Treatment Arm
PATS Visit timepoint vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Screening Visit | 496 | 7.2 | ± 15.9 | 1.3 | 0.0 | 122.6 | 59 | 555 |
Baseline Visit | - | - | - | - | - | - | 332 | 332 |
Month-6 Interim Visit | - | - | - | - | - | - | 283 | 283 |
Month-12 Endpoint Visit | 231 | 1.8 | ± 4.7 | 0.0 | 0.0 | 40.3 | 60 | 291 |
Assigned treatment arm vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
Screening Visit
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Total | 329 | 1.3 | ± 2.0 | 0.6 | 0.0 | 13.6 | 1 | 330 |
Early Adenotonsillectomy | 167 | 1.2 | ± 2.0 | 0.5 | 0.0 | 13.6 | - | 167 |
Watchful Waiting with Supportive Care | 162 | 1.4 | ± 1.9 | 0.7 | 0.0 | 9.4 | 1 | 163 |
Assigned treatment arm vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
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 - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
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 - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
Month-12 Endpoint Visit
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Total | 231 | 1.8 | ± 4.7 | 0.0 | 0.0 | 40.3 | 60 | 291 |
Early Adenotonsillectomy | 117 | 0.8 | ± 2.0 | 0.0 | 0.0 | 17.6 | 30 | 147 |
Watchful Waiting with Supportive Care | 114 | 2.9 | ± 6.2 | 0.6 | 0.0 | 40.3 | 30 | 144 |
Child's sex vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
Screening Visit
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Total | 496 | 7.2 | ± 15.9 | 1.3 | 0.0 | 122.6 | 59 | 555 |
Male | 257 | 6.9 | ± 15.3 | 1.4 | 0.0 | 122.6 | 29 | 286 |
Female | 239 | 7.5 | ± 16.5 | 1.2 | 0.0 | 109.4 | 30 | 269 |
Child's sex vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
Baseline Visit
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Total | - | - | - | - | - | - | 332 | 332 |
Male | - | - | - | - | - | - | 162 | 162 |
Female | - | - | - | - | - | - | 170 | 170 |
Child's sex vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
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 - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
Month-12 Endpoint Visit
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Total | 231 | 1.8 | ± 4.7 | 0.0 | 0.0 | 40.3 | 60 | 291 |
Male | 119 | 2.0 | ± 4.7 | 0.5 | 0.0 | 40.3 | 26 | 145 |
Female | 112 | 1.6 | ± 4.6 | 0.0 | 0.0 | 34.2 | 34 | 146 |
Child's race vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
Screening Visit
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Total | 496 | 7.2 | ± 15.9 | 1.3 | 0.0 | 122.6 | 59 | 555 |
American Indian/Alaska Native | 3 | 0.5 | ± 0.5 | 0.6 | 0.0 | 0.9 | - | 3 |
Asian | 9 | 4.0 | ± 8.4 | 0.0 | 0.0 | 25.4 | 1 | 10 |
Native Hawaiian or Other Pacific Islander | 1 | 0.7 | - | 0.7 | 0.7 | 0.7 | - | 1 |
Black or African American | 128 | 13.4 | ± 23.4 | 3.0 | 0.0 | 122.6 | 33 | 161 |
White | 329 | 4.7 | ± 11.0 | 0.9 | 0.0 | 99.0 | 22 | 351 |
More than one race | 23 | 10.2 | ± 18.4 | 1.2 | 0.0 | 63.0 | 2 | 25 |
Unknown or not reported | 3 | 6.7 | ± 6.3 | 6.0 | 0.8 | 13.4 | 1 | 4 |
Child's race vs Calculated - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
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 - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
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 - Obstructive apnea (all desats) Hypopnea (3% desat) Index in REM sleep
Month-12 Endpoint Visit
N | Mean | StdDev | Median | Min | Max | Unknown | Total | |
---|---|---|---|---|---|---|---|---|
Total | 231 | 1.8 | ± 4.7 | 0.0 | 0.0 | 40.3 | 60 | 291 |
American Indian/Alaska Native | 2 | 0.0 | ± 0.0 | 0.0 | 0.0 | 0.0 | 1 | 3 |
Asian | 4 | 0.7 | ± 1.0 | 0.4 | 0.0 | 2.1 | - | 4 |
Native Hawaiian or Other Pacific Islander | - | - | - | - | - | - | - | - |
Black or African American | 56 | 3.4 | ± 6.9 | 0.3 | 0.0 | 40.3 | 12 | 68 |
White | 156 | 1.3 | ± 2.6 | 0.0 | 0.0 | 20.0 | 47 | 203 |
More than one race | 12 | 3.0 | ± 9.8 | 0.0 | 0.0 | 34.2 | - | 12 |
Unknown or not reported | 1 | 0.0 | - | 0.0 | 0.0 | 0.0 | - | 1 |