{
    "info": {
        "nct_id": "NCT03355157",
        "official_title": "A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).",
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        "exclusion_criteria": "1. Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab.\n2. Asymptomatic oligometastases of the bone as the only site of metastatic disease.\n3. Uncontrolled/untreated central nervous system lesions.\n4. Patients who received treatment for metastatic/relapsed breast cancer.\n5. Inadequate organ function as per physician's assessment immediate prior to randomization.\n6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use.\n7. Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy.\n8. Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy.\n9. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption.\n10. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to six months after treatment. Male patients: Intention to beget a child during the study and up to six months after treatment.",
        "miscellaneous_criteria": ""
    },
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        },
        {
            "identified_line": {
                "line": "5. Inadequate organ function as per physician's assessment immediate prior to randomization.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Inadequate organ function"
                        ],
                        "criterion": "organ function",
                        "requirement_type": "adequacy",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "Inadequate organ function"
                    ],
                    "criterion": "organ function",
                    "requirement_type": "adequacy",
                    "expected_value": false
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Treatment with preparations containing St. John´s Wort"
                        ],
                        "criterion": "St. John´s Wort",
                        "requirement_type": "treatment",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "within the last 7 days prior to randomization"
                        ],
                        "criterion": "St. John´s Wort treatment",
                        "requirement_type": "recency",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 7
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "concurrent use"
                        ],
                        "criterion": "St. John´s Wort",
                        "requirement_type": "concurrent use",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Treatment with preparations containing St. John´s Wort"
                                ],
                                "criterion": "St. John´s Wort",
                                "requirement_type": "treatment",
                                "expected_value": true
                            },
                            {
                                "exact_snippets": [
                                    "within the last 7 days prior to randomization"
                                ],
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                                "requirement_type": "recency",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 7
                                        }
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": [
                            "concurrent use"
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                        "criterion": "St. John´s Wort",
                        "requirement_type": "concurrent use",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Known severe hypersensitivity reactions",
                            "compounds or excipients similar to palbociclib"
                        ],
                        "criterion": "hypersensitivity reactions",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    },
                    {
                        "exact_snippets": [
                            "Known severe hypersensitivity reactions",
                            "planned chemotherapy"
                        ],
                        "criterion": "hypersensitivity reactions",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    },
                    {
                        "exact_snippets": [
                            "Known severe hypersensitivity reactions",
                            "planned endocrine therapy"
                        ],
                        "criterion": "hypersensitivity reactions",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Known severe hypersensitivity reactions",
                                    "compounds or excipients similar to palbociclib"
                                ],
                                "criterion": "hypersensitivity reactions",
                                "requirement_type": "severity",
                                "expected_value": "severe"
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Known severe hypersensitivity reactions",
                                    "planned chemotherapy"
                                ],
                                "criterion": "hypersensitivity reactions",
                                "requirement_type": "severity",
                                "expected_value": "severe"
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Known severe hypersensitivity reactions",
                                    "planned endocrine therapy"
                                ],
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                                "requirement_type": "severity",
                                "expected_value": "severe"
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Existing contraindication against the use of palbociclib"
                        ],
                        "criterion": "palbociclib",
                        "requirement_type": "contraindication",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "planned chemotherapy"
                        ],
                        "criterion": "chemotherapy",
                        "requirement_type": "planned",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "planned endocrine therapy"
                        ],
                        "criterion": "endocrine therapy",
                        "requirement_type": "planned",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Existing contraindication against the use of palbociclib"
                                ],
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                                "requirement_type": "contraindication",
                                "expected_value": true
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "planned chemotherapy"
                                ],
                                "criterion": "chemotherapy",
                                "requirement_type": "planned",
                                "expected_value": true
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "planned endocrine therapy"
                                ],
                                "criterion": "endocrine therapy",
                                "requirement_type": "planned",
                                "expected_value": true
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption.",
                "criterions": [
                    {
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                            "hereditary problems of galactose intolerance"
                        ],
                        "criterion": "galactose intolerance",
                        "requirement_type": "hereditary problems",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Lapp lactase deficiency"
                        ],
                        "criterion": "Lapp lactase deficiency",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "glucose-galactose malabsorption"
                        ],
                        "criterion": "glucose-galactose malabsorption",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "hereditary problems of galactose intolerance"
                        ],
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                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Lapp lactase deficiency"
                        ],
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                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "glucose-galactose malabsorption"
                        ],
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                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab.",
                "criterions": [
                    {
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                            "Indication for poly-chemotherapy"
                        ],
                        "criterion": "poly-chemotherapy",
                        "requirement_type": "indication",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Indication for single-agent endocrine therapy"
                        ],
                        "criterion": "single-agent endocrine therapy",
                        "requirement_type": "indication",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Indication for bevacizumab"
                        ],
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                        "requirement_type": "indication",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": [
                            "Indication for poly-chemotherapy"
                        ],
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                        "requirement_type": "indication",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Indication for single-agent endocrine therapy"
                        ],
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                        "requirement_type": "indication",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Indication for bevacizumab"
                        ],
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                        "requirement_type": "indication",
                        "expected_value": true
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "10. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to six months after treatment. Male patients: Intention to beget a child during the study and up to six months after treatment.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Female patients: pregnancy"
                        ],
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                        "requirement_type": "status",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "Female patients: lactation"
                        ],
                        "criterion": "lactation",
                        "requirement_type": "status",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "Female patients:",
                            "intention to become pregnant during the study and up to six months after treatment"
                        ],
                        "criterion": "intention to become pregnant",
                        "requirement_type": "status",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "Male patients:",
                            "Intention to beget a child during the study and up to six months after treatment"
                        ],
                        "criterion": "intention to beget a child",
                        "requirement_type": "status",
                        "expected_value": false
                    }
                ]
            },
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                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": [
                                            "Female patients: pregnancy"
                                        ],
                                        "criterion": "pregnancy",
                                        "requirement_type": "status",
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                                    },
                                    {
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                                            "Female patients: lactation"
                                        ],
                                        "criterion": "lactation",
                                        "requirement_type": "status",
                                        "expected_value": true
                                    }
                                ]
                            },
                            {
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                                    "Female patients:",
                                    "intention to become pregnant during the study and up to six months after treatment"
                                ],
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                                "requirement_type": "status",
                                "expected_value": true
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}