TABLE 5.
Adverse Effect Rates
| Adverse Effect | Baseline |
Stimulant Monotherapy End Point |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Aggression Responder Group |
Aggression Refractory Group |
χ2 (P) | Aggression Responder Group |
Aggression Refractory Group |
χ2 (P) | |||||
| n | % | n | % | n | % | n | % | |||
| Abdominal pain | 1 | 1 | 3 | 9 | 0 | 0 | 1 | 3 | ||
| Anxiety or nervousness | 4 | 15 | 7 | 22 | 4 | 13 | 8 | 26 | ||
| Enuresis | 2 | 6 | 1 | 3 | 1 | 3 | 1 | 3 | ||
| Bite fingernails | 4 | 15 | 8 | 25 | 4 | 13 | 5 | 16 | ||
| Bruises easily | 1 | 3 | 1 | 3 | 1 | 3 | 0 | 0 | ||
| Crying | 3 | 11 | 8 | 25 | 3 | 10 | 5 | 16 | ||
| Insomnia, initial | 6 | 22 | 15 | 47 | 3.88 (.05) | 6 | 20 | 11 | 38 | |
| Decrease appetite | 6 | 22 | 5 | 16 | 3 | 20 | 10 | 32 | ||
| Diarrhea | 1 | 3 | 0 | 0 | 1 | 3 | 1 | 3 | ||
| Insomnia, middle | 2 | 7 | 2 | 9 | 1 | 3 | 3 | 9 | ||
| Dizzy | 1 | 3 | 2 | 6 | 0 | 0 | 1 | 3 | ||
| Dry mouth | 1 | 4 | 3 | 10 | 1 | 3 | 1 | 3 | ||
| Headache | 5 | 19 | 1 | 3 | 3.80 (.05) | 1 | 3 | 0 | 0 | |
| Increase appetite | 2 | 7 | 4 | 13 | 0 | 0 | 1 | 3 | ||
| Irritability | 10 | 37 | 16 | 50 | 4 | 13 | 12 | 39 | 5.07 (.03) | |
| Low energy | 3 | 11 | 2 | 7 | 1 | 3 | 1 | 3 | ||
| Nightmares | 1 | 2 | 6 | 0 | 0 | 2 | 6 | |||
| Rash | 1 | 3 | 0 | 0 | 0 | 0 | 1 | 3 | ||
| Restlessness | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 9 | 3.05 (.09) | |
| Sadness | 3 | 11 | 7 | 22 | 3 | 10 | 6 | 19 | ||
| Shaking | 1 | 3 | 0 | 0 | 1 | 3 | 1 | 3 | ||
| Stares into space | 2 | 7 | 3 | 9 | 1 | 3 | 2 | 6 | ||
| Stomachache | 2 | 7 | 2 | 7 | 2 | 7 | 3 | 10 | ||
| Heart races | 1 | 3 | 1 | 3 | 1 | 3 | 1 | 3 | ||
| Less talkative | 3 | 11 | 2 | 6 | 2 | 6 | 2 | 6 | ||
| Overly talkative | 10 | 37 | 8 | 25 | 3 | 10 | 5 | 16 | ||
| Tics | 2 | 6 | 2 | 6 | 2 | 7 | 1 | 3 | ||
| Tired | 1 | 3 | 1 | 3 | 1 | 3 | 1 | 3 | ||
| Trouble waking | 1 | 3 | 0 | 0 | 1 | 3 | 0 | 0 | ||
| Tremors | 1 | 3 | 0 | 0 | 0 | 0 | 2 | 6 | ||
| Lack of interest | 2 | 6 | 2 | 6 | 1 | 3 | 5 | 16 | 2.81 (.10) | |
| Unusually happy | 3 | 9 | 3 | 9 | 6 | 7 | 6 | 6 | ||
| Early waking | 3 | 11 | 7 | 22 | 3 | 10 | 3 | 9 | ||