{
    "info": {
        "nct_id": "NCT02044380",
        "official_title": "An Open Label Trial of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n1. Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Epidermal Growth Factor Receptor (EGFR) mutation-positive results per the institution's testing methodology\n3. Male or female patients age >=18 years\n4. Adequate organ function, defined as all of the following:\n\n   1. Absolute neutrophil count (ANC) >1500/mm3\n   2. Platelet count>75,000/mm3\n   3. Serum creatinine<1.5 times of the upper limit of (institutional) normal and/or creatinine clearance (measured or calculated)>45ml/min\n   4. Total bilirubin <1.5 times upper limit of (institutional) normal\n   5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (if related to liver metastases < five times ULN)\n5. Eastern Cooperative Oncology Group (ECOG) score between 0-2\n6. Written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) guidelines and local law\n7. Recovery from any previous therapy related toxicity to <=CTCAE Grade 1 at study entry (except for stable sensory neuropathy <=CTCAE Grade 2 and alopecia)\n\nExclusion criteria:\n\n1. Prior treatment with an EGFR tyrosine kinase inhibitor (TKI)\n2. Hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)\n3. Radiotherapy within 28 days prior to drug administration, except as follows:\n\n   1. Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and\n   2. Single dose palliative treatment for symptomatic metastases outside above allowance to be discussed with sponsor prior to enrolling\n4. Major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial\n5. Known hypersensitivity to afatinib or any of its excipients\n6. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment\n7. Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended\n8. Childbearing potential who:\n\n   1. are nursing or\n   2. are pregnant or\n   3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol\n9. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of safety for the trial drug\n10. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured\n11. Requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation\n12. Known pre-existing interstitial lung disease\n13. Presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or Common Terminology Criteria grade =2 diarrhea of any aetiology) based on investigator assessment\n14. Active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier\n15. Meningeal carcinomatosis\n16. Symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of corticosteroid)"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "1. Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)",
                    "criterion": "Non-small Cell Lung Cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Epidermal Growth Factor Receptor (EGFR) mutation-positive results per the institution's testing methodology",
            "criterions": [
                {
                    "exact_snippets": "Epidermal Growth Factor Receptor (EGFR) mutation-positive results",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "per the institution's testing methodology",
                    "criterion": "testing methodology",
                    "requirements": [
                        {
                            "requirement_type": "methodology",
                            "expected_value": "institution's"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Male or female patients age >=18 years",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age >=18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Adequate organ function, defined as all of the following:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Absolute neutrophil count (ANC) >1500/mm3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >1500/mm3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Platelet count>75,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count>75,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 75000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Serum creatinine<1.5 times of the upper limit of (institutional) normal and/or creatinine clearance (measured or calculated)>45ml/min",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine<1.5 times of the upper limit of (institutional) normal",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times of the upper limit of (institutional) normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (measured or calculated)>45ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 45,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Total bilirubin <1.5 times upper limit of (institutional) normal",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin <1.5 times upper limit of (institutional) normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times upper limit of (institutional) normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (if related to liver metastases < five times ULN)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate Amino Transferase (AST) ... < three times the upper limit of (institutional) normal",
                    "criterion": "Aspartate Amino Transferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times the upper limit of (institutional) normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine Amino Transferase (ALT) ... < three times the upper limit of (institutional) normal",
                    "criterion": "Alanine Amino Transferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times the upper limit of (institutional) normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate Amino Transferase (AST) ... (if related to liver metastases < five times ULN)",
                    "criterion": "Aspartate Amino Transferase (AST) level related to liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine Amino Transferase (ALT) ... (if related to liver metastases < five times ULN)",
                    "criterion": "Alanine Amino Transferase (ALT) level related to liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) score between 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score between 0-2",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) guidelines and local law",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent by patient or guardian",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "consistent with International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) guidelines",
                    "criterion": "consent consistency with ICH-GCP guidelines",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "consistent with ... local law",
                    "criterion": "consent consistency with local law",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Recovery from any previous therapy related toxicity to <=CTCAE Grade 1 at study entry (except for stable sensory neuropathy <=CTCAE Grade 2 and alopecia)",
            "criterions": [
                {
                    "exact_snippets": "Recovery from any previous therapy related toxicity to <=CTCAE Grade 1",
                    "criterion": "therapy related toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stable sensory neuropathy <=CTCAE Grade 2",
                    "criterion": "stable sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Prior treatment with an EGFR tyrosine kinase inhibitor (TKI)",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with an EGFR tyrosine kinase inhibitor (TKI)",
                    "criterion": "EGFR tyrosine kinase inhibitor (TKI) treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)",
            "criterions": [
                {
                    "exact_snippets": "Hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment",
                    "criterion": "hormonal anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted",
                    "criterion": "continued use of anti-androgens and/or gonadorelin analogues",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Radiotherapy within 28 days prior to drug administration, except as follows:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy within 28 days prior to drug administration",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and",
            "criterions": [
                {
                    "exact_snippets": "Palliative radiation to organs other than chest may be allowed",
                    "criterion": "palliative radiation to organs other than chest",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks prior to drug administration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Single dose palliative treatment for symptomatic metastases outside above allowance to be discussed with sponsor prior to enrolling",
            "criterions": [
                {
                    "exact_snippets": "Single dose palliative treatment for symptomatic metastases",
                    "criterion": "palliative treatment for symptomatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "single"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastases outside above allowance",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "outside above allowance"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks before starting trial treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for surgery during the projected course of the trial",
                    "criterion": "scheduled surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the projected course of the trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Known hypersensitivity to afatinib or any of its excipients",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to afatinib",
                    "criterion": "hypersensitivity to afatinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of its excipients",
                    "criterion": "hypersensitivity to excipients of afatinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment",
            "criterions": [
                {
                    "exact_snippets": "History or presence of clinically relevant cardiovascular abnormalities",
                    "criterion": "cardiovascular abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure New York Heart Association (NYHA) classification of 3",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA classification",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Myocardial infarction within 6 months prior to starting trial treatment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended",
            "criterions": [
                {
                    "exact_snippets": "Women of Child-Bearing Potential (WOCBP)",
                    "criterion": "Women of Child-Bearing Potential (WOCBP)",
                    "requirements": [
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men who are able to father a child",
                    "criterion": "men who are able to father a child",
                    "requirements": [
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Childbearing potential who:",
            "criterions": [
                {
                    "exact_snippets": "Childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. are nursing or",
            "criterions": [
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. are pregnant or",
            "criterions": [
                {
                    "exact_snippets": "are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol",
            "criterions": [
                {
                    "exact_snippets": "are not using an acceptable method of birth control",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "do not plan to continue using this method throughout the trial",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "do not agree to submit to pregnancy testing required by this protocol",
                    "criterion": "pregnancy testing",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of safety for the trial drug",
            "criterions": [
                {
                    "exact_snippets": "Any history of or concomitant condition",
                    "criterion": "history of condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any history of or concomitant condition",
                    "criterion": "concomitant condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be 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": "except effectively treated non-melanoma skin cancers",
                    "criterion": "non-melanoma skin cancers",
                    "requirements": [
                        {
                            "requirement_type": "treatment effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... ductal carcinoma in situ",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured",
                    "criterion": "effectively treated malignancy",
                    "requirements": [
                        {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "cure status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation",
            "criterions": [
                {
                    "exact_snippets": "Requiring treatment with any of the prohibited concomitant medications",
                    "criterion": "prohibited concomitant medications",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known pre-existing interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Known pre-existing interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or Common Terminology Criteria grade =2 diarrhea of any aetiology) based on investigator assessment",
            "criterions": [
                {
                    "exact_snippets": "Presence of poorly controlled gastrointestinal disorders ... Crohn's disease, ulcerative colitis, malabsorption",
                    "criterion": "poorly controlled gastrointestinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Common Terminology Criteria grade =2 diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "Common Terminology Criteria grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA)",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA)",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known Human Immunodeficiency Virus (HIV) carrier",
                    "criterion": "HIV carrier",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "known"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Meningeal carcinomatosis",
            "criterions": [
                {
                    "exact_snippets": "Meningeal carcinomatosis",
                    "criterion": "meningeal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of corticosteroid)",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic brain metastases, who were previously treated",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "previously treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stable Disease (SD) for at least 4 weeks",
                    "criterion": "disease stability",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stable doses of corticosteroid",
                    "criterion": "corticosteroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        }
    ]
}