Name
psg_total_apnea_hyp_4p
Label
Total number of respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
Units
number of events
Type
integer
PATS Visit timepoint vs Total number of respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
N Mean StdDev Median Min Max Unknown Total
Screening Visit 499 22.1 ± 53.4 6.0 0.0 685.0 56 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 232 6.4 ± 16.4 3.0 0.0 200.0 59 291
Assigned treatment arm vs Total number of respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 330 5.9 ± 6.2 4.0 0.0 37.0 - 330
Early Adenotonsillectomy 167 5.7 ± 6.3 4.0 0.0 36.0 - 167
Watchful Waiting with Supportive Care 163 6.0 ± 6.1 4.0 0.0 37.0 - 163
Assigned treatment arm vs Total number of respiratory events ([all apneas] and [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 respiratory events ([all apneas] and [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 respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 6.4 ± 16.4 3.0 0.0 200.0 59 291
Early Adenotonsillectomy 117 3.9 ± 5.0 3.0 0.0 43.0 30 147
Watchful Waiting with Supportive Care 115 9.0 ± 22.5 3.0 0.0 200.0 29 144
Child's sex vs Total number of respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 22.1 ± 53.4 6.0 0.0 685.0 56 555
Male 258 23.7 ± 60.8 6.5 0.0 685.0 28 286
Female 241 20.4 ± 44.2 6.0 0.0 434.0 28 269
Child's sex vs Total number of respiratory events ([all apneas] and [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 respiratory events ([all apneas] and [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 respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 6.4 ± 16.4 3.0 0.0 200.0 59 291
Male 120 6.5 ± 11.7 3.0 0.0 96.0 25 145
Female 112 6.3 ± 20.3 2.0 0.0 200.0 34 146
Child's race vs Total number of respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 22.1 ± 53.4 6.0 0.0 685.0 56 555
American Indian/Alaska Native 3 2.7 ± 2.5 3.0 0.0 5.0 - 3
Asian 9 10.4 ± 13.6 4.0 0.0 35.0 1 10
Native Hawaiian or Other Pacific Islander 1 47.0 - 47.0 47.0 47.0 - 1
Black or African American 128 36.7 ± 85.0 9.0 0.0 685.0 33 161
White 332 16.9 ± 36.4 6.0 0.0 473.0 19 351
More than one race 23 22.0 ± 33.5 7.0 0.0 108.0 2 25
Unknown or not reported 3 15.3 ± 5.0 16.0 10.0 20.0 1 4
Child's race vs Total number of respiratory events ([all apneas] and [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 respiratory events ([all apneas] and [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 respiratory events ([all apneas] and [hypopneas with >= 4% oxygen desaturation])
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 6.4 ± 16.4 3.0 0.0 200.0 59 291
American Indian/Alaska Native 3 2.7 ± 3.8 1.0 0.0 7.0 - 3
Asian 4 1.8 ± 1.7 1.5 0.0 4.0 - 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 56 10.3 ± 29.1 4.0 0.0 200.0 12 68
White 156 5.0 ± 7.6 3.0 0.0 61.0 47 203
More than one race 12 8.9 ± 22.2 1.5 0.0 79.0 - 12
Unknown or not reported 1 4.0 - 4.0 4.0 4.0 - 1