{
    "info": {
        "nct_id": "NCT03424980",
        "official_title": "A Real-world Non-interventional Observational Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors (TKIs) in the Patients With Non-small Cell Lung Cancer Complicated With Brain Metastases",
        "inclusion_criteria": "* The patients were treated with lung cancer and were enrolled from Jan 2013 to Jun 2017\n* The patients with advanced (Clinical stage: Phase IV) non-small cell lung cancer who have complete core health medical records (HMRs);\n* The patients who are observed with brain metastases diagnosed by imaging methods;\n* The patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness;\n* The patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors;",
        "exclusion_criteria": "No exclusion criteria are included in the study given that the study is designed as non-interventional and all the treatments followed real-world clinical practice and experiences of clinical physicians.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The patients were treated with lung cancer and were enrolled from Jan 2013 to Jun 2017",
            "criterions": [
                {
                    "exact_snippets": "patients were treated with lung cancer",
                    "criterion": "lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "enrolled from Jan 2013 to Jun 2017",
                    "criterion": "enrollment period",
                    "requirements": [
                        {
                            "requirement_type": "date range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2013,
                                        "unit": "year"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2017,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patients with advanced (Clinical stage: Phase IV) non-small cell lung cancer who have complete core health medical records (HMRs);",
            "criterions": [
                {
                    "exact_snippets": "advanced (Clinical stage: Phase IV) non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Phase IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "complete core health medical records (HMRs)",
                    "criterion": "health medical records",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patients who are observed with brain metastases diagnosed by imaging methods;",
            "criterions": [
                {
                    "exact_snippets": "brain metastases diagnosed by imaging methods",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "imaging methods"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness;",
            "criterions": [
                {
                    "exact_snippets": "complete clinical data for diagnosis time of brain metastases",
                    "criterion": "clinical data for diagnosis time of brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complete clinical data for ... overall survival/effectiveness",
                    "criterion": "clinical data for overall survival/effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors;",
            "criterions": [
                {
                    "exact_snippets": "administered with tyrosine kinase inhibitors",
                    "criterion": "tyrosine kinase inhibitors administration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "combination therapies of tyrosine kinase inhibitors",
                    "criterion": "combination therapies with tyrosine kinase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "No exclusion criteria are included in the study given that the study is designed as non-interventional and all the treatments followed real-world clinical practice and experiences of clinical physicians.",
            "criterions": [
                {
                    "exact_snippets": "No exclusion criteria are included in the study",
                    "criterion": "exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}