{
    "info": {
        "nct_id": "NCT05052801",
        "official_title": "A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression",
        "inclusion_criteria": "* Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\n* Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\n* Eastern Cooperative Oncology Group (ECOG) less than or equal to 1\n* Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\n* Participant has no contraindications to mFOLFOX6 chemotherapy\n* Adequate organ and bone marrow function:\n\n  * absolute neutrophil count greater than or equal to 1.5 times 10^9/L\n  * platelet count greater than or equal to 100 times 10^9/L\n  * hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\n  * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\n  * calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)\n  * international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "* Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)\n* Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway\n* Known human epidermal growth factor receptor 2 (HER2) positive\n* Untreated or symptomatic central nervous system (CNS) disease or brain metastases\n* Peripheral sensory neuropathy greater than or equal to Grade 2\n* Clinically significant cardiac disease\n* Other malignancy within the last 2 years (exceptions for definitively treated disease)\n* Chronic or systemic ophthalmological disorders\n* Major surgery or other investigational study within 28 days prior to first dose of study treatment\n* Palliative radiotherapy within 14 days prior to the first dose of study treatment\n* Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy",
            "criterions": [
                {
                    "exact_snippets": "Adults",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically documented",
                    "criterion": "cancer documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "cancer resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric or gastroesophageal junction cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric",
                                "gastroesophageal junction"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to curative therapy",
                    "criterion": "curative therapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy",
            "criterions": [
                {
                    "exact_snippets": "Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining",
                    "criterion": "FGFR2b tumor cell staining",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "staining intensity",
                            "expected_value": [
                                "2+",
                                "3+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "centrally performed immunohistochemistry (IHC) testing",
                    "criterion": "IHC testing",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "centrally performed"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy",
                    "criterion": "tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "archival",
                                "fresh biopsy"
                            ]
                        },
                        {
                            "requirement_type": "archival sample timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 180,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) less than or equal to 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) less than or equal to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "measurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-measurable, but evaluable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "non-measurable"
                        },
                        {
                            "requirement_type": "evaluability",
                            "expected_value": "evaluable"
                        }
                    ]
                },
                {
                    "exact_snippets": "according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1",
                    "criterion": "disease evaluation criteria",
                    "requirements": [
                        {
                            "requirement_type": "criteria version",
                            "expected_value": "RECIST V 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has no contraindications to mFOLFOX6 chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "no contraindications to mFOLFOX6 chemotherapy",
                    "criterion": "contraindications to mFOLFOX6 chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and bone marrow function:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ ... function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* absolute neutrophil count greater than or equal to 1.5 times 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count greater than or equal to 1.5 times 10^9/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelet count greater than or equal to 100 times 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "platelet count greater than or equal to 100 times 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment",
                    "criterion": "red blood cell (RBC) transfusion",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days prior to the first dose of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)",
            "criterions": [
                {
                    "exact_snippets": "aspartate aminotransferase (AST) ... less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement)",
                    "criterion": "aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "liver involvement"
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement)",
                    "criterion": "alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "liver involvement"
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 1.5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "liver involvement"
                        },
                        {
                            "requirement_type": "exception",
                            "expected_value": "Gilbert's disease"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)",
            "criterions": [
                {
                    "exact_snippets": "calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute",
                    "criterion": "creatinine clearance (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/minute"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)",
                    "criterion": "creatinine clearance calculation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "Cockcroft and Gault formula"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN",
                    "criterion": "INR or PT",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable dose for 6 weeks prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment for metastatic or unresectable disease",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "metastatic disease",
                                "unresectable disease"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment",
                    "criterion": "prior adjuvant, neo-adjuvant, and peri-operative therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway",
                    "criterion": "prior treatment with selective inhibitor of FGF-FGFR pathway",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known human epidermal growth factor receptor 2 (HER2) positive",
            "criterions": [
                {
                    "exact_snippets": "Known human epidermal growth factor receptor 2 (HER2) positive",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated or symptomatic central nervous system (CNS) disease or brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Untreated or symptomatic central nervous system (CNS) disease",
                    "criterion": "central nervous system (CNS) disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "symptom status",
                            "expected_value": "symptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral sensory neuropathy greater than or equal to Grade 2",
            "criterions": [
                {
                    "exact_snippets": "Peripheral sensory neuropathy greater than or equal to Grade 2",
                    "criterion": "peripheral sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignancy within the last 2 years (exceptions for definitively treated disease)",
            "criterions": [
                {
                    "exact_snippets": "Other malignancy within the last 2 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions for definitively treated disease",
                    "criterion": "definitively treated disease",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic or systemic ophthalmological disorders",
            "criterions": [
                {
                    "exact_snippets": "Chronic or systemic ophthalmological disorders",
                    "criterion": "ophthalmological disorders",
                    "requirements": [
                        {
                            "requirement_type": "chronicity",
                            "expected_value": [
                                "chronic",
                                "systemic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery or other investigational study within 28 days prior to first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Major surgery ... within 28 days prior to first dose of study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other investigational study within 28 days prior to first dose of study treatment",
                    "criterion": "participation in other investigational study",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Palliative radiotherapy within 14 days prior to the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Palliative radiotherapy within 14 days prior to the first dose of study treatment",
                    "criterion": "palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of or recent history (within 6 months) of corneal defects",
                    "criterion": "corneal defects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of or recent history (within 6 months) of ... corneal ulcerations",
                    "criterion": "corneal ulcerations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of or recent history (within 6 months) of ... keratitis",
                    "criterion": "keratitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of or recent history (within 6 months) of ... keratoconus",
                    "criterion": "keratoconus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of corneal transplant",
                    "criterion": "corneal transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer",
                    "criterion": "abnormalities of the cornea",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased risk of developing a corneal ulcer"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}