{
    "info": {
        "nct_id": "NCT01607957",
        "official_title": "Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies",
        "inclusion_criteria": "1. Has provided written informed consent\n2. Has adenocarcinoma of the colon or rectum\n3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer\n4. ECOG performance status of 0 or 1\n5. Is able to take medications orally\n6. Has adequate organ function (bone marrow, kidney and liver)\n7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Certain serious illnesses or medical condition(s)\n2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration\n3. Has received TAS-102\n4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies\n5. Is a pregnant or lactating female",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Has provided written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Has provided written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has adenocarcinoma of the colon or rectum",
            "criterions": [
                {
                    "exact_snippets": "adenocarcinoma of the colon",
                    "criterion": "adenocarcinoma of the colon",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the ... rectum",
                    "criterion": "adenocarcinoma of the rectum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer",
            "criterions": [
                {
                    "exact_snippets": "failed at least 2 prior regimens of standard chemotherapies",
                    "criterion": "prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic colorectal cancer",
                    "criterion": "metastatic colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ECOG performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Is able to take medications orally",
            "criterions": [
                {
                    "exact_snippets": "Is able to take medications orally",
                    "criterion": "ability to take medications orally",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has adequate organ function (bone marrow, kidney and liver)",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function (bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate organ function ... kidney",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate organ function ... liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential ... must agree to adequate birth control",
                    "criterion": "birth control agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Males must agree to adequate birth control",
                    "criterion": "birth control agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "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 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": "1. Certain serious illnesses or medical condition(s)",
            "criterions": [
                {
                    "exact_snippets": "serious illnesses or medical condition(s)",
                    "criterion": "serious illnesses or medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration",
            "criterions": [
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. major surgery",
                    "criterion": "recent major surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... anticancer therapy",
                    "criterion": "recent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... extended field radiation",
                    "criterion": "recent extended field radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... received investigational agent",
                    "criterion": "recent investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has received TAS-102",
            "criterions": [
                {
                    "exact_snippets": "Has received TAS-102",
                    "criterion": "TAS-102",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicity of greater than or equal to CTCAE Grade 2",
                    "criterion": "toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "attributed to any prior therapies",
                    "criterion": "prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "attribution",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Is a pregnant or lactating female",
            "criterions": [
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating female",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lactating"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}