Name
psg_mndroa2
Label
Minimum SaO2 with arousals (REM, Other, 2% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 with arousals (REM, Other, 2% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 358 90.4 ± 5.3 92.0 61.0 97.0 197 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 120 92.2 ± 3.5 93.0 79.0 97.0 171 291
Assigned treatment arm vs Minimum SaO2 with arousals (REM, Other, 2% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 213 92.2 ± 2.9 93.0 77.0 96.0 117 330
Early Adenotonsillectomy 98 92.0 ± 3.1 93.0 77.0 96.0 69 167
Watchful Waiting with Supportive Care 115 92.5 ± 2.6 93.0 82.0 96.0 48 163
Assigned treatment arm vs Minimum SaO2 with arousals (REM, Other, 2% 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, 2% 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, 2% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 120 92.2 ± 3.5 93.0 79.0 97.0 171 291
Early Adenotonsillectomy 51 93.2 ± 2.8 94.0 80.0 96.0 96 147
Watchful Waiting with Supportive Care 69 91.5 ± 3.8 93.0 79.0 97.0 75 144
Child's sex vs Minimum SaO2 with arousals (REM, Other, 2% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 358 90.4 ± 5.3 92.0 61.0 97.0 197 555
Male 182 90.4 ± 5.1 92.0 63.0 96.0 104 286
Female 176 90.4 ± 5.4 92.0 61.0 97.0 93 269
Child's sex vs Minimum SaO2 with arousals (REM, Other, 2% 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, 2% 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, 2% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 120 92.2 ± 3.5 93.0 79.0 97.0 171 291
Male 57 92.3 ± 3.8 94.0 79.0 96.0 88 145
Female 63 92.1 ± 3.4 93.0 80.0 97.0 83 146
Child's race vs Minimum SaO2 with arousals (REM, Other, 2% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 358 90.4 ± 5.3 92.0 61.0 97.0 197 555
American Indian/Alaska Native 1 95.0 - 95.0 95.0 95.0 2 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 95 89.1 ± 7.0 92.0 61.0 96.0 66 161
White 237 90.9 ± 4.3 92.0 67.0 97.0 114 351
More than one race 18 90.1 ± 4.5 91.0 79.0 95.0 7 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, 2% 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, 2% 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, 2% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 120 92.2 ± 3.5 93.0 79.0 97.0 171 291
American Indian/Alaska Native 1 94.0 - 94.0 94.0 94.0 2 3
Asian 2 94.5 ± 0.7 94.5 94.0 95.0 2 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 29 92.1 ± 3.7 93.0 85.0 97.0 39 68
White 83 92.2 ± 3.6 93.0 79.0 96.0 120 203
More than one race 5 91.2 ± 3.7 92.0 86.0 95.0 7 12
Unknown or not reported - - - - - - 1 1