{
    "info": {
        "nct_id": "NCT02726009",
        "official_title": "An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer",
        "inclusion_criteria": "* Has given written informed consent before any study-related activity is performed\n* Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment\n* Age greater than or equal to 18 years and less than 80 years\n* Advanced hormone-dependent prostate cancer without any other clinically significant disorder\n* Easten Cooperative Oncology Group score ≤ 2\n* PSA ≥ 2 ng/mL at screening\n* Life expectancy of at least 12 months as per the investigator's judgement\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 79 Years",
        "exclusion_criteria": "* Previous or concurrent hormonal management of prostate cancer\n* Contraindication for prescription of Firmagon®\n* Concurrent treatment with a 5-α-reductase inhibitor\n* Considered as a candidate for curative therapy\n* History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema\n* QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications\n* Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin\n* Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)\n* Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer\n* Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Has given written informed consent before any study-related activity is performed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Has given written informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "given",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "Advanced hormone-dependent prostate cancer"
                    ],
                    "criterion": "prostate cancer",
                    "requirement_type": "type",
                    "expected_value": "advanced hormone-dependent"
                },
                {
                    "exact_snippets": [
                        "androgen deprivation therapy is indicated"
                    ],
                    "criterion": "androgen deprivation therapy",
                    "requirement_type": "indication",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Firmagon® is intended to be used for treatment"
                    ],
                    "criterion": "Firmagon®",
                    "requirement_type": "intended use",
                    "expected_value": "treatment"
                }
            ]
        },
        {
            "line": "* Age greater than or equal to 18 years and less than 80 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age greater than or equal to 18 years",
                        "less than 80 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            },
                            {
                                "operator": "<",
                                "value": 80
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Advanced hormone-dependent prostate cancer without any other clinically significant disorder",
            "criterions": [
                {
                    "exact_snippets": [
                        "Advanced hormone-dependent prostate cancer"
                    ],
                    "criterion": "prostate cancer",
                    "requirement_type": "type",
                    "expected_value": "advanced hormone-dependent"
                },
                {
                    "exact_snippets": [
                        "without any other clinically significant disorder"
                    ],
                    "criterion": "other clinically significant disorder",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Easten Cooperative Oncology Group score ≤ 2",
            "criterions": [
                {
                    "exact_snippets": [
                        "Easten Cooperative Oncology Group score ≤ 2"
                    ],
                    "criterion": "Easten Cooperative Oncology Group score",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* PSA ≥ 2 ng/mL at screening",
            "criterions": [
                {
                    "exact_snippets": [
                        "PSA ≥ 2 ng/mL"
                    ],
                    "criterion": "PSA",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 months as per the investigator's judgement",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy of at least 12 months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "minimum duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 12
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be MALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific value",
                    "expected_value": "male"
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 79 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 79 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 79
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previous or concurrent hormonal management of prostate cancer",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous or concurrent hormonal management of prostate cancer"
                    ],
                    "criterion": "hormonal management of prostate cancer",
                    "requirement_type": "temporal",
                    "expected_value": [
                        "previous",
                        "concurrent"
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication for prescription of Firmagon®",
            "criterions": [
                {
                    "exact_snippets": [
                        "Contraindication for prescription of Firmagon®"
                    ],
                    "criterion": "Firmagon® prescription",
                    "requirement_type": "contraindication",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Concurrent treatment with a 5-α-reductase inhibitor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Concurrent treatment",
                        "5-α-reductase inhibitor"
                    ],
                    "criterion": "5-α-reductase inhibitor",
                    "requirement_type": "concurrent treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Considered as a candidate for curative therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Considered as a candidate for curative therapy"
                    ],
                    "criterion": "curative therapy",
                    "requirement_type": "eligibility",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of severe untreated asthma"
                    ],
                    "criterion": "asthma",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "History of severe untreated asthma"
                    ],
                    "criterion": "asthma",
                    "requirement_type": "treatment status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "anaphylactic reactions"
                    ],
                    "criterion": "anaphylactic reactions",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "severe urticaria"
                    ],
                    "criterion": "urticaria",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "angioedema"
                    ],
                    "criterion": "angioedema",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications",
            "criterions": [
                {
                    "exact_snippets": [
                        "QTc interval over 450 msec"
                    ],
                    "criterion": "QTc interval",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 450
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "risk factors for torsades de pointes"
                    ],
                    "criterion": "torsades de pointes",
                    "requirement_type": "risk factors",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "on Class IA and Class III anti arrhythmic medications"
                    ],
                    "criterion": "Class IA and Class III anti arrhythmic medications",
                    "requirement_type": "usage",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": [
                        "Cancer within the last 5 years"
                    ],
                    "criterion": "cancer",
                    "requirement_type": "time since diagnosis",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "except prostate cancer"
                    ],
                    "criterion": "prostate cancer",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "surgically removed basal or squamous cell carcinoma of the skin"
                    ],
                    "criterion": "basal or squamous cell carcinoma of the skin",
                    "requirement_type": "surgical removal",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known or suspected hepatic"
                    ],
                    "criterion": "hepatic disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "symptomatic biliary disease"
                    ],
                    "criterion": "biliary disease",
                    "requirement_type": "symptomatic",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "moderate to severe chronic hepatic impairment"
                    ],
                    "criterion": "chronic hepatic impairment",
                    "requirement_type": "severity",
                    "expected_value": [
                        "moderate",
                        "severe"
                    ]
                }
            ]
        },
        {
            "line": "* Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer",
            "criterions": [
                {
                    "exact_snippets": [
                        "clinically significant laboratory abnormalities"
                    ],
                    "criterion": "laboratory abnormalities",
                    "requirement_type": "clinical significance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "disorders other than prostate cancer"
                    ],
                    "criterion": "disorders",
                    "requirement_type": "exclusion",
                    "expected_value": "prostate cancer"
                }
            ]
        },
        {
            "line": "* Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections",
            "criterions": [
                {
                    "exact_snippets": [
                        "Hepatitis B Virus (HBV)"
                    ],
                    "criterion": "Hepatitis B Virus",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Hepatitis C Virus (HCV)"
                    ],
                    "criterion": "Hepatitis C Virus",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Human Immunodeficiency Virus (HIV)"
                    ],
                    "criterion": "Human Immunodeficiency Virus",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}