{
    "info": {
        "nct_id": "NCT05140382",
        "official_title": "A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination With Anti-cancer Agents in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or Classical Hodgkin Lymphoma",
        "inclusion_criteria": "* Participants who are diagnosed with one of the following, as defined by the World Health Organisation:\n\n  * Peripheral T-cell Lymphoma\n  * Classical Hodgkin Lymphoma\n* Eastern Cooperative Oncology Group performance status of ≤ 2.\n* Must have received at least 1 prior line of therapy for the treatment of current disease and have documented relapsed or refractory active disease requiring treatment, defined as:\n\n  * Recurrence of disease after response to prior line(s) of therapy, or\n  * Progressive disease after completion of or on the treatment regimen preceding entry into the study, or\n  * Disease which did not achieve an objective response (CR or PR).\n* Uric acid level < ULN at screening. If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.\n* Willing and able to participate in all required evaluations and procedures in this study protocol including receiving IV administration of study drug and being admitted, if required, for at least 24 hours during study drug administration.\n* Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.\n* Adequate haematologic function at screening.\n* PTCL Only: All participants with PTCL must be willing and able to provide baseline bone marrow aspirate and/or biopsy no older than 3 months and agree to undergo post-treatment bone marrow biopsy when required to confirm response.\n\nAdditional Module 1 Inclusion Criteria\n\nPrior lines of therapy:\n\n* PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.\n\n  * Non NK-PTCL (Cohort 1): Prior therapy must have included an alkylating agent and/or anthracycline. In addition, ALCL participants must have received brentuximab vedotin (BV) as part of prior therapy.\n  * NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase.\n* cHL (Cohort 3): Participants must have failed at least 2 prior therapies for the treatment of cHL (including BV and anti-PD1) except where unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease.\n* Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm (according to the Lugano (2014) criteria [Cheson et al 2014]).\n\nExclusion Criteria\n\nType of Participant and Disease Characteristics:\n\n* PTCL only: Presence of bulky disease (defined as largest lymphoma lesion ≥ 10 cm) or a LDH value > 3 x ULN.\n* PTCL only: Diagnosis of any of the following: Lymphoblastic/precursor T-cell lymphoma or leukaemia; T-cell prolymphocytic leukaemia; T-cell large granular lymphocytic leukaemia; Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome).\n\nMedical Conditions:\n\n* With the exception of alopecia and neuropathy, presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.\n* Presence of, or history of, CNS lymphoma, leptomeningeal disease, or spinal cord compression.\n* History of prior non-haematological malignancy except for the following:\n\n  * Malignancy treated with curative intent and with no evidence of active disease present for more than 1 year prior to screening and felt to be at low risk for recurrence by treating physician.\n  * Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.\n  * Adequately treated carcinoma in situ without current evidence of disease.\n* Any evidence of:\n\n  * Severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]).\n  * Current unstable or uncompensated respiratory or cardiac conditions.\n  * Uncontrolled hypertension.\n  * Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).\n  * IV anti-infective treatment within 1 week before first dose of study drug.\n* Known history of infection with HIV.\n* Serologic status reflecting active hepatitis B or C infection:\n\n  * Participants who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative PCR result before enrolment. Those who are hepatitis B surface antigen positive or hepatitis B PCR-positive will be excluded.\n  * Participants who are hepatitis C antibody positive will need to have a negative PCR result before enrolment. Those who are hepatitis C PCR-positive will be excluded.\n* Any of the following cardiac criteria:\n\n  * Resting QT interval corrected using Fridericia's formula (QTcF) ≥ 470 msec obtained from a single ECG.\n  * Any clinically important abnormalities in rhythm (except for participants with a pacemaker in place), conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).\n  * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.\n* Documented confirmation and ongoing treatment of adrenal gland insufficiency or pancreatitis.\n* Undergone any of the following procedures or experienced any of the following conditions within 6 months prior to first dose:\n\n  * Coronary artery bypass graft\n  * Angioplasty\n  * Vascular stent\n  * Myocardial infarction\n  * Angina pectoris\n  * CHF (New York Heart Association Class ≥ 2)\n  * Ventricular arrhythmias requiring continuous therapy\n  * Atrial fibrillation, which is judged as uncontrolled by the treating physician\n  * Haemorrhagic or thrombotic stroke, including transient ischemic attacks or any other CNS bleeding\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 130 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants who are diagnosed with one of the following, as defined by the World Health Organisation:",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with one of the following, as defined by the World Health Organisation",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": "World Health Organisation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral T-cell Lymphoma",
            "criterions": [
                {
                    "exact_snippets": "Peripheral T-cell Lymphoma",
                    "criterion": "Peripheral T-cell Lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Classical Hodgkin Lymphoma",
            "criterions": [
                {
                    "exact_snippets": "Classical Hodgkin Lymphoma",
                    "criterion": "Classical Hodgkin Lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group performance status of ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status of ≤ 2",
                    "criterion": "Eastern Cooperative Oncology Group performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have received at least 1 prior line of therapy for the treatment of current disease and have documented relapsed or refractory active disease requiring treatment, defined as:",
            "criterions": [
                {
                    "exact_snippets": "Must have received at least 1 prior line of therapy",
                    "criterion": "prior line of therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "documented relapsed or refractory active disease requiring treatment",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrence of disease after response to prior line(s) of therapy, or",
            "criterions": [
                {
                    "exact_snippets": "Recurrence of disease after response to prior line(s) of therapy",
                    "criterion": "recurrence of disease",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "after response to prior line(s) of therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease after completion of or on the treatment regimen preceding entry into the study, or",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease after completion of or on the treatment regimen preceding entry into the study",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after completion of or on the treatment regimen preceding entry into the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease which did not achieve an objective response (CR or PR).",
            "criterions": [
                {
                    "exact_snippets": "Disease which did not achieve an objective response (CR or PR)",
                    "criterion": "disease response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "CR",
                                "PR"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uric acid level < ULN at screening. If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.",
            "criterions": [
                {
                    "exact_snippets": "Uric acid level < ULN at screening",
                    "criterion": "uric acid level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If hyperuricaemia is present at screening",
                    "criterion": "hyperuricaemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to participate in all required evaluations and procedures in this study protocol including receiving IV administration of study drug and being admitted, if required, for at least 24 hours during study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to participate in all required evaluations and procedures",
                    "criterion": "willingness and ability to participate",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including receiving IV administration of study drug",
                    "criterion": "IV administration of study drug",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "being admitted, if required, for at least 24 hours during study drug administration",
                    "criterion": "admission for at least 24 hours",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.",
            "criterions": [
                {
                    "exact_snippets": "Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.",
                    "criterion": "tumour tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate haematologic function at screening.",
            "criterions": [
                {
                    "exact_snippets": "Adequate haematologic function",
                    "criterion": "haematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PTCL Only: All participants with PTCL must be willing and able to provide baseline bone marrow aspirate and/or biopsy no older than 3 months and agree to undergo post-treatment bone marrow biopsy when required to confirm response.",
            "criterions": [
                {
                    "exact_snippets": "PTCL Only",
                    "criterion": "PTCL diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to provide baseline bone marrow aspirate and/or biopsy",
                    "criterion": "baseline bone marrow aspirate and/or biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline bone marrow aspirate and/or biopsy no older than 3 months",
                    "criterion": "baseline bone marrow aspirate and/or biopsy age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to undergo post-treatment bone marrow biopsy when required to confirm response",
                    "criterion": "post-treatment bone marrow biopsy",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Additional Module 1 Inclusion Criteria",
            "criterions": [
                {
                    "exact_snippets": "Additional Module 1 Inclusion Criteria",
                    "criterion": "module inclusion",
                    "requirements": [
                        {
                            "requirement_type": "module",
                            "expected_value": "Module 1"
                        },
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Prior lines of therapy:",
            "criterions": [
                {
                    "exact_snippets": "Prior lines of therapy",
                    "criterion": "lines of therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.",
            "criterions": [
                {
                    "exact_snippets": "Participants must have failed at least 1 prior therapy for the treatment of PTCL.",
                    "criterion": "prior therapy for PTCL",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "therapy"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non NK-PTCL (Cohort 1): Prior therapy must have included an alkylating agent and/or anthracycline. In addition, ALCL participants must have received brentuximab vedotin (BV) as part of prior therapy.",
            "criterions": [
                {
                    "exact_snippets": "Non NK-PTCL (Cohort 1)",
                    "criterion": "cohort",
                    "requirements": [
                        {
                            "requirement_type": "name",
                            "expected_value": "Non NK-PTCL (Cohort 1)"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy must have included an alkylating agent",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "alkylating agent"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy must have included ... anthracycline",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "anthracycline"
                        }
                    ]
                },
                {
                    "exact_snippets": "ALCL participants must have received brentuximab vedotin (BV) as part of prior therapy",
                    "criterion": "prior therapy for ALCL participants",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "brentuximab vedotin (BV)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment must have included a platinum agent",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "platinum agent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment must have included ... asparaginase",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "asparaginase"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* cHL (Cohort 3): Participants must have failed at least 2 prior therapies for the treatment of cHL (including BV and anti-PD1) except where unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease.",
            "criterions": [
                {
                    "exact_snippets": "cHL (Cohort 3)",
                    "criterion": "cHL",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "failed at least 2 prior therapies",
                    "criterion": "prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "therapies"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including BV and anti-PD1",
                    "criterion": "prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "BV",
                                "anti-PD1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease",
                    "criterion": "inability to receive BV or anti-PD1",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": [
                                "neuropathy",
                                "autoimmune disease"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm (according to the Lugano (2014) criteria [Cheson et al 2014]).",
            "criterions": [
                {
                    "exact_snippets": "Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm",
                    "criterion": "lymphoma disease lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "FDG-avidity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Type of Participant and Disease Characteristics:",
            "criterions": [
                {
                    "exact_snippets": "Type of Participant",
                    "criterion": "participant type",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PTCL only: Presence of bulky disease (defined as largest lymphoma lesion ≥ 10 cm) or a LDH value > 3 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "PTCL only: Presence of bulky disease (defined as largest lymphoma lesion ≥ 10 cm)",
                    "criterion": "bulky disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PTCL only: ... LDH value > 3 x ULN",
                    "criterion": "LDH value",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PTCL only: Diagnosis of any of the following: Lymphoblastic/precursor T-cell lymphoma or leukaemia; T-cell prolymphocytic leukaemia; T-cell large granular lymphocytic leukaemia; Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome).",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of any of the following: Lymphoblastic/precursor T-cell lymphoma or leukaemia",
                    "criterion": "Lymphoblastic/precursor T-cell lymphoma or leukaemia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... T-cell prolymphocytic leukaemia",
                    "criterion": "T-cell prolymphocytic leukaemia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... T-cell large granular lymphocytic leukaemia",
                    "criterion": "T-cell large granular lymphocytic leukaemia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome)",
                    "criterion": "Cutaneous T-cell lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Medical Conditions:",
            "criterions": [
                {
                    "exact_snippets": "Medical Conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With the exception of alopecia and neuropathy, presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.",
            "criterions": [
                {
                    "exact_snippets": "presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1",
                    "criterion": "unresolved non haematological toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of, or history of, CNS lymphoma, leptomeningeal disease, or spinal cord compression.",
            "criterions": [
                {
                    "exact_snippets": "Presence of, or history of, CNS lymphoma",
                    "criterion": "CNS lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of, or history of, ... leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of, or history of, ... spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of prior non-haematological malignancy except for the following:",
            "criterions": [
                {
                    "exact_snippets": "History of prior non-haematological malignancy",
                    "criterion": "prior non-haematological malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Malignancy treated with curative intent and with no evidence of active disease present for more than 1 year prior to screening and felt to be at low risk for recurrence by treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Malignancy treated with curative intent",
                    "criterion": "malignancy treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of active disease present for more than 1 year prior to screening",
                    "criterion": "active disease evidence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "felt to be at low risk for recurrence by treating physician",
                    "criterion": "recurrence risk",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.",
            "criterions": [
                {
                    "exact_snippets": "Adequately treated lentigo maligna melanoma without current evidence of disease",
                    "criterion": "lentigo maligna melanoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        },
                        {
                            "requirement_type": "current evidence of disease",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately controlled non-melanomatous skin cancer",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "adequately controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequately treated carcinoma in situ without current evidence of disease.",
            "criterions": [
                {
                    "exact_snippets": "Adequately treated carcinoma in situ",
                    "criterion": "carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "without current evidence of disease",
                    "criterion": "current evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any evidence of:",
            "criterions": [
                {
                    "exact_snippets": "Any evidence of",
                    "criterion": "evidence of condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]).",
            "criterions": [
                {
                    "exact_snippets": "Severe or uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hepatic impairment",
                    "criterion": "hepatic impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "interstitial lung disease [bilateral, diffuse, parenchymal lung disease]",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "characteristics",
                            "expected_value": [
                                "bilateral",
                                "diffuse",
                                "parenchymal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current unstable or uncompensated respiratory or cardiac conditions.",
            "criterions": [
                {
                    "exact_snippets": "unstable or uncompensated respiratory ... conditions",
                    "criterion": "respiratory conditions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "compensation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable or uncompensated ... cardiac conditions",
                    "criterion": "cardiac conditions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "compensation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled active systemic fungal, bacterial, viral, or other infection",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment",
                    "criterion": "infection symptoms",
                    "requirements": [
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "response to treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* IV anti-infective treatment within 1 week before first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "IV anti-infective treatment within 1 week before first dose of study drug.",
                    "criterion": "IV anti-infective treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "week"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of infection with HIV.",
            "criterions": [
                {
                    "exact_snippets": "Known history of infection with HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serologic status reflecting active hepatitis B or C infection:",
            "criterions": [
                {
                    "exact_snippets": "Serologic status reflecting active hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serologic status reflecting active ... C infection",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative PCR result before enrolment. Those who are hepatitis B surface antigen positive or hepatitis B PCR-positive will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "hepatitis B core antibody (anti-HBc) positive",
                    "criterion": "hepatitis B core antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surface antigen negative",
                    "criterion": "hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "negative PCR result",
                    "criterion": "hepatitis B PCR",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B surface antigen positive",
                    "criterion": "hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B PCR-positive",
                    "criterion": "hepatitis B PCR",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who are hepatitis C antibody positive will need to have a negative PCR result before enrolment. Those who are hepatitis C PCR-positive will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "hepatitis C antibody positive",
                    "criterion": "hepatitis C antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative PCR result",
                    "criterion": "hepatitis C PCR",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C PCR-positive",
                    "criterion": "hepatitis C PCR",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any of the following cardiac criteria:",
            "criterions": [
                {
                    "exact_snippets": "Any of the following cardiac criteria",
                    "criterion": "cardiac criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Resting QT interval corrected using Fridericia's formula (QTcF) ≥ 470 msec obtained from a single ECG.",
            "criterions": [
                {
                    "exact_snippets": "Resting QT interval corrected using Fridericia's formula (QTcF) ≥ 470 msec",
                    "criterion": "QT interval",
                    "requirements": [
                        {
                            "requirement_type": "correction method",
                            "expected_value": "Fridericia's formula"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any clinically important abnormalities in rhythm (except for participants with a pacemaker in place), conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).",
            "criterions": [
                {
                    "exact_snippets": "clinically important abnormalities in rhythm",
                    "criterion": "ECG rhythm",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically important abnormalities in ... conduction",
                    "criterion": "ECG conduction",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically important abnormalities in ... morphology of resting ECG",
                    "criterion": "ECG morphology",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.",
            "criterions": [
                {
                    "exact_snippets": "QTc prolongation",
                    "criterion": "QTc prolongation",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmic events",
                    "criterion": "arrhythmic events",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of long QT syndrome",
                    "criterion": "family history of long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unexplained sudden death under 40 years of age",
                    "criterion": "unexplained sudden death under 40 years of age",
                    "requirements": [
                        {
                            "requirement_type": "risk factors",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented confirmation and ongoing treatment of adrenal gland insufficiency or pancreatitis.",
            "criterions": [
                {
                    "exact_snippets": "Documented confirmation and ongoing treatment of adrenal gland insufficiency",
                    "criterion": "adrenal gland insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented confirmation and ongoing treatment of ... pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergone any of the following procedures or experienced any of the following conditions within 6 months prior to first dose:",
            "criterions": [
                {
                    "exact_snippets": "Undergone any of the following procedures or experienced any of the following conditions within 6 months prior to first dose",
                    "criterion": "procedures or conditions",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coronary artery bypass graft",
            "criterions": [
                {
                    "exact_snippets": "Coronary artery bypass graft",
                    "criterion": "coronary artery bypass graft",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Angioplasty",
            "criterions": [
                {
                    "exact_snippets": "Angioplasty",
                    "criterion": "angioplasty",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vascular stent",
            "criterions": [
                {
                    "exact_snippets": "Vascular stent",
                    "criterion": "vascular stent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Angina pectoris",
            "criterions": [
                {
                    "exact_snippets": "Angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CHF (New York Heart Association Class ≥ 2)",
            "criterions": [
                {
                    "exact_snippets": "CHF (New York Heart Association Class ≥ 2)",
                    "criterion": "CHF",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "New York Heart Association Class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ventricular arrhythmias requiring continuous therapy",
            "criterions": [
                {
                    "exact_snippets": "Ventricular arrhythmias requiring continuous therapy",
                    "criterion": "ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": "continuous therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Atrial fibrillation, which is judged as uncontrolled by the treating physician",
            "criterions": [
                {
                    "exact_snippets": "Atrial fibrillation, which is judged as uncontrolled by the treating physician",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Haemorrhagic or thrombotic stroke, including transient ischemic attacks or any other CNS bleeding",
            "criterions": [
                {
                    "exact_snippets": "Haemorrhagic or thrombotic stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "haemorrhagic",
                                "thrombotic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attacks",
                    "criterion": "transient ischemic attacks",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CNS bleeding",
                    "criterion": "CNS bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 130 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 130 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 130,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}