Name
psg_total_apnea_hyp_3p
Label
Total number of respiratory events ([all apneas] and [hypopneas with >= 3% oxygen desaturation])
Units
number of events
Type
integer
PATS Visit timepoint vs Total number of respiratory events ([all apneas] and [hypopneas with >= 3% oxygen desaturation])
N Mean StdDev Median Min Max Unknown Total
Screening Visit 499 29.0 ± 62.1 9.0 0.0 734.0 56 555
Baseline Visit - - - - - - 332 332
Month-6 Interim Visit - - - - - - 283 283
Month-12 Endpoint Visit 232 9.4 ± 21.6 4.0 0.0 234.0 59 291
Assigned treatment arm vs Total number of respiratory events ([all apneas] and [hypopneas with >= 3% oxygen desaturation])
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 330 7.9 ± 7.5 6.0 0.0 40.0 - 330
Early Adenotonsillectomy 167 7.9 ± 7.8 6.0 0.0 40.0 - 167
Watchful Waiting with Supportive Care 163 7.8 ± 7.3 6.0 0.0 39.0 - 163
Assigned treatment arm vs Total number of respiratory events ([all apneas] and [hypopneas with >= 3% 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 >= 3% 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 >= 3% oxygen desaturation])
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 9.4 ± 21.6 4.0 0.0 234.0 59 291
Early Adenotonsillectomy 117 5.2 ± 6.6 3.0 0.0 49.0 30 147
Watchful Waiting with Supportive Care 115 13.6 ± 29.4 6.0 0.0 234.0 29 144
Child's sex vs Total number of respiratory events ([all apneas] and [hypopneas with >= 3% oxygen desaturation])
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 29.0 ± 62.1 9.0 0.0 734.0 56 555
Male 258 30.8 ± 70.5 10.0 0.0 734.0 28 286
Female 241 27.0 ± 51.8 8.0 0.0 462.0 28 269
Child's sex vs Total number of respiratory events ([all apneas] and [hypopneas with >= 3% 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 >= 3% 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 >= 3% oxygen desaturation])
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 9.4 ± 21.6 4.0 0.0 234.0 59 291
Male 120 9.4 ± 15.1 5.5 0.0 116.0 25 145
Female 112 9.4 ± 26.9 3.0 0.0 234.0 34 146
Child's race vs Total number of respiratory events ([all apneas] and [hypopneas with >= 3% oxygen desaturation])
Screening Visit
N Mean StdDev Median Min Max Unknown Total
Total 499 29.0 ± 62.1 9.0 0.0 734.0 56 555
American Indian/Alaska Native 3 4.7 ± 2.5 5.0 2.0 7.0 - 3
Asian 9 13.9 ± 17.6 6.0 0.0 51.0 1 10
Native Hawaiian or Other Pacific Islander 1 67.0 - 67.0 67.0 67.0 - 1
Black or African American 128 46.4 ± 95.0 12.5 0.0 734.0 33 161
White 332 22.8 ± 45.2 8.0 0.0 556.0 19 351
More than one race 23 29.3 ± 42.8 7.0 0.0 139.0 2 25
Unknown or not reported 3 20.7 ± 8.1 16.0 16.0 30.0 1 4
Child's race vs Total number of respiratory events ([all apneas] and [hypopneas with >= 3% 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 >= 3% 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 >= 3% oxygen desaturation])
Month-12 Endpoint Visit
N Mean StdDev Median Min Max Unknown Total
Total 232 9.4 ± 21.6 4.0 0.0 234.0 59 291
American Indian/Alaska Native 3 5.0 ± 7.8 1.0 0.0 14.0 - 3
Asian 4 7.0 ± 9.0 4.0 0.0 20.0 - 4
Native Hawaiian or Other Pacific Islander - - - - - - - -
Black or African American 56 14.0 ± 34.7 4.5 0.0 234.0 12 68
White 156 7.4 ± 10.7 4.0 0.0 75.0 47 203
More than one race 12 16.0 ± 43.3 2.5 0.0 153.0 - 12
Unknown or not reported 1 4.0 - 4.0 4.0 4.0 - 1