Name
psg_mndroa4
Label
Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 291 89.5 ± 5.5 91.0 61.0 97.0 264 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 89 91.4 ± 3.7 93.0 79.0 97.0 202 291
Assigned treatment arm vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 162 91.7 ± 3.0 92.5 77.0 97.0 168 330
Early Adenotonsillectomy 71 91.4 ± 3.3 92.0 77.0 96.0 96 167
Watchful Waiting with Supportive Care 91 92.0 ± 2.7 93.0 82.0 97.0 72 163
Assigned treatment arm vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
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 Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
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 Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 89 91.4 ± 3.7 93.0 79.0 97.0 202 291
Early Adenotonsillectomy 37 92.7 ± 3.0 93.0 80.0 96.0 110 147
Watchful Waiting with Supportive Care 52 90.6 ± 3.9 92.0 79.0 97.0 92 144
Child's sex vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 291 89.5 ± 5.5 91.0 61.0 97.0 264 555
Male 146 89.5 ± 5.3 91.0 63.0 97.0 140 286
Female 145 89.6 ± 5.7 91.0 61.0 96.0 124 269
Child's sex vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 332 332
Male - - - - - - 162 162
Female - - - - - - 170 170
Child's sex vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
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 Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 89 91.4 ± 3.7 93.0 79.0 97.0 202 291
Male 37 91.2 ± 4.2 92.0 79.0 96.0 108 145
Female 52 91.6 ± 3.4 93.0 80.0 97.0 94 146
Child's race vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 291 89.5 ± 5.5 91.0 61.0 97.0 264 555
American Indian/Alaska Native - - - - - - 3 3
Asian 3 92.0 ± 2.0 92.0 90.0 94.0 7 10
Native Hawaiian or Other Pacific Islander 1 92.0 - 92.0 92.0 92.0 - 1
Black or African American 84 88.4 ± 7.2 91.0 61.0 96.0 77 161
White 187 90.1 ± 4.4 91.0 67.0 97.0 164 351
More than one race 13 88.6 ± 4.5 90.0 79.0 94.0 12 25
Unknown or not reported 3 82.7 ± 5.1 84.0 77.0 87.0 1 4
Child's race vs Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
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 Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
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 Minimum SaO2 with arousals (REM, Other, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 89 91.4 ± 3.7 93.0 79.0 97.0 202 291
American Indian/Alaska Native - - - - - - 3 3
Asian - - - - - - 4 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 24 91.6 ± 3.7 92.0 85.0 97.0 44 68
White 61 91.4 ± 3.8 93.0 79.0 96.0 142 203
More than one race 4 91.3 ± 3.6 92.5 86.0 94.0 8 12
Unknown or not reported - - - - - - 1 1