Name
psg_mndnba5
Label
Minimum SaO2 with arousals (NREM, Back, 5% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 with arousals (NREM, Back, 5% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 221 91.6 ± 3.6 92.0 77.0 98.0 334 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 59 92.8 ± 3.6 93.0 80.0 98.0 232 291
Assigned treatment arm vs Minimum SaO2 with arousals (NREM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 104 93.2 ± 2.4 93.0 82.0 98.0 226 330
Early Adenotonsillectomy 53 93.3 ± 2.1 93.0 89.0 97.0 114 167
Watchful Waiting with Supportive Care 51 93.1 ± 2.8 93.0 82.0 98.0 112 163
Assigned treatment arm vs Minimum SaO2 with arousals (NREM, Back, 5% 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 (NREM, Back, 5% 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 (NREM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 59 92.8 ± 3.6 93.0 80.0 98.0 232 291
Early Adenotonsillectomy 29 92.8 ± 3.5 93.0 80.0 97.0 118 147
Watchful Waiting with Supportive Care 30 92.7 ± 3.7 93.5 81.0 98.0 114 144
Child's sex vs Minimum SaO2 with arousals (NREM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 221 91.6 ± 3.6 92.0 77.0 98.0 334 555
Male 120 91.5 ± 3.8 92.0 80.0 98.0 166 286
Female 101 91.8 ± 3.5 92.0 77.0 97.0 168 269
Child's sex vs Minimum SaO2 with arousals (NREM, Back, 5% 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 (NREM, Back, 5% 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 (NREM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 59 92.8 ± 3.6 93.0 80.0 98.0 232 291
Male 36 92.4 ± 4.1 93.0 80.0 98.0 109 145
Female 23 93.4 ± 2.5 94.0 88.0 97.0 123 146
Child's race vs Minimum SaO2 with arousals (NREM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 221 91.6 ± 3.6 92.0 77.0 98.0 334 555
American Indian/Alaska Native 1 92.0 - 92.0 92.0 92.0 2 3
Asian 6 92.7 ± 2.2 93.0 89.0 95.0 4 10
Native Hawaiian or Other Pacific Islander 1 87.0 - 87.0 87.0 87.0 - 1
Black or African American 61 91.8 ± 4.3 93.0 77.0 98.0 100 161
White 140 91.6 ± 3.5 92.0 80.0 97.0 211 351
More than one race 11 92.4 ± 2.0 92.0 90.0 96.0 14 25
Unknown or not reported 1 88.0 - 88.0 88.0 88.0 3 4
Child's race vs Minimum SaO2 with arousals (NREM, Back, 5% 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 (NREM, Back, 5% 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 (NREM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 59 92.8 ± 3.6 93.0 80.0 98.0 232 291
American Indian/Alaska Native 1 92.0 - 92.0 92.0 92.0 2 3
Asian 1 95.0 - 95.0 95.0 95.0 3 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 12 93.4 ± 3.7 94.5 87.0 98.0 56 68
White 42 93.0 ± 3.1 93.0 81.0 97.0 161 203
More than one race 2 90.5 ± 2.1 90.5 89.0 92.0 10 12
Unknown or not reported 1 80.0 - 80.0 80.0 80.0 - 1