Name
psg_mndrba4
Label
Minimum SaO2 with arousals (REM, Back, 4% desat) (%)
Units
percent (%)
Type
integer
PATS Visit timepoint vs Minimum SaO2 with arousals (REM, Back, 4% desat) (%)
N Mean StdDev Median Min Max Unknown Total
Screening Visit 171 90.6 ± 4.6 92.0 70.0 98.0 384 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 63 91.9 ± 3.1 93.0 83.0 97.0 228 291
Assigned treatment arm vs Minimum SaO2 with arousals (REM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 89 92.2 ± 2.9 93.0 82.0 98.0 241 330
Early Adenotonsillectomy 39 92.1 ± 2.6 92.0 84.0 97.0 128 167
Watchful Waiting with Supportive Care 50 92.2 ± 3.2 93.0 82.0 98.0 113 163
Assigned treatment arm vs Minimum SaO2 with arousals (REM, 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 (REM, 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 (REM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 63 91.9 ± 3.1 93.0 83.0 97.0 228 291
Early Adenotonsillectomy 31 92.3 ± 2.5 93.0 84.0 97.0 116 147
Watchful Waiting with Supportive Care 32 91.4 ± 3.7 92.0 83.0 96.0 112 144
Child's sex vs Minimum SaO2 with arousals (REM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 171 90.6 ± 4.6 92.0 70.0 98.0 384 555
Male 87 90.9 ± 4.1 92.0 78.0 98.0 199 286
Female 84 90.3 ± 5.0 91.5 70.0 98.0 185 269
Child's sex vs Minimum SaO2 with arousals (REM, 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 (REM, 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 (REM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 63 91.9 ± 3.1 93.0 83.0 97.0 228 291
Male 38 91.8 ± 3.1 92.0 83.0 96.0 107 145
Female 25 92.0 ± 3.2 93.0 83.0 97.0 121 146
Child's race vs Minimum SaO2 with arousals (REM, Back, 4% desat) (%)
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 171 90.6 ± 4.6 92.0 70.0 98.0 384 555
American Indian/Alaska Native - - - - - - 3 3
Asian 3 88.7 ± 2.9 87.0 87.0 92.0 7 10
Native Hawaiian or Other Pacific Islander - - - - - - 1 1
Black or African American 48 91.1 ± 4.8 93.0 70.0 97.0 113 161
White 115 90.4 ± 4.5 91.0 75.0 98.0 236 351
More than one race 5 91.4 ± 4.0 92.0 85.0 96.0 20 25
Unknown or not reported - - - - - - 4 4
Child's race vs Minimum SaO2 with arousals (REM, 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 (REM, 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 (REM, Back, 4% desat) (%)
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 63 91.9 ± 3.1 93.0 83.0 97.0 228 291
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 16 91.6 ± 3.4 92.5 83.0 96.0 52 68
White 44 91.9 ± 3.1 92.5 83.0 97.0 159 203
More than one race 2 94.0 ± 1.4 94.0 93.0 95.0 10 12
Unknown or not reported - - - - - - 1 1