{
    "info": {
        "nct_id": "NCT02759601",
        "official_title": "A Phase I/II Dose Escalation Trial of HDAC Inhibitor Tefinostat for Cancer Associated Inflamation in Hepatocellular Carcinoma",
        "inclusion_criteria": "1. Signed, informed consent.\n2. Histologically or cytologically confirmed malignant HCC refractory to standard therapy or for which no standard therapy exists.\n\n   a. Patients with alcoholic cirrhosis may be included dependent on clinical judgement as to their ability to conform to the protocol.\n3. Patient is not a transplant candidate.\n4. Hepatitis is controlled by antiviral therapy (PEG-IFN, ribavirin, telaprevir, etc). Prophylactic Lamivudine for HBV carriers.\n5. Child-Pugh classification A or B7.\n6. Adequate bone marrow, hepatic and renal function including the following:\n\n   * Hb ≥ 9.0g/dL, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥75 x 109/L.\n   * Total bilirubin ≤ 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome.\n   * AST (SGOT), ALT (SGPT) ≤ baseline + 4 x upper normal limit .\n   * Creatinine ≤ 1.5 x upper normal limit.\n   * Serum albumin > 28g/L.\n   * INR < 1.5 or a Pt/PTT within normal limits.\n7. Age ≥ 18 years.\n8. Performance status (PS) 0-2 (ECOG scale).\n9. Estimated life expectancy greater than 3 months.\n10. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Anti-cancer therapy including chemotherapy, radiotherapy, TACE, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial.\n2. Use of medicines known to prolong QTc within 14 days prior to the first dose of study drug (see Appendix III).\n3. Candidate for surgical resection, orthotopic liver transplantation, or loco-regional therapy such as radio-frequency ablation or chemoembolization.\n4. History of organ allograft.\n5. Co-existing active infection or serious concurrent illness.\n6. Significant cardiovascular disease as defined by:\n\n   * History of congestive heart failure requiring therapy.\n   * History of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry.\n   * Presence of severe valvular heart disease.\n   * Presence of a ventricular arrhythmia requiring treatment.\n   * LVEF < 50% (or less than institutional norm- some places have 45%).\n   * QTc interval ≥ 450ms for men and ≥ 470ms for women (using Bazett's formula).\n7. Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the study.\n8. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.\n9. Gastrointestinal disorders that may interfere with absorption of the study drug.\n10. Patients requiring palliative radiotherapy within the last 4 weeks of study entry.\n11. Uncontrolled hypercalcaemia (>CTCAE v4.03 grade I).\n12. Pregnant or breast-feeding women.\n13. Patients who have received an investigational drug within the last 4 weeks.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Signed, informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed, informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically or cytologically confirmed malignant HCC refractory to standard therapy or for which no standard therapy exists.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed malignant HCC",
                    "criterion": "malignant HCC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to standard therapy",
                    "criterion": "refractory to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no standard therapy exists",
                    "criterion": "standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "a. Patients with alcoholic cirrhosis may be included dependent on clinical judgement as to their ability to conform to the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Patients with alcoholic cirrhosis",
                    "criterion": "alcoholic cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to conform to the protocol",
                    "criterion": "ability to conform to the protocol",
                    "requirements": [
                        {
                            "requirement_type": "clinical judgement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient is not a transplant candidate.",
            "criterions": [
                {
                    "exact_snippets": "Patient is not a transplant candidate",
                    "criterion": "transplant candidacy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Hepatitis is controlled by antiviral therapy (PEG-IFN, ribavirin, telaprevir, etc). Prophylactic Lamivudine for HBV carriers.",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis is controlled by antiviral therapy (PEG-IFN, ribavirin, telaprevir, etc)",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prophylactic Lamivudine for HBV carriers",
                    "criterion": "HBV carrier status",
                    "requirements": [
                        {
                            "requirement_type": "prophylactic treatment",
                            "expected_value": "Lamivudine"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Child-Pugh classification A or B7.",
            "criterions": [
                {
                    "exact_snippets": "Child-Pugh classification A or B7",
                    "criterion": "Child-Pugh classification",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "A",
                                "B7"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hb ≥ 9.0g/dL, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥75 x 109/L.",
            "criterions": [
                {
                    "exact_snippets": "Hb ≥ 9.0g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count ≥ 1.5 x 109/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥75 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 x upper normal limit",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome",
                    "criterion": "Gilberts Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "attribution",
                            "expected_value": "elevated bilirubin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (SGOT), ALT (SGPT) ≤ baseline + 4 x upper normal limit .",
            "criterions": [
                {
                    "exact_snippets": "AST (SGOT) ... ≤ baseline + 4 x upper normal limit",
                    "criterion": "AST (SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT (SGPT) ≤ baseline + 4 x upper normal limit",
                    "criterion": "ALT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.5 x upper normal limit.",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 x upper normal limit",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper normal limit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum albumin > 28g/L.",
            "criterions": [
                {
                    "exact_snippets": "Serum albumin > 28g/L",
                    "criterion": "serum albumin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INR < 1.5 or a Pt/PTT within normal limits.",
            "criterions": [
                {
                    "exact_snippets": "INR < 1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Pt/PTT within normal limits",
                    "criterion": "Pt/PTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "within normal limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Performance status (PS) 0-2 (ECOG scale).",
            "criterions": [
                {
                    "exact_snippets": "Performance status (PS) 0-2 (ECOG scale)",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Estimated life expectancy greater than 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy greater than 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary).",
            "criterions": [
                {
                    "exact_snippets": "Female patients with reproductive potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum pregnancy test within 7 days prior to start of trial",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to start of trial"
                        }
                    ]
                },
                {
                    "exact_snippets": "Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the treatment period and for 3 months after discontinuation of treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary)",
                    "criterion": "acceptable methods of contraception",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "IUD",
                                "oral contraceptive",
                                "subdermal implant",
                                "double barrier (condom with a contraceptive sponge or contraceptive pessary)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Anti-cancer therapy including chemotherapy, radiotherapy, TACE, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial.",
            "criterions": [
                {
                    "exact_snippets": "Anti-cancer therapy including chemotherapy, radiotherapy, TACE, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial.",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Use of medicines known to prolong QTc within 14 days prior to the first dose of study drug (see Appendix III).",
            "criterions": [
                {
                    "exact_snippets": "Use of medicines known to prolong QTc",
                    "criterion": "use of QTc-prolonging medicines",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days prior to the first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Candidate for surgical resection, orthotopic liver transplantation, or loco-regional therapy such as radio-frequency ablation or chemoembolization.",
            "criterions": [
                {
                    "exact_snippets": "Candidate for surgical resection",
                    "criterion": "surgical resection candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Candidate for ... orthotopic liver transplantation",
                    "criterion": "orthotopic liver transplantation candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Candidate for ... loco-regional therapy such as radio-frequency ablation or chemoembolization",
                    "criterion": "loco-regional therapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of organ allograft.",
            "criterions": [
                {
                    "exact_snippets": "History of organ allograft",
                    "criterion": "organ allograft",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Co-existing active infection or serious concurrent illness.",
            "criterions": [
                {
                    "exact_snippets": "Co-existing active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serious concurrent illness",
                    "criterion": "serious concurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Significant cardiovascular disease as defined by:",
            "criterions": [
                {
                    "exact_snippets": "Significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of congestive heart failure requiring therapy.",
            "criterions": [
                {
                    "exact_snippets": "History of congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring therapy",
                    "criterion": "therapy for congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry.",
            "criterions": [
                {
                    "exact_snippets": "History of unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... myocardial infarction up to 6 months prior to trial entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of severe valvular heart disease.",
            "criterions": [
                {
                    "exact_snippets": "Presence of severe valvular heart disease.",
                    "criterion": "valvular heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of a ventricular arrhythmia requiring treatment.",
            "criterions": [
                {
                    "exact_snippets": "Presence of a ventricular arrhythmia requiring treatment.",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* LVEF < 50% (or less than institutional norm- some places have 45%).",
            "criterions": [
                {
                    "exact_snippets": "LVEF < 50% (or less than institutional norm- some places have 45%)",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 45,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QTc interval ≥ 450ms for men and ≥ 470ms for women (using Bazett's formula).",
            "criterions": [
                {
                    "exact_snippets": "QTc interval ≥ 450ms for men",
                    "criterion": "QTc interval for men",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval ... ≥ 470ms for women",
                    "criterion": "QTc interval for women",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Any co-existing medical condition ... will substantially increase the risk",
                    "criterion": "co-existing medical condition",
                    "requirements": [
                        {
                            "requirement_type": "risk increase",
                            "expected_value": "substantial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "altered mental status",
                    "criterion": "altered mental status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "precluding understanding of the informed consent process",
                    "criterion": "understanding of the informed consent process",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "precluding ... completion of the necessary studies",
                    "criterion": "completion of the necessary studies",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Gastrointestinal disorders that may interfere with absorption of the study drug.",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal disorders that may interfere with absorption of the study drug.",
                    "criterion": "gastrointestinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with drug absorption",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients requiring palliative radiotherapy within the last 4 weeks of study entry.",
            "criterions": [
                {
                    "exact_snippets": "requiring palliative radiotherapy",
                    "criterion": "palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the last 4 weeks of study entry",
                    "criterion": "time since last palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Uncontrolled hypercalcaemia (>CTCAE v4.03 grade I).",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypercalcaemia (>CTCAE v4.03 grade I)",
                    "criterion": "hypercalcaemia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE v4.03 grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Pregnant or breast-feeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients who have received an investigational drug within the last 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received an investigational drug within the last 4 weeks.",
                    "criterion": "investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "6. Adequate bone marrow, hepatic and renal function including the following:",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}