Table 4 Patient Characteristics in the Two Subjects With Tardive Dyskinesia Reported as an Adverse Event
Case 1 | Case 2 | |||
|---|---|---|---|---|
Gender | Female | Male | ||
Age | 9 y | 7 y | ||
Diagnosis | Attention-deficit/hyperactivity disorder – oppositional defiant disorder | Disruptive behavior disorder | ||
Intelligence quotient (IQ) | 40 | 52 | ||
NCBRF total score | ||||
Baseline | 47 | 42 | ||
Endpoint | 11 | 31 | ||
Timepoint | Risperidone dose (mg/day) | Dyskinesia score | Risperidone dose (mg/day) | Dyskinesia score |
Baseline | 0.300 | 0 | 0.300 | 0 |
Week 1 | 0.667 | 0 | 0.778 | 0 |
Week 2 | 0.914 | 0 | 1.000 | 0 |
Week 3 | 1.114 | 0 | 1.000 | 1 |
Week 4 | 1.200 | 0 | 1.000 | 0 |
Week 8 | 1.090 | 0 | 1.540 | 0 |
Week 12 | 1.000 | 0 | 1.600 | 0 |
Week 16 | 1.000 | 3 | 1.580 | 0 |
Week 20 | 1.000 | 2 | 0.300 | 0 |
Week 24 | 0.813 | 1 | ||
Week 36 | 0.800 | 1 | ||
Week 48 | 0.783 | 9 | ||