Name
psg_mndnbp4
Label
Minimum SaO2 (NREM, Back, 4% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 (NREM, Back, 4% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 201 90.9 ± 3.3 92.0 77.0 96.0 354 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 60 92.0 ± 3.1 92.5 80.0 96.0 231 291
Assigned treatment arm vs Minimum SaO2 (NREM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 86 92.3 ± 2.1 92.0 82.0 96.0 244 330
Early Adenotonsillectomy 42 92.6 ± 1.7 93.0 89.0 96.0 125 167
Watchful Waiting with Supportive Care 44 91.9 ± 2.4 92.0 82.0 95.0 119 163
Assigned treatment arm vs Minimum SaO2 (NREM, Back, 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 (NREM, Back, 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 (NREM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 60 92.0 ± 3.1 92.5 80.0 96.0 231 291
Early Adenotonsillectomy 34 92.3 ± 2.9 93.0 80.0 95.0 113 147
Watchful Waiting with Supportive Care 26 91.5 ± 3.3 92.0 81.0 96.0 118 144
Child's sex vs Minimum SaO2 (NREM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 201 90.9 ± 3.3 92.0 77.0 96.0 354 555
Male 110 90.8 ± 3.5 92.0 80.0 96.0 176 286
Female 91 91.0 ± 3.2 92.0 77.0 96.0 178 269
Child's sex vs Minimum SaO2 (NREM, Back, 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 (NREM, Back, 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 (NREM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 60 92.0 ± 3.1 92.5 80.0 96.0 231 291
Male 38 91.7 ± 3.6 92.5 80.0 96.0 107 145
Female 22 92.4 ± 2.0 92.5 88.0 95.0 124 146
Child's race vs Minimum SaO2 (NREM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 201 90.9 ± 3.3 92.0 77.0 96.0 354 555
American Indian/Alaska Native 1 92.0 - 92.0 92.0 92.0 2 3
Asian 6 92.3 ± 2.1 93.0 89.0 94.0 4 10
Native Hawaiian or Other Pacific Islander 1 87.0 - 87.0 87.0 87.0 - 1
Black or African American 53 90.9 ± 4.0 92.0 77.0 96.0 108 161
White 128 90.8 ± 3.2 91.5 80.0 96.0 223 351
More than one race 10 91.9 ± 1.5 92.0 90.0 95.0 15 25
Unknown or not reported 2 90.0 ± 2.8 90.0 88.0 92.0 2 4
Child's race vs Minimum SaO2 (NREM, Back, 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 (NREM, Back, 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 (NREM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 60 92.0 ± 3.1 92.5 80.0 96.0 231 291
American Indian/Alaska Native 1 92.0 - 92.0 92.0 92.0 2 3
Asian - - - - - - 4 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 17 92.5 ± 2.6 93.0 87.0 96.0 51 68
White 37 92.1 ± 2.8 93.0 81.0 96.0 166 203
More than one race 4 91.8 ± 2.1 92.0 89.0 94.0 8 12
Unknown or not reported 1 80.0 - 80.0 80.0 80.0 - 1