{
    "info": {
        "nct_id": "NCT00539331",
        "official_title": "A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb",
        "inclusion_criteria": "* Having histologically or cytologically confirmed NSCLC\n* Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC\n* WHO performance status 0-1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Untreated unstable brain or meningeal metastases\n* Patient with inappropriate laboratory tests values\n* Patient with poorly controlled hypertension",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Having histologically or cytologically confirmed NSCLC",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC",
            "criterions": [
                {
                    "exact_snippets": "previously untreated advanced/metastatic (Stage IIIB/IV)",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "previously untreated advanced/metastatic",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "postsurgery recurrent NSCLC",
                    "criterion": "NSCLC recurrence",
                    "requirements": [
                        {
                            "requirement_type": "recurrence status",
                            "expected_value": "postsurgery recurrent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status 0-1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Untreated unstable brain or meningeal metastases",
            "criterions": [
                {
                    "exact_snippets": "Untreated unstable brain ... metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Untreated unstable ... meningeal metastases",
                    "criterion": "meningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with inappropriate laboratory tests values",
            "criterions": [
                {
                    "exact_snippets": "inappropriate laboratory tests values",
                    "criterion": "laboratory tests values",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with poorly controlled hypertension",
            "criterions": [
                {
                    "exact_snippets": "poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}