psg_apnea_hypopnea_index psg_arousal_index_lt3_comments
Name
psg_arousal_index_lt3
Label
Arousal index < 3 events per hour verified
Domain
no0_yes1
  • 0: No
  • 1: Yes
Type
choices
Arousal index < 3 events per hour verified vs PATS Visit timepoint
Screening Visit Baseline Visit Month-6 Interim Visit Month-12 Endpoint Visit
Total 555 332 283 291
No 475 - - 216
Yes 24 - - 16
Unknown 56 332 283 59
Arousal index < 3 events per hour verified vs Assigned treatment arm
Screening Visit
Early Adenotonsillectomy Watchful Waiting with Supportive Care Total
Total 167 163 330
No 158 153 311
Yes 9 10 19
Arousal index < 3 events per hour verified vs Assigned treatment arm
Baseline Visit
Early Adenotonsillectomy Watchful Waiting with Supportive Care Total
Total 167 163 330
No - - -
Yes - - -
Unknown 167 163 330
Arousal index < 3 events per hour verified vs Assigned treatment arm
Month-6 Interim Visit
Early Adenotonsillectomy Watchful Waiting with Supportive Care Total
Total 140 143 283
No - - -
Yes - - -
Unknown 140 143 283
Arousal index < 3 events per hour verified vs Assigned treatment arm
Month-12 Endpoint Visit
Early Adenotonsillectomy Watchful Waiting with Supportive Care Total
Total 147 144 291
No 107 109 216
Yes 10 6 16
Unknown 30 29 59
Arousal index < 3 events per hour verified vs Child's sex
Screening Visit
Male Female Total
Total 286 269 555
No 249 226 475
Yes 9 15 24
Unknown 28 28 56
Arousal index < 3 events per hour verified vs Child's sex
Baseline Visit
Male Female Total
Total 162 170 332
No - - -
Yes - - -
Unknown 162 170 332
Arousal index < 3 events per hour verified vs Child's sex
Month-6 Interim Visit
Male Female Total
Total 137 146 283
No - - -
Yes - - -
Unknown 137 146 283
Arousal index < 3 events per hour verified vs Child's sex
Month-12 Endpoint Visit
Male Female Total
Total 145 146 291
No 114 102 216
Yes 6 10 16
Unknown 25 34 59
Arousal index < 3 events per hour verified vs Child's race
Screening Visit
American Indian/Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than one race Unknown or not reported Total
Total 3 10 1 161 351 25 4 555
No 3 9 1 119 317 23 3 475
Yes - - - 9 15 - - 24
Unknown - 1 - 33 19 2 1 56
Arousal index < 3 events per hour verified vs Child's race
Baseline Visit
American Indian/Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than one race Unknown or not reported Total
Total 3 6 - 73 235 14 1 332
No - - - - - - - -
Yes - - - - - - - -
Unknown 3 6 - 73 235 14 1 332
Arousal index < 3 events per hour verified vs Child's race
Month-6 Interim Visit
American Indian/Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than one race Unknown or not reported Total
Total 3 4 - 64 200 12 - 283
No - - - - - - - -
Yes - - - - - - - -
Unknown 3 4 - 64 200 12 - 283
Arousal index < 3 events per hour verified vs Child's race
Month-12 Endpoint Visit
American Indian/Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than one race Unknown or not reported Total
Total 3 4 - 68 203 12 1 291
No 2 4 - 52 145 12 1 216
Yes 1 - - 4 11 - - 16
Unknown - - - 12 47 - - 59