Study Status

Nickname Protocol Nickname
Study Status Active
Site Activation 176 / 190 (92.6%)
Participant Enrollment 1301 / 1300 (100.1%)

Introduction

This report was modified for {gsm.simaerep}

Study Overview

69 Red KRIs
106 Amber KRIs

Summary Charts

Site Overview

As of 2025-11-04, AA-AA-000-0000 has 1301 participants enrolled across 176 sites. 175 Site-KRI combinations have been flagged across 81 sites as shown in the Study Overview Table above.
  • 38 sites have at least one red KRI
  • 81 sites have at least one red or amber KRI
  • 95 sites have neither red nor amber KRIs

Results

Adverse Event Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X024 (Rinard) 7 74 140 0.53 1.00
0X027 (Owens) 10 93 210 0.44 1.00
0X159 (Flores) 33 397 695 0.57 1.00
0X003 (Drake) 13 4 276 0.01 -1.00
0X080 (el-Mousa) 17 18 390 0.05 -1.00
0X124 (Salas Dominguez) 27 35 596 0.06 -1.00
0X126 (Torres) 20 8 390 0.02 -1.00
0X153 (Voss) 28 25 597 0.04 -1.00
0X161 (Vangoey) 69 143 1442 0.10 -1.00
0X043 (Ford) 5 0 101 0.00 -1.00
0X059 (Foster) 15 14 312 0.04 -1.00
0X163 (el-Vaziri) 28 42 601 0.07 -1.00
0X180 (Tran) 12 12 261 0.05 -1.00
0X175 (Gonzalez) 16 129 366 0.35 1.00
0X125 (Pond) 10 11 230 0.05 -1.00
0X157 (Arellano) 9 6 188 0.03 -1.00
0X026 (el-Samra) 15 18 314 0.06 -1.00
0X106 (Hill) 5 1 107 0.01 -1.00
0X122 (el-Salameh) 17 23 352 0.07 -1.00
0X054 (Vargas Padilla) 2 33 47 0.70 1.00
0X041 (Yazzie) 3 37 66 0.56 0.99
0X164 (Jiron) 4 0 80 0.00 -0.99
0X014 (Som) 25 150 533 0.28 0.99
0X160 (Liggett) 4 0 65 0.00 -0.99
0X169 (Kanack) 3 42 75 0.56 0.99
0X016 (el-Shaker) 7 7 161 0.04 -0.99
0X129 (Martinez) 10 18 240 0.07 -0.99
0X188 (Jenkins) 7 58 158 0.37 0.99
0X035 (el-Saladin) 22 130 470 0.28 0.99
0X100 (Browne) 7 11 169 0.07 -0.98
0X178 (Kessenich) 11 12 221 0.05 -0.98
0X090 (el-Attar) 1 17 16 1.06 0.98
0X006 (al-Sultana) 4 34 82 0.41 0.98
0X063 (Pinto) 7 56 155 0.36 0.98
0X154 (Cloud) 23 138 544 0.25 0.98
0X119 (Cousins) 5 4 107 0.04 -0.97
X187X (al-Hasen) 8 9 165 0.05 -0.97
0X069 (Ello) 4 4 96 0.04 -0.97
0X132 (Choi) 5 38 105 0.36 0.97
0X020 (Hamlin) 5 6 114 0.05 -0.97
0X088 (Correa) 11 19 232 0.08 -0.97
0X116 (el-Ameen) 7 8 143 0.06 -0.97
0X057 (Aragon) 6 43 130 0.33 0.96
0X013 (el-Allam) 6 8 136 0.06 -0.95
0X068 (al-Sesay) 2 0 41 0.00 -0.95


Serious Adverse Event Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 10 84 0.12 1.00
0X161 (Vangoey) 69 14 1442 0.01 1.00
0X124 (Salas Dominguez) 27 8 596 0.01 0.99
0X052 (Agenar) 58 11 1284 0.01 0.97
0X090 (el-Attar) 1 1 16 0.06 0.97
0X021 (Lee) 4 3 109 0.03 0.97
0X131 (Tran) 1 1 16 0.06 0.96
0X143 (el-Salih) 8 4 192 0.02 0.96
0X167 (al-Koroma) 43 8 920 0.01 0.95
0X091 (Ostrom) 20 6 448 0.01 0.95


Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X027 (Owens) 10 74 210 0.35 1.00
0X142 (Garnett) 5 36 110 0.33 1.00
0X155 (al-Sani) 4 49 81 0.60 1.00
0X014 (Som) 25 0 533 0.00 -1.00
0X087 (Vigo) 27 0 620 0.00 -1.00
0X030 (Hutchinson) 2 21 48 0.44 1.00
0X174 (Broughton) 3 21 64 0.33 1.00
0X066 (Lipps) 1 13 23 0.57 1.00
0X123 (Martinez) 5 25 100 0.25 0.99
0X033 (Taylor) 1 12 21 0.57 0.99
0X082 (Ramirez) 8 26 170 0.15 0.99
0X026 (el-Samra) 15 40 314 0.13 0.99
0X126 (Torres) 20 1 390 0.00 -0.99
0X047 (Ruvalcaba) 1 10 20 0.50 0.99
0X143 (el-Salih) 8 27 192 0.14 0.99
0X104 (James) 12 33 263 0.13 0.99
0X065 (Hill) 36 9 768 0.01 -0.98
0X039 (Kimler) 5 17 97 0.18 0.98
0X012 (Mansfield) 5 19 103 0.18 0.98
0X156 (Ashcroft-Bitsilly) 9 26 201 0.13 0.98
0X045 (Horton) 4 18 92 0.20 0.98
0X081 (Hendee) 4 17 82 0.21 0.97
0X041 (Yazzie) 3 14 66 0.21 0.97
0X077 (Gonzalez) 8 21 143 0.15 0.97
0X124 (Salas Dominguez) 27 55 596 0.09 0.97
0X154 (Cloud) 23 48 544 0.09 0.97
0X091 (Ostrom) 20 2 448 0.00 -0.96
0X131 (Tran) 1 7 16 0.44 0.96
X067X (Zamora) 1 9 20 0.45 0.96
0X076 (Farr) 17 3 386 0.01 -0.96
0X167 (al-Koroma) 43 18 920 0.02 -0.96
0X127 (Pascual) 4 15 89 0.17 0.96
0X063 (Pinto) 7 19 155 0.12 0.95


Important Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X027 (Owens) 10 8 210 0.04 1.00
0X063 (Pinto) 7 7 155 0.05 1.00
0X124 (Salas Dominguez) 27 13 596 0.02 1.00
0X155 (al-Sani) 4 4 81 0.05 0.99
0X142 (Garnett) 5 4 110 0.04 0.99
0X097 (Thompson) 5 4 114 0.04 0.98
0X121 (Rodriguez-Cruz) 1 2 17 0.12 0.98
0X066 (Lipps) 1 2 23 0.09 0.98
0X157 (Arellano) 9 4 188 0.02 0.97
0X030 (Hutchinson) 2 2 48 0.04 0.96
0X082 (Ramirez) 8 4 170 0.02 0.95
0X123 (Martinez) 5 3 100 0.03 0.95


Adverse Event Rate ZScore

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X159 (Flores) 33 400 697 0.57 6.62
0X027 (Owens) 10 114 210 0.54 3.35
0X024 (Rinard) 7 83 140 0.59 3.11
0X054 (Vargas Padilla) 2 35 47 0.74 2.45
0X090 (el-Attar) 1 17 16 1.06 2.22
0X175 (Gonzalez) 16 129 366 0.35 2.15
0X041 (Yazzie) 3 39 66 0.59 2.12
0X169 (Kanack) 3 42 75 0.56 2.10
0X153 (Voss) 28 25 597 0.04 -2.00
0X126 (Torres) 20 8 390 0.02 -1.88
0X124 (Salas Dominguez) 27 36 597 0.06 -1.72
0X161 (Vangoey) 69 148 1443 0.10 -1.67
0X003 (Drake) 13 5 276 0.02 -1.61
0X163 (el-Vaziri) 28 42 601 0.07 -1.58
0X080 (el-Mousa) 17 19 390 0.05 -1.53
0X026 (el-Samra) 15 18 314 0.06 -1.28
0X180 (Tran) 12 13 261 0.05 -1.24
0X122 (el-Salameh) 17 24 352 0.07 -1.23
0X157 (Arellano) 9 6 188 0.03 -1.21
0X125 (Pond) 10 11 230 0.05 -1.18
0X178 (Kessenich) 11 12 222 0.05 -1.11
0X043 (Ford) 5 0 102 0.00 -1.09
0X106 (Hill) 5 1 107 0.01 -1.06
0X016 (el-Shaker) 7 7 161 0.04 -1.03


Adverse Event Rate MultCorr

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X024 (Rinard) 7 74 140 0.53 1.00
0X027 (Owens) 10 93 210 0.44 1.00
0X159 (Flores) 33 397 695 0.57 1.00
0X003 (Drake) 13 4 276 0.01 -1.00
0X043 (Ford) 5 0 101 0.00 -1.00
0X059 (Foster) 15 14 312 0.04 -1.00
0X080 (el-Mousa) 17 18 390 0.05 -1.00
0X124 (Salas Dominguez) 27 35 596 0.06 -1.00
0X126 (Torres) 20 8 390 0.02 -1.00
0X153 (Voss) 28 25 597 0.04 -1.00
0X106 (Hill) 5 1 107 0.01 -0.98
0X161 (Vangoey) 69 143 1442 0.10 -0.98
0X163 (el-Vaziri) 28 42 601 0.07 -0.98
0X164 (Jiron) 4 0 80 0.00 -0.98
0X157 (Arellano) 9 6 188 0.03 -0.97
0X180 (Tran) 12 12 261 0.05 -0.97
0X026 (el-Samra) 15 18 314 0.06 -0.96
0X125 (Pond) 10 11 230 0.05 -0.96
0X175 (Gonzalez) 16 129 366 0.35 0.96
0X016 (el-Shaker) 7 7 161 0.04 -0.93
0X122 (el-Salameh) 17 23 352 0.07 -0.93
0X178 (Kessenich) 11 12 221 0.05 -0.88
0X160 (Liggett) 4 0 65 0.00 -0.88
0X054 (Vargas Padilla) 2 33 47 0.70 0.86
0X014 (Som) 25 150 533 0.28 0.85
0X041 (Yazzie) 3 37 66 0.56 0.85
0X090 (el-Attar) 1 17 16 1.06 0.85
0X035 (el-Saladin) 22 130 470 0.28 0.81
0X169 (Kanack) 3 42 75 0.56 0.81
0X188 (Jenkins) 7 58 158 0.37 0.81
0X129 (Martinez) 10 18 240 0.07 -0.81
X187X (al-Hasen) 8 9 165 0.05 -0.81
0X020 (Hamlin) 5 6 114 0.05 -0.80
0X100 (Browne) 7 11 169 0.07 -0.80
0X119 (Cousins) 5 4 107 0.04 -0.78
0X006 (al-Sultana) 4 34 82 0.41 0.77
0X063 (Pinto) 7 56 155 0.36 0.77
0X069 (Ello) 4 4 96 0.04 -0.75


Treatment Discontinuation Rate - ZScore

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 4 5 0.80 4.13
0X170 (Herlin) 4 3 4 0.75 3.43
0X011 (Gallegos) 5 3 5 0.60 2.95
0X152 (Batchelder) 7 3 7 0.43 2.29
0X077 (Gonzalez) 8 3 8 0.38 2.05


Treatment Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 4 102 0.04 1.00
0X170 (Herlin) 4 3 85 0.04 1.00
0X011 (Gallegos) 5 3 100 0.03 1.00
0X167 (al-Koroma) 43 1 889 0.00 -0.98
0X052 (Agenar) 58 2 1207 0.00 -0.98
0X037 (el-Mostafa) 3 2 62 0.03 0.98
0X093 (Depoyster) 28 0 594 0.00 -0.97
0X022 (al-Nawaz) 3 2 64 0.03 0.97


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model Score ExpectedNumerator AnalysisType Threshold nAccrualThreshold Priority Flag RiskScoreWeight AccrualThreshold AccrualMetric MetricID
Analysis kri0001 Site AE Adverse Event Rate Adverse Events Visits bootstrap-simaerep Over/Under-Reporting Probability Delta Expected AEs identity -0.99, -0.95, 0.95, 0.99 1 0 NA NA NA NA Analysis_kri0001
Analysis kri0002 Site SAE Serious Adverse Event Rate Serious Adverse Events Visits bootstrap-simaerep Over/Under-Reporting Probability Delta Expexted SAEs identity -0.99, -0.95, 0.95, 0.99 1 0 NA NA NA NA Analysis_kri0002
Analysis kri0003 Site PD Protocol Deviation Rate Protocol Deviations Visits bootstrap-simaerep Over/Under-Reporting Probability Delta Expected PDs identity -0.99, -0.95, 0.95, 0.99 1 0 NA NA NA NA Analysis_kri0003
Analysis kri0004 Site IPD Important Protocol Deviation Rate Important Protocol Deviations Visits bootstrap-simaerep Over/Under-Reporting Probability Expected IPDs identity -0.99, -0.95, 0.95, 0.99 1 0 NA NA NA NA Analysis_kri0004
Analysis kri0005 Site AE-ZScore Adverse Event Rate ZScore Adverse Events Visit Normal Approximation Adjusted Z-Score NA rate -2,-1,2,3 1 0 NA NA NA NA Analysis_kri0005
Analysis kri0006 Site AE Mult Adverse Event Rate MultCorr Adverse Events Visits bootstrap-simaerep Over/Under-Reporting Probability Delta Expected AEs identity -0.95, -0.75, 0.75, 0.95 1 0 NA NA NA NA Analysis_kri0006
Analysis kri0007 Site TDSC-ZScore Treatment Discontinuation Rate - ZScore Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation Adjusted Z-Score NA binary 2,3 NA 0 0,1,2 0,16,32 3 Numerator Analysis_kri0007
Analysis kri0008 Site TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Visits bootstrap-simaerep Over/Under-Reporting Probability Expected Discontinuations identity -0.99, -0.95, 0.95, 0.99 1 0 NA NA NA NA Analysis_kri0008