{
    "info": {
        "nct_id": "NCT03173092",
        "official_title": "An Open-Label, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) in Patients With Multiple Myeloma Previously Receiving a Bortezomib-Based Induction Regimen (US MM-6)",
        "inclusion_criteria": "1. Must have a diagnosis of a MM using current IMWG diagnostic criteria and have received 1 prior line of therapy.\n\n   * Participants must have completed 3 cycles of a bortezomib-based induction regimen (as defined by current NCCN guidelines) and have no evidence of disease progression as defined by IMWG criteria.\n   * Participants with light chain and free light chain (FLC) only may be enrolled if they meet all the criteria for a diagnosis of MM.\n   * Participants must be considered by their physician eligible to receiving the IRD regimen.\n2. Must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.\n\n   o Stem cell harvest and mobilization regimen is acceptable if clinically indicated, but must first be confirmed by the Takeda Medical Monitor.\n3. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 at time of enrollment.\n4. Female participants who:\n\n   * Are postmenopausal for at least 1 year before the screening visit, OR\n   * Are surgically sterile, OR\n   * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\n   * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).\n5. Male participants, even if surgically sterilized (that is, status post-vasectomy), must agree to one of the following:\n\n   * Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\n   * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. Non-interventional trials (that is, observational trials) are permitted at any time point.\n2. Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.\n3. Major surgery within 14 days before enrollment.\n4. Radiotherapy within 14 days before enrollment (if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib).\n5. Central nervous system involvement by MM.\n6. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.\n7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.\n8. Systemic treatment, within 14 days before the first dose of ixazomib, with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.\n9. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.\n10. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.\n11. Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.\n12. Have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.\n13. PD on first-line therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Must have a diagnosis of a MM using current IMWG diagnostic criteria and have received 1 prior line of therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "diagnosis of a MM using current IMWG diagnostic criteria"
                    ],
                    "criterion": "multiple myeloma",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "have received 1 prior line of therapy"
                    ],
                    "criterion": "prior line of therapy",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "* Participants must have completed 3 cycles of a bortezomib-based induction regimen (as defined by current NCCN guidelines) and have no evidence of disease progression as defined by IMWG criteria.",
            "criterions": [
                {
                    "exact_snippets": [
                        "completed 3 cycles of a bortezomib-based induction regimen"
                    ],
                    "criterion": "bortezomib-based induction regimen",
                    "requirement_type": "completion",
                    "expected_value": {
                        "operator": "=",
                        "value": 3
                    }
                },
                {
                    "exact_snippets": [
                        "no evidence of disease progression"
                    ],
                    "criterion": "disease progression",
                    "requirement_type": "evidence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Participants with light chain and free light chain (FLC) only may be enrolled if they meet all the criteria for a diagnosis of MM.",
            "criterions": [
                {
                    "exact_snippets": [
                        "light chain and free light chain (FLC) only"
                    ],
                    "criterion": "light chain and free light chain (FLC)",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "meet all the criteria for a diagnosis of MM"
                    ],
                    "criterion": "diagnosis of MM",
                    "requirement_type": "criteria fulfillment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Participants must be considered by their physician eligible to receiving the IRD regimen.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Participants must be considered by their physician eligible"
                    ],
                    "criterion": "eligibility by physician",
                    "requirement_type": "assessment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "receiving the IRD regimen"
                    ],
                    "criterion": "IRD regimen",
                    "requirement_type": "eligibility",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "transplant ineligible"
                    ],
                    "criterion": "transplant eligibility",
                    "requirement_type": "status",
                    "expected_value": "ineligible"
                },
                {
                    "exact_snippets": [
                        "transplant eligible"
                    ],
                    "criterion": "transplant eligibility",
                    "requirement_type": "status",
                    "expected_value": "eligible"
                },
                {
                    "exact_snippets": [
                        "not expect to undergo transplant for at least 24 months after study enrollment"
                    ],
                    "criterion": "transplant",
                    "requirement_type": "timing",
                    "expected_value": ">= 24 months"
                }
            ]
        },
        {
            "line": "o Stem cell harvest and mobilization regimen is acceptable if clinically indicated, but must first be confirmed by the Takeda Medical Monitor.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Stem cell harvest and mobilization regimen is acceptable"
                    ],
                    "criterion": "stem cell harvest and mobilization regimen",
                    "requirement_type": "acceptability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "must first be confirmed by the Takeda Medical Monitor"
                    ],
                    "criterion": "confirmation by Takeda Medical Monitor",
                    "requirement_type": "requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 at time of enrollment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Eastern Cooperative Oncology Group (ECOG) performance status",
                        "0, 1, or 2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1",
                        "2"
                    ]
                },
                {
                    "exact_snippets": [
                        "other performance status",
                        "0, 1, or 2"
                    ],
                    "criterion": "other performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1",
                        "2"
                    ]
                }
            ]
        },
        {
            "line": "4. Female participants who:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female participants"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                }
            ]
        },
        {
            "line": "* Are postmenopausal for at least 1 year before the screening visit, OR",
            "criterions": [
                {
                    "exact_snippets": [
                        "postmenopausal for at least 1 year"
                    ],
                    "criterion": "menopausal status",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Are surgically sterile, OR",
            "criterions": [
                {
                    "exact_snippets": [
                        "surgically sterile"
                    ],
                    "criterion": "surgical sterility",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR",
            "criterions": [
                {
                    "exact_snippets": [
                        "childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "agree to practice 2 effective methods of contraception"
                    ],
                    "criterion": "contraception methods",
                    "requirement_type": "quantity",
                    "expected_value": ">=2"
                },
                {
                    "exact_snippets": [
                        "from the time of signing the informed consent form through 90 days after the last dose of study drug"
                    ],
                    "criterion": "contraception duration",
                    "requirement_type": "duration",
                    "expected_value": "from the time of signing the informed consent form through 90 days after the last dose of study drug"
                }
            ]
        },
        {
            "line": "* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Agree to practice true abstinence"
                    ],
                    "criterion": "abstinence",
                    "requirement_type": "agreement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "when this is in line with the preferred and usual lifestyle of the participant"
                    ],
                    "criterion": "lifestyle",
                    "requirement_type": "alignment",
                    "expected_value": "preferred and usual"
                },
                {
                    "exact_snippets": [
                        "periodic abstinence [example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception"
                    ],
                    "criterion": "contraception methods",
                    "requirement_type": "acceptability",
                    "expected_value": [
                        "calendar",
                        "ovulation",
                        "symptothermal",
                        "post-ovulation",
                        "withdrawal"
                    ]
                }
            ]
        },
        {
            "line": "5. Male participants, even if surgically sterilized (that is, status post-vasectomy), must agree to one of the following:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Male participants"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "male"
                },
                {
                    "exact_snippets": [
                        "surgically sterilized",
                        "status post-vasectomy"
                    ],
                    "criterion": "surgical sterilization",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR",
            "criterions": [
                {
                    "exact_snippets": [
                        "Agree to practice effective barrier contraception"
                    ],
                    "criterion": "barrier contraception",
                    "requirement_type": "agreement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "during the entire study treatment period and through 90 days after the last dose of study drug"
                    ],
                    "criterion": "barrier contraception",
                    "requirement_type": "duration",
                    "expected_value": "entire study treatment period and through 90 days after the last dose of study drug"
                }
            ]
        },
        {
            "line": "* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Agree to practice true abstinence"
                    ],
                    "criterion": "abstinence",
                    "requirement_type": "agreement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Periodic abstinence (example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception"
                    ],
                    "criterion": "contraception methods",
                    "requirement_type": "acceptability",
                    "expected_value": [
                        "calendar",
                        "ovulation",
                        "symptothermal",
                        "post-ovulation",
                        "withdrawal"
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. Non-interventional trials (that is, observational trials) are permitted at any time point.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Participation in other interventional clinical trials"
                    ],
                    "criterion": "participation in interventional clinical trials",
                    "requirement_type": "prohibition",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Participation in other interventional clinical trials",
                        "within 30 days of the start of this trial"
                    ],
                    "criterion": "participation in interventional clinical trials",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Participation in other interventional clinical trials",
                        "throughout the duration of this trial"
                    ],
                    "criterion": "participation in interventional clinical trials",
                    "requirement_type": "duration",
                    "expected_value": "prohibited"
                },
                {
                    "exact_snippets": [
                        "Non-interventional trials (that is, observational trials) are permitted at any time point"
                    ],
                    "criterion": "participation in non-interventional trials",
                    "requirement_type": "permission",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "fully recovered",
                        "less than or equal to [<=] Grade 1 toxicity",
                        "reversible effects of prior chemotherapy"
                    ],
                    "criterion": "recovery from prior chemotherapy",
                    "requirement_type": "toxicity level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "3. Major surgery within 14 days before enrollment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Major surgery within 14 days before enrollment"
                    ],
                    "criterion": "major surgery",
                    "requirement_type": "time since",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 14
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. Radiotherapy within 14 days before enrollment (if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Radiotherapy within 14 days before enrollment"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "operator": ">=",
                        "value": 14
                    }
                },
                {
                    "exact_snippets": [
                        "if the involved field is small, 7 days will be considered a sufficient interval"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "operator": ">=",
                        "value": 7
                    }
                }
            ]
        },
        {
            "line": "5. Central nervous system involvement by MM.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Central nervous system involvement by MM"
                    ],
                    "criterion": "central nervous system",
                    "requirement_type": "involvement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Central nervous system involvement by MM"
                    ],
                    "criterion": "multiple myeloma",
                    "requirement_type": "involvement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "6. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Infection requiring systemic antibiotic therapy"
                    ],
                    "criterion": "infection",
                    "requirement_type": "treatment",
                    "expected_value": "systemic antibiotic therapy"
                },
                {
                    "exact_snippets": [
                        "serious infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                },
                {
                    "exact_snippets": [
                        "within 14 days before study enrollment"
                    ],
                    "criterion": "infection",
                    "requirement_type": "timeframe",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 14
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.",
            "criterions": [
                {
                    "exact_snippets": [
                        "uncontrolled cardiovascular conditions"
                    ],
                    "criterion": "cardiovascular conditions",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "uncontrolled hypertension"
                    ],
                    "criterion": "hypertension",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "uncontrolled cardiac arrhythmias"
                    ],
                    "criterion": "cardiac arrhythmias",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "symptomatic congestive heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "symptomatic",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unstable angina"
                    ],
                    "criterion": "angina",
                    "requirement_type": "stability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "myocardial infarction within the past 6 months"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "time since occurrence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "9. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Ongoing or active systemic infection"
                    ],
                    "criterion": "systemic infection",
                    "requirement_type": "status",
                    "expected_value": "active"
                },
                {
                    "exact_snippets": [
                        "active hepatitis B or C virus infection"
                    ],
                    "criterion": "hepatitis B or C virus infection",
                    "requirement_type": "status",
                    "expected_value": "active"
                },
                {
                    "exact_snippets": [
                        "known human immunodeficiency virus positive"
                    ],
                    "criterion": "human immunodeficiency virus",
                    "requirement_type": "status",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "10. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Diagnosed or treated for another malignancy within 2 years before study enrollment"
                    ],
                    "criterion": "another malignancy",
                    "requirement_type": "diagnosis or treatment timing",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "previously diagnosed with another malignancy and have any evidence of residual disease"
                    ],
                    "criterion": "another malignancy",
                    "requirement_type": "residual disease evidence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection"
                    ],
                    "criterion": "nonmelanoma skin cancer or carcinoma in situ",
                    "requirement_type": "resection status",
                    "expected_value": "complete resection"
                }
            ]
        },
        {
            "line": "11. Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.",
            "criterions": [
                {
                    "exact_snippets": [
                        "greater than or equal to (>=) Grade 2 peripheral neuropathy"
                    ],
                    "criterion": "peripheral neuropathy",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Grade 1 with pain on clinical examination"
                    ],
                    "criterion": "peripheral neuropathy",
                    "requirement_type": "severity with pain",
                    "expected_value": "Grade 1"
                }
            ]
        },
        {
            "line": "12. Have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.",
            "criterions": [
                {
                    "exact_snippets": [
                        "previously been treated with ixazomib"
                    ],
                    "criterion": "ixazomib treatment",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "participated in a study with ixazomib"
                    ],
                    "criterion": "ixazomib study participation",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "13. PD on first-line therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "PD on first-line therapy"
                    ],
                    "criterion": "progressive disease",
                    "requirement_type": "treatment line",
                    "expected_value": "first-line"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "8. Systemic treatment, within 14 days before the first dose of ixazomib, with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Systemic treatment, within 14 days before the first dose of ixazomib, with strong cytochrome P450 3A (CYP3A) inducers"
                    ],
                    "criterion": "systemic treatment with strong CYP3A inducers",
                    "requirement_type": "time since last use",
                    "expected_value": {
                        "operator": ">=",
                        "value": 14
                    }
                },
                {
                    "exact_snippets": [
                        "use of Ginkgo biloba"
                    ],
                    "criterion": "use of Ginkgo biloba",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "use of St. John's wort"
                    ],
                    "criterion": "use of St. John's wort",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}