Table 4.
Treatment-Emergent Adverse Events and Vital Signs: Safety Analyses Data Set
| Treatment-emergent adverse events (occurring in ≥5% of patients in any edivoxetine group or OROS MPH group and twice the rate in placebo group) | |||||
|---|---|---|---|---|---|
| Placebo (%) n=78 | Edivoxetine 0.1 (%) n=76 | Edivoxetine 0.2 (%) n=75 | Edivoxetine 0.3 (%) n=75 | OROS MPHa (%) n=36 | |
| Upper abdominal pain | 9.0 | 18.4 | 4.0 | 14.7 | 22.2 |
| Nausea | 5.1 | 6.6 | 17.3* | 13.3 | 8.3 |
| Vomiting | 3.8 | 9.2 | 12.0 | 13.3* | 2.8 |
| Decreased appetite | 3.8 | 7.9 | 13.3* | 10.7 | 47.2* |
| Irritability | 5.1 | 13.2 | 9.3 | 6.7 | 16.7 |
| Somnolence | 6.4 | 5.3 | 18.7* | 5.3 | 0.0 |
| Sedation | 1.3 | 5.3 | 9.3* | 5.3 | 8.3 |
| Increased heart rate | 0.0 | 2.6 | 0.0 | 5.3 | 2.8 |
| Diarrhea | 2.6 | 6.6 | 4.0 | 1.3 | 0.0 |
| Aggression | 1.3 | 1.3 | 2.7 | 2.7 | 5.6 |
| Altered mood | 1.3 | 1.3 | 4.0 | 2.7 | 5.6 |
| Affect lability | 0.0 | 0.0 | 0.0 | 1.3 | 5.6 |
| Cough | 5.1 | 3.9 | 1.3 | 2.7 | 11.1 |
| Fatigue | 3.8 | 3.9 | 4.0 | 4.0 | 11.1 |
| Initial insomnia | 2.6 | 2.6 | 1.3 | 1.3 | 5.6 |
| Insomnia | 6.4 | 6.6 | 5.3 | 2.7 | 19.4 |
| Depressed mood | 0.0 | 0.0 | 0.0 | 0.0 | 5.6 |
| Gastroenteritis | 0.0 | 0.0 | 0.0 | 0.0 | 5.6 |
| Oropharyngeal pain | 2.6 | 2.6 | 4.0 | 0.0 | 5.6 |
| Sleep disorder | 0.0 | 0.0 | 1.3 | 0.0 | 11.1* |
| Weight decreased | 0.0 | 0.0 | 1.3 | 0.0 | 11.1* |
| Vital signs, weight, and height | |||||
|---|---|---|---|---|---|
| LS mean change from baseline to week 8 | |||||
| Weight (kg) | 1.3 | −0.1* | 0.2* | −0.3* | −1.85† |
| Height (cm) | 0.7 | 0.8 | 0.7 | 0.6 | 0.9 |
| Pulse (bpm) sitting | −1.2 | 7.0* | 12.0* | 11.9* | 4.49† |
| Diastolic BP (mmHg) sitting | −1.1 | 5.8* | 7.0* | 5.2* | 2.93 |
| Systolic BP (mmHg) sitting | 0.7 | 4.6* | 5.7* | 5.1* | 2.75 |
| Percentage of patients with potentially clinically significant QTc changes at any time | |||||
|---|---|---|---|---|---|
| QTc Fridericia's >30 ms increase | 1.3 | 1.4 | 5.6 | 0.0 | 2.9 |
| QTc Fridericia's >450 ms increase | 0.0 | 1.4 | 1.4 | 0.0 | 0.0 |
| Percentage of patients with a categorical shift in BP | ||||||
|---|---|---|---|---|---|---|
| Sitting diastolic BP increase ≥5 mmHg and ≥95th percentile | At end-point | 1.3 | 8.1 | 9.6* | 4.1 | 5.7 |
| At any time | 10.3 | 18.9 | 26.0* | 23.3* | 11.4 | |
| Sitting systolic BP increase ≥5 mmHg and ≥95th percentile | At end-point | 6.4 | 8.1 | 9.6 | 2.7 | 2.9 |
| At any time | 16.7 | 21.6 | 30.1 | 17.8 | 25.7 | |
a
Patients who received OROS MPH were in the stimulant-naïve strata only.
*
p<0.05 vs. placebo; †p<0.05 vs. the stimulant-naïve placebo group.
0.1=0.1 mg/kg/day; 0.2=0.2 mg/kg/day; 0.3=0.3 mg/kg/day.
BP, blood pressure; LS, least squares; OROS MPH, osmotic-release oral system methylphenidate; QTc, corrected QT interval.