{
    "info": {
        "nct_id": "NCT00942162",
        "official_title": "GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma",
        "inclusion_criteria": "* Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable.\n* Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification, this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.\n* Written informed consent obtained from the patient prior to performance of any study specific procedure.\n* Patient is >= 18 years at the time of signature of the informed consent form.\n* The patient's tumor shows expression of MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.\n* Fresh tissue from the same lesion as used for MAGE-A3 expression testing must be available for the testing of the predictive gene signature.\n* Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing.\n* Patient fully recovered from any previous intervention (i.e., biopsy).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria\n* If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to registration in the trial, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.\n* In the opinion of the investigator, the patient can and will comply with the protocol requirements.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.\n* The patient has at any time received any systemic anticancer treatment.\n* Prior systemic treatment with an immunomodulator or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial;\n* Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial.\n* Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial\n* The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.\n* The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents.\n* The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.\n* The patient has a family history of congenital or hereditary immunodeficiency.\n* The patient is known to be positive for Human Immunodeficiency Virus (HIV).\n* History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.\n* The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix and effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.\n* The patient has psychiatric or addictive disorders\n* The patient has an uncontrolled bleeding disorder.\n* The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first investigational treatment injection or planned use during the study period.\n* Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). For female patients: the patient is pregnant or lactating.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable.",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically proven metastatic cutaneous melanoma",
                    "criterion": "metastatic cutaneous melanoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification, this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.",
            "criterions": [
                {
                    "exact_snippets": "regional or distant cutaneous, subcutaneous or lymph-node metastasis",
                    "criterion": "metastasis location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "regional",
                                "distant",
                                "cutaneous",
                                "subcutaneous",
                                "lymph-node"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease is not amenable to curative treatment with surgery",
                    "criterion": "curative treatment with surgery",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable stage III melanoma",
                    "criterion": "melanoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "unresectable stage III"
                        }
                    ]
                },
                {
                    "exact_snippets": "in-transit metastases",
                    "criterion": "in-transit metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IV M1a melanoma",
                    "criterion": "melanoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "stage IV M1a"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent obtained from the patient prior to performance of any study specific procedure.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent obtained from the patient",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is >= 18 years at the time of signature of the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Patient is >= 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient's tumor shows expression of MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.",
            "criterions": [
                {
                    "exact_snippets": "tumor shows expression of MAGE-A3",
                    "criterion": "MAGE-A3 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "RT-PCR analysis on a fresh tumor tissue sample",
                    "criterion": "RT-PCR analysis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "RT-PCR"
                        }
                    ]
                },
                {
                    "exact_snippets": "fresh tumor tissue sample obtained during the screening phase",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "fresh"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the screening phase"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fresh tissue from the same lesion as used for MAGE-A3 expression testing must be available for the testing of the predictive gene signature.",
            "criterions": [
                {
                    "exact_snippets": "Fresh tissue from the same lesion as used for MAGE-A3 expression testing must be available",
                    "criterion": "fresh tissue from the same lesion as used for MAGE-A3 expression testing",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "testing of the predictive gene signature",
                    "criterion": "predictive gene signature testing",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing.",
            "criterions": [
                {
                    "exact_snippets": "Formalin-fixed paraffin-embedded (FFPE) tissue must be available",
                    "criterion": "FFPE tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complementary MAGE-A3 and gene signature testing",
                    "criterion": "MAGE-A3 and gene signature testing",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "complementary testing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient fully recovered from any previous intervention (i.e., biopsy).",
            "criterions": [
                {
                    "exact_snippets": "Patient fully recovered from any previous intervention",
                    "criterion": "recovery from previous intervention",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fully recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone-marrow reserve",
                    "criterion": "bone-marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to registration in the trial, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.",
            "criterions": [
                {
                    "exact_snippets": "patient is female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-childbearing"
                        }
                    ]
                },
                {
                    "exact_snippets": "childbearing potential ... practice adequate contraception for at least 30 days prior to registration",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "continue such precautions during the entire study treatment period and for 2 months after completion of the injection series",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In the opinion of the investigator, the patient can and will comply with the protocol requirements.",
            "criterions": [
                {
                    "exact_snippets": "the patient can and will comply with the protocol requirements",
                    "criterion": "protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "ability and willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.",
            "criterions": [
                {
                    "exact_snippets": "unresectable stage IV M1b,c melanoma",
                    "criterion": "melanoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV M1b,c"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ocular and mucosal melanoma",
                    "criterion": "melanoma type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "ocular",
                                "mucosal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has at any time received any systemic anticancer treatment.",
            "criterions": [
                {
                    "exact_snippets": "The patient has at any time received any systemic anticancer treatment.",
                    "criterion": "systemic anticancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior systemic treatment with an immunomodulator or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial;",
            "criterions": [
                {
                    "exact_snippets": "Prior systemic treatment with an immunomodulator ... is permitted",
                    "criterion": "prior systemic treatment with an immunomodulator",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "loco-regional radiotherapy is permitted",
                    "criterion": "loco-regional radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the last dose was administered at least 30 days before the registration into this trial",
                    "criterion": "time since last dose of prior adjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial.",
            "criterions": [
                {
                    "exact_snippets": "Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed",
                    "criterion": "previous adjuvant treatment with a cancer vaccine",
                    "requirements": [
                        {
                            "requirement_type": "tumor antigen",
                            "expected_value": {
                                "operator": "!=",
                                "value": 1,
                                "unit": "MAGE-A3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if the last administration took place at least 8 weeks before registration into the trial",
                    "criterion": "time since last administration of cancer vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial",
            "criterions": [
                {
                    "exact_snippets": "Prior isolated limb perfusion is permitted ... last dose was administered at least 30 days before registration",
                    "criterion": "prior isolated limb perfusion",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.",
            "criterions": [
                {
                    "exact_snippets": "The patient is scheduled to receive any anti-cancer specific treatment",
                    "criterion": "scheduled anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immunomodulating agents",
                    "criterion": "immunomodulating agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents.",
            "criterions": [
                {
                    "exact_snippets": "concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids",
                    "criterion": "systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "concomitant treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concomitant chronic treatment ... any other immunosuppressive agents",
                    "criterion": "immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "concomitant treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.",
            "criterions": [
                {
                    "exact_snippets": "history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with vitiligo are not excluded",
                    "criterion": "vitiligo",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has a family history of congenital or hereditary immunodeficiency.",
            "criterions": [
                {
                    "exact_snippets": "family history of congenital or hereditary immunodeficiency",
                    "criterion": "family history of immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is known to be positive for Human Immunodeficiency Virus (HIV).",
            "criterions": [
                {
                    "exact_snippets": "positive for Human Immunodeficiency Virus (HIV)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic disease",
                    "criterion": "allergic disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "reactions likely to be exacerbated by any component of the ASCI treatment",
                    "criterion": "reactions to ASCI treatment components",
                    "requirements": [
                        {
                            "requirement_type": "likelihood of exacerbation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix and effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.",
            "criterions": [
                {
                    "exact_snippets": "previous or concomitant malignancies at other sites",
                    "criterion": "malignancies at other sites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "effectively treated non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "effectively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "effectively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "effectively treated malignancy that has been in remission for over 5 years",
                    "criterion": "malignancy in remission",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "effectively treated"
                        },
                        {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has psychiatric or addictive disorders",
            "criterions": [
                {
                    "exact_snippets": "psychiatric ... disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "addictive disorders",
                    "criterion": "addictive disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has an uncontrolled bleeding disorder.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.",
            "criterions": [
                {
                    "exact_snippets": "concurrent severe medical problems, unrelated to the malignancy",
                    "criterion": "concurrent severe medical problems",
                    "requirements": [
                        {
                            "requirement_type": "relation to malignancy",
                            "expected_value": "unrelated"
                        }
                    ]
                },
                {
                    "exact_snippets": "would significantly limit full compliance with the study",
                    "criterion": "compliance with the study",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "expose the patient to unacceptable risk",
                    "criterion": "risk to patient",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "unacceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first investigational treatment injection or planned use during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first investigational treatment injection",
                    "criterion": "use of investigational or non-registered product",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planned use during the study period",
                    "criterion": "planned use of investigational or non-registered product",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). For female patients: the patient is pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": "Concurrently participating in another clinical study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient has been or will be exposed to an investigational or a non-investigational product",
                    "criterion": "exposure to investigational or non-investigational product",
                    "requirements": [
                        {
                            "requirement_type": "exposure",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "For female patients: the patient is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "For female patients: ... or lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}