Name
psg_mndnba4
Label
Minimum SaO2 with arousals (NREM, Back, 4% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 with arousals (NREM, Back, 4% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 252 91.7 ± 3.5 92.0 77.0 98.0 303 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 80 92.7 ± 3.0 93.0 80.0 97.0 211 291
Assigned treatment arm vs Minimum SaO2 with arousals (NREM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 127 93.1 ± 2.3 93.0 82.0 98.0 203 330
Early Adenotonsillectomy 64 93.4 ± 1.9 93.0 89.0 97.0 103 167
Watchful Waiting with Supportive Care 63 92.9 ± 2.6 93.0 82.0 98.0 100 163
Assigned treatment arm vs Minimum SaO2 with arousals (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 with arousals (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 with arousals (NREM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 80 92.7 ± 3.0 93.0 80.0 97.0 211 291
Early Adenotonsillectomy 43 92.9 ± 2.9 93.0 80.0 97.0 104 147
Watchful Waiting with Supportive Care 37 92.5 ± 3.2 93.0 81.0 97.0 107 144
Child's sex vs Minimum SaO2 with arousals (NREM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 252 91.7 ± 3.5 92.0 77.0 98.0 303 555
Male 138 91.6 ± 3.6 92.0 80.0 98.0 148 286
Female 114 91.8 ± 3.4 92.0 77.0 97.0 155 269
Child's sex vs Minimum SaO2 with arousals (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 with arousals (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 with arousals (NREM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 80 92.7 ± 3.0 93.0 80.0 97.0 211 291
Male 49 92.4 ± 3.5 93.0 80.0 97.0 96 145
Female 31 93.1 ± 2.1 93.0 88.0 96.0 115 146
Child's race vs Minimum SaO2 with arousals (NREM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 252 91.7 ± 3.5 92.0 77.0 98.0 303 555
American Indian/Alaska Native 1 92.0 - 92.0 92.0 92.0 2 3
Asian 7 92.6 ± 2.0 94.0 89.0 94.0 3 10
Native Hawaiian or Other Pacific Islander 1 87.0 - 87.0 87.0 87.0 - 1
Black or African American 67 91.9 ± 4.1 93.0 77.0 98.0 94 161
White 161 91.6 ± 3.3 92.0 80.0 97.0 190 351
More than one race 13 92.6 ± 1.9 92.0 90.0 96.0 12 25
Unknown or not reported 2 90.0 ± 2.8 90.0 88.0 92.0 2 4
Child's race vs Minimum SaO2 with arousals (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 with arousals (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 with arousals (NREM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 80 92.7 ± 3.0 93.0 80.0 97.0 211 291
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 18 92.7 ± 2.7 93.5 87.0 97.0 50 68
White 55 93.0 ± 2.8 93.0 81.0 97.0 148 203
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