{
"study": {
"study_id": "GSK-104",
"study_name": "이상지질혈증 환자 대상 복합제 유효성 평가",
"protocol_no": "GSK-104-001",
"sponsor_name": "GSK",
"phase": "Phase 3"
},
"design": {
"dsn_nm": "GSK-104 V1.0",
"tot_unit": 5,
"ver": "V1.0",
"cycle": "N",
"day_base": 0,
"week_scope": 28
},
"timepoints": [
{
"seq": 1,
"timepoint_title": "Visit 1",
"all_timepoint": "-4W",
"dsn_ty_cd": "SCR",
"day": -28,
"err_interval": 10080,
"err_interval2": 0,
"memo": "스크리닝"
},
{
"seq": 2,
"timepoint_title": "Visit 2",
"all_timepoint": "0W",
"dsn_ty_cd": "BASE",
"day": 0,
"err_interval": 20160,
"err_interval2": 0,
"memo": "베이스라인/무작위배정"
}
],
"procedures": [
{"seq": 1, "dsn_prcd_nm": "서면동의"},
{"seq": 2, "dsn_prcd_nm": "인구학적 정보"},
{"seq": 3, "dsn_prcd_nm": "활력징후"}
],
"mapping": [
{"timepoint_seq": 1, "procedure_seq": 1},
{"timepoint_seq": 1, "procedure_seq": 2},
{"timepoint_seq": 1, "procedure_seq": 3},
{"timepoint_seq": 2, "procedure_seq": 3}
],
"subject_groups": [
{
"name": "시험군",
"cond": "Dapagliflozin 10mg + Rosuvastatin 20mg 복합제",
"cnt": 80,
"medi": "GSK03정"
},
{
"name": "대조군1",
"cond": "Dapagliflozin 10mg 단독",
"cnt": 80,
"medi": "GSK01정 + 위약"
}
]
}