{
    "info": {
        "nct_id": "NCT02115048",
        "official_title": "A Randomized Open-label Phase II Study of Letrozole Plus Afatinib Versus Letrozole Alone in First-line Treatment of Advanced ER+, HER2- Postmenopausal Breast Cancer With Low ER Expression",
        "inclusion_criteria": "* Signed and dated informed consent.\n* Postmenopausal females, 18 years of age or older.\n* Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease.\n* HER2 negative breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is HER2 negative by FISH or Immunohistochemistry (IHC).\n* ER positive breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is ER+ with low expression (H-score [1-159]).\n* Paraffin-embedded tumor block(s) or 15 to 20 unstained slides available for centralized assessment of ER, PR, and HER2.\n* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or bone-only non measurable disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.\n* Adequate hematological, hepatic and renal functions.\n* Baseline left ventricular ejection fraction (LVEF) 50%.\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.\n* Prior treatment with any type of systemic therapy for advanced disease.\n* Prior treatment with letrozole in (neo)adjuvant setting with disease-free interval ≤ 12 months from completion of treatment until randomization.\n* Prior treatment with any anti HER-family targeted therapy in (neo)adjuvant setting.\n* Any concurrent or previous malignancy within 5 years prior to randomization, except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm.\n* Non-measurable disease according to RECIST 1.1, with the exception of bone-only non-measurable disease.\n* Known pre-existing interstitial lung disease.\n* Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom.\n* History or presence of clinically relevant cardiovascular abnormalities as per investigator assessment.\n* Any other concomitant serious illness or organ system dysfunction as per investigator assessment\n* Any contraindication to oral agents.\n* Active hepatitis B infection, active hepatitis C infection or known HIV carrier.\n* Known or suspected active drug or alcohol abuse.\n* Known hypersensitivity to afatinib or letrozole or the excipients of any of the trial drugs.\n* Concomitant treatment with strong inhibitor of P-gp.\n* Any ongoing acute clinically significant toxic effect of prior anticancer therapy or any persisting complication of prior surgery.\n* Subjects with known history of keratitis, ulcerative keratitis or severe dry eye.\n* Participation in the active phase of other clinical trials of investigational agents in which last study treatment was administered within 2 weeks prior to randomization",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Signed and dated informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed and dated informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed and dated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal females, 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal females",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically proven diagnosis of adenocarcinoma of the breast",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of locally recurrent disease not amenable to resection or radiation therapy with curative intent",
                    "criterion": "locally recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment amenability",
                            "expected_value": "not amenable to resection or radiation therapy with curative intent"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2 negative breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is HER2 negative by FISH or Immunohistochemistry (IHC).",
            "criterions": [
                {
                    "exact_snippets": "HER2 negative breast cancer",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Central testing (required for all subjects) must demonstrate that the tumor is HER2 negative by FISH or Immunohistochemistry (IHC)",
                    "criterion": "HER2 testing method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "FISH",
                                "Immunohistochemistry (IHC)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ER positive breast cancer. Central testing (required for all subjects) must demonstrate that the tumor is ER+ with low expression (H-score [1-159]).",
            "criterions": [
                {
                    "exact_snippets": "ER positive breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "ER status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Central testing (required for all subjects) must demonstrate that the tumor is ER+",
                    "criterion": "tumor ER status",
                    "requirements": [
                        {
                            "requirement_type": "ER status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "low expression (H-score [1-159])",
                    "criterion": "ER expression level",
                    "requirements": [
                        {
                            "requirement_type": "H-score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": ""
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 159,
                                        "unit": ""
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Paraffin-embedded tumor block(s) or 15 to 20 unstained slides available for centralized assessment of ER, PR, and HER2.",
            "criterions": [
                {
                    "exact_snippets": "Paraffin-embedded tumor block(s) or 15 to 20 unstained slides available",
                    "criterion": "tumor sample availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "centralized assessment of ER, PR, and HER2",
                    "criterion": "centralized assessment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "ER",
                                "PR",
                                "HER2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or bone-only non measurable disease.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "bone-only non measurable disease",
                    "criterion": "bone-only disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "non measurable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematological, hepatic and renal functions.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematological ... functions.",
                    "criterion": "hematological function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... functions.",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal functions.",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline left ventricular ejection fraction (LVEF) 50%.",
            "criterions": [
                {
                    "exact_snippets": "Baseline left ventricular ejection fraction (LVEF) 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "baseline value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.",
            "criterions": [
                {
                    "exact_snippets": "Willingness and ability to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... other trial procedures",
                    "criterion": "compliance with other trial procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with any type of systemic therapy for advanced disease.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with any type of systemic therapy for advanced disease.",
                    "criterion": "prior treatment with systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with letrozole in (neo)adjuvant setting with disease-free interval ≤ 12 months from completion of treatment until randomization.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with letrozole in (neo)adjuvant setting",
                    "criterion": "prior treatment with letrozole",
                    "requirements": [
                        {
                            "requirement_type": "setting",
                            "expected_value": "(neo)adjuvant"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease-free interval ≤ 12 months from completion of treatment until randomization",
                    "criterion": "disease-free interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with any anti HER-family targeted therapy in (neo)adjuvant setting.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with any anti HER-family targeted therapy",
                    "criterion": "anti HER-family targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(neo)adjuvant setting",
                    "criterion": "treatment setting",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any concurrent or previous malignancy within 5 years prior to randomization, except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm.",
            "criterions": [
                {
                    "exact_snippets": "Any concurrent or previous malignancy within 5 years prior to randomization",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately and radically treated basal or squamous skin cancer",
                    "criterion": "basal or squamous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "adequately and radically treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... other non-invasive/in-situ neoplasm",
                    "criterion": "non-invasive/in-situ neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "non-invasive/in-situ"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-measurable disease according to RECIST 1.1, with the exception of bone-only non-measurable disease.",
            "criterions": [
                {
                    "exact_snippets": "Non-measurable disease according to RECIST 1.1",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST 1.1"
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bone-only non-measurable disease",
                    "criterion": "disease location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "bone"
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known pre-existing interstitial lung disease.",
            "criterions": [
                {
                    "exact_snippets": "Known pre-existing interstitial lung disease.",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom.",
            "criterions": [
                {
                    "exact_snippets": "Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom.",
                    "criterion": "gastrointestinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        },
                        {
                            "requirement_type": "symptom",
                            "expected_value": "diarrhea"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or presence of clinically relevant cardiovascular abnormalities as per investigator assessment.",
            "criterions": [
                {
                    "exact_snippets": "History or presence of clinically relevant cardiovascular abnormalities",
                    "criterion": "cardiovascular abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical relevance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other concomitant serious illness or organ system dysfunction as per investigator assessment",
            "criterions": [
                {
                    "exact_snippets": "Any other concomitant serious illness",
                    "criterion": "concomitant serious illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "organ system dysfunction",
                    "criterion": "organ system dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any contraindication to oral agents.",
            "criterions": [
                {
                    "exact_snippets": "contraindication to oral agents",
                    "criterion": "contraindication to oral agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hepatitis B infection, active hepatitis C infection or known HIV carrier.",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B infection",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C infection",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known HIV carrier",
                    "criterion": "HIV carrier",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known or suspected active drug or alcohol abuse.",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected active drug ... abuse.",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known or suspected active ... alcohol abuse.",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to afatinib or letrozole or the excipients of any of the trial drugs.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to afatinib",
                    "criterion": "hypersensitivity to afatinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity to ... letrozole",
                    "criterion": "hypersensitivity to letrozole",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity to ... the excipients of any of the trial drugs",
                    "criterion": "hypersensitivity to excipients of trial drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant treatment with strong inhibitor of P-gp.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant treatment with strong inhibitor of P-gp.",
                    "criterion": "concomitant treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "strong inhibitor of P-gp"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any ongoing acute clinically significant toxic effect of prior anticancer therapy or any persisting complication of prior surgery.",
            "criterions": [
                {
                    "exact_snippets": "Any ongoing acute clinically significant toxic effect of prior anticancer therapy",
                    "criterion": "toxic effect of prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any persisting complication of prior surgery",
                    "criterion": "complication of prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with known history of keratitis, ulcerative keratitis or severe dry eye.",
            "criterions": [
                {
                    "exact_snippets": "known history of keratitis",
                    "criterion": "keratitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of ... ulcerative keratitis",
                    "criterion": "ulcerative keratitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of ... severe dry eye",
                    "criterion": "severe dry eye",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in the active phase of other clinical trials of investigational agents in which last study treatment was administered within 2 weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Participation in the active phase of other clinical trials of investigational agents",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "investigational agents"
                        }
                    ]
                },
                {
                    "exact_snippets": "last study treatment was administered within 2 weeks prior to randomization",
                    "criterion": "time since last study treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}