psg_total_hypopneas_3p psg_total_mixapnea
Name
psg_total_hypopneas_4p
Label
Total number of hypopneas with >= 4% oxygen desaturation
Units
number of events
Type
integer
Tags
ttlnumhp_hp3x4u_f1t1
PATS Visit timepoint vs Total number of hypopneas with >= 4% oxygen desaturation
N Mean StdDev Median Min Max Unknown Total
Screening Visit 499 7.8 ± 21.8 1.0 0.0 254.0 56 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 232 2.0 ± 8.6 0.0 0.0 105.0 59 291
Assigned treatment arm vs Total number of hypopneas with >= 4% oxygen desaturation
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 330 1.0 ± 1.8 0.0 0.0 14.0 - 330
Early Adenotonsillectomy 167 1.0 ± 1.7 0.0 0.0 14.0 - 167
Watchful Waiting with Supportive Care 163 1.1 ± 1.9 0.0 0.0 10.0 - 163
Assigned treatment arm vs Total number of hypopneas with >= 4% oxygen desaturation
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 Total number of hypopneas with >= 4% oxygen desaturation
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 Total number of hypopneas with >= 4% oxygen desaturation
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 2.0 ± 8.6 0.0 0.0 105.0 59 291
Early Adenotonsillectomy 117 0.6 ± 1.6 0.0 0.0 14.0 30 147
Watchful Waiting with Supportive Care 115 3.4 ± 12.0 0.0 0.0 105.0 29 144
Child's sex vs Total number of hypopneas with >= 4% oxygen desaturation
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 7.8 ± 21.8 1.0 0.0 254.0 56 555
Male 258 8.6 ± 25.3 1.0 0.0 254.0 28 286
Female 241 6.9 ± 17.2 1.0 0.0 192.0 28 269
Child's sex vs Total number of hypopneas with >= 4% oxygen desaturation
Baseline Visit
N Mean StdDev Median Min Max Unknown Total
Total - - - - - - 332 332
Male - - - - - - 162 162
Female - - - - - - 170 170
Child's sex vs Total number of hypopneas with >= 4% oxygen desaturation
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 Total number of hypopneas with >= 4% oxygen desaturation
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 2.0 ± 8.6 0.0 0.0 105.0 59 291
Male 120 1.7 ± 5.1 0.0 0.0 43.0 25 145
Female 112 2.3 ± 11.3 0.0 0.0 105.0 34 146
Child's race vs Total number of hypopneas with >= 4% oxygen desaturation
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 7.8 ± 21.8 1.0 0.0 254.0 56 555
American Indian/Alaska Native 3 0.3 ± 0.6 0.0 0.0 1.0 - 3
Asian 9 4.1 ± 6.5 0.0 0.0 17.0 1 10
Native Hawaiian or Other Pacific Islander 1 35.0 - 35.0 35.0 35.0 - 1
Black or African American 128 15.5 ± 37.6 2.5 0.0 254.0 33 161
White 332 5.0 ± 11.1 1.0 0.0 75.0 19 351
More than one race 23 6.8 ± 14.0 0.0 0.0 56.0 2 25
Unknown or not reported 3 8.7 ± 7.6 7.0 2.0 17.0 1 4
Child's race vs Total number of hypopneas with >= 4% oxygen desaturation
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 Total number of hypopneas with >= 4% oxygen desaturation
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 Total number of hypopneas with >= 4% oxygen desaturation
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 2.0 ± 8.6 0.0 0.0 105.0 59 291
American Indian/Alaska Native 3 0.0 ± 0.0 0.0 0.0 0.0 - 3
Asian 4 0.0 ± 0.0 0.0 0.0 0.0 - 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 56 4.5 ± 15.1 0.0 0.0 105.0 12 68
White 156 1.0 ± 3.5 0.0 0.0 30.0 47 203
More than one race 12 4.4 ± 14.1 0.0 0.0 49.0 - 12
Unknown or not reported 1 0.0 - 0.0 0.0 0.0 - 1