{
    "info": {
        "nct_id": "NCT04455620",
        "official_title": "Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors",
        "inclusion_criteria": "* Histological documentation of the original primary tumor via a pathology report.\n* Measurable disease per RECIST1.1.\n\nFor Part 1:\n\n* Histologically confirmed solid tumor that is metastatic or of advanced unresectable stage and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. If there is no contraindication, patients should have exhausted all SoC therapies before entering the trial, if possible.\n\nFor all Parts:\n\n* ≥18 years of age.\n* Must sign an informed consent form (ICF) indicating that he or she understands the purpose and procedures required for the trial and are willing to participate in the trial prior to any trial-related assessments or procedures.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Adequate coagulation function at screening as required by the protocol.\n* Adequate hematologic function at screening as required by the protocol.\n* Adequate hepatic function at screening as required by the protocol.\n* Adequate renal function at screening as required by the protocol.\n* Able and willing to attend trial visits as required by the protocol.\n* Women of childbearing potential (WOCBP) must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test/value at screening. Patients who are postmenopausal or permanently sterilized can be considered as not having reproductive potential.\n* WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 6 months after last BNT151 treatment.\n* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the trial and for 6 months after receiving the last dose of BNT151.\n* WOCBP must agree to use highly effective contraception during the trial and for 6 months after receiving the last dose of BNT151. Birth control methods are considered highly effective if they have a failure rate of less than 1% per year, when used consistently and correctly.\n* Biomarker Cohort: At selected US sites only: at enrollment patients must agree to have one pre-dose biopsy and lesion that is deemed accessible by the investigator. If possible, at least one on-treatment biopsy should be accessible from same tumor lesion.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Use of any investigational medical product or device within 28 days before administration of first dose of trial treatment.\n* Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of trial treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment; any live vaccine within 4 weeks of the start of trial treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment.\n* Ongoing participation in the active treatment phase of interventional clinical trial.\n* Receives concurrent systemic (oral or IV) steroid therapy >10 mg prednisone daily or its equivalent for an underlying condition.\n* Has had major surgery within the 4 weeks before the first dose of BNT151.\n* Ongoing or active infection requiring IV treatment with anti-infective therapy that has been administered less than 2 weeks prior to the first dose of BNT151.\n* Has ongoing side effects to any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Grade ≤1.\n\nMedical conditions:\n\n* Current evidence of new or growing brain or leptomeningeal metastases during screening. Patients with known brain metastases may be eligible if they:\n* had radiotherapy, surgery or stereotactic surgery for the brain metastases;\n* have no neurological symptoms (excluding Grade ≤2 neuropathy);\n* have stable brain metastasis on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent;\n* are not undergoing acute corticosteroid therapy or steroid taper.\n* Has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago.\n* Effusions (pleural, pericardial, or ascites) requiring drainage.\n* History of autoimmune disease active or past including but not limited to inflammatory bowel disease, systemic lupus erythematosus (SLE), ankylosing spondylitis, scleroderma, or multiple sclerosis. Has any active immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents (e.g., azathioprine, cyclosporine A) with the exception of patients with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and patients with a history of Grave's disease with stable thyroid function. Patients with controlled hyperthyroidism must be negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid stimulating immunoglobulin prior to administration of trial treatment.\n* Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T˗cell (CD4+) counts <350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.\n* Known history/positive serology for hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy). Patients with positive serology must have HBV viral load below the limit of quantification.\n* Active HCV infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.\n* Known hypersensitivity to a component of any trial treatment.\n* Any contraindication to the combination therapies as per United States Prescribing Information (USPI) or Summary of Product Characteristics (SmPC) for patients receiving BNT151 in combination with other systemic anticancer agent(s).\n* Another primary malignancy that has not been in remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (including but not limited to adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ).\n\nOther comorbidities:\n\n* Abnormal ECGs that are clinically significant, such as Fridericia-corrected QT prolongation >480 ms.\n* In the opinion of the treating investigator, has any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the trial results; these conditions include, but are not limited to:\n* Ongoing or active infection requiring antibiotic/antiviral/antifungal therapy\n* Concurrent congestive heart failure (New York Heart Association [NYHA] Functional Classification Class III or IV)\n* Concurrent unstable angina\n* Concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation)\n* Acute coronary syndrome within the previous 6 months\n* Pulmonary embolism within the previous 3 months\n* Significant pulmonary disease (shortness of breath at rest or on mild exertion) for example due concurrent severe obstructive pulmonary disease.\n* Cognitive, psychological or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocol or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures.\n* Is pregnant or breastfeeding.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological documentation of the original primary tumor via a pathology report.",
            "criterions": [
                {
                    "exact_snippets": "Histological documentation of the original primary tumor via a pathology report.",
                    "criterion": "original primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histological"
                        },
                        {
                            "requirement_type": "source",
                            "expected_value": "pathology report"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease per RECIST1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease per RECIST1.1.",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "per RECIST1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "For Part 1:",
            "criterions": [
                {
                    "exact_snippets": "Part 1",
                    "criterion": "trial part",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": "Part 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed solid tumor that is metastatic or of advanced unresectable stage and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. If there is no contraindication, patients should have exhausted all SoC therapies before entering the trial, if possible.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or of advanced unresectable stage",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "advanced unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no available standard therapy likely to confer clinical benefit",
                    "criterion": "standard therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patient who is not a candidate for such available therapy",
                    "criterion": "candidate for available therapy",
                    "requirements": [
                        {
                            "requirement_type": "candidate status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients should have exhausted all SoC therapies",
                    "criterion": "SoC therapies",
                    "requirements": [
                        {
                            "requirement_type": "exhaustion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must sign an informed consent form (ICF) indicating that he or she understands the purpose and procedures required for the trial and are willing to participate in the trial prior to any trial-related assessments or procedures.",
            "criterions": [
                {
                    "exact_snippets": "Must sign an informed consent form (ICF)",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that he or she understands the purpose and procedures required for the trial",
                    "criterion": "understanding of trial purpose and procedures",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are willing to participate in the trial",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate coagulation function at screening as required by the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate coagulation function",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as required by the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function at screening as required by the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic function at screening as required by the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function at screening as required by the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as required by the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able and willing to attend trial visits as required by the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to attend trial visits",
                    "criterion": "attendance at trial visits",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential (WOCBP) must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test/value at screening. Patients who are postmenopausal or permanently sterilized can be considered as not having reproductive potential.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WOCBP) must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test/value at screening.",
                    "criterion": "serum beta-hCG test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are postmenopausal or permanently sterilized can be considered as not having reproductive potential.",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal or permanently sterilized"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 6 months after last BNT151 treatment.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP must agree not to donate eggs (ova, oocytes)",
                    "criterion": "egg donation",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "during the entire trial, until 6 months after last BNT151 treatment",
                    "criterion": "duration of egg donation restriction",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "entire trial and 6 months after last BNT151 treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the trial and for 6 months after receiving the last dose of BNT151.",
            "criterions": [
                {
                    "exact_snippets": "A man who is sexually active with a woman of childbearing potential",
                    "criterion": "sexual activity with a woman of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has not had a vasectomy",
                    "criterion": "vasectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use a barrier method of birth control",
                    "criterion": "use of barrier method of birth control",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "all men must also not donate sperm during the trial and for 6 months after receiving the last dose of BNT151",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WOCBP must agree to use highly effective contraception during the trial and for 6 months after receiving the last dose of BNT151. Birth control methods are considered highly effective if they have a failure rate of less than 1% per year, when used consistently and correctly.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP must agree to use highly effective contraception during the trial and for 6 months after receiving the last dose of BNT151.",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the trial and for 6 months after receiving the last dose of BNT151"
                        }
                    ]
                },
                {
                    "exact_snippets": "Birth control methods are considered highly effective if they have a failure rate of less than 1% per year, when used consistently and correctly.",
                    "criterion": "contraception effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biomarker Cohort: At selected US sites only: at enrollment patients must agree to have one pre-dose biopsy and lesion that is deemed accessible by the investigator. If possible, at least one on-treatment biopsy should be accessible from same tumor lesion.",
            "criterions": [
                {
                    "exact_snippets": "at enrollment patients must agree to have one pre-dose biopsy",
                    "criterion": "pre-dose biopsy",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion that is deemed accessible by the investigator",
                    "criterion": "lesion accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one on-treatment biopsy should be accessible from same tumor lesion",
                    "criterion": "on-treatment biopsy accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "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": "* Use of any investigational medical product or device within 28 days before administration of first dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Use of any investigational medical product or device within 28 days before administration of first dose of trial treatment.",
                    "criterion": "use of investigational medical product or device",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing participation in the active treatment phase of interventional clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing participation in the active treatment phase of interventional clinical trial.",
                    "criterion": "participation in interventional clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        },
                        {
                            "requirement_type": "phase",
                            "expected_value": "active treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receives concurrent systemic (oral or IV) steroid therapy >10 mg prednisone daily or its equivalent for an underlying condition.",
            "criterions": [
                {
                    "exact_snippets": "Receives concurrent systemic (oral or IV) steroid therapy >10 mg prednisone daily",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone daily"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had major surgery within the 4 weeks before the first dose of BNT151.",
            "criterions": [
                {
                    "exact_snippets": "Has had major surgery within the 4 weeks before the first dose of BNT151.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing or active infection requiring IV treatment with anti-infective therapy that has been administered less than 2 weeks prior to the first dose of BNT151.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "active"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring IV treatment with anti-infective therapy",
                    "criterion": "IV treatment with anti-infective therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "administered less than 2 weeks prior to the first dose of BNT151",
                    "criterion": "time since last anti-infective therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has ongoing side effects to any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Grade ≤1.",
            "criterions": [
                {
                    "exact_snippets": "ongoing side effects to any prior therapy or procedures",
                    "criterion": "ongoing side effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Grade ≤1",
                    "criterion": "recovery to NCI CTCAE v5.0 Grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Medical conditions:",
            "criterions": [
                {
                    "exact_snippets": "Medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current evidence of new or growing brain or leptomeningeal metastases during screening. Patients with known brain metastases may be eligible if they:",
            "criterions": [
                {
                    "exact_snippets": "Current evidence of new or growing brain or leptomeningeal metastases during screening.",
                    "criterion": "brain or leptomeningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "growth",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* had radiotherapy, surgery or stereotactic surgery for the brain metastases;",
            "criterions": [
                {
                    "exact_snippets": "had radiotherapy ... for the brain metastases",
                    "criterion": "radiotherapy for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had ... surgery ... for the brain metastases",
                    "criterion": "surgery for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had ... stereotactic surgery for the brain metastases",
                    "criterion": "stereotactic surgery for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* have no neurological symptoms (excluding Grade ≤2 neuropathy);",
            "criterions": [
                {
                    "exact_snippets": "no neurological symptoms",
                    "criterion": "neurological symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Grade ≤2 neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* have stable brain metastasis on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent;",
            "criterions": [
                {
                    "exact_snippets": "stable brain metastasis on the computed tomography (CT) or magnetic resonance imaging (MRI) scan",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks before signing the informed consent",
                    "criterion": "timing of CT or MRI scan",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* are not undergoing acute corticosteroid therapy or steroid taper.",
            "criterions": [
                {
                    "exact_snippets": "are not undergoing acute corticosteroid therapy",
                    "criterion": "acute corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "steroid taper",
                    "criterion": "steroid taper",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago.",
            "criterions": [
                {
                    "exact_snippets": "history of a cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of a ... transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Effusions (pleural, pericardial, or ascites) requiring drainage.",
            "criterions": [
                {
                    "exact_snippets": "Effusions (pleural, pericardial, or ascites) requiring drainage.",
                    "criterion": "effusions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "pleural",
                                "pericardial",
                                "ascites"
                            ]
                        },
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": "requiring drainage"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of autoimmune disease active or past including but not limited to inflammatory bowel disease, systemic lupus erythematosus (SLE), ankylosing spondylitis, scleroderma, or multiple sclerosis. Has any active immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents (e.g., azathioprine, cyclosporine A) with the exception of patients with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and patients with a history of Grave's disease with stable thyroid function. Patients with controlled hyperthyroidism must be negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid stimulating immunoglobulin prior to administration of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune disease active or past including but not limited to inflammatory bowel disease, systemic lupus erythematosus (SLE), ankylosing spondylitis, scleroderma, or multiple sclerosis.",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has any active immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents (e.g., azathioprine, cyclosporine A)",
                    "criterion": "active immunologic disorder",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "immunosuppression with steroids or other immunosuppressive agents"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and patients with a history of Grave's disease with stable thyroid function.",
                    "criterion": "exceptions for immunologic disorders",
                    "requirements": [
                        {
                            "requirement_type": "conditions",
                            "expected_value": [
                                "isolated vitiligo",
                                "resolved childhood asthma",
                                "atopic dermatitis",
                                "controlled hypoadrenalism",
                                "hypopituitarism",
                                "history of Grave's disease with stable thyroid function"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with controlled hyperthyroidism must be negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid stimulating immunoglobulin prior to administration of trial treatment.",
                    "criterion": "controlled hyperthyroidism",
                    "requirements": [
                        {
                            "requirement_type": "antibody status",
                            "expected_value": "negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid stimulating immunoglobulin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T˗cell (CD4+) counts <350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.",
            "criterions": [
                {
                    "exact_snippets": "Known history of seropositivity for human immunodeficiency virus (HIV)",
                    "criterion": "HIV seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CD4+ T˗cell (CD4+) counts <350 cells/µL",
                    "criterion": "CD4+ T-cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 350,
                                "unit": "cells/µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections",
                    "criterion": "AIDS-defining opportunistic infections",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history/positive serology for hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy). Patients with positive serology must have HBV viral load below the limit of quantification.",
            "criterions": [
                {
                    "exact_snippets": "Known history/positive serology for hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "serology",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring active antiviral therapy",
                    "criterion": "antiviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless immune due to vaccination",
                    "criterion": "hepatitis B immunity",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "vaccination"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless ... resolved natural infection",
                    "criterion": "hepatitis B immunity",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "resolved natural infection"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless passive immunization due to immunoglobulin therapy",
                    "criterion": "hepatitis B immunity",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "passive immunization due to immunoglobulin therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with positive serology must have HBV viral load below the limit of quantification",
                    "criterion": "HBV viral load",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "limit of quantification"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active HCV infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Active HCV infection",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed",
                    "criterion": "HCV viral load",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "below the limit of quantification"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to a component of any trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to a component of any trial treatment.",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any contraindication to the combination therapies as per United States Prescribing Information (USPI) or Summary of Product Characteristics (SmPC) for patients receiving BNT151 in combination with other systemic anticancer agent(s).",
            "criterions": [
                {
                    "exact_snippets": "Any contraindication to the combination therapies as per United States Prescribing Information (USPI) or Summary of Product Characteristics (SmPC)",
                    "criterion": "contraindication to combination therapies",
                    "requirements": [
                        {
                            "requirement_type": "reference",
                            "expected_value": [
                                "United States Prescribing Information (USPI)",
                                "Summary of Product Characteristics (SmPC)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients receiving BNT151 in combination with other systemic anticancer agent(s)",
                    "criterion": "BNT151 in combination with other systemic anticancer agent(s)",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Another primary malignancy that has not been in remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (including but not limited to adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ).",
            "criterions": [
                {
                    "exact_snippets": "Another primary malignancy that has not been in remission for at least 2 years",
                    "criterion": "primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "negligible risk of metastasis or death",
                    "criterion": "risk of metastasis or death",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "negligible"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... basal or squamous cell skin cancer",
                    "criterion": "basal or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... localized prostate cancer",
                    "criterion": "localized prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... ductal carcinoma in situ",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other comorbidities:",
            "criterions": [
                {
                    "exact_snippets": "Other comorbidities",
                    "criterion": "comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal ECGs that are clinically significant, such as Fridericia-corrected QT prolongation >480 ms.",
            "criterions": [
                {
                    "exact_snippets": "Abnormal ECGs that are clinically significant",
                    "criterion": "ECG",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Fridericia-corrected QT prolongation >480 ms",
                    "criterion": "QT interval",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In the opinion of the treating investigator, has any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the trial results; these conditions include, but are not limited to:",
            "criterions": [
                {
                    "exact_snippets": "any concurrent conditions that could pose an undue medical hazard",
                    "criterion": "concurrent conditions",
                    "requirements": [
                        {
                            "requirement_type": "medical hazard",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any concurrent conditions that could ... interfere with the interpretation of the trial results",
                    "criterion": "concurrent conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with trial results",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing or active infection requiring antibiotic/antiviral/antifungal therapy",
            "criterions": [
                {
                    "exact_snippets": "Ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "active"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring antibiotic/antiviral/antifungal therapy",
                    "criterion": "infection treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent unstable angina",
            "criterions": [
                {
                    "exact_snippets": "Concurrent unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation)",
            "criterions": [
                {
                    "exact_snippets": "Concurrent cardiac arrhythmia requiring treatment",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding asymptomatic atrial fibrillation",
                    "criterion": "asymptomatic atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute coronary syndrome within the previous 6 months",
            "criterions": [
                {
                    "exact_snippets": "Acute coronary syndrome within the previous 6 months",
                    "criterion": "acute coronary syndrome",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pulmonary embolism within the previous 3 months",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary embolism within the previous 3 months",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant pulmonary disease (shortness of breath at rest or on mild exertion) for example due concurrent severe obstructive pulmonary disease.",
            "criterions": [
                {
                    "exact_snippets": "Significant pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "shortness of breath at rest or on mild exertion",
                    "criterion": "shortness of breath",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "at rest",
                                "on mild exertion"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "severe obstructive pulmonary disease",
                    "criterion": "obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cognitive, psychological or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocol or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures.",
            "criterions": [
                {
                    "exact_snippets": "Cognitive, psychological or psychosocial impediment",
                    "criterion": "cognitive, psychological or psychosocial impediment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "impair the ability of the patient to receive therapy according to the protocol",
                    "criterion": "ability to receive therapy according to the protocol",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures",
                    "criterion": "ability to comply with the informed consent process, protocol, or protocol-required visits and procedures",
                    "requirements": [
                        {
                            "requirement_type": "adverse effect",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "For all Parts:",
            "criterions": [
                {
                    "exact_snippets": "Part 1: Histologically confirmed advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "Part 2: Histologically confirmed advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "Part 3: Histologically confirmed advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of trial treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment; any live vaccine within 4 weeks of the start of trial treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of trial treatment",
                    "criterion": "radiotherapy, chemotherapy, molecularly-targeted agents, tyrosine kinase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has been receiving: immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment",
                    "criterion": "immunotherapy/monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has been receiving: any live vaccine within 4 weeks of the start of trial treatment",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has been receiving: nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment",
                    "criterion": "nitrosoureas, antibody-drug conjugates, radioactive isotopes",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent congestive heart failure (New York Heart Association [NYHA] Functional Classification Class III or IV)",
            "criterions": [
                {
                    "exact_snippets": "concurrent congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association [NYHA] Functional Classification Class III or IV",
                    "criterion": "NYHA Functional Classification",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}