{
    "info": {
        "nct_id": "NCT01967160",
        "official_title": "A Non-interventional Pharmacovigilance Study of Osteonecrosis of the Jaw and Infection Leading to Hospitalization Among Patients With Cancer Treated With XGEVA™ or Zoledronic Acid in Sweden, Denmark, and Norway",
        "inclusion_criteria": "* ≥ 18 years old\n* diagnosed with cancer\n* subsequent to cancer diagnosis, initiating cancer-related antiresorptive treatment during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from cancer-related treatment with oral or IV bisphosphonates at the dose indicated for SRE prevention of less than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions)\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* history of radiation treatment for head and neck cancer before a subject's potential index date\n* hypercalcemia of malignancy as the sole indication for treatment with an anti-resorptive agent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* diagnosed with cancer",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* subsequent to cancer diagnosis, initiating cancer-related antiresorptive treatment during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from cancer-related treatment with oral or IV bisphosphonates at the dose indicated for SRE prevention of less than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions)",
            "criterions": [
                {
                    "exact_snippets": "subsequent to cancer diagnosis",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "subsequent"
                        }
                    ]
                },
                {
                    "exact_snippets": "initiating cancer-related antiresorptive treatment during the treatment cohort identification period with XGEVA or zoledronic acid",
                    "criterion": "cancer-related antiresorptive treatment",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "XGEVA",
                                "zoledronic acid"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "switching to XGEVA from cancer-related treatment with oral or IV bisphosphonates",
                    "criterion": "switching to XGEVA",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": [
                                "oral bisphosphonates",
                                "IV bisphosphonates"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at the dose indicated for SRE prevention of less than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions)",
                    "criterion": "SRE prevention dose duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "IV infusions"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "monthly oral prescriptions"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* history of radiation treatment for head and neck cancer before a subject's potential index date",
            "criterions": [
                {
                    "exact_snippets": "history of radiation treatment for head and neck cancer",
                    "criterion": "radiation treatment history",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "head and neck cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hypercalcemia of malignancy as the sole indication for treatment with an anti-resorptive agent",
            "criterions": [
                {
                    "exact_snippets": "hypercalcemia of malignancy",
                    "criterion": "hypercalcemia of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "indication for treatment",
                            "expected_value": "sole"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with an anti-resorptive agent",
                    "criterion": "treatment with an anti-resorptive agent",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "hypercalcemia of malignancy"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}