cubeCDMS

S-77-005

Graphic List

	V1YYYY-MM-DD	V2YYYY-MM-DD	V3null	V4YYYY-MM-DD	Serious Adverse Event(Main All)1 (SAE(MALL))null	V6null	V7null
	Screening	Screening	Main Study/4W(±1W)	Main Study/8W(±1W)	Main Study/12W(±1W)	Extension Study/16W(±1W)	Extension Study/20W(±1W)
Enrollment
Visit
Demographics
Substance Use
Medical History
Vital Signs
ECG Test Results
Pregnancy Test
Local Laboratory Test
Central Laboratory Test
Inclusion/Exclusion Criteria
Randomization
CT Scan
CT Evaluation Ⅰ
CT Evaluation Ⅱ
IP Prescription
Drug Accountability

방문	일정	저장 상태	임시 저장	미 저장	NA	오픈 쿼리
Enrollment		1/1	0/1	0/1	0/1	0
V1	Screening/ -4W(±1W)	5/10	0/10	5/10	1/10	5
V2	Main Study/ 0W	5/10	0/10	5/10	1/10	7
V3	Main Study/ 4W(±1W)	2/5	0/5	3/5	0/5	2
V4	Main Study/ 8W(±1W)	0/5	0/5	5/5	0/5	0
V5	Main Study/ 12W(±1W)	0/11	0/11	11/11	5/11	0
Drug Accountability		0/1	0/1	1/1	0/1	0
Patient Diary		1/1	0/1	0/1	0/1	0
Adverse Event		0/1	0/1	1/1	0/1	0
Prior and Concomitant Medications		0/1	0/1	1/1	0/1	0
Disposition		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	1/1	0
V6	Extension Study/ 16W(±1W)	0/5	0/5	5/5	5/5	0
V7	Extension Study/ 20W(±1W)	0/9	0/9	9/9	9/9	0
Drug Accountability		0/1	0/1	1/1	1/1	0
Patient Diary		0/1	0/1	1/1	1/1	0
Adverse Event		0/1	0/1	1/1	1/1	0
Prior and Concomitant Medications		0/1	0/1	1/1	1/1	0
Disposition		0/1	0/1	1/1	1/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0
PI Signature		0/1	0/1	1/1	0/1	0

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