Name
psg_mndrba5
Label
Minimum SaO2 with arousals (REM, Back, 5% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 with arousals (REM, Back, 5% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 143 90.2 ± 4.9 91.0 70.0 98.0 412 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 40 91.0 ± 3.5 91.5 83.0 97.0 251 291
Assigned treatment arm vs Minimum SaO2 with arousals (REM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 70 91.9 ± 3.3 92.0 82.0 98.0 260 330
Early Adenotonsillectomy 29 91.8 ± 2.9 92.0 84.0 98.0 138 167
Watchful Waiting with Supportive Care 41 92.0 ± 3.6 92.0 82.0 98.0 122 163
Assigned treatment arm vs Minimum SaO2 with arousals (REM, 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 (REM, 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 (REM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 40 91.0 ± 3.5 91.5 83.0 97.0 251 291
Early Adenotonsillectomy 20 91.9 ± 2.8 92.0 84.0 97.0 127 147
Watchful Waiting with Supportive Care 20 90.1 ± 4.0 90.0 83.0 96.0 124 144
Child's sex vs Minimum SaO2 with arousals (REM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 143 90.2 ± 4.9 91.0 70.0 98.0 412 555
Male 72 90.5 ± 4.3 91.0 78.0 98.0 214 286
Female 71 89.8 ± 5.4 91.0 70.0 98.0 198 269
Child's sex vs Minimum SaO2 with arousals (REM, 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 (REM, 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 (REM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 40 91.0 ± 3.5 91.5 83.0 97.0 251 291
Male 22 90.5 ± 3.4 91.0 83.0 96.0 123 145
Female 18 91.7 ± 3.7 93.0 83.0 97.0 128 146
Child's race vs Minimum SaO2 with arousals (REM, Back, 5% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 143 90.2 ± 4.9 91.0 70.0 98.0 412 555
American Indian/Alaska Native - - - - - - 3 3
Asian 3 90.7 ± 3.2 92.0 87.0 93.0 7 10
Native Hawaiian or Other Pacific Islander - - - - - - 1 1
Black or African American 38 90.4 ± 5.2 92.0 70.0 98.0 123 161
White 98 90.0 ± 4.8 91.0 75.0 98.0 253 351
More than one race 4 92.0 ± 5.2 93.5 85.0 96.0 21 25
Unknown or not reported - - - - - - 4 4
Child's race vs Minimum SaO2 with arousals (REM, 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 (REM, 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 (REM, Back, 5% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 40 91.0 ± 3.5 91.5 83.0 97.0 251 291
American Indian/Alaska Native - - - - - - 3 3
Asian 1 89.0 - 89.0 89.0 89.0 3 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 11 90.6 ± 3.7 91.0 83.0 96.0 57 68
White 27 91.1 ± 3.6 92.0 83.0 97.0 176 203
More than one race 1 93.0 - 93.0 93.0 93.0 11 12
Unknown or not reported - - - - - - 1 1