{
    "info": {
        "nct_id": "NCT03224182",
        "official_title": "A Randomized, Multicenter, Two-Arm, Single-Dose, Double-Blind, Placebo-CONtrolled Phase 3 Study of Intravesical Qapzola™ (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer (CONQUER)",
        "inclusion_criteria": "1. Participant must have had a clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer according to the 2016 American Urological Association (AUA) Guidelines, except for strongly-suspected papillary urothelial neoplasm of low malignant potential (PUNLMP).\n2. Participant was willing to give written informed consent and was able to adhere to dosing and visit schedules, and meet all study requirements.\n3. Participant was at least 18 years of age and <90 years of age at the time Informed Consent is signed.\n4. Participant was willing to practice two forms of contraception, one of which must have been a barrier method, from study entry until at least 35 days after study treatment. Participants surgically sterilized or who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) did not require contraception.\n5. Females of childbearing potential had a negative pregnancy test within 30 days prior to randomization. Females who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) or were surgically sterilized did not require this test.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 89 Years",
        "exclusion_criteria": "1. Participant had malignancy or life-threatening systemic disease or a history of advanced, serious, life-threatening malignancy/disease within the last 5 years, except very low-risk prostate cancer.\n2. Participant had used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment or had plans to use any of these during the course of the study.\n3. Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy).\n4. Participant had a history of allergy to red color food dye or any other component of Qapzola, placebo, or their diluents.\n5. Participant had a surgical procedure 4 weeks prior to TURBT or had other surgical procedures performed at the time of TURBT or within 4 weeks after TURBT.\n6. Participant had any unstable or uncontrolled medical condition that would make it potentially unsafe to undergo TURBT including a previous stroke or myocardial infarction within 6 months.\n7. Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive study treatment or undergo study procedures.\n8. Participant had a bleeding disorder or a screening platelet count <100×10^9/per liter (L), or required continuous anticoagulation or bridging anticoagulation during the procedure.\n9. Participant had a hemoglobin value <10 grams per deciliter (g/dL) at Screening.\n10. Participant had confirmed extravesical urothelial disease (upper tract and urethral including prostatic urethral).\n11. Participant had history of previous bladder cancer:\n\n    * High-Risk NMIBC as classified per the 2016 AUA Guidelines\n    * Bladder cancer that was muscle invasive or positive for lymph node or distant metastasis.\n12. Participant had received any previous intravesical therapy for bladder cancer- chemotherapy, immunotherapy, or previous exposure to Qapzola in the previous 3 years.\n13. Participant had a tumor in the bladder diverticulum.\n14. Participant had a history of interstitial cystitis.\n15. Participant was pregnant or breast-feeding.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Participant must have had a clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer according to the 2016 American Urological Association (AUA) Guidelines, except for strongly-suspected papillary urothelial neoplasm of low malignant potential (PUNLMP).",
            "criterions": [
                {
                    "exact_snippets": "clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer",
                    "criterion": "non-muscle invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "low- to intermediate-risk"
                        }
                    ]
                },
                {
                    "exact_snippets": "according to the 2016 American Urological Association (AUA) Guidelines",
                    "criterion": "diagnosis guidelines",
                    "requirements": [
                        {
                            "requirement_type": "guideline year",
                            "expected_value": "2016"
                        },
                        {
                            "requirement_type": "guideline source",
                            "expected_value": "American Urological Association (AUA)"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for strongly-suspected papillary urothelial neoplasm of low malignant potential (PUNLMP)",
                    "criterion": "papillary urothelial neoplasm of low malignant potential (PUNLMP)",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participant was willing to give written informed consent and was able to adhere to dosing and visit schedules, and meet all study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Participant was willing to give written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to adhere to dosing and visit schedules",
                    "criterion": "adherence to dosing and visit schedules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meet all study requirements",
                    "criterion": "study requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participant was at least 18 years of age and <90 years of age at the time Informed Consent is signed.",
            "criterions": [
                {
                    "exact_snippets": "Participant was at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "<90 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participant was willing to practice two forms of contraception, one of which must have been a barrier method, from study entry until at least 35 days after study treatment. Participants surgically sterilized or who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) did not require contraception.",
            "criterions": [
                {
                    "exact_snippets": "Participant was willing to practice two forms of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "forms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "one of which must have been a barrier method",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "barrier method"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants surgically sterilized ... did not require contraception",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal for at least 1 year (defined as more than 12 months since last menses) did not require contraception",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Females of childbearing potential had a negative pregnancy test within 30 days prior to randomization. Females who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) or were surgically sterilized did not require this test.",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential",
                    "criterion": "females of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "pregnancy test result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Females of childbearing potential ... within 30 days prior to randomization",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Females who were postmenopausal for at least 1 year (defined as more than 12 months since last menses)",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Females who ... were surgically sterilized",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 89 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 89 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 89,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Participant had malignancy or life-threatening systemic disease or a history of advanced, serious, life-threatening malignancy/disease within the last 5 years, except very low-risk prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Participant had malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "life-threatening systemic disease",
                    "criterion": "life-threatening systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of advanced, serious, life-threatening malignancy/disease within the last 5 years",
                    "criterion": "history of advanced, serious, life-threatening malignancy/disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except very low-risk prostate cancer",
                    "criterion": "very low-risk prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participant had used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment or had plans to use any of these during the course of the study.",
            "criterions": [
                {
                    "exact_snippets": "Participant had used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment",
                    "criterion": "use of investigational drugs, biologics, or devices",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had plans to use any of these during the course of the study",
                    "criterion": "plans to use investigational drugs, biologics, or devices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy).",
            "criterions": [
                {
                    "exact_snippets": "received any pelvic radiotherapy (including external beam and/or brachytherapy)",
                    "criterion": "pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participant had a history of allergy to red color food dye or any other component of Qapzola, placebo, or their diluents.",
            "criterions": [
                {
                    "exact_snippets": "history of allergy to red color food dye",
                    "criterion": "allergy to red color food dye",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of allergy to ... any other component of Qapzola",
                    "criterion": "allergy to any other component of Qapzola",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of allergy to ... placebo",
                    "criterion": "allergy to placebo",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of allergy to ... their diluents",
                    "criterion": "allergy to their diluents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Participant had a surgical procedure 4 weeks prior to TURBT or had other surgical procedures performed at the time of TURBT or within 4 weeks after TURBT.",
            "criterions": [
                {
                    "exact_snippets": "Participant had a surgical procedure 4 weeks prior to TURBT",
                    "criterion": "surgical procedure prior to TURBT",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "had other surgical procedures performed at the time of TURBT",
                    "criterion": "surgical procedures at the time of TURBT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical procedures performed ... within 4 weeks after TURBT",
                    "criterion": "surgical procedures after TURBT",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Participant had any unstable or uncontrolled medical condition that would make it potentially unsafe to undergo TURBT including a previous stroke or myocardial infarction within 6 months.",
            "criterions": [
                {
                    "exact_snippets": "unstable or uncontrolled medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": "previous"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive study treatment or undergo study procedures.",
            "criterions": [
                {
                    "exact_snippets": "active uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "urinary tract infection",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "underlying medical condition",
                    "criterion": "underlying medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other serious illness",
                    "criterion": "serious illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Participant had a bleeding disorder or a screening platelet count <100×10^9/per liter (L), or required continuous anticoagulation or bridging anticoagulation during the procedure.",
            "criterions": [
                {
                    "exact_snippets": "bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "screening platelet count <100×10^9/per liter (L)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "required continuous anticoagulation",
                    "criterion": "continuous anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required ... bridging anticoagulation during the procedure",
                    "criterion": "bridging anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Participant had a hemoglobin value <10 grams per deciliter (g/dL) at Screening.",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin value <10 grams per deciliter (g/dL)",
                    "criterion": "hemoglobin value",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "grams per deciliter (g/dL)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Participant had confirmed extravesical urothelial disease (upper tract and urethral including prostatic urethral).",
            "criterions": [
                {
                    "exact_snippets": "confirmed extravesical urothelial disease",
                    "criterion": "extravesical urothelial disease",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "upper tract",
                    "criterion": "location of urothelial disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "upper tract"
                        }
                    ]
                },
                {
                    "exact_snippets": "urethral including prostatic urethral",
                    "criterion": "location of urothelial disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "urethral",
                                "prostatic urethral"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Participant had history of previous bladder cancer:",
            "criterions": [
                {
                    "exact_snippets": "history of previous bladder cancer",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High-Risk NMIBC as classified per the 2016 AUA Guidelines",
            "criterions": [
                {
                    "exact_snippets": "High-Risk NMIBC as classified per the 2016 AUA Guidelines",
                    "criterion": "High-Risk NMIBC",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "per the 2016 AUA Guidelines"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bladder cancer that was muscle invasive or positive for lymph node or distant metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Bladder cancer that was muscle invasive",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "muscle invasive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bladder cancer ... positive for lymph node",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "lymph node involvement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Bladder cancer ... positive for ... distant metastasis",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "distant metastasis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Participant had received any previous intravesical therapy for bladder cancer- chemotherapy, immunotherapy, or previous exposure to Qapzola in the previous 3 years.",
            "criterions": [
                {
                    "exact_snippets": "Participant had received any previous intravesical therapy for bladder cancer",
                    "criterion": "previous intravesical therapy for bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy",
                    "criterion": "previous immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous exposure to Qapzola in the previous 3 years",
                    "criterion": "previous exposure to Qapzola",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Participant had a tumor in the bladder diverticulum.",
            "criterions": [
                {
                    "exact_snippets": "tumor in the bladder diverticulum",
                    "criterion": "tumor in bladder diverticulum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Participant had a history of interstitial cystitis.",
            "criterions": [
                {
                    "exact_snippets": "history of interstitial cystitis",
                    "criterion": "interstitial cystitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Participant was pregnant or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "Participant was pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}