Study Status

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

Study Overview

5 Red KRIs
63 Amber KRIs

Summary Charts

Group Overview

As of 2025-04-01, AA-AA-000-0000 has 767 participants enrolled across 144 sites. 68 Site-KRI combinations have been flagged across 50 sites as shown in the Study Overview Table above.
  • 5 sites have at least one red KRI
  • 50 sites have at least one red or amber KRI
  • 97 sites have neither red nor amber KRIs

Results

Adverse Event Rate

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X2649 (Deer) 4 19 102 0.19 2.42
0X1750 (Smith) 7 39 289 0.13 2.06
0X6073 (Smith) 5 1 133 0.01 -2.00
0X8764 (Smith) 7 14 305 0.05 -1.48
0X759 (Smith) 7 14 303 0.05 -1.46
0X1982 (Smith) 7 19 345 0.06 -1.18
0X9069 (Deer) 7 9 192 0.05 -1.14
0X3289 (Deer) 5 13 251 0.05 -1.13
0X8792 (Smith) 7 15 280 0.05 -1.12
0X8609 (Doe) 4 2 72 0.03 -1.07
0X4959 (Doe) 6 16 285 0.06 -1.03
0X474 (Doe) 3 4 102 0.04 -1.01


Serious Adverse Event Rate

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Group Enrolled Numerator Denominator Metric Score Flag
0X2649 (Deer) 4 12 102 0.12 2.69
0X8764 (Smith) 7 5 305 0.02 -1.72
0X3289 (Deer) 5 4 251 0.02 -1.58
0X8792 (Smith) 7 5 280 0.02 -1.56
0X6073 (Smith) 5 1 133 0.01 -1.50
0X7127 (Deer) 8 5 263 0.02 -1.44
0X7815 (Smith) 7 5 251 0.02 -1.36
0X759 (Smith) 7 7 303 0.02 -1.29
0X1756 (Doe) 9 7 295 0.02 -1.24
0X474 (Doe) 3 1 102 0.01 -1.23
0X9609 (Smith) 3 0 60 0.00 -1.22
0X856 (Smith) 3 0 52 0.00 -1.13
0X8799 (Doe) 9 12 420 0.03 -1.12
0X9346 (Doe) 13 15 491 0.03 -1.05
0X4264 (Deer) 6 7 269 0.03 -1.04
0X9737 (Doe) 12 18 565 0.03 -1.01


Non-Important Protocol Deviation Rate

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Group Enrolled Numerator Denominator Metric Score Flag
0X4761 (Doe) 3 9 65 0.14 2.72


Important Protocol Deviation Rate

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Group Enrolled Numerator Denominator Metric Score Flag
0X7502 (Deer) 6 9 80 0.11 2.27
0X7469 (Doe) 5 14 156 0.09 2.12
0X7052 (Doe) 4 7 61 0.11 2.04


Grade 3+ Lab Abnormality Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
0X9069 (Deer) 7 85 4191 0.02 2.80
0X8351 (Deer) 10 207 17246 0.01 -2.75
0X3893 (Smith) 3 26 1056 0.02 2.50
0X856 (Smith) 3 26 1079 0.02 2.40
0X474 (Doe) 3 100 5294 0.02 2.37
0X7815 (Smith) 7 135 7432 0.02 2.32
0X4483 (Deer) 4 45 2149 0.02 2.25
0X8625 (Deer) 12 291 17299 0.02 2.17
0X4323 (Smith) 11 588 36578 0.02 2.04


Study Discontinuation Rate

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Group Enrolled Numerator Denominator Metric Score Flag
0X8788 (Deer) 8 5 8 0.62 5.40
0X1710 (Deer) 4 2 4 0.50 2.93
0X2532 (Doe) 8 3 8 0.38 2.90
0X3289 (Deer) 5 2 5 0.40 2.49
0X7469 (Doe) 5 2 5 0.40 2.49
0X8351 (Deer) 10 3 10 0.30 2.40


Treatment Discontinuation Rate

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X6073 (Smith) 5 3 5 0.60 3.42
0X9580 (Deer) 6 3 6 0.50 2.98
0X1966 (Deer) 4 2 4 0.50 2.43
0X2649 (Deer) 4 2 4 0.50 2.43
0X6209 (Smith) 8 3 8 0.38 2.32


Query Rate

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Nothing flagged for this KRI.


Delayed Query Resolution Rate

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X7983 (Smith) 6 1060 1128 0.94 3.03
0X2901 (Doe) 6 1233 1316 0.94 2.90
0X3909 (Smith) 5 1312 1410 0.93 2.11
0X4871 (Doe) 4 442 470 0.94 2.01


Delayed Data Entry Rate

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Group Enrolled Numerator Denominator Metric Score Flag
0X6831 (Deer) 4 80 1128 0.07 3.43
0X3695 (Deer) 2 30 376 0.08 2.82
0X914 (Deer) 2 29 376 0.08 2.57


Data Change Rate

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Group Enrolled Numerator Denominator Metric Score Flag
0X025 (Doe) 4 1258 4512 0.28 2.89
0X5384 (Smith) 10 10395 39104 0.27 2.59
0X1257 (Doe) 4 2834 10528 0.27 2.14


Screen Failure Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
0X101 (Deer) 2 6 8 0.75 3.37
0X4874 (Doe) 2 4 6 0.67 2.45
0X6831 (Deer) 4 5 9 0.56 2.23
0X213 (Smith) 16 0 16 0.00 -2.15
0X474 (Doe) 3 4 7 0.57 2.06
0X6273 (Deer) 3 4 7 0.57 2.06


PK Collection Compliance Rate

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Nothing flagged for this KRI.


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold AccrualThreshold AccrualMetric Priority Flag MetricID
Analysis kri0001 Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 Denominator 0 NA Analysis_kri0001
Analysis kri0002 Site 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_kri0002
Analysis kri0003 Site 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_kri0003
Analysis kri0004 Site 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_kri0004
Analysis kri0005 Site 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_kri0005
Analysis kri0006 Site SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 Denominator 0 NA Analysis_kri0006
Analysis kri0007 Site TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 Denominator 0 NA Analysis_kri0007
Analysis kri0008 Site QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score 2,3 30 Denominator 0 NA Analysis_kri0008
Analysis kri0009 Site 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_kri0009
Analysis kri0010 Site 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_kri0010
Analysis kri0011 Site 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_kri0011
Analysis kri0012 Site SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 Denominator 0 NA Analysis_kri0012
Analysis kri0013 Site 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_kri0013