{
"info": {
"nct_id": "NCT02816164",
"official_title": "A Multi Centre Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (REaCT-G2)",
"inclusion_criteria": "* Histologically confirmed primary breast cancer\n* Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy\n* ≥19 years of age\n* Able to provide verbal consent\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
"exclusion_criteria": "* Contraindication to Filgrastim",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histologically confirmed primary breast cancer",
"criterions": [
{
"exact_snippets": [
"Histologically confirmed"
],
"criterion": "breast cancer",
"requirement_type": "confirmation method",
"expected_value": "histological"
},
{
"exact_snippets": [
"primary breast cancer"
],
"criterion": "breast cancer",
"requirement_type": "type",
"expected_value": "primary"
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Histologically confirmed"
],
"criterion": "breast cancer",
"requirement_type": "confirmation method",
"expected_value": "histological"
},
{
"exact_snippets": [
"primary breast cancer"
],
"criterion": "breast cancer",
"requirement_type": "type",
"expected_value": "primary"
}
]
}
},
{
"identified_line": {
"line": "* Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy",
"criterions": [
{
"exact_snippets": [
"Planned to start docetaxel component of FEC-D or AC-D"
],
"criterion": "docetaxel component of FEC-D or AC-D",
"requirement_type": "planned start",
"expected_value": true
},
{
"exact_snippets": [
"first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy"
],
"criterion": "dose-dense AC-T, TC, FEC-D or TAC chemotherapy",
"requirement_type": "first cycle",
"expected_value": true
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": [
"Planned to start docetaxel component of FEC-D or AC-D"
],
"criterion": "docetaxel component of FEC-D or AC-D",
"requirement_type": "planned start",
"expected_value": true
}
]
},
{
"and_criteria": [
{
"exact_snippets": [
"first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy"
],
"criterion": "dose-dense AC-T, TC, FEC-D or TAC chemotherapy",
"requirement_type": "first cycle",
"expected_value": true
}
]
}
]
}
},
{
"identified_line": {
"line": "* Able to provide verbal consent",
"criterions": [
{
"exact_snippets": [
"Able to provide verbal consent"
],
"criterion": "verbal consent",
"requirement_type": "ability",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Able to provide verbal consent"
],
"criterion": "verbal consent",
"requirement_type": "ability",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "volunteer health status",
"requirement_type": "allowance",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "volunteer health status",
"requirement_type": "allowance",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 19 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 19 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 19
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"minimum age of 19 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 19
}
}
]
}
},
{
"identified_line": {
"line": "* ≥19 years of age",
"criterions": [
{
"exact_snippets": [
">=19 years of age"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 19
}
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
">=19 years of age"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 19
}
]
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Contraindication to Filgrastim",
"criterions": [
{
"exact_snippets": [
"Contraindication to Filgrastim"
],
"criterion": "Filgrastim",
"requirement_type": "contraindication",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Contraindication to Filgrastim"
],
"criterion": "Filgrastim",
"requirement_type": "contraindication",
"expected_value": true
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}