Name
psg_mndnbp2
Label
Minimum SaO2 (NREM, Back, 2% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 (NREM, Back, 2% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 300 92.1 ± 3.3 93.0 77.0 98.0 255 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 110 93.0 ± 2.7 93.0 80.0 97.0 181 291
Assigned treatment arm vs Minimum SaO2 (NREM, Back, 2% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 162 93.3 ± 2.1 94.0 82.0 98.0 168 330
Early Adenotonsillectomy 79 93.4 ± 1.8 93.0 89.0 97.0 88 167
Watchful Waiting with Supportive Care 83 93.3 ± 2.4 94.0 82.0 98.0 80 163
Assigned treatment arm vs Minimum SaO2 (NREM, Back, 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 (NREM, Back, 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 (NREM, Back, 2% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 110 93.0 ± 2.7 93.0 80.0 97.0 181 291
Early Adenotonsillectomy 56 93.1 ± 2.6 93.0 80.0 97.0 91 147
Watchful Waiting with Supportive Care 54 93.0 ± 2.8 93.5 81.0 97.0 90 144
Child's sex vs Minimum SaO2 (NREM, Back, 2% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 300 92.1 ± 3.3 93.0 77.0 98.0 255 555
Male 170 92.0 ± 3.4 93.0 80.0 98.0 116 286
Female 130 92.1 ± 3.2 93.0 77.0 97.0 139 269
Child's sex vs Minimum SaO2 (NREM, Back, 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 (NREM, Back, 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 (NREM, Back, 2% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 110 93.0 ± 2.7 93.0 80.0 97.0 181 291
Male 65 92.8 ± 3.1 93.0 80.0 97.0 80 145
Female 45 93.3 ± 1.9 94.0 88.0 96.0 101 146
Child's race vs Minimum SaO2 (NREM, Back, 2% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 300 92.1 ± 3.3 93.0 77.0 98.0 255 555
American Indian/Alaska Native 3 93.7 ± 1.5 94.0 92.0 95.0 - 3
Asian 8 92.9 ± 2.0 94.0 89.0 95.0 2 10
Native Hawaiian or Other Pacific Islander 1 87.0 - 87.0 87.0 87.0 - 1
Black or African American 76 92.1 ± 3.9 93.0 77.0 98.0 85 161
White 196 92.0 ± 3.2 93.0 80.0 97.0 155 351
More than one race 13 92.5 ± 1.9 92.0 90.0 96.0 12 25
Unknown or not reported 3 91.7 ± 3.5 92.0 88.0 95.0 1 4
Child's race vs Minimum SaO2 (NREM, Back, 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 (NREM, Back, 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 (NREM, Back, 2% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 110 93.0 ± 2.7 93.0 80.0 97.0 181 291
American Indian/Alaska Native 1 92.0 - 92.0 92.0 92.0 2 3
Asian 2 94.0 ± 1.4 94.0 93.0 95.0 2 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 22 93.2 ± 2.6 94.0 87.0 97.0 46 68
White 79 93.2 ± 2.4 93.0 81.0 97.0 124 203
More than one race 5 92.2 ± 2.0 92.0 89.0 94.0 7 12
Unknown or not reported 1 80.0 - 80.0 80.0 80.0 - 1