Name
psg_odi4
Label
Calculated - Oxygen desaturation index (ODI) 4%
Calculation
psg_odi4 = ((dsrem4 * minremp) + (dsnr4 * (slp_time - minremp))) / slpprdp
Units
percent (%)
Type
numeric
PATS Visit timepoint vs Calculated - Oxygen desaturation index (ODI) 4%
N Mean StdDev Median Min Max Unknown Total
Screening Visit 499 2.7 ± 7.0 0.9 0.0 94.5 56 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 232 1.0 ± 1.7 0.5 0.0 18.2 59 291
Assigned treatment arm vs Calculated - Oxygen desaturation index (ODI) 4%
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 330 0.8 ± 0.9 0.5 0.0 5.0 - 330
Early Adenotonsillectomy 167 0.8 ± 0.9 0.4 0.0 4.1 - 167
Watchful Waiting with Supportive Care 163 0.8 ± 0.9 0.6 0.0 5.0 - 163
Assigned treatment arm vs Calculated - Oxygen desaturation index (ODI) 4%
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 Calculated - Oxygen desaturation index (ODI) 4%
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 Calculated - Oxygen desaturation index (ODI) 4%
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 1.0 ± 1.7 0.5 0.0 18.2 59 291
Early Adenotonsillectomy 117 0.7 ± 0.8 0.5 0.0 5.8 30 147
Watchful Waiting with Supportive Care 115 1.2 ± 2.2 0.6 0.0 18.2 29 144
Child's sex vs Calculated - Oxygen desaturation index (ODI) 4%
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 2.7 ± 7.0 0.9 0.0 94.5 56 555
Male 258 3.1 ± 8.8 0.9 0.0 94.5 28 286
Female 241 2.2 ± 4.5 0.8 0.0 40.4 28 269
Child's sex vs Calculated - Oxygen desaturation index (ODI) 4%
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 332 332
Male - - - - - - 162 162
Female - - - - - - 170 170
Child's sex vs Calculated - Oxygen desaturation index (ODI) 4%
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 Calculated - Oxygen desaturation index (ODI) 4%
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 1.0 ± 1.7 0.5 0.0 18.2 59 291
Male 120 1.0 ± 1.4 0.6 0.0 10.7 25 145
Female 112 0.9 ± 2.0 0.5 0.0 18.2 34 146
Child's race vs Calculated - Oxygen desaturation index (ODI) 4%
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 2.7 ± 7.0 0.9 0.0 94.5 56 555
American Indian/Alaska Native 3 0.5 ± 0.6 0.3 0.0 1.2 - 3
Asian 9 1.3 ± 1.6 0.4 0.0 4.3 1 10
Native Hawaiian or Other Pacific Islander 1 5.3 - 5.3 5.3 5.3 - 1
Black or African American 128 4.3 ± 10.5 1.3 0.0 94.5 33 161
White 332 2.1 ± 5.5 0.7 0.0 80.9 19 351
More than one race 23 2.1 ± 3.3 0.7 0.0 14.4 2 25
Unknown or not reported 3 2.7 ± 1.4 3.3 1.1 3.7 1 4
Child's race vs Calculated - Oxygen desaturation index (ODI) 4%
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 Calculated - Oxygen desaturation index (ODI) 4%
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 Calculated - Oxygen desaturation index (ODI) 4%
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 1.0 ± 1.7 0.5 0.0 18.2 59 291
American Indian/Alaska Native 3 0.9 ± 0.9 1.0 0.0 1.7 - 3
Asian 4 0.4 ± 0.3 0.3 0.08 0.8 - 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 56 1.4 ± 2.8 0.6 0.0 18.2 12 68
White 156 0.8 ± 1.0 0.5 0.0 5.8 47 203
More than one race 12 1.3 ± 2.4 0.5 0.0 8.6 - 12
Unknown or not reported 1 1.0 - 1.0 1.0 1.0 - 1