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 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
Black | White | Other | Total | |
---|---|---|---|---|
Total | 249 | 156 | 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 | 2 | 4 | - | 6 |
Other | 4 | - | 1 | 5 |
Unknown | 243 | 152 | 47 | 442 |
Why was the participant unblinded? vs Race
Follow-up
Black | White | Other | Total | |
---|---|---|---|---|
Total | 249 | 156 | 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 | 2 | 4 | - | 6 |
Other | 4 | - | 1 | 5 |
Unknown | 243 | 152 | 47 | 442 |