{
    "info": {
        "nct_id": "NCT00842348",
        "official_title": "Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour",
        "inclusion_criteria": "1. Had provided written informed consent prior to any study-related procedures.\n2. Had been enrolled and treated in Study 2-55-52030-726 and either:\n\n   * Was stable at 96 weeks of treatment (whatever the treatment received during the 2 years of participation, i.e. no code break at Week 96); or,\n   * Had received at least one injection in Study 2-55-52030-726 and had disease progression, confirmed by central assessment, during the course of the study and code break showed placebo.\n3. Had a World Health Organisation (WHO) performance score lower than or equal to 2.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Had been enrolled and treated in the frame of the protocol and had disease progression during the study and the code break showed a treatment with lanreotide Autogel 120 mg.\n2. Had received any new treatment for the entero-pancreatic NET since the end of participation in the study.\n3. Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET.\n4. Had been treated with radionuclide at any time prior to study entry.\n5. Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg.\n6. Were likely to require treatment during the study with drugs that were not permitted by the study protocol.\n7. Were at risk of pregnancy or lactation. Females of childbearing potential had to provide a negative pregnancy test at the start of study and had to be using oral, double barrier or injectable contraception. Non-childbearing potential was defined as postmenopause for at least 1 year, or surgical sterilisation or hysterectomy at least 3 months before the start of the study.\n8. Had any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.\n9. Had abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might have jeopardised the patient's safety or decreased the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.\n10. Previous enrolment in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Had provided written informed consent prior to any study-related procedures.",
            "criterions": [
                {
                    "exact_snippets": "provided written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Had been enrolled and treated in Study 2-55-52030-726 and either:",
            "criterions": [
                {
                    "exact_snippets": "Had been enrolled and treated in Study 2-55-52030-726",
                    "criterion": "enrollment and treatment in Study 2-55-52030-726",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Was stable at 96 weeks of treatment (whatever the treatment received during the 2 years of participation, i.e. no code break at Week 96); or,",
            "criterions": [
                {
                    "exact_snippets": "stable at 96 weeks of treatment",
                    "criterion": "stability at 96 weeks of treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "no code break at Week 96",
                    "criterion": "code break at Week 96",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had received at least one injection in Study 2-55-52030-726 and had disease progression, confirmed by central assessment, during the course of the study and code break showed placebo.",
            "criterions": [
                {
                    "exact_snippets": "Had received at least one injection in Study 2-55-52030-726",
                    "criterion": "injection in Study 2-55-52030-726",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had disease progression, confirmed by central assessment, during the course of the study",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "central assessment"
                        }
                    ]
                },
                {
                    "exact_snippets": "code break showed placebo",
                    "criterion": "code break result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "placebo"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Had a World Health Organisation (WHO) performance score lower than or equal to 2.",
            "criterions": [
                {
                    "exact_snippets": "World Health Organisation (WHO) performance score lower than or equal to 2",
                    "criterion": "WHO performance score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "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": "1. Had been enrolled and treated in the frame of the protocol and had disease progression during the study and the code break showed a treatment with lanreotide Autogel 120 mg.",
            "criterions": [
                {
                    "exact_snippets": "Had been enrolled and treated in the frame of the protocol",
                    "criterion": "enrollment and treatment in the protocol",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "completed"
                        }
                    ]
                },
                {
                    "exact_snippets": "had disease progression during the study",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the code break showed a treatment with lanreotide Autogel 120 mg",
                    "criterion": "treatment with lanreotide Autogel",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": "120 mg"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Had received any new treatment for the entero-pancreatic NET since the end of participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Had received any new treatment for the entero-pancreatic NET",
                    "criterion": "new treatment for entero-pancreatic NET",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET.",
            "criterions": [
                {
                    "exact_snippets": "likely to require any additional concomitant treatment to lanreotide Autogel 120 mg",
                    "criterion": "requirement for additional concomitant treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Had been treated with radionuclide at any time prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Had been treated with radionuclide at any time prior to study entry.",
                    "criterion": "radionuclide treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg.",
            "criterions": [
                {
                    "exact_snippets": "history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg",
                    "criterion": "hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Were likely to require treatment during the study with drugs that were not permitted by the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "require treatment during the study with drugs that were not permitted by the study protocol",
                    "criterion": "requirement for non-permitted drugs",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Were at risk of pregnancy or lactation. Females of childbearing potential had to provide a negative pregnancy test at the start of study and had to be using oral, double barrier or injectable contraception. Non-childbearing potential was defined as postmenopause for at least 1 year, or surgical sterilisation or hysterectomy at least 3 months before the start of the study.",
            "criterions": [
                {
                    "exact_snippets": "at risk of pregnancy",
                    "criterion": "risk of pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Females of childbearing potential had to provide a negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Females of childbearing potential ... had to be using oral, double barrier or injectable contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "oral",
                                "double barrier",
                                "injectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-childbearing potential was defined as postmenopause for at least 1 year",
                    "criterion": "postmenopause",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-childbearing potential was defined as ... surgical sterilisation or hysterectomy at least 3 months before the start of the study",
                    "criterion": "surgical sterilisation or hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Had any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.",
            "criterions": [
                {
                    "exact_snippets": "Had any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study",
                    "criterion": "mental condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on understanding",
                            "expected_value": "unable to understand the nature, scope and possible consequences of the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of an uncooperative attitude",
                    "criterion": "uncooperative attitude",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Had abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might have jeopardised the patient's safety or decreased the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.",
            "criterions": [
                {
                    "exact_snippets": "abnormal findings at Visit 1",
                    "criterion": "abnormal findings at Visit 1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other medical condition(s)",
                    "criterion": "other medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory findings that, in the opinion of the investigator, might have jeopardised the patient's safety or decreased the chance of obtaining satisfactory data",
                    "criterion": "laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "impact on safety or data quality",
                            "expected_value": "jeopardise safety or decrease data quality"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Previous enrolment in this study.",
            "criterions": [
                {
                    "exact_snippets": "Previous enrolment in this study.",
                    "criterion": "previous enrolment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}