Name
psg_pctsa95
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 8.5 ± 17.9 0.7 0.0 99.9 56 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 232 5.5 ± 13.1 0.3 0.0 67.3 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 5.1 ± 12.6 0.3 0.0 95.3 - 330
Early Adenotonsillectomy 167 5.3 ± 12.4 0.4 0.0 67.0 - 167
Watchful Waiting with Supportive Care 163 4.8 ± 12.8 0.3 0.0 95.3 - 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 5.5 ± 13.1 0.3 0.0 67.3 59 291
Early Adenotonsillectomy 117 4.7 ± 12.7 0.2 0.0 67.3 30 147
Watchful Waiting with Supportive Care 115 6.4 ± 13.5 0.5 0.0 64.6 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 8.5 ± 17.9 0.7 0.0 99.9 56 555
Male 258 8.5 ± 18.1 0.8 0.0 99.9 28 286
Female 241 8.5 ± 17.7 0.5 0.0 97.0 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 5.5 ± 13.1 0.3 0.0 67.3 59 291
Male 120 6.0 ± 13.4 0.3 0.0 64.6 25 145
Female 112 5.0 ± 12.7 0.3 0.0 67.3 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 8.5 ± 17.9 0.7 0.0 99.9 56 555
American Indian/Alaska Native 3 7.1 ± 6.2 9.1 0.1 12.0 - 3
Asian 9 1.0 ± 1.1 0.8 0.0 3.3 1 10
Native Hawaiian or Other Pacific Islander 1 5.0 - 5.0 5.0 5.0 - 1
Black or African American 128 7.8 ± 14.4 0.9 0.0 88.6 33 161
White 332 9.2 ± 19.5 0.6 0.0 99.9 19 351
More than one race 23 7.0 ± 17.3 0.7 0.0 77.7 2 25
Unknown or not reported 3 3.5 ± 4.0 1.2 1.2 8.2 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 5.5 ± 13.1 0.3 0.0 67.3 59 291
American Indian/Alaska Native 3 38.9 ± 34.2 52.1 0.1 64.6 - 3
Asian 4 2.6 ± 4.6 0.5 0.0 9.4 - 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 56 1.9 ± 5.4 0.2 0.0 31.9 12 68
White 156 6.5 ± 14.1 0.4 0.0 67.3 47 203
More than one race 12 3.3 ± 6.8 0.3 0.0 23.2 - 12
Unknown or not reported 1 0.6 - 0.6 0.6 0.6 - 1