{
    "info": {
        "nct_id": "NCT02504372",
        "official_title": "A Randomized, Phase 3 Trial With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo for Patients With Early Stage NSCLC After Resection and Completion of Standard Adjuvant Therapy (PEARLS)",
        "inclusion_criteria": "* Pathological diagnosis of NSCLC confirmed at surgery, any histology. Participants with two synchronous primary non-small cell lung cancers are excluded from the study\n* Union for International Cancer Control (UICC) v7 Stage IB with T ≥ 4 cm, II-IIIA NSCLC after complete surgical resection with resection margins proved microscopically free of disease (R0). Carcinoma in situ can be present at the bronchial margin\n* Available tumor sample obtained at surgical resection for programmed cell death ligand-1 (PD-L1) Immunohistochemistry (IHC) expression assessment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n* Adequate organ function performed within 10 days of treatment initiation\n* Female participants of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first infusion of study medication). If the urine test cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible\n* Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity starting with the first infusion of study treatment through 120 days after the last infusion of study treatment\n* Female participants who are breast feeding must discontinue nursing prior to the first infusion of study medication and until 120 days after the last infusion study treatment\n* Male participants must agree to use an adequate method of contraception starting with the first infusion of study treatment through 120 days after the last infusion of study treatment\n* Absence of severe comorbidities that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration\n* No prior or planned neo-adjuvant or adjuvant radiotherapy and/or neo-adjuvant chemotherapy for the current malignancy is allowed\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Evidence of disease at clinical examination and/or baseline radiological assessment as documented by contrast enhanced chest/upper abdomen CT scan, brain CT/MRI and clinical examination\n* More than 4 cycles of adjuvant therapy\n* Prior treatment with anti-programmed cell death (anti-PD)-1, anti-PD ligand-1/2, anti-CD137, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) modulators or any other immune-modulating agents\n* Live vaccine within 30 days prior to the first infusion of study treatment\n* Current participation or treatment with an investigational agent or use of an investigational device within 4 weeks of the first infusion of study treatment\n* History of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C\n* Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days prior to the first infusion of study treatment\n* History of interstitial lung disease or (non-infectious) pneumonitis that required oral or IV steroids (other than COPD exacerbation) or current pneumonitis\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of a hematologic or primary solid tumor malignancy, unless in remission for at least 5 years with the exception of pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix\n* Previous allogeneic tissue/solid organ transplant\n* Active infection requiring therapy\n* Surgery- or chemotherapy-related toxicity (non-hematological) not resolved to Grade 1 with the exception of alopecia, fatigue, neuropathy and lack of appetite /nausea\n* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last infusion of study treatment\n* Participant will not be eligible if the participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective site Review Board approval is given allowing exception to this criterion for a specific participant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathological diagnosis of NSCLC confirmed at surgery, any histology. Participants with two synchronous primary non-small cell lung cancers are excluded from the study",
            "criterions": [
                {
                    "exact_snippets": "Pathological diagnosis of NSCLC confirmed at surgery",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathological at surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "any histology",
                    "criterion": "NSCLC histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "two synchronous primary non-small cell lung cancers",
                    "criterion": "synchronous primary NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Union for International Cancer Control (UICC) v7 Stage IB with T ≥ 4 cm, II-IIIA NSCLC after complete surgical resection with resection margins proved microscopically free of disease (R0). Carcinoma in situ can be present at the bronchial margin",
            "criterions": [
                {
                    "exact_snippets": "Union for International Cancer Control (UICC) v7 Stage IB",
                    "criterion": "UICC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IB"
                        }
                    ]
                },
                {
                    "exact_snippets": "T ≥ 4 cm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "II-IIIA NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "IIIA"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "complete surgical resection",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resection margins proved microscopically free of disease (R0)",
                    "criterion": "resection margins",
                    "requirements": [
                        {
                            "requirement_type": "microscopic disease presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Carcinoma in situ can be present at the bronchial margin",
                    "criterion": "carcinoma in situ at bronchial margin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Available tumor sample obtained at surgical resection for programmed cell death ligand-1 (PD-L1) Immunohistochemistry (IHC) expression assessment",
            "criterions": [
                {
                    "exact_snippets": "Available tumor sample obtained at surgical resection",
                    "criterion": "tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "source",
                            "expected_value": "surgical resection"
                        }
                    ]
                },
                {
                    "exact_snippets": "programmed cell death ligand-1 (PD-L1) Immunohistochemistry (IHC) expression assessment",
                    "criterion": "PD-L1 IHC expression",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function performed within 10 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 10 days of treatment initiation",
                    "criterion": "timing of organ function assessment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participants of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first infusion of study medication). If the urine test cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible",
            "criterions": [
                {
                    "exact_snippets": "Female participants of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative urine or serum pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "at screening (within 72 hours of first infusion of study medication)",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours of first infusion of study medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity starting with the first infusion of study treatment through 120 days after the last infusion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Female participants of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to use 2 methods of birth control",
                    "criterion": "birth control methods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "or be surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "surgically sterile"
                        }
                    ]
                },
                {
                    "exact_snippets": "or abstain from heterosexual activity",
                    "criterion": "abstinence from heterosexual activity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abstain"
                        }
                    ]
                },
                {
                    "exact_snippets": "starting with the first infusion of study treatment through 120 days after the last infusion of study treatment",
                    "criterion": "duration of birth control or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "start",
                            "expected_value": "first infusion of study treatment"
                        },
                        {
                            "requirement_type": "end",
                            "expected_value": "120 days after the last infusion of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participants who are breast feeding must discontinue nursing prior to the first infusion of study medication and until 120 days after the last infusion study treatment",
            "criterions": [
                {
                    "exact_snippets": "Female participants who are breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must discontinue nursing prior to the first infusion of study medication and until 120 days after the last infusion study treatment",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male participants must agree to use an adequate method of contraception starting with the first infusion of study treatment through 120 days after the last infusion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Male participants",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use an adequate method of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting with the first infusion of study treatment through 120 days after the last infusion of study treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from first infusion through 120 days after last infusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of severe comorbidities that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration",
            "criterions": [
                {
                    "exact_snippets": "Absence of severe comorbidities",
                    "criterion": "severe comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or planned neo-adjuvant or adjuvant radiotherapy and/or neo-adjuvant chemotherapy for the current malignancy is allowed",
            "criterions": [
                {
                    "exact_snippets": "No prior or planned neo-adjuvant or adjuvant radiotherapy",
                    "criterion": "neo-adjuvant or adjuvant radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior or planned ... neo-adjuvant chemotherapy",
                    "criterion": "neo-adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior or planned ... adjuvant ... chemotherapy",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Evidence of disease at clinical examination and/or baseline radiological assessment as documented by contrast enhanced chest/upper abdomen CT scan, brain CT/MRI and clinical examination",
            "criterions": [
                {
                    "exact_snippets": "Evidence of disease at clinical examination",
                    "criterion": "disease presence",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "clinical examination"
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of disease at ... baseline radiological assessment",
                    "criterion": "disease presence",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "baseline radiological assessment"
                        }
                    ]
                },
                {
                    "exact_snippets": "contrast enhanced chest/upper abdomen CT scan",
                    "criterion": "contrast enhanced chest/upper abdomen CT scan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain CT/MRI",
                    "criterion": "brain CT/MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical examination",
                    "criterion": "clinical examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 cycles of adjuvant therapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 cycles of adjuvant therapy",
                    "criterion": "adjuvant therapy cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "cycles"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with anti-programmed cell death (anti-PD)-1, anti-PD ligand-1/2, anti-CD137, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) modulators or any other immune-modulating agents",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with anti-programmed cell death (anti-PD)-1",
                    "criterion": "prior treatment with anti-PD-1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... anti-PD ligand-1/2",
                    "criterion": "prior treatment with anti-PD ligand-1/2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... anti-CD137",
                    "criterion": "prior treatment with anti-CD137",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) modulators",
                    "criterion": "prior treatment with CTLA-4 modulators",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... any other immune-modulating agents",
                    "criterion": "prior treatment with any other immune-modulating agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Live vaccine within 30 days prior to the first infusion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Live vaccine within 30 days prior to the first infusion of study treatment",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current participation or treatment with an investigational agent or use of an investigational device within 4 weeks of the first infusion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Current participation or treatment with an investigational agent",
                    "criterion": "participation or treatment with an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of an investigational device within 4 weeks of the first infusion of study treatment",
                    "criterion": "use of an investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days prior to the first infusion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Chronic use of immunosuppressive agents",
                    "criterion": "use of immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic corticosteroids",
                    "criterion": "use of systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "any use in the last 3 days prior to the first infusion of study treatment",
                    "criterion": "use of immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any use in the last 3 days prior to the first infusion of study treatment",
                    "criterion": "use of systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of interstitial lung disease or (non-infectious) pneumonitis that required oral or IV steroids (other than COPD exacerbation) or current pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(non-infectious) pneumonitis that required oral or IV steroids",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "oral or IV steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "current pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "current",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease that has required systemic treatment in past 2 years",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "required systemic treatment in past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of a hematologic or primary solid tumor malignancy, unless in remission for at least 5 years with the exception of pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "History of a hematologic or primary solid tumor malignancy",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless in remission for at least 5 years",
                    "criterion": "remission duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pT1-2 prostatic cancer Gleason score < 6",
                    "criterion": "prostatic cancer Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "Gleason score"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non melanomatous skin cancer",
                    "criterion": "non melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous allogeneic tissue/solid organ transplant",
            "criterions": [
                {
                    "exact_snippets": "Previous allogeneic tissue/solid organ transplant",
                    "criterion": "allogeneic tissue/solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection requiring therapy",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring therapy",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgery- or chemotherapy-related toxicity (non-hematological) not resolved to Grade 1 with the exception of alopecia, fatigue, neuropathy and lack of appetite /nausea",
            "criterions": [
                {
                    "exact_snippets": "Surgery- or chemotherapy-related toxicity (non-hematological) not resolved to Grade 1",
                    "criterion": "surgery- or chemotherapy-related toxicity (non-hematological)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "fatigue",
                    "criterion": "fatigue",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of appetite /nausea",
                    "criterion": "lack of appetite /nausea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last infusion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to ... father children",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant will not be eligible if the participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective site Review Board approval is given allowing exception to this criterion for a specific participant",
            "criterions": [
                {
                    "exact_snippets": "Participant will not be eligible if the participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial",
                    "criterion": "immediate family member involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": "investigational site or Sponsor staff directly involved with this trial"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless prospective site Review Board approval is given allowing exception to this criterion for a specific participant",
                    "criterion": "site Review Board approval",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* History of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C",
            "criterions": [
                {
                    "exact_snippets": "History of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No known active Hepatitis B",
                    "criterion": "Hepatitis B status",
                    "requirements": [
                        {
                            "requirement_type": "active infection",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known active ... Hepatitis C",
                    "criterion": "Hepatitis C status",
                    "requirements": [
                        {
                            "requirement_type": "active infection",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}