ubl2 ubl_pidate
Name
ubl3
Label
Why was the participant unblinded?
Domain
unblinded
  • 1: Neuropsychological scores fell outside the accepted range
  • 2: Participant experienced an sae related to medical intervention
  • 3: Parent or child inadvertently disclosed their treatment arm
  • 98: Other
Type
choices
Why was the participant unblinded? vs Visit Number
Baseline Follow-up
Total 453 453
Neuropsychological scores fell outside the accepted range - -
Participant experienced an sae related to medical intervention - -
Parent or child inadvertently disclosed their treatment arm 6 6
Other 5 5
Unknown 442 442
Why was the participant unblinded? vs Treatment Arm
Baseline
Early adenotonsillectomy Watchful waiting Total
Total 226 227 453
Neuropsychological scores fell outside the accepted range - - -
Participant experienced an sae related to medical intervention - - -
Parent or child inadvertently disclosed their treatment arm 4 2 6
Other 2 3 5
Unknown 220 222 442
Why was the participant unblinded? vs Treatment Arm
Follow-up
Early adenotonsillectomy Watchful waiting Total
Total 226 227 453
Neuropsychological scores fell outside the accepted range - - -
Participant experienced an sae related to medical intervention - - -
Parent or child inadvertently disclosed their treatment arm 4 2 6
Other 2 3 5
Unknown 220 222 442
Why was the participant unblinded? vs Age
Baseline
5-7 yrs old 8-10 yrs old Total
Total 329 124 453
Neuropsychological scores fell outside the accepted range - - -
Participant experienced an sae related to medical intervention - - -
Parent or child inadvertently disclosed their treatment arm 4 2 6
Other 4 1 5
Unknown 321 121 442
Why was the participant unblinded? vs Age
Follow-up
5-7 yrs old 8-10 yrs old Total
Total 262 137 399
Neuropsychological scores fell outside the accepted range - - -
Participant experienced an sae related to medical intervention - - -
Parent or child inadvertently disclosed their treatment arm 4 2 6
Other 4 1 5
Unknown 254 134 388
Why was the participant unblinded? vs Gender
Baseline
Female Male Total
Total 234 219 453
Neuropsychological scores fell outside the accepted range - - -
Participant experienced an sae related to medical intervention - - -
Parent or child inadvertently disclosed their treatment arm 2 4 6
Other 2 3 5
Unknown 230 212 442
Why was the participant unblinded? vs Gender
Follow-up
Female Male Total
Total 234 219 453
Neuropsychological scores fell outside the accepted range - - -
Participant experienced an sae related to medical intervention - - -
Parent or child inadvertently disclosed their treatment arm 2 4 6
Other 2 3 5
Unknown 230 212 442
Why was the participant unblinded? vs Race
Baseline
White Black Other Total
Total 156 249 48 453
Neuropsychological scores fell outside the accepted range - - - -
Participant experienced an sae related to medical intervention - - - -
Parent or child inadvertently disclosed their treatment arm 4 2 - 6
Other - 4 1 5
Unknown 152 243 47 442
Why was the participant unblinded? vs Race
Follow-up
White Black Other Total
Total 156 249 48 453
Neuropsychological scores fell outside the accepted range - - - -
Participant experienced an sae related to medical intervention - - - -
Parent or child inadvertently disclosed their treatment arm 4 2 - 6
Other - 4 1 5
Unknown 152 243 47 442