{
    "info": {
        "nct_id": "NCT01243762",
        "official_title": "Phase I Parallel Arm Study of MK-0646 (Dalotuzumab) + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + MK-8669 (Ridaforolimus) Doublets (MK-MK Doublets) in Patients With Advanced Cancer",
        "inclusion_criteria": "* Participants must not have any medical conditions that may impact compliance with the protocol, limit interpretation of study results, or pose an unacceptable medical risk.\n* Participant must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (EGOG) Performance Scale.\n* Participant is able to swallow capsules and has no condition that will preclude swallowing and absorbing oral medications on an ongoing basis.\n* Participant has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with prostatic specific antigen (PSA) < 1.0; or has undergone potentially curative therapy with no evidence of that disease for five years, or is deemed at low risk for recurrence by his/her treating physician.\n* Participant has at least one measurable metastatic or recurrent lesion according to Response Criteria in Solid Tumors (RECIST).\n\nPart 1:\n\n* Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. There is no limit on the number of prior treatment regimens.\n\nPart 2:\n\n* A female participant assigned to the dalotuzumab + MK-2206 or dalotuzumab + ridaforolimus treatment arms must have histologically-confirmed metastatic or recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. Participants may have received any number of prior treatment regimens.\n* A participant assigned to the dalotuzumab + MK-0752 treatment arms must have histologically-confirmed metastatic or recurrent wild-type KRAS colorectal cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. Participants may have received any number of prior treatment regimens.\n* Participant agrees to provide archival tumor tissue sample or undergo biopsy for analysis of gene expression levels.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participant has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas or mitomycin C) or who has not recovered from adverse events due to agents administered more than 4 weeks earlier, or major surgery <4 weeks earlier.\n* Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with a monoclonal antibody will be eligible to participate after a 28 day washout period.\n* Participants with known central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded.\n* Participant has significant or uncontrolled cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a myocardial infarction within the last 6 months.\n* Participant is known to have diabetes that is poorly controlled.\n* Participant is pregnant, breastfeeding, or expecting to conceive or father children during the study.\n* Participant is known to be human immunodeficiency virus (HIV)-positive.\n* Participant has active Hepatitis B or C infection.\n* Participant has symptomatic ascites or pleural effusion.\n* Participant requires treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for at least two weeks prior to the first dose of study drug.\n* Participant requires treatment with medication(s) that strongly or moderately induce or inhibit cytochrome P450.\n* Participant is using growth hormone or growth hormone inhibitors.\n* Participant requires treatment with therapeutic warfarin.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants must not have any medical conditions that may impact compliance with the protocol, limit interpretation of study results, or pose an unacceptable medical risk.",
            "criterions": [
                {
                    "exact_snippets": "Participants must not have any medical conditions that may impact compliance with the protocol",
                    "criterion": "medical conditions impacting protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must not have any medical conditions that may ... limit interpretation of study results",
                    "criterion": "medical conditions limiting interpretation of study results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must not have any medical conditions that may ... pose an unacceptable medical risk",
                    "criterion": "medical conditions posing unacceptable medical risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (EGOG) Performance Scale.",
            "criterions": [
                {
                    "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group (EGOG) Performance Scale",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Eastern Cooperative Oncology Group (EGOG) Performance Scale"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is able to swallow capsules and has no condition that will preclude swallowing and absorbing oral medications on an ongoing basis.",
            "criterions": [
                {
                    "exact_snippets": "Participant is able to swallow capsules",
                    "criterion": "ability to swallow capsules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no condition that will preclude swallowing",
                    "criterion": "condition precluding swallowing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no condition that will preclude ... absorbing oral medications",
                    "criterion": "condition precluding absorption of oral medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with prostatic specific antigen (PSA) < 1.0; or has undergone potentially curative therapy with no evidence of that disease for five years, or is deemed at low risk for recurrence by his/her treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Participant has no history of a prior malignancy",
                    "criterion": "history of prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of cervical intraepithelial neoplasia",
                    "criterion": "cervical intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated localized prostate carcinoma with prostatic specific antigen (PSA) < 1.0",
                    "criterion": "localized prostate carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        },
                        {
                            "requirement_type": "prostatic specific antigen (PSA) level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": ""
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone potentially curative therapy with no evidence of that disease for five years",
                    "criterion": "potentially curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "deemed at low risk for recurrence by his/her treating physician",
                    "criterion": "risk for recurrence",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has at least one measurable metastatic or recurrent lesion according to Response Criteria in Solid Tumors (RECIST).",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable metastatic or recurrent lesion according to Response Criteria in Solid Tumors (RECIST)",
                    "criterion": "metastatic or recurrent lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "criteria",
                            "expected_value": "Response Criteria in Solid Tumors (RECIST)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Part 1:",
            "criterions": [
                {
                    "exact_snippets": "Part 1",
                    "criterion": "trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. There is no limit on the number of prior treatment regimens.",
            "criterions": [
                {
                    "exact_snippets": "histologically-confirmed metastatic or locally advanced solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed to respond to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed despite standard therapy",
                    "criterion": "progression despite standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which standard therapy does not exist",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participant is not a candidate for standard therapy",
                    "criterion": "candidate for standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to undergo standard therapy",
                    "criterion": "willingness to undergo standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no limit on the number of prior treatment regimens",
                    "criterion": "number of prior treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": "no limit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A female participant assigned to the dalotuzumab + MK-2206 or dalotuzumab + ridaforolimus treatment arms must have histologically-confirmed metastatic or recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. Participants may have received any number of prior treatment regimens.",
            "criterions": [
                {
                    "exact_snippets": "female participant",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "dalotuzumab + MK-2206 or dalotuzumab + ridaforolimus treatment arms",
                    "criterion": "treatment arm assignment",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "dalotuzumab + MK-2206",
                                "dalotuzumab + ridaforolimus"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically-confirmed metastatic or recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "metastatic or recurrent platinum-resistant ovarian cancer",
                                "fallopian tube cancer",
                                "primary peritoneal cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "failed to respond",
                                "progressed despite",
                                "no standard therapy exists",
                                "not a candidate",
                                "unwilling to undergo"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants may have received any number of prior treatment regimens",
                    "criterion": "prior treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "any number"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A participant assigned to the dalotuzumab + MK-0752 treatment arms must have histologically-confirmed metastatic or recurrent wild-type KRAS colorectal cancer that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist, or participant is not a candidate for standard therapy, or is unwilling to undergo standard therapy. Participants may have received any number of prior treatment regimens.",
            "criterions": [
                {
                    "exact_snippets": "histologically-confirmed metastatic or recurrent wild-type KRAS colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "KRAS status",
                            "expected_value": "wild-type"
                        }
                    ]
                },
                {
                    "exact_snippets": "failed to respond to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed despite standard therapy",
                    "criterion": "progression despite standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which standard therapy does not exist",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participant is not a candidate for standard therapy",
                    "criterion": "candidate for standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to undergo standard therapy",
                    "criterion": "willingness to undergo standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants may have received any number of prior treatment regimens",
                    "criterion": "number of prior treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant agrees to provide archival tumor tissue sample or undergo biopsy for analysis of gene expression levels.",
            "criterions": [
                {
                    "exact_snippets": "Participant agrees to provide archival tumor tissue sample or undergo biopsy",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "analysis of gene expression levels",
                    "criterion": "gene expression levels",
                    "requirements": [
                        {
                            "requirement_type": "analysis",
                            "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": "* Participant has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas or mitomycin C) or who has not recovered from adverse events due to agents administered more than 4 weeks earlier, or major surgery <4 weeks earlier.",
            "criterions": [
                {
                    "exact_snippets": "Participant has had chemotherapy ... within 4 weeks prior to study Day 1",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has had ... radiotherapy ... within 4 weeks prior to study Day 1",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has had ... biological therapy (including monoclonal antibodies) within 4 weeks prior to study Day 1",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has had ... nitrosoureas or mitomycin C ... 6 weeks",
                    "criterion": "nitrosoureas or mitomycin C",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant ... who has not recovered from adverse events due to agents administered more than 4 weeks earlier",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant ... major surgery <4 weeks earlier",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with a monoclonal antibody will be eligible to participate after a 28 day washout period.",
            "criterions": [
                {
                    "exact_snippets": "Participant is currently participating or has participated in a study with an investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer",
                    "criterion": "participation in a study with an investigational compound or device",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants previously treated with a monoclonal antibody will be eligible to participate after a 28 day washout period",
                    "criterion": "previous treatment with a monoclonal antibody",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with known central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded.",
            "criterions": [
                {
                    "exact_snippets": "known central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has significant or uncontrolled cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a myocardial infarction within the last 6 months.",
            "criterions": [
                {
                    "exact_snippets": "significant or uncontrolled cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association (NYHA) Class III-IV heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "NYHA Class III-IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is known to have diabetes that is poorly controlled.",
            "criterions": [
                {
                    "exact_snippets": "Participant is known to have diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled",
                    "criterion": "diabetes control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is pregnant, breastfeeding, or expecting to conceive or father children during the study.",
            "criterions": [
                {
                    "exact_snippets": "Participant is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children during the study",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is known to be human immunodeficiency virus (HIV)-positive.",
            "criterions": [
                {
                    "exact_snippets": "Participant is known to be human immunodeficiency virus (HIV)-positive.",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has symptomatic ascites or pleural effusion.",
            "criterions": [
                {
                    "exact_snippets": "Participant has symptomatic ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant requires treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for at least two weeks prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Participant requires treatment with immunosuppressive agents other than prescribed corticosteroids",
                    "criterion": "treatment with immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prescribed corticosteroids at stable doses for at least two weeks prior to the first dose of study drug",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable doses"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant requires treatment with medication(s) that strongly or moderately induce or inhibit cytochrome P450.",
            "criterions": [
                {
                    "exact_snippets": "Participant requires treatment with medication(s) that strongly or moderately induce or inhibit cytochrome P450.",
                    "criterion": "medication requirement",
                    "requirements": [
                        {
                            "requirement_type": "induction or inhibition",
                            "expected_value": [
                                "strongly induce",
                                "moderately induce",
                                "strongly inhibit",
                                "moderately inhibit"
                            ]
                        },
                        {
                            "requirement_type": "target",
                            "expected_value": "cytochrome P450"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is using growth hormone or growth hormone inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "Participant is using growth hormone",
                    "criterion": "growth hormone usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant is using ... growth hormone inhibitors",
                    "criterion": "growth hormone inhibitor usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant requires treatment with therapeutic warfarin.",
            "criterions": [
                {
                    "exact_snippets": "Participant requires treatment with therapeutic warfarin.",
                    "criterion": "treatment with therapeutic warfarin",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Part 2:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Participant has active Hepatitis B or C infection.",
            "criterions": [
                {
                    "exact_snippets": "active Hepatitis B",
                    "criterion": "Hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "active Hepatitis C",
                    "criterion": "Hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}