Childhood Adenotonsillectomy Trial

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