Study Status

Nickname Protocol Nickname
Study Status Active

Study Overview

9 Red KRIs
116 Amber KRIs

Summary Charts

Group Overview

As of 2012-12-31, AA-AA-000-0000 has 50 participants enrolled across 154 sites. 125 Site-KRI combinations have been flagged across 89 sites as shown in the Study Overview Table above.
  • 8 sites have at least one red KRI
  • 89 sites have at least one red or amber KRI
  • 65 sites have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X036 (Gonzales) 2 327 6619 0.05 -2.25
0X052 (Agenar) 3 378 7502 0.05 -2.04
0X045 (Horton) 4 383 6013 0.06 2.49
X187X (al-Hasen) 4 521 8423 0.06 2.24
0X027 (Owens) 1 113 1652 0.07 2.11
0X024 (Rinard) 4 491 8002 0.06 2.00
0X004 (Touch) 3 360 7137 0.05 -1.97
0X096 (el-Agha) 4 274 5510 0.05 -1.95
0X057 (Aragon) 1 33 823 0.04 -1.91
0X066 (Lipps) 2 187 3792 0.05 -1.73
0X115 (John) 3 266 5249 0.05 -1.62
0X165 (Pinar) 1 73 1569 0.05 -1.57
0X034 (Yeadon) 2 222 4392 0.05 -1.52
0X179 (Terry) 3 339 6552 0.05 -1.45
0X090 (el-Attar) 4 302 5850 0.05 -1.40
0X166 (Garcia) 5 484 9192 0.05 -1.35
0X123 (Martinez) 1 66 1391 0.05 -1.34
0X143 (el-Salih) 1 66 1391 0.05 -1.34
0X170 (Herlin) 1 66 1391 0.05 -1.34
0X135 (Hager) 2 193 3793 0.05 -1.32
0X029 (Truong) 3 202 3960 0.05 -1.32
0X013 (el-Allam) 2 153 3027 0.05 -1.26
0X177 (Crowe) 3 136 2694 0.05 -1.20
0X042 (el-Massoud) 3 265 5092 0.05 -1.19
0X134 (Keese) 1 111 2219 0.05 -1.18
0X095 (Gonzales) 3 274 5257 0.05 -1.18
0X159 (Flores) 2 193 3743 0.05 -1.14
0X110 (Cleckley) 2 188 3628 0.05 -1.06
0X030 (Hutchinson) 2 111 2191 0.05 -1.05
0X010 (al-Radi) 1 52 1070 0.05 -1.01
0X103 (al-Mona) 3 226 4317 0.05 -1.01
0X121 (Rodriguez-Cruz) 1 73 1467 0.05 -1.00
KRI Score
KRI Metric
Numerator


Serious Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X052 (Agenar) 3 178 7502 0.02 -2.36
0X177 (Crowe) 3 57 2694 0.02 -2.19
0X147 (Lamping) 1 63 1585 0.04 2.62
0X004 (Touch) 3 176 7137 0.02 -1.85
0X036 (Gonzales) 2 163 6619 0.02 -1.80
0X144 (el-Kaber) 3 141 5783 0.02 -1.79
0X096 (el-Agha) 4 134 5510 0.02 -1.77
0X149 (Lesley) 4 206 8218 0.03 -1.77
0X188 (Jenkins) 4 185 7427 0.02 -1.76
0X010 (al-Radi) 1 21 1070 0.02 -1.67
0X115 (John) 3 129 5249 0.02 -1.62
0X165 (Pinar) 1 34 1569 0.02 -1.56
0X166 (Garcia) 5 236 9192 0.03 -1.53
0X179 (Terry) 3 165 6552 0.03 -1.52
0X057 (Aragon) 1 16 823 0.02 -1.50
0X095 (Gonzales) 3 131 5257 0.02 -1.48
0X042 (el-Massoud) 3 127 5092 0.02 -1.44
0X134 (Keese) 1 52 2219 0.02 -1.37
0X051 (al-Miah) 3 118 4708 0.03 -1.34
0X047 (Ruvalcaba) 2 65 2707 0.02 -1.33
0X097 (Thompson) 1 32 1405 0.02 -1.23
0X116 (el-Ameen) 2 62 2551 0.02 -1.21
0X154 (Cloud) 2 91 3631 0.03 -1.18
0X050 (Tull) 3 117 4597 0.03 -1.17
0X137 (Wilson) 2 46 1907 0.02 -1.09
0X138 (Black) 1 38 1597 0.02 -1.08
X044X (Anderson) 2 77 3064 0.03 -1.06
0X123 (Martinez) 1 33 1391 0.02 -1.02
0X143 (el-Salih) 1 33 1391 0.02 -1.02
0X170 (Herlin) 1 33 1391 0.02 -1.02
KRI Score
KRI Metric
Numerator


Non-Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X050 (Tull) 3 141 4597 0.03 -2.74
0X138 (Black) 1 43 1597 0.03 -2.11
0X144 (el-Kaber) 3 296 5783 0.05 2.09
KRI Score
KRI Metric
Numerator


Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X036 (Gonzales) 2 334 6619 0.05 2.22
0X096 (el-Agha) 4 186 5510 0.03 -2.18
0X034 (Yeadon) 2 228 4392 0.05 2.14
0X133 (Pope) 1 120 2149 0.06 2.11
X067X (Zamora) 1 120 2149 0.06 2.11
KRI Score
KRI Metric
Numerator


Grade 3+ Lab Abnormality Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X038 (Culhane) 2 39 1586 0.02 2.61
0X031 (Garrison) 1 27 1034 0.03 2.45
0X101 (Flood) 1 27 1034 0.03 2.45
0X130 (Burroughs-Chock) 2 47 2086 0.02 2.33
0X190 (Longwolf) 2 47 2086 0.02 2.33
0X113 (Wilde) 5 35 3411 0.01 -2.08
0X088 (Correa) 3 35 3376 0.01 -2.03
KRI Score
KRI Metric
Numerator


Study Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X093 (Depoyster) 6 51 54 0.94 3.08
0X012 (Mansfield) 2 20 17 1.18 2.84
0X127 (Pascual) 1 15 12 1.25 2.68
0X130 (Burroughs-Chock) 2 25 24 1.04 2.61
0X190 (Longwolf) 2 25 24 1.04 2.61
0X102 (Solis) 4 37 43 0.86 2.11
0X161 (Vangoey) 4 11 38 0.29 -2.10
KRI Score
KRI Metric
Numerator


Treatment Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X040 (Porter) 1 8 7 1.14 2.96
0X178 (Kessenich) 1 8 7 1.14 2.96
0X120 (Strock) 3 18 24 0.75 2.58
0X141 (Esquibel) 3 19 28 0.68 2.22
0X151 (Poveromo) 5 6 37 0.16 -2.20
0X108 (Keys) 2 2 21 0.10 -2.12
0X103 (al-Mona) 3 2 20 0.10 -2.03
KRI Score
KRI Metric
Numerator


Query Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X138 (Black) 1 2312 18736 0.12 3.10
0X164 (Jiron) 2 7701 70698 0.11 2.38
0X105 (Patalan) 3 6312 57616 0.11 2.29
KRI Score
KRI Metric
Numerator


Outstanding Query Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X147 (Lamping) 1 88 1832 0.05 3.09
0X155 (al-Sani) 4 145 16188 0.01 -2.50
0X174 (Broughton) 2 116 3295 0.04 2.42
0X072 (Lopez) 2 72 9552 0.01 -2.24
0X075 (Dabit) 2 116 3540 0.03 2.16
0X074 (Moran) 3 188 6609 0.03 2.13
0X045 (Horton) 4 232 8754 0.03 2.02
0X062 (Davis Jr) 1 24 4812 0.00 -2.01
0X026 (el-Samra) 4 319 12847 0.02 2.01
KRI Score
KRI Metric
Numerator


Outstanding Data Entry Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X164 (Jiron) 2 349566 7105953 0.05 -3.01
0X117 (Guevara) 1 105570 2165625 0.05 -2.54
0X118 (el-Dia) 1 105570 2165625 0.05 -2.54
0X049 (Mccracken) 2 350130 7086957 0.05 -2.25
0X087 (Vigo) 3 320950 6492555 0.05 -2.06
0X151 (Poveromo) 5 594477 11985250 0.05 -2.02
KRI Score
KRI Metric
Numerator


Data Change Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X157 (Arellano) 3 27997 113268 0.25 -2.71
0X022 (al-Nawaz) 4 40460 162101 0.25 -2.60
0X081 (Hendee) 2 15796 64287 0.25 -2.29
0X153 (Voss) 3 19047 70114 0.27 2.19
0X105 (Patalan) 3 14156 57616 0.25 -2.17
0X126 (Torres) 1 12265 44737 0.27 2.10
0X018 (Bocanegra) 2 8597 31040 0.28 2.08
0X055 (Jung) 2 16006 64777 0.25 -2.07
KRI Score
KRI Metric
Numerator


Screen Failure Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X057 (Aragon) 1 6 286 0.02 3.48
0X054 (Vargas Padilla) 2 7 447 0.02 2.97
0X052 (Agenar) 3 21 2315 0.01 2.85
0X010 (al-Radi) 1 6 396 0.02 2.67
0X063 (Pinto) 2 8 686 0.01 2.39
0X048 (Friedrich) 1 6 465 0.01 2.30
0X006 (al-Sultana) 1 3 163 0.02 2.22
0X121 (Rodriguez-Cruz) 1 6 516 0.01 2.06
KRI Score
KRI Metric
Numerator


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold nMinDenominator Priority Output Name Description MetricID
Analysis kri0001 Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 0 NA NA 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 0 NA NA 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 0 NA NA NA Analysis_kri0003
Analysis kri0004 Site PD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 0 NA NA 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 0 NA NA 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 0 NA NA 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 0 NA NA NA Analysis_kri0007
Analysis kri0008 Site QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_kri0008
Analysis kri0009 Site OQRY Outstanding Query Rate Queries Open > 30 Days Total Queries Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_kri0009
Analysis kri0010 Site ODAT Outstanding Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_kri0010
Analysis kri0011 Site CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 NA NA 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 0 NA NA NA Analysis_kri0012