Country KRI Overview

Study: AA-AA-000-0000 (OAK-38)

Study Status

Show Details

Nickname	OAK-38
Status	Active
Site Activation	144 / 150 (96%)
Participant Enrollment	767 / 1000 (76.7%)

Studyid	AA-AA-000-0000
Nickname	OAK-38
Protocol Title	Protocol Title P
Status	Active
Num Plan Site	150
Num Plan Subj	1000
Act Fpfv	2012-01-02
Est Fpfv	2012-01-07
Est Lplv	2012-07-24
Est Lpfv	2012-03-26
Therapeutic Area	Virology
Protocol Indication	Hematology
Phase	P2
Product	Product Name 14
Site Target	150
Participant Target	1000
Participants Enrolled	767
Sites Enrolled	144
Percent Sites Activated	96
Site Activation	144 / 150 (96%)
Percent Participants Enrolled	76.7
Participant Enrollment	767 / 1000 (76.7%)

Study Overview

0 Red KRIs

0 Amber KRIs

Summary Charts

Group Overview

As of 2025-04-01, AA-AA-000-0000 has 767 participants enrolled across 3 countries. 0 Country-KRI combinations have been flagged across 0 countries as shown in the Study Overview Table above.

• 0 countries have at least one red KRI
• 0 countries have at least one red or amber KRI
• 3 countries have neither red nor amber KRIs

Results

Adverse Event Rate

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Nothing flagged for this KRI.

Serious Adverse Event Rate

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Nothing flagged for this KRI.

Non-Important Protocol Deviation Rate

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Nothing flagged for this KRI.

Important Protocol Deviation Rate

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Nothing flagged for this KRI.

Grade 3+ Lab Abnormality Rate

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Nothing flagged for this KRI.

Study Discontinuation Rate

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Nothing flagged for this KRI.

Treatment Discontinuation Rate

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Time Series

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Nothing flagged for this KRI.

Query Rate

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Nothing flagged for this KRI.

Delayed Query Resolution Rate

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Nothing flagged for this KRI.

Delayed Data Entry Rate

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Nothing flagged for this KRI.

Data Change Rate

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Nothing flagged for this KRI.

Screen Failure Rate

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Nothing flagged for this KRI.

PK Collection Compliance Rate

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Time Series

Metric Table

Nothing flagged for this KRI.

Metric Details

Type	ID	GroupLevel	Abbreviation	Metric	Numerator	Denominator	Model	AnalysisType	Score	Threshold	AccrualThreshold	AccrualMetric	Priority	Flag	MetricID
Analysis	cou0001	Country	AE	Adverse Event Rate	Adverse Events	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-2,-1,2,3	30	Denominator	0	NA	Analysis_cou0001
Analysis	cou0002	Country	SAE	Serious Adverse Event Rate	Serious Adverse Events	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-2,-1,2,3	30	Denominator	0	NA	Analysis_cou0002
Analysis	cou0003	Country	PD	Non-Important Protocol Deviation Rate	Non-Important Protocol Deviations	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-3,-2,2,3	30	Denominator	0	NA	Analysis_cou0003
Analysis	cou0004	Country	IPD	Important Protocol Deviation Rate	Important Protocol Deviations	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-3,-2,2,3	30	Denominator	0	NA	Analysis_cou0004
Analysis	cou0005	Country	LB	Grade 3+ Lab Abnormality Rate	Grade 3+ Abnormal Labs Samples	Total Lab Samples	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	30	Denominator	0	NA	Analysis_cou0005
Analysis	cou0006	Country	SDSC	Study Discontinuation Rate	Subjects Discontinued - Study	Enrolled Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3	Denominator	0	NA	Analysis_cou0006
Analysis	cou0007	Country	TDSC	Treatment Discontinuation Rate	Subjects Discontinued - Treatment	Enrolled Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3	Denominator	0	NA	Analysis_cou0007
Analysis	cou0008	Country	QRY	Query Rate	Queries	Total Data Points	Normal Approximation	rate	Adjusted Z-Score	2,3	30	Denominator	0	NA	Analysis_cou0008
Analysis	cou0009	Country	OQRY	Delayed Query Resolution Rate	Queries That Were Open > 30 Days	Total Queries	Normal Approximation	binary	Adjusted Z-Score	2,3	30	Denominator	0	NA	Analysis_cou0009
Analysis	cou0010	Country	ODAT	Delayed Data Entry Rate	Data Pages Entered > 10 Days	Total Data Pages	Normal Approximation	binary	Adjusted Z-Score	2,3	30	Denominator	0	NA	Analysis_cou0010
Analysis	cou0011	Country	CDAT	Data Change Rate	Data Points with 1+ Change	Total Data Points	Normal Approximation	binary	Adjusted Z-Score	2,3	30	Denominator	0	NA	Analysis_cou0011
Analysis	cou0012	Country	SF	Screen Failure Rate	Screen Failures	Screened Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3	Denominator	0	NA	Analysis_cou0012
Analysis	cou0013	Country	PK	PK Collection Compliance Rate	PK Samples Collected	PK Samples Expected	Identity	identity	PK Collection Compliance Rate	0.9,0.85	3	Difference	0	-2,-1,0	Analysis_cou0013