{
    "info": {
        "nct_id": "NCT02326376",
        "official_title": "Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medication Errors Including Re-use of Syringe",
        "inclusion_criteria": "* Informed consent by the patient and/or caregiver\n* Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator\nHealthy volunteers allowed",
        "exclusion_criteria": "* None",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Informed consent by the patient and/or caregiver",
                "criterions": [
                    {
                        "exact_snippets": "Informed consent by the patient",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Informed consent by the ... caregiver",
                        "criterion": "informed consent by caregiver",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Informed consent by the patient",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Informed consent by the ... caregiver",
                        "criterion": "informed consent by caregiver",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator",
                "criterions": [
                    {
                        "exact_snippets": "Kineret treatment ... according to the Summary of Product Characteristics (SmPC)",
                        "criterion": "Kineret treatment",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": "according to the Summary of Product Characteristics (SmPC)"
                        }
                    },
                    {
                        "exact_snippets": "as confirmed by the Investigator",
                        "criterion": "confirmation by Investigator",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Kineret treatment ... according to the Summary of Product Characteristics (SmPC)",
                        "criterion": "Kineret treatment",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": "according to the Summary of Product Characteristics (SmPC)"
                        }
                    },
                    {
                        "exact_snippets": "as confirmed by the Investigator",
                        "criterion": "confirmation by Investigator",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* None",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}