Name
psg_pctsa95h
Label
Percent sleep time SaO2 is below < 95%
Units
percent (%)
Type
numeric
PATS Visit timepoint vs Percent sleep time SaO2 is below < 95%
N Mean StdDev Median Min Max Unknown Total
Screening Visit 499 4.4 ± 12.6 0.2 0.0 100.0 56 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 232 1.6 ± 4.2 0.1 0.0 26.0 59 291
Assigned treatment arm vs Percent sleep time SaO2 is below < 95%
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 330 1.8 ± 6.9 0.1 0.0 87.0 - 330
Early Adenotonsillectomy 167 1.6 ± 5.1 0.1 0.0 45.0 - 167
Watchful Waiting with Supportive Care 163 1.9 ± 8.4 0.1 0.0 87.0 - 163
Assigned treatment arm vs Percent sleep time SaO2 is below < 95%
Baseline 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 Percent sleep time SaO2 is below < 95%
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 283 283
Early Adenotonsillectomy - - - - - - 140 140
Watchful Waiting with Supportive Care - - - - - - 143 143
Assigned treatment arm vs Percent sleep time SaO2 is below < 95%
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 1.6 ± 4.2 0.1 0.0 26.0 59 291
Early Adenotonsillectomy 117 1.3 ± 3.9 0.0 0.0 26.0 30 147
Watchful Waiting with Supportive Care 115 1.9 ± 4.5 0.1 0.0 25.0 29 144
Child's sex vs Percent sleep time SaO2 is below < 95%
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 4.4 ± 12.6 0.2 0.0 100.0 56 555
Male 258 4.9 ± 13.5 0.3 0.0 100.0 28 286
Female 241 3.8 ± 11.5 0.2 0.0 87.0 28 269
Child's sex vs Percent sleep time SaO2 is below < 95%
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 332 332
Male - - - - - - 162 162
Female - - - - - - 170 170
Child's sex vs Percent sleep time SaO2 is below < 95%
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 283 283
Male - - - - - - 137 137
Female - - - - - - 146 146
Child's sex vs Percent sleep time SaO2 is below < 95%
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 1.6 ± 4.2 0.1 0.0 26.0 59 291
Male 120 1.9 ± 4.9 0.1 0.0 26.0 25 145
Female 112 1.2 ± 3.2 0.05 0.0 16.0 34 146
Child's race vs Percent sleep time SaO2 is below < 95%
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 4.4 ± 12.6 0.2 0.0 100.0 56 555
American Indian/Alaska Native 3 1.9 ± 1.6 2.5 0.0 3.1 - 3
Asian 9 0.4 ± 0.6 0.1 0.0 1.4 1 10
Native Hawaiian or Other Pacific Islander 1 2.7 - 2.7 2.7 2.7 - 1
Black or African American 128 4.0 ± 9.0 0.3 0.0 59.0 33 161
White 332 4.7 ± 14.1 0.2 0.0 100.0 19 351
More than one race 23 3.9 ± 10.5 0.2 0.0 48.0 2 25
Unknown or not reported 3 1.9 ± 1.8 0.9 0.8 4.0 1 4
Child's race vs Percent sleep time SaO2 is below < 95%
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 332 332
American Indian/Alaska Native - - - - - - 3 3
Asian - - - - - - 6 6
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American - - - - - - 73 73
White - - - - - - 235 235
More than one race - - - - - - 14 14
Unknown or not reported - - - - - - 1 1
Child's race vs Percent sleep time SaO2 is below < 95%
Month-6 Interim Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 283 283
American Indian/Alaska Native - - - - - - 3 3
Asian - - - - - - 4 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American - - - - - - 64 64
White - - - - - - 200 200
More than one race - - - - - - 12 12
Unknown or not reported - - - - - - - -
Child's race vs Percent sleep time SaO2 is below < 95%
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 1.6 ± 4.2 0.1 0.0 26.0 59 291
American Indian/Alaska Native 3 17.0 ± 14.7 25.0 0.0 26.0 - 3
Asian 4 2.4 ± 4.7 0.1 0.0 9.4 - 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 56 0.9 ± 2.8 0.0 0.0 17.0 12 68
White 156 1.5 ± 3.8 0.1 0.0 21.0 47 203
More than one race 12 1.5 ± 3.5 0.05 0.0 12.0 - 12
Unknown or not reported 1 0.4 - 0.4 0.4 0.4 - 1