
"criterion": "acute exacerbations of the underlying condition",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within the previous 12 months"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Myocardial infarction or unstable angina pectoris within ≤ 6 months of randomization",
"criterions": [
{
"exact_snippets": "Myocardial infarction ... within ≤ 6 months of randomization",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "unstable angina pectoris within ≤ 6 months of randomization",
"criterion": "unstable angina pectoris",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Myocardial infarction ... within \u0010 6 months of randomization",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "unstable angina pectoris within \u0010 6 months of randomization",
"criterion": "unstable angina pectoris",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "32. History of bowel obstruction (including subocclusive disease) related to underlying disease, a history of ab-dominal fistula, GI perforation, or intra-abdominal abscess, or evidence of deep infiltration of the bowel by pelvic examination or on computed tomography, or clinical symptoms of bowel obstruction.",
"criterions": [
{
"exact_snippets": "History of bowel obstruction (including subocclusive disease)",
"criterion": "bowel obstruction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of abdominal fistula",
"criterion": "abdominal fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... GI perforation",
"criterion": "GI perforation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... intra-abdominal abscess",
"criterion": "intra-abdominal abscess",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "evidence of deep infiltration of the bowel by pelvic examination or on computed tomography",
"criterion": "deep infiltration of the bowel",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "clinical symptoms of bowel obstruction",
"criterion": "bowel obstruction",
"requirement": {
"requirement_type": "clinical symptoms",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of bowel obstruction (including subocclusive disease)",
"criterion": "bowel obstruction",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "related to underlying disease",
"criterion": "underlying disease",
"requirement": {
"requirement_type": "relation",
"expected_value": true
}
}
]
},
{
"exact_snippets": "history of abdominal fistula",
"criterion": "abdominal fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "history of ... GI perforation",
"criterion": "GI perforation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "history of ... intra-abdominal abscess",
"criterion": "intra-abdominal abscess",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "evidence of deep infiltration of the bowel by pelvic examination or on computed tomography",
"criterion": "deep infiltration of the bowel",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "36. Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab, paclitaxel, pegylated liposomal doxorubicin, or their excipients that contra-indicates the subject's participation.",
"criterions": [
{
"exact_snippets": "Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab",
"criterion": "hypersensitivity reaction or allergy to drugs chemically related to bevacizumab",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known hypersensitivity reaction or allergy to drugs chemically related to paclitaxel",
"criterion": "hypersensitivity reaction or allergy to drugs chemically related to paclitaxel",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known hypersensitivity reaction or allergy to drugs chemically related to pegylated liposomal doxorubicin",
"criterion": "hypersensitivity reaction or allergy to drugs chemically related to pegylated liposomal doxorubicin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Known hypersensitivity reaction or allergy to ... their excipients",
"criterion": "hypersensitivity reaction or allergy to excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab",
"criterion": "hypersensitivity reaction or allergy to drugs chemically related to bevacizumab",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "... that contra-indicates the subject's participation",
"criterion": "contra-indication for participation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Known hypersensitivity reaction or allergy to drugs chemically related to paclitaxel",
"criterion": "hypersensitivity reaction or allergy to drugs chemically related to paclitaxel",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "... that contra-indicates the subject's participation",
"criterion": "contra-indication for participation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Known hypersensitivity reaction or allergy to drugs chemically related to pegylated liposomal doxorubicin",
"criterion": "hypersensitivity reaction or allergy to drugs chemically related to pegylated liposomal doxorubicin",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "... that contra-indicates the subject's participation",
"criterion": "contra-indication for participation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Known hypersensitivity reaction or allergy to ... their excipients",
"criterion": "hypersensitivity reaction or allergy to excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "... that contra-indicates the subject's participation",
"criterion": "contra-indication for participation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
]
}
}
],
"failed_miscellaneous": []
}