{
    "info": {
        "nct_id": "NCT01500720",
        "official_title": "Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria :\n\n* Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy\n* Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)\n* Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1\n\nExclusion criteria:\n\n* Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study\n* More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes\n* Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)\n* Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization\n* Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included\n* Participants with known leptomeningeal metastases\n* History of other, invasive neoplasm requiring ongoing therapy\n* Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization\n* Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack\n* Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results\n* Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)\n* Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization\n* Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of \"effective method of contraception\" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation\n* History of hypersensitivity to polysorbate 80\n* Inadequate organ and bone marrow function as evidenced by:\n\n  * Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)\n  * Absolute neutrophil count <1.5 x 10^9 per liter\n  * Platelet count <100 x 10^9 per liter\n  * Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)\n  * Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN\n  * Total bilirubin >1.0 x ULN\n  * Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Histological/cytological proven",
                    "criterion": "diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic small cell lung cancer",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "small cell lung cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "small cell lung cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive disease during or after first line platinum based chemotherapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressive disease"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "first line platinum based chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "legal age of majority",
                            "expected_value": "country's legal age of majority"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)",
            "criterions": [
                {
                    "exact_snippets": "Participants with measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)",
                    "criterion": "RECIST version",
                    "requirements": [
                        {
                            "requirement_type": "version",
                            "expected_value": "1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study",
            "criterions": [
                {
                    "exact_snippets": "Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form",
                    "criterion": "IRB-approved participant informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes",
            "criterions": [
                {
                    "exact_snippets": "More than one prior chemotherapy regimen",
                    "criterion": "prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with topotecan",
                    "criterion": "prior treatment with topotecan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... taxanes",
                    "criterion": "prior treatment with taxanes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)",
            "criterions": [
                {
                    "exact_snippets": "Less than 28 days elapsed from prior treatment with chemotherapy",
                    "criterion": "elapsed time since chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Less than 28 days elapsed from prior treatment with ... radiotherapy",
                    "criterion": "elapsed time since radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Less than 28 days elapsed from prior treatment with ... surgery",
                    "criterion": "elapsed time since surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiotherapy for bone pain palliation is allowed",
                    "criterion": "radiotherapy for bone pain palliation",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization",
            "criterions": [
                {
                    "exact_snippets": "Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03)",
                    "criterion": "adverse events from prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "NCI CTCAE v4.03"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled Central Nervous System (CNS) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "participants with CNS metastases may have previous irradiation",
                    "criterion": "previous irradiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participants with stable disease or response to irradiation",
                    "criterion": "disease stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable or response to irradiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are without CNS symptoms",
                    "criterion": "CNS symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "on a maximum steroid dose of dexamethasone 8 mg daily or equivalent",
                    "criterion": "steroid dose",
                    "requirements": [
                        {
                            "requirement_type": "maximum dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "mg daily"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with known leptomeningeal metastases",
            "criterions": [
                {
                    "exact_snippets": "known leptomeningeal metastases",
                    "criterion": "leptomeningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of other, invasive neoplasm requiring ongoing therapy",
            "criterions": [
                {
                    "exact_snippets": "History of other, invasive neoplasm requiring ongoing therapy",
                    "criterion": "invasive neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ongoing therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Participation in another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any concurrent treatment with any investigational drug within 30 days prior to randomization",
                    "criterion": "concurrent treatment with investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction ... within 6 months prior to study enrollment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe/unstable angina pectoris ... within 6 months prior to study enrollment",
                    "criterion": "severe/unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary/peripheral artery bypass graft ... within 6 months prior to study enrollment",
                    "criterion": "coronary/peripheral artery bypass graft",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association class III or IV congestive heart failure ... within 6 months prior to study enrollment",
                    "criterion": "New York Heart Association class III or IV congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke ... within 6 months prior to study enrollment",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack ... within 6 months prior to study enrollment",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results",
            "criterions": [
                {
                    "exact_snippets": "Any severe acute or chronic medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive serum or urine pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of \"effective method of contraception\" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation",
            "criterions": [
                {
                    "exact_snippets": "Participant with reproductive potential (M/F)",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment",
                    "criterion": "agreement to use contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Effective method of contraception should also be adapted to local regulation",
                    "criterion": "adaptation to local regulation",
                    "requirements": [
                        {
                            "requirement_type": "adaptation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity to polysorbate 80",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to polysorbate 80",
                    "criterion": "hypersensitivity to polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate organ and bone marrow function as evidenced by:",
            "criterions": [
                {
                    "exact_snippets": "Inadequate organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count <1.5 x 10^9 per liter",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count <1.5 x 10^9 per liter",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x 10^9 per liter"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count <100 x 10^9 per liter",
            "criterions": [
                {
                    "exact_snippets": "Platelet count <100 x 10^9 per liter",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 10^9 per liter"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) ... >2.5 x Upper Limit of Normal (ULN)",
                    "criterion": "Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)",
                    "criterion": "alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline Phosphatase (AP) >2.5 x ULN",
                    "criterion": "Alkaline Phosphatase (AP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "liver metastases AP >5 x ULN",
                    "criterion": "Alkaline Phosphatase (AP) with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin >1.0 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin >1.0 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.",
            "criterions": [
                {
                    "exact_snippets": "Serum Creatinine >1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine 1.0 - 1.5 x ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.0,
                                        "unit": "x ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance <60 milliliter per minute (mL/min)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "milliliter per minute (mL/min)"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria :",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        },
        {
            "line": "* Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)",
            "criterions": [
                {
                    "exact_snippets": "Known Human Immunodeficiency Virus (HIV) disease",
                    "criterion": "HIV disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",
            "criterions": []
        }
    ]
}