{
    "info": {
        "nct_id": "NCT02301962",
        "official_title": "An Open Label, Multicenter, Non-Comparative, Phase IV Study of Panitumumab to Characterize Its Safety, Tolerability and Activity in Indian Subjects With Previously Treated Wild-Type RAS (KRAS and NRAS), Metastatic Colorectal Cancer",
        "inclusion_criteria": "* Subject or subject's legally acceptable representative has provided informed consent.\n* Male or female >=18 years of age.\n* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum.\n\nMetastatic disease.\n\n* Wild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor status.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Measurable or non-measurable disease per RECIST Version 1.1.\n* Must have failed after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens for metastatic disease. Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen. Metastatic relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease. Laboratory: Adequate baseline organ function defined by (<=7 days prior to first dose of study treatment).\n* Hematologic function, as follows: Absolute neutrophil count (ANC) >=1.5 x 10^9/Liter (L), Platelet count >=75 x 10^9/L, Hemoglobin >=8.0 gram/deciliter (g/dL).\n* Renal function, as follows: Creatinine <=1.5 x upper limit of normal (ULN).\n* Hepatic function, as follows: Aspartate aminotransferase (AST) <=3 x ULN, Alanine aminotransferase (ALT) <=3 x ULN, Total Bilirubin <=1.5 x ULN.\n* Metabolic function, as follows: Serum Magnesium within normal limits. Serum Calcium within normal limits. Serum Potassium within normal limits.\n* All prior treatment related toxicities common terminology criteria for adverse events (CTCAE) version 4.03 <=Grade 1 at the time of enrollment.\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use adequate contraception, during the study and for 2 months following the last dose of study treatment. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use adequate contraception, from time of signing informed consent until 5 months after the last dose of study treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History or known presence of central nervous system metastases.\n* History of another malignancy except: Malignancy treated with curative intent and with no known active disease present for >=5 years prior to enrolment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panitumumab or excipients that contraindicates their participation.\n* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g., panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib, lapatinib).\n* Antitumor therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy <=30 days before first dose of study treatment or not recovered from any acute toxicity.\n* Other investigational procedure <=30 days before study entry.\n* History of interstitial lung disease (ILD) e.g., interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest computer tomography.\n* Subject previously enrolled to this study.\n* History of keratitis, ulcerative keratitis or severe dry eye.\n* Major surgery (e.g., requiring general anesthesia) <=30 days before first dose of study treatment. Subjects must have recovered from any surgery related toxicities.\n* Minor surgical procedure (e.g., open biopsy) <=7 days before first dose of study treatment, or not yet recovered from prior minor surgery Note: uncomplicated placement of vascular access device, fine needle aspiration, thoracocentesis or paracentesis >=3 days prior to first dose of study treatment is acceptable.\n* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=6 months prior to enrolment.\n* History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration, compliance with the study procedures or may interfere with the interpretation of the results.\n* Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event <=30 days before first dose of study treatment. If on anticoagulation, subject must be on stable therapeutic dose prior to first dose of study treatment.\n* Subject who is pregnant or breast feeding, or planning to become pregnant during treatment and within 2 months after the discontinuation of study treatment.\n* Known positive test(s) for human immunodeficiency virus infection (testing is not required in the absence of clinical suspicion).\n* Active infection requiring systemic treatment or any uncontrolled infection <=14 days prior to first dose of study treatment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).\n* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subject or subject's legally acceptable representative has provided informed consent.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Subject or subject's legally acceptable representative has provided informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Male or female >=18 years of age.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Male or female"
                    ],
                    "criterion": "gender",
                    "requirement_type": "N/A",
                    "expected_value": [
                        "male",
                        "female"
                    ]
                },
                {
                    "exact_snippets": [
                        ">=18 years of age"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histologically or cytologically confirmed diagnosis"
                    ],
                    "criterion": "diagnosis confirmation method",
                    "requirement_type": "method",
                    "expected_value": [
                        "histologically",
                        "cytologically"
                    ]
                },
                {
                    "exact_snippets": [
                        "adenocarcinoma of the colon or rectum"
                    ],
                    "criterion": "adenocarcinoma",
                    "requirement_type": "location",
                    "expected_value": [
                        "colon",
                        "rectum"
                    ]
                }
            ]
        },
        {
            "line": "Metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Metastatic disease"
                    ],
                    "criterion": "metastatic disease",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1",
                        "2"
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or non-measurable disease per RECIST Version 1.1.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Measurable or non-measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": [
                        "measurable",
                        "non-measurable"
                    ]
                },
                {
                    "exact_snippets": [
                        "per RECIST Version 1.1"
                    ],
                    "criterion": "RECIST Version",
                    "requirement_type": "version",
                    "expected_value": "1.1"
                }
            ]
        },
        {
            "line": "* Must have failed after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens for metastatic disease. Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen. Metastatic relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease. Laboratory: Adequate baseline organ function defined by (<=7 days prior to first dose of study treatment).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must have failed after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens"
                    ],
                    "criterion": "chemotherapy regimen failure",
                    "requirement_type": "specific regimens",
                    "expected_value": [
                        "fluoropyrimidine",
                        "oxaliplatin",
                        "irinotecan"
                    ]
                },
                {
                    "exact_snippets": [
                        "Failure is defined as either disease progression (clinical or radiological)"
                    ],
                    "criterion": "disease progression",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen"
                    ],
                    "criterion": "intolerance to chemotherapy regimen",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Metastatic relapse within 6 months after completing adjuvant chemotherapy"
                    ],
                    "criterion": "metastatic relapse",
                    "requirement_type": "time since adjuvant chemotherapy",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Adequate baseline organ function"
                    ],
                    "criterion": "baseline organ function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Hematologic function, as follows: Absolute neutrophil count (ANC) >=1.5 x 10^9/Liter (L), Platelet count >=75 x 10^9/L, Hemoglobin >=8.0 gram/deciliter (g/dL).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Absolute neutrophil count (ANC) >=1.5 x 10^9/Liter (L)"
                    ],
                    "criterion": "absolute neutrophil count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1500000000.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Platelet count >=75 x 10^9/L"
                    ],
                    "criterion": "platelet count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 75000000000.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Hemoglobin >=8.0 gram/deciliter (g/dL)"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 8.0
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Renal function, as follows: Creatinine <=1.5 x upper limit of normal (ULN).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Renal function",
                        "Creatinine <=1.5 x upper limit of normal (ULN)"
                    ],
                    "criterion": "creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Hepatic function, as follows: Aspartate aminotransferase (AST) <=3 x ULN, Alanine aminotransferase (ALT) <=3 x ULN, Total Bilirubin <=1.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Aspartate aminotransferase (AST) <=3 x ULN"
                    ],
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Alanine aminotransferase (ALT) <=3 x ULN"
                    ],
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Total Bilirubin <=1.5 x ULN"
                    ],
                    "criterion": "Total Bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Metabolic function, as follows: Serum Magnesium within normal limits. Serum Calcium within normal limits. Serum Potassium within normal limits.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum Magnesium within normal limits"
                    ],
                    "criterion": "serum magnesium",
                    "requirement_type": "range",
                    "expected_value": "within normal limits"
                },
                {
                    "exact_snippets": [
                        "Serum Calcium within normal limits"
                    ],
                    "criterion": "serum calcium",
                    "requirement_type": "range",
                    "expected_value": "within normal limits"
                },
                {
                    "exact_snippets": [
                        "Serum Potassium within normal limits"
                    ],
                    "criterion": "serum potassium",
                    "requirement_type": "range",
                    "expected_value": "within normal limits"
                }
            ]
        },
        {
            "line": "* All prior treatment related toxicities common terminology criteria for adverse events (CTCAE) version 4.03 <=Grade 1 at the time of enrollment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "All prior treatment related toxicities",
                        "common terminology criteria for adverse events (CTCAE) version 4.03 <=Grade 1"
                    ],
                    "criterion": "prior treatment related toxicities",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use adequate contraception, during the study and for 2 months following the last dose of study treatment. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use adequate contraception, from time of signing informed consent until 5 months after the last dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women of childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "negative serum pregnancy test"
                    ],
                    "criterion": "serum pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "Women of childbearing potential",
                        "agree to use adequate contraception",
                        "during the study and for 2 months following the last dose of study treatment"
                    ],
                    "criterion": "contraception use",
                    "requirement_type": "duration",
                    "expected_value": "during the study and for 2 months following the last dose of study treatment"
                },
                {
                    "exact_snippets": [
                        "Men with a female partner of childbearing potential",
                        "either had a prior vasectomy"
                    ],
                    "criterion": "vasectomy",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Men with a female partner of childbearing potential",
                        "agree to use adequate contraception",
                        "from time of signing informed consent until 5 months after the last dose of study treatment"
                    ],
                    "criterion": "contraception use",
                    "requirement_type": "duration",
                    "expected_value": "from time of signing informed consent until 5 months after the last dose of study treatment"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History or known presence of central nervous system metastases.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History or known presence of central nervous system metastases"
                    ],
                    "criterion": "central nervous system metastases",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "History or known presence of central nervous system metastases"
                    ],
                    "criterion": "central nervous system metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of another malignancy except: Malignancy treated with curative intent and with no known active disease present for >=5 years prior to enrolment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of another malignancy"
                    ],
                    "criterion": "history of malignancy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Malignancy treated with curative intent",
                        "no known active disease present for >=5 years prior to enrolment",
                        "felt to be at low risk for recurrence by the treating physician"
                    ],
                    "criterion": "malignancy treatment",
                    "requirement_type": "outcome",
                    "expected_value": "curative intent, no active disease for >=5 years, low risk for recurrence"
                },
                {
                    "exact_snippets": [
                        "Adequately treated non-melanomatous skin cancer",
                        "without evidence of disease"
                    ],
                    "criterion": "non-melanomatous skin cancer",
                    "requirement_type": "treatment outcome",
                    "expected_value": "adequately treated, no evidence of disease"
                },
                {
                    "exact_snippets": [
                        "Adequately treated cervical carcinoma in situ",
                        "without evidence of disease"
                    ],
                    "criterion": "cervical carcinoma in situ",
                    "requirement_type": "treatment outcome",
                    "expected_value": "adequately treated, no evidence of disease"
                },
                {
                    "exact_snippets": [
                        "Prostatic intraepithelial neoplasia",
                        "without evidence of prostate cancer"
                    ],
                    "criterion": "prostatic intraepithelial neoplasia",
                    "requirement_type": "presence",
                    "expected_value": "no evidence of prostate cancer"
                }
            ]
        },
        {
            "line": "* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panitumumab or excipients that contraindicates their participation.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known immediate or delayed hypersensitivity reaction",
                        "to drugs chemically related to panitumumab"
                    ],
                    "criterion": "hypersensitivity reaction",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "idiosyncrasy",
                        "to drugs chemically related to panitumumab"
                    ],
                    "criterion": "idiosyncrasy",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g., panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib, lapatinib).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior anti-epidermal growth factor receptor (EGFr) antibody therapy"
                    ],
                    "criterion": "anti-epidermal growth factor receptor (EGFr) antibody therapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "treatment with small molecule EGFr inhibitors"
                    ],
                    "criterion": "small molecule EGFr inhibitors",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Antitumor therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy <=30 days before first dose of study treatment or not recovered from any acute toxicity.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Antitumor therapy",
                        "<=30 days before first dose of study treatment"
                    ],
                    "criterion": "antitumor therapy",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "investigational agent or therapy",
                        "<=30 days before first dose of study treatment"
                    ],
                    "criterion": "investigational agent or therapy",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "not recovered from any acute toxicity"
                    ],
                    "criterion": "acute toxicity",
                    "requirement_type": "recovery",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Other investigational procedure <=30 days before study entry.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Other investigational procedure",
                        "<=30 days before study entry"
                    ],
                    "criterion": "investigational procedure",
                    "requirement_type": "time since last",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* History of interstitial lung disease (ILD) e.g., interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest computer tomography.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of interstitial lung disease (ILD)"
                    ],
                    "criterion": "interstitial lung disease (ILD)",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "evidence of ILD on baseline chest computer tomography"
                    ],
                    "criterion": "interstitial lung disease (ILD)",
                    "requirement_type": "evidence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Subject previously enrolled to this study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Subject previously enrolled to this study"
                    ],
                    "criterion": "previous enrollment",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of keratitis, ulcerative keratitis or severe dry eye.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of keratitis"
                    ],
                    "criterion": "keratitis",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "ulcerative keratitis"
                    ],
                    "criterion": "ulcerative keratitis",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "severe dry eye"
                    ],
                    "criterion": "dry eye",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            ]
        },
        {
            "line": "* Major surgery (e.g., requiring general anesthesia) <=30 days before first dose of study treatment. Subjects must have recovered from any surgery related toxicities.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Major surgery",
                        "<=30 days before first dose of study treatment"
                    ],
                    "criterion": "major surgery",
                    "requirement_type": "time since",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Subjects must have recovered from any surgery related toxicities"
                    ],
                    "criterion": "surgery related toxicities",
                    "requirement_type": "recovery",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Minor surgical procedure (e.g., open biopsy) <=7 days before first dose of study treatment, or not yet recovered from prior minor surgery Note: uncomplicated placement of vascular access device, fine needle aspiration, thoracocentesis or paracentesis >=3 days prior to first dose of study treatment is acceptable.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Minor surgical procedure",
                        "<=7 days before first dose of study treatment"
                    ],
                    "criterion": "minor surgical procedure",
                    "requirement_type": "time since",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 7
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "not yet recovered from prior minor surgery"
                    ],
                    "criterion": "recovery from prior minor surgery",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "uncomplicated placement of vascular access device",
                        "fine needle aspiration",
                        "thoracocentesis",
                        "paracentesis",
                        ">=3 days prior to first dose of study treatment is acceptable"
                    ],
                    "criterion": "procedure",
                    "requirement_type": "time since",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=6 months prior to enrolment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Clinically significant cardiovascular disease"
                    ],
                    "criterion": "cardiovascular disease",
                    "requirement_type": "severity",
                    "expected_value": "clinically significant"
                },
                {
                    "exact_snippets": [
                        "myocardial infarction"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unstable angina"
                    ],
                    "criterion": "unstable angina",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "symptomatic congestive heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "symptoms",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "serious uncontrolled cardiac arrhythmia"
                    ],
                    "criterion": "cardiac arrhythmia",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "<=6 months prior to enrolment"
                    ],
                    "criterion": "time since cardiovascular event",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration, compliance with the study procedures or may interfere with the interpretation of the results.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of any medical or psychiatric condition"
                    ],
                    "criterion": "medical or psychiatric condition",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "laboratory abnormality"
                    ],
                    "criterion": "laboratory abnormality",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event <=30 days before first dose of study treatment. If on anticoagulation, subject must be on stable therapeutic dose prior to first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Unstable pulmonary embolism"
                    ],
                    "criterion": "pulmonary embolism",
                    "requirement_type": "stability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "deep vein thrombosis"
                    ],
                    "criterion": "deep vein thrombosis",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "other significant arterial/venous thromboembolic event"
                    ],
                    "criterion": "arterial/venous thromboembolic event",
                    "requirement_type": "significance",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "<=30 days before first dose of study treatment"
                    ],
                    "criterion": "time since thromboembolic event",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "If on anticoagulation, subject must be on stable therapeutic dose"
                    ],
                    "criterion": "anticoagulation",
                    "requirement_type": "dose stability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Subject who is pregnant or breast feeding, or planning to become pregnant during treatment and within 2 months after the discontinuation of study treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Subject who is pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "breast feeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "planning to become pregnant during treatment and within 2 months after the discontinuation of study treatment"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "intention",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Known positive test(s) for human immunodeficiency virus infection (testing is not required in the absence of clinical suspicion).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known positive test(s) for human immunodeficiency virus infection"
                    ],
                    "criterion": "human immunodeficiency virus infection",
                    "requirement_type": "test result",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "* Active infection requiring systemic treatment or any uncontrolled infection <=14 days prior to first dose of study treatment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active infection requiring systemic treatment"
                    ],
                    "criterion": "active infection",
                    "requirement_type": "treatment requirement",
                    "expected_value": "systemic"
                },
                {
                    "exact_snippets": [
                        "uncontrolled infection <=14 days prior to first dose of study treatment"
                    ],
                    "criterion": "uncontrolled infection",
                    "requirement_type": "time since last occurrence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 14
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements.",
            "criterions": [
                {
                    "exact_snippets": [
                        "disorder that compromises the ability of the subject to give written informed consent"
                    ],
                    "criterion": "disorder",
                    "requirement_type": "impact on consent ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "disorder that compromises the ability of the subject",
                        "to comply with study procedures"
                    ],
                    "criterion": "disorder",
                    "requirement_type": "impact on compliance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unwilling or unable to comply with study requirements"
                    ],
                    "criterion": "compliance with study requirements",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Wild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor status.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Wild-type KRAS",
                        "without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]"
                    ],
                    "criterion": "KRAS",
                    "requirement_type": "mutation status",
                    "expected_value": "wild-type"
                },
                {
                    "exact_snippets": [
                        "Wild-type NRAS",
                        "without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]"
                    ],
                    "criterion": "NRAS",
                    "requirement_type": "mutation status",
                    "expected_value": "wild-type"
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}