{
    "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": [
        {
            "line": "* Informed consent by the patient and/or caregiver",
            "criterions": [
                {
                    "exact_snippets": "Informed consent by the patient",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Informed consent by the ... caregiver",
                    "criterion": "informed consent by caregiver",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "according to the Summary of Product Characteristics (SmPC)"
                        }
                    ]
                },
                {
                    "exact_snippets": "as confirmed by the Investigator",
                    "criterion": "confirmation by Investigator",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* None",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}