Enrollment
Enrollment
V1
Visit
Demographics
Substance Use
Medical History
Vital Signs
ECG Test Results
Pregnancy Test
Local Laboratory Test
Inclusion/Exclusion Criteria
IP Prescription
V2
Visit
Vital Signs
ECG Test Results
Local Laboratory Test
Central Laboratory Test
Randomization
CT Scan
CT Evaluation Ⅰ
CT Evaluation Ⅱ
IP Prescription
V3
Visit
Vital Signs
ECG Test Results
Local Laboratory Test
IP Prescription
V4
Visit
Vital Signs
ECG Test Results
Local Laboratory Test
IP Prescription
V5
Visit
Vital Signs
ECG Test Results
Pregnancy Test
Local Laboratory Test
Central Laboratory Test
Inclusion/Exclusion Criteria
CT Scan
CT Evaluation Ⅰ
CT Evaluation Ⅱ
IP Prescription
Main UV
MUV1
Visit
Vital Signs
ECG Test Results
Local Laboratory Test
Main All
Drug Accountability
Patient Diary
Adverse Event
Prior and Concomitant Medications
Disposition
Principal Investigator’s Signature
V6
Visit
Vital Signs
ECG Test Results
Local Laboratory Test
IP Prescription
V7
Visit
Vital Signs
ECG Test Results
Pregnancy Test
Local Laboratory Test
Central Laboratory Test
CT Scan
CT Evaluation Ⅰ
CT Evaluation Ⅱ
Extension All
Drug Accountability
Patient Diary
Adverse Event
Prior and Concomitant Medications
Disposition
PI Signature
Principal Investigator’s Signature
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CRF V1.0[-] / EDC Effective 2016-02-13
Adverse Event
Were any adverse events experienced?
Adverse Event
Record all adverse events noted from Visit 1 to study completion.
Line Number Adverse event Start date TEAE Outcome End date
Serious Severity Relationship to study treatment Action taken with study treatment Other action taken
추가
1
No
Recovered/Resolved
Hospitalization
Mild
Not related
Not applicable
Drug treatment
2
Yes
Recovered/Resolved with sequelae
Other medically important event
Moderate
Possibly related
Drug withdrawn
Drug treatment
3
Yes
Recovered/Resolved
[NotSelected]
Severe
Possibly related
Not applicable
None
4
Yes
Recovering/Resolving
[NotSelected]
Mild
Related
Not applicable
Drug treatment
5
[NotSelected]
[NotSelected]
[NotSelected]
[NotSelected]
[NotSelected]
[NotSelected]
[NotSelected]
추가 추가
  • 입력오류
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  • 수정된 자료
  • 원본 자료
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  • 모호한 쿼리