Study Status

Nickname OAK-38
Status Active
Site Activation 145 / 150 (96.7%)
Participant Enrollment 763 / 1000 (76.3%)

Study Overview

0 Red KRIs
1 Amber KRIs

Summary Charts

Country Overview

As of 2025-04-01, AA-AA-000-0000 has 763 participants enrolled across 3 countries. 1 Country-KRI combinations have been flagged across 1 countries as shown in the Study Overview Table above.
  • 0 countries have at least one red KRI
  • 1 countries have at least one red or amber KRI
  • 2 countries have neither red nor amber KRIs

Missing delta columns in dfResults: Flag_Change, Flag_Previous, Score_Change, Score_Previous, Numerator_Previous, Denominator_Previous, Metric_Previous . Not rendering list of newly changed flags.NULL

Results

Adverse Event Rate

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
US 297 806 10663 0.08 -1.3
Time Series


Serious Adverse Event Rate

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Nothing flagged for this KRI.

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Non-Important Protocol Deviation Rate

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Nothing flagged for this KRI.

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Important Protocol Deviation Rate

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Nothing flagged for this KRI.

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Grade 3+ Lab Abnormality Rate

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Nothing flagged for this KRI.

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Study Discontinuation Rate

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Nothing flagged for this KRI.

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Treatment Discontinuation Rate

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Nothing flagged for this KRI.

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Query Rate

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Nothing flagged for this KRI.

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Delayed Query Resolution Rate

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Nothing flagged for this KRI.

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Delayed Data Entry Rate

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Nothing flagged for this KRI.

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Data Change Rate

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Nothing flagged for this KRI.

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Screen Failure Rate

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Nothing flagged for this KRI.

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PK Collection Compliance Rate

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metricTable

Nothing flagged for this KRI.

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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 2,3 10 Numerator 0 0,1,2 Analysis_cou0005
Analysis cou0006 Country SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator 0 0,1,2 Analysis_cou0006
Analysis cou0007 Country TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator 0 0,1,2 Analysis_cou0007
Analysis cou0008 Country QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score 2,3 30 Numerator 0 0,1,2 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 Numerator 0 0,1,2 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 Numerator 0 0,1,2 Analysis_cou0010
Analysis cou0011 Country CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score 2,3 100 Numerator 0 0,1,2 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