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 464 453
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 453 442
Why was the participant unblinded? vs Treatment Arm
Baseline
Early adenotonsillectomy (EAT) Watchful waiting with supportive care (WWSC) 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 (EAT) Watchful waiting with supportive care (WWSC) 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 years old 8 - 10 years 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 years old 8 - 10 years 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