Study Status
Show Details
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
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
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
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
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
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
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
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
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
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
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
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
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
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