Name
avgfragmentationindex_we
Label
[Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Units
percent (%)
Type
numeric
PATS Visit timepoint vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit - - - - - - 555 555
Baseline Visit 215 12.0 ± 4.5 11.6 0.0 24.3 117 332
Month-6 Interim Visit 143 12.1 ± 4.7 11.4 3.9 29.2 140 283
Month-12 Endpoint Visit 112 12.9 ± 5.2 11.8 1.4 30.0 179 291
Assigned treatment arm vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 330 330
Early Adenotonsillectomy - - - - - - 167 167
Watchful Waiting with Supportive Care - - - - - - 163 163
Assigned treatment arm vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total 215 12.0 ± 4.5 11.6 0.0 24.3 115 330
Early Adenotonsillectomy 111 12.4 ± 4.7 11.9 0.0 24.3 56 167
Watchful Waiting with Supportive Care 104 11.7 ± 4.3 11.5 1.3 21.5 59 163
Assigned treatment arm vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total 143 12.1 ± 4.7 11.4 3.9 29.2 140 283
Early Adenotonsillectomy 74 11.8 ± 4.3 11.3 4.5 23.2 66 140
Watchful Waiting with Supportive Care 69 12.4 ± 5.1 11.6 3.9 29.2 74 143
Assigned treatment arm vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 112 12.9 ± 5.2 11.8 1.4 30.0 179 291
Early Adenotonsillectomy 53 13.9 ± 5.3 12.8 1.4 24.1 94 147
Watchful Waiting with Supportive Care 59 12.0 ± 4.9 11.3 3.9 30.0 85 144
Child's sex vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 555 555
Male - - - - - - 286 286
Female - - - - - - 269 269
Child's sex vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total 215 12.0 ± 4.5 11.6 0.0 24.3 117 332
Male 108 12.5 ± 4.5 11.8 1.3 24.3 54 162
Female 107 11.6 ± 4.4 11.0 0.0 22.9 63 170
Child's sex vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total 143 12.1 ± 4.7 11.4 3.9 29.2 140 283
Male 72 12.4 ± 4.4 11.9 3.9 28.1 65 137
Female 71 11.8 ± 5.0 11.0 4.5 29.2 75 146
Child's sex vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 112 12.9 ± 5.2 11.8 1.4 30.0 179 291
Male 60 12.9 ± 5.1 11.8 1.4 22.9 85 145
Female 52 12.9 ± 5.2 11.9 4.2 30.0 94 146
Child's race vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 555 555
American Indian/Alaska Native - - - - - - 3 3
Asian - - - - - - 10 10
Native Hawaiian or Other Pacific Islander - - - - - - 1 1
Black or African American - - - - - - 161 161
White - - - - - - 351 351
More than one race - - - - - - 25 25
Unknown or not reported - - - - - - 4 4
Child's race vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total 215 12.0 ± 4.5 11.6 0.0 24.3 117 332
American Indian/Alaska Native 2 11.1 ± 0.5 11.1 10.8 11.4 1 3
Asian 3 11.4 ± 6.6 8.8 6.4 18.9 3 6
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 53 11.7 ± 4.0 11.7 1.3 21.5 20 73
White 143 12.3 ± 4.8 11.6 0.0 24.3 92 235
More than one race 13 10.8 ± 2.9 10.6 6.2 16.0 1 14
Unknown or not reported 1 13.6 - 13.6 13.6 13.6 - 1
Child's race vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total 143 12.1 ± 4.7 11.4 3.9 29.2 140 283
American Indian/Alaska Native 2 8.8 ± 0.9 8.8 8.1 9.5 1 3
Asian 1 18.9 - 18.9 18.9 18.9 3 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 34 12.1 ± 4.1 11.7 6.1 23.5 30 64
White 96 12.2 ± 4.9 11.3 3.9 29.2 104 200
More than one race 10 11.1 ± 4.9 10.0 6.6 22.8 2 12
Unknown or not reported - - - - - - - -
Child's race vs [Main Sleep] Average fragmentation index per main sleep (on weekend days) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 112 12.9 ± 5.2 11.8 1.4 30.0 179 291
American Indian/Alaska Native 2 14.4 ± 6.0 14.4 10.2 18.7 1 3
Asian 2 11.6 ± 4.1 11.6 8.8 14.5 2 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 24 12.4 ± 6.3 10.8 3.9 30.0 44 68
White 75 13.3 ± 4.8 12.1 5.0 24.1 128 203
More than one race 9 10.9 ± 5.4 9.7 1.4 19.7 3 12
Unknown or not reported - - - - - - 1 1