Name
psg_mndnbp5
Label
Minimum SaO2 (NREM, Back, 5% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 (NREM, Back, 5% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 135 89.8 ± 3.3 91.0 77.0 94.0 420 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 25 90.1 ± 3.7 92.0 80.0 95.0 266 291
Assigned treatment arm vs Minimum SaO2 (NREM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 45 91.3 ± 2.0 92.0 82.0 94.0 285 330
Early Adenotonsillectomy 24 91.7 ± 1.4 92.0 89.0 94.0 143 167
Watchful Waiting with Supportive Care 21 90.8 ± 2.5 91.0 82.0 94.0 142 163
Assigned treatment arm vs Minimum SaO2 (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 (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 (NREM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 25 90.1 ± 3.7 92.0 80.0 95.0 266 291
Early Adenotonsillectomy 15 90.9 ± 3.7 92.0 80.0 95.0 132 147
Watchful Waiting with Supportive Care 10 89.0 ± 3.7 89.0 81.0 94.0 134 144
Child's sex vs Minimum SaO2 (NREM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 135 89.8 ± 3.3 91.0 77.0 94.0 420 555
Male 72 89.4 ± 3.4 90.0 80.0 94.0 214 286
Female 63 90.1 ± 3.2 91.0 77.0 94.0 206 269
Child's sex vs Minimum SaO2 (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 (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 (NREM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 25 90.1 ± 3.7 92.0 80.0 95.0 266 291
Male 14 89.1 ± 4.5 90.0 80.0 95.0 131 145
Female 11 91.5 ± 2.0 92.0 88.0 94.0 135 146
Child's race vs Minimum SaO2 (NREM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 135 89.8 ± 3.3 91.0 77.0 94.0 420 555
American Indian/Alaska Native 1 92.0 - 92.0 92.0 92.0 2 3
Asian 3 91.0 ± 1.7 92.0 89.0 92.0 7 10
Native Hawaiian or Other Pacific Islander 1 87.0 - 87.0 87.0 87.0 - 1
Black or African American 39 89.8 ± 4.0 91.0 77.0 94.0 122 161
White 82 89.6 ± 3.1 90.0 80.0 94.0 269 351
More than one race 8 91.4 ± 1.1 91.5 90.0 93.0 17 25
Unknown or not reported 1 88.0 - 88.0 88.0 88.0 3 4
Child's race vs Minimum SaO2 (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 (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 (NREM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 25 90.1 ± 3.7 92.0 80.0 95.0 266 291
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 6 90.7 ± 3.0 90.5 87.0 95.0 62 68
White 15 90.4 ± 3.5 92.0 81.0 94.0 188 203
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