Study Status

Description Value
Participants Enrolled 1301
Sites Enrolled 176
Study Status Active
protocol_row_id 1-1G9113
protocol_number AA-AA-000-0000
Description Value
Participants Enrolled 1301
Sites Enrolled 176
Study Status Active
protocol_row_id 1-1G9113
protocol_number AA-AA-000-0000
protocol_title Protocol Title
nickname Protocol Nickname
protocol_type Investigator Sponsored
phase P3
num_plan_site 190
num_site_actl 176
est_fpfv 2003-01-01
act_fpfv 2003-01-01
est_lplv 2021-06-01
act_lplv 2021-06-01
est_lpfv 2020-06-01
act_lpfv 2020-06-01
status Active
num_plan_subj 1300
num_enrolled_subj_m 1301
protocol_indication Protocol Indication
product Product
therapeutic_area Therapeutic Area
protocol_product_number 123
x_rbm_flg Y

Study Overview

25 Red KRIs
80 Amber KRIs
As of 2024-08-14, AA-AA-000-0000 has 1301 participants enrolled across 176 sites. 25 Site-KRI combinations have been flagged across 17 sites as shown in the Study Overview Table above.
  • 17 sites have at least one red KRI
  • 73 sites have at least one red or amber KRI
  • 179 sites have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X159 (Flores) 33 400 24166 0.02 6.55
0X024 (Rinard) 7 83 4736 0.02 3.14
0X027 (Owens) 10 114 7957 0.01 3.04
0X090 (el-Attar) 1 17 475 0.04 2.44
0X054 (Vargas Padilla) 2 35 1647 0.02 2.40
0X041 (Yazzie) 3 39 2034 0.02 2.33
0X169 (Kanack) 3 42 2406 0.02 2.23
0X175 (Gonzalez) 16 129 12408 0.01 2.21
0X153 (Voss) 28 25 20902 0.00 -1.96
0X126 (Torres) 20 8 13774 0.00 -1.85
0X163 (el-Vaziri) 28 42 22818 0.00 -1.69
0X124 (Salas Dominguez) 27 36 20748 0.00 -1.67
0X161 (Vangoey) 69 148 50949 0.00 -1.66
0X003 (Drake) 13 5 10519 0.00 -1.66
0X080 (el-Mousa) 17 19 13479 0.00 -1.48
0X122 (el-Salameh) 17 24 13320 0.00 -1.31
0X180 (Tran) 12 13 9602 0.00 -1.27
0X157 (Arellano) 9 6 6832 0.00 -1.21
0X026 (el-Samra) 15 18 10653 0.00 -1.21
0X125 (Pond) 10 11 7803 0.00 -1.13
0X043 (Ford) 5 0 3779 0.00 -1.10
0X178 (Kessenich) 11 12 7627 0.00 -1.06
0X106 (Hill) 5 1 3536 0.00 -1.00

Serious Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 10 2286 0 10.10
0X109 (Nguyen) 1 2 715 0 3.54
0X131 (Tran) 1 1 441 0 2.23
0X021 (Lee) 4 3 3387 0 2.16
0X090 (el-Attar) 1 1 475 0 2.14

Non-Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X124 (Salas Dominguez) 27 223 20748 0.01 4.18
0X155 (al-Sani) 4 55 2852 0.02 3.52
0X016 (el-Shaker) 7 74 4976 0.01 3.31
0X027 (Owens) 10 98 7957 0.01 3.19
0X026 (el-Samra) 15 111 10653 0.01 2.85
0X065 (Hill) 36 10 26286 0.00 -2.58
0X064 (al-Mussa) 5 44 3396 0.01 2.25
0X057 (Aragon) 6 54 4824 0.01 2.15

Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X124 (Salas Dominguez) 27 48 20748 0.00 5.96
0X064 (al-Mussa) 5 11 3396 0.00 3.64
X185X (Landry) 1 4 720 0.01 3.09
0X173 (el-Yusuf) 1 1 53 0.02 3.04
0X130 (Burroughs-Chock) 9 14 7678 0.00 2.65
0X027 (Owens) 10 14 7957 0.00 2.57
0X016 (el-Shaker) 7 10 4976 0.00 2.43
0X183 (Gray) 1 3 744 0.00 2.19
0X152 (Batchelder) 7 9 4966 0.00 2.12

Grade 3+ Lab Abnormality Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 40 1607 0.02 6.62
0X024 (Rinard) 7 50 2958 0.02 5.75
0X079 (Gomez) 3 21 1297 0.02 3.62
0X022 (al-Nawaz) 3 14 872 0.02 2.94
0X147 (Lamping) 3 15 1003 0.01 2.89
0X028 (Gonzales) 1 8 491 0.02 2.24

Study Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X170 (Herlin) 4 3 4 0.75 3.58
0X011 (Gallegos) 5 3 5 0.60 3.09
0X103 (al-Mona) 5 3 5 0.60 3.09
0X022 (al-Nawaz) 3 2 3 0.67 2.71
0X037 (el-Mostafa) 3 2 3 0.67 2.71
0X152 (Batchelder) 7 3 7 0.43 2.42
0X077 (Gonzalez) 8 3 8 0.38 2.17

Treatment Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 4 5 0.80 4.38
0X011 (Gallegos) 5 3 5 0.60 3.15
0X022 (al-Nawaz) 3 2 3 0.67 2.76
0X037 (el-Mostafa) 3 2 3 0.67 2.76
0X152 (Batchelder) 7 3 7 0.43 2.48
0X170 (Herlin) 4 2 4 0.50 2.27
0X077 (Gonzalez) 8 3 8 0.38 2.23

Query Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X129 (Martinez) 10 420 18120 0.02 2.92
0X059 (Foster) 15 416 23484 0.02 -2.36
0X162 (Campa) 7 262 11375 0.02 2.21
0X043 (Ford) 5 124 7597 0.02 -2.17
0X075 (Dabit) 8 316 13957 0.02 2.13
0X171 (Hoffpauir) 12 462 20974 0.02 2.01
0X159 (Flores) 33 978 52327 0.02 -2.01
0X151 (Poveromo) 15 474 26102 0.02 -2.00

Outstanding Query Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X002 (Biolchini) 1 5 30 0.17 5.00
0X118 (el-Dia) 2 6 87 0.07 2.88
0X087 (Vigo) 27 32 977 0.03 2.64
0X168 (Pinch) 3 6 98 0.06 2.58
0X162 (Campa) 7 11 262 0.04 2.29
0X081 (Hendee) 4 6 117 0.05 2.15
0X148 (Suess) 3 4 65 0.06 2.12
0X080 (el-Mousa) 17 3 579 0.01 -2.07
0X141 (Esquibel) 1 3 43 0.07 2.06

Outstanding Data Entry Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X159 (Flores) 33 311 6123 0.05 3.03
0X143 (el-Salih) 8 46 1696 0.03 -2.88
0X171 (Hoffpauir) 12 134 2454 0.05 2.78
0X083 (el-Aman) 10 105 1913 0.05 2.52
0X085 (al-Mussa) 1 16 203 0.08 2.38
0X069 (Ello) 4 21 848 0.02 -2.35
0X029 (Truong) 4 45 749 0.06 2.23
0X186 (Gallegos-Neiberger) 2 25 379 0.07 2.11

Data Change Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X180 (Tran) 12 4923 19665 0.25 -3.25
0X089 (al-Nouri) 4 1699 6863 0.25 -2.49
0X088 (Correa) 11 4406 17468 0.25 -2.44
0X015 (Martinez) 3 1340 4897 0.27 2.41
0X005 (Arshad) 7 2912 11606 0.25 -2.35
0X139 (el-Khalifa) 2 812 2931 0.28 2.32
0X184 (Kapoor) 6 2776 10333 0.27 2.25
0X002 (Biolchini) 1 396 1658 0.24 -2.10

Screen Failure Rate

Summary Charts

Summary
KRI Metric
KRI Score

Group Enrolled Numerator Denominator Metric Score Flag
0X023 (Avena) 34 4 38 0.11 -3.15
0X081 (Hendee) 4 21 25 0.84 2.82
0X127 (Pascual) 4 20 24 0.83 2.71
X185X (Landry) 1 14 15 0.93 2.71
0X108 (Keys) 4 17 21 0.81 2.38
0X087 (Vigo) 27 6 33 0.18 -2.30
0X124 (Salas Dominguez) 27 6 33 0.18 -2.30

Metric Details

MetricID File GroupLevel Abbreviation Metric Numerator Denominator Model Score Type Threshold nMinDenominator
kri0001 kri0001.yaml Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation Adjusted Z-Score rate -2,-1,2,3 30
kri0002 kri0002.yaml Site SAE Serious Adverse Event Rate Serious Adverse Events Days on Study Normal Approximation Adjusted Z-Score rate -2,-1,2,3 30
kri0003 kri0003.yaml Site PD Non-Important Protocol Deviation Rate Non-Important Protocol Deviations Days on Study Normal Approximation Adjusted Z-Score rate -3,-2,2,3 30
kri0004 kri0004.yaml Site PD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation Adjusted Z-Score rate -3,-2,2,3 30
kri0005 kri0005.yaml Site LB Grade 3+ Lab Abnormality Rate Grade 3+ Abnormal Labs Samples Total Lab Samples Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0006 kri0006.yaml Site SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation Adjusted Z-Score binary -3,-2,2,3 3
kri0007 kri0007.yaml Site TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation Adjusted Z-Score binary -3,-2,2,3 3
kri0008 kri0008.yaml Site QRY Query Rate Queries Total Data Points Normal Approximation Adjusted Z-Score rate -3,-2,2,3 30
kri0009 kri0009.yaml Site OQRY Outstanding Query Rate Queries Open > 30 Days Total Queries Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0010 kri0010.yaml Site ODAT Outstanding Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0011 kri0011.yaml Site CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0012 kri0012.yaml Site SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation Adjusted Z-Score binary -3,-2,2,3 3