{
    "info": {
        "nct_id": "NCT05429762",
        "official_title": "Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors",
        "inclusion_criteria": "* Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC) adenocarcinoma, nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GC/GEJ) adenocarcinoma, metastatic disease at study entry.\n* Participants with documented disease progression, for which, in the judgment of the Investigator, no alternative medical therapy is available.\n* Expression of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) will be assessed centrally using the most recent archival tumor tissue (or, if not available, a fresh biopsy sample) and at least 5 fresh-cut slides of formalin-fixed paraffin embedded (FFPE) tumor tissue sectioned. If less material is available, the participant could still be considered eligible after discussion with the Sponsor.\n\n  * Participants with CRC tumors may be assumed to have adequate CEACAM5 expression without testing results (it will be assessed retrospectively),\n  * Participants with NSQ NSCLC must have tumors expressing CEACAM5 or high circulating CEA if tumor tissue is not available.\n  * Participants with GC/GEJ must have tumors expressing CEACAM5\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as determined by the Investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to1.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) and is a WOCBP and agrees to use a contraceptive method that is highly effective and for at least 7 months after the last dose of treatment. administration.\n* Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration.\n* Capable of giving signed informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Untreated brain metastases that may be considered active or leptomeningeal metastasis. A participant with asymptomatic brain metastasis/metastases is eligible.\n* Significant concomitant illness\n* History within the last 2 years of an invasive malignancy other than that treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.\n* Any major surgery within 3 weeks prior to of first study intervention administration.\n* Known uncontrolled infection with human immunodeficiency virus (HIV). Participants with a well-controlled HIV infection/disease must be on antiretroviral therapy (ART) to be eligible.\n* Active infection with hepatitis A, B, or C.\n* Nonresolution of any prior treatment-related toxicity .\n* Unresolved corneal disorder or any previous corneal disorder.\n* Use of contact lenses is not permitted.\n* Prior history of Torsades de Pointes, or congenital long QT syndrome.\n* Patient receives (and cannot discontinue) or is scheduled to receive a QT-prolonging drug unless if deemed necessary for the participant as per the investigators' judgment and started at least 4 weeks prior IMP administration at the same dose and the same frequency.\n* QTcF interval >480 msec on screening ECG.\n* Poor bone marrow, liver, kidney functions, or electrolytes values\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC) adenocarcinoma, nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GC/GEJ) adenocarcinoma, metastatic disease at study entry.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC) adenocarcinoma",
                    "criterion": "colorectal cancer adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "nonsquamous non small cell lung cancer (NSQ NSCLC)",
                    "criterion": "nonsquamous non small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric/ gastroesophageal junction (GC/GEJ) adenocarcinoma",
                    "criterion": "gastric/gastroesophageal junction adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease at study entry",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with documented disease progression, for which, in the judgment of the Investigator, no alternative medical therapy is available.",
            "criterions": [
                {
                    "exact_snippets": "documented disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no alternative medical therapy is available",
                    "criterion": "alternative medical therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expression of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) will be assessed centrally using the most recent archival tumor tissue (or, if not available, a fresh biopsy sample) and at least 5 fresh-cut slides of formalin-fixed paraffin embedded (FFPE) tumor tissue sectioned. If less material is available, the participant could still be considered eligible after discussion with the Sponsor.",
            "criterions": [
                {
                    "exact_snippets": "Expression of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5)",
                    "criterion": "CEACAM5 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "most recent archival tumor tissue (or, if not available, a fresh biopsy sample)",
                    "criterion": "tumor tissue sample availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 5 fresh-cut slides of formalin-fixed paraffin embedded (FFPE) tumor tissue sectioned",
                    "criterion": "FFPE tumor tissue slides",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "slides"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with CRC tumors may be assumed to have adequate CEACAM5 expression without testing results (it will be assessed retrospectively),",
            "criterions": [
                {
                    "exact_snippets": "Participants with CRC tumors",
                    "criterion": "CRC tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate CEACAM5 expression",
                    "criterion": "CEACAM5 expression",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with NSQ NSCLC must have tumors expressing CEACAM5 or high circulating CEA if tumor tissue is not available.",
            "criterions": [
                {
                    "exact_snippets": "Participants with NSQ NSCLC",
                    "criterion": "NSQ NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors expressing CEACAM5",
                    "criterion": "tumor CEACAM5 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high circulating CEA",
                    "criterion": "circulating CEA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor tissue is not available",
                    "criterion": "tumor tissue availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with GC/GEJ must have tumors expressing CEACAM5",
            "criterions": [
                {
                    "exact_snippets": "Participants with GC/GEJ must have tumors expressing CEACAM5",
                    "criterion": "tumors",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": "CEACAM5"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as determined by the Investigator.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 to1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 to1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) and is a WOCBP and agrees to use a contraceptive method that is highly effective and for at least 7 months after the last dose of treatment. administration.",
            "criterions": [
                {
                    "exact_snippets": "female participant",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not a woman of childbearing potential (WOCBP)",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "is a WOCBP and agrees to use a contraceptive method that is highly effective and for at least 7 months after the last dose of treatment",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "at least 7 months after the last dose of treatment"
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration.",
            "criterions": [
                {
                    "exact_snippets": "Male participant",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use effective contraception methods",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during and for at least 4 months after the last dose of treatment administration",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Capable of giving signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Capable of giving signed informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "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": "* Untreated brain metastases that may be considered active or leptomeningeal metastasis. A participant with asymptomatic brain metastasis/metastases is eligible.",
            "criterions": [
                {
                    "exact_snippets": "Untreated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases that may be considered active",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal metastasis",
                    "criterion": "leptomeningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic brain metastasis/metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptom status",
                            "expected_value": "asymptomatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant concomitant illness",
            "criterions": [
                {
                    "exact_snippets": "Significant concomitant illness",
                    "criterion": "concomitant illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History within the last 2 years of an invasive malignancy other than that treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.",
            "criterions": [
                {
                    "exact_snippets": "History within the last 2 years of an invasive malignancy other than that treated in this study",
                    "criterion": "invasive malignancy history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 2 years"
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "other than that treated in this study"
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of resected/ablated basal or squamous-cell carcinoma of the skin",
                    "criterion": "basal or squamous-cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "resected",
                                "ablated"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "exception"
                        }
                    ]
                },
                {
                    "exact_snippets": "other local tumors considered cured by local treatment",
                    "criterion": "local tumors",
                    "requirements": [
                        {
                            "requirement_type": "treatment outcome",
                            "expected_value": "considered cured by local treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any major surgery within 3 weeks prior to of first study intervention administration.",
            "criterions": [
                {
                    "exact_snippets": "Any major surgery within 3 weeks prior to of first study intervention administration.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known uncontrolled infection with human immunodeficiency virus (HIV). Participants with a well-controlled HIV infection/disease must be on antiretroviral therapy (ART) to be eligible.",
            "criterions": [
                {
                    "exact_snippets": "Known uncontrolled infection with human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with a well-controlled HIV infection/disease must be on antiretroviral therapy (ART)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "well-controlled"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "antiretroviral therapy (ART)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection with hepatitis A, B, or C.",
            "criterions": [
                {
                    "exact_snippets": "Active infection with hepatitis A",
                    "criterion": "hepatitis A infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active infection with hepatitis ... B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active infection with hepatitis ... C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nonresolution of any prior treatment-related toxicity .",
            "criterions": [
                {
                    "exact_snippets": "Nonresolution of any prior treatment-related toxicity",
                    "criterion": "prior treatment-related toxicity",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresolved corneal disorder or any previous corneal disorder.",
            "criterions": [
                {
                    "exact_snippets": "Unresolved corneal disorder",
                    "criterion": "corneal disorder",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "unresolved"
                        }
                    ]
                },
                {
                    "exact_snippets": "any previous corneal disorder",
                    "criterion": "corneal disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of contact lenses is not permitted.",
            "criterions": [
                {
                    "exact_snippets": "Use of contact lenses is not permitted.",
                    "criterion": "contact lenses",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior history of Torsades de Pointes, or congenital long QT syndrome.",
            "criterions": [
                {
                    "exact_snippets": "Prior history of Torsades de Pointes",
                    "criterion": "Torsades de Pointes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient receives (and cannot discontinue) or is scheduled to receive a QT-prolonging drug unless if deemed necessary for the participant as per the investigators' judgment and started at least 4 weeks prior IMP administration at the same dose and the same frequency.",
            "criterions": [
                {
                    "exact_snippets": "Patient receives (and cannot discontinue) or is scheduled to receive a QT-prolonging drug",
                    "criterion": "QT-prolonging drug",
                    "requirements": [
                        {
                            "requirement_type": "scheduled or ongoing use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "started at least 4 weeks prior IMP administration",
                    "criterion": "QT-prolonging drug",
                    "requirements": [
                        {
                            "requirement_type": "start time relative to IMP administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at the same dose and the same frequency",
                    "criterion": "QT-prolonging drug",
                    "requirements": [
                        {
                            "requirement_type": "dose consistency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "frequency consistency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QTcF interval >480 msec on screening ECG.",
            "criterions": [
                {
                    "exact_snippets": "QTcF interval >480 msec",
                    "criterion": "QTcF interval",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poor bone marrow, liver, kidney functions, or electrolytes values",
            "criterions": [
                {
                    "exact_snippets": "Poor bone marrow ... functions",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poor ... liver ... functions",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poor ... kidney functions",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poor ... electrolytes values",
                    "criterion": "electrolyte values",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Participant not suitable for participation, whatever the reason, as judged by the Investigator",
                    "criterion": "suitability for participation",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "as judged by the Investigator"
                        }
                    ]
                },
                {
                    "exact_snippets": "medical or clinical conditions",
                    "criterion": "medical or clinical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participants potentially at risk of noncompliance to study procedures",
                    "criterion": "risk of noncompliance",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}