Table 2.

Adverse Events

Side EffectPooled placebo (n=25)Pooled active (n=25)1.4 mg (n=3)2.8 mg (n=5)4.6 mg (n=5)6.8 mg (n=6)9.6 mg (n=6)
n(%)n(%)n(%)n(%)n(%)n(%)n(%)
Autonomic
Tachycardia1 (4%)0 (0%)
Bradycardia0 (0%)1 (4%)1 (4%)
Chest tightness2 (8%)0 (0%)
CNS/psychiatric
Headache2 (8%)1 (4%)1 (4%)
Dizziness3 (12%)0 (0%)
Irritability0 (0%)1 (4%)1 (4%)
Lightheadedness3 (12%)0 (0%)
Blurry vision1 (4%)0 (0%)
Fatigue1 (4%)0 (0%)
Sleepiness2 (8%)0 (0%)
Gastrointestinal
Nausea0 (0%)1 (4%)1 (4%)
Skin disorders
Itchiness1 (4%)0 (0%)
Other
Flu-like symptoms1 (4%)0 (0%)
Fever1 (4%)0 (0%)
Nasal congestion0 (0%)1 (4%)1 (4%)
Side EffectPooled placebo (n=25)Pooled active (n=25)1.4 mg (n=3)2.8 mg (n=5)4.6 mg (n=5)6.8 mg (n=6)9.6 mg (n=6)
n(%)n(%)n(%)n(%)n(%)n(%)n(%)
Autonomic
Tachycardia1 (4%)0 (0%)
Bradycardia0 (0%)1 (4%)1 (4%)
Chest tightness2 (8%)0 (0%)
CNS/psychiatric
Headache2 (8%)1 (4%)1 (4%)
Dizziness3 (12%)0 (0%)
Irritability0 (0%)1 (4%)1 (4%)
Lightheadedness3 (12%)0 (0%)
Blurry vision1 (4%)0 (0%)
Fatigue1 (4%)0 (0%)
Sleepiness2 (8%)0 (0%)
Gastrointestinal
Nausea0 (0%)1 (4%)1 (4%)
Skin disorders
Itchiness1 (4%)0 (0%)
Other
Flu-like symptoms1 (4%)0 (0%)
Fever1 (4%)0 (0%)
Nasal congestion0 (0%)1 (4%)1 (4%)

n=24 subjects overlapped in both the pooled placebo and pooled active groups, but one subject dropped out after participating in a placebo condition and did not complete an active condition, and another subject dropped out after participating in an active condition and did not complete a placebo condition.

Number of subjects experiencing an adverse event: only events rated “possibly,” “probably,” or “definitely” related to drug were included.

Table 2.

Adverse Events

Side EffectPooled placebo (n=25)Pooled active (n=25)1.4 mg (n=3)2.8 mg (n=5)4.6 mg (n=5)6.8 mg (n=6)9.6 mg (n=6)
n(%)n(%)n(%)n(%)n(%)n(%)n(%)
Autonomic
Tachycardia1 (4%)0 (0%)
Bradycardia0 (0%)1 (4%)1 (4%)
Chest tightness2 (8%)0 (0%)
CNS/psychiatric
Headache2 (8%)1 (4%)1 (4%)
Dizziness3 (12%)0 (0%)
Irritability0 (0%)1 (4%)1 (4%)
Lightheadedness3 (12%)0 (0%)
Blurry vision1 (4%)0 (0%)
Fatigue1 (4%)0 (0%)
Sleepiness2 (8%)0 (0%)
Gastrointestinal
Nausea0 (0%)1 (4%)1 (4%)
Skin disorders
Itchiness1 (4%)0 (0%)
Other
Flu-like symptoms1 (4%)0 (0%)
Fever1 (4%)0 (0%)
Nasal congestion0 (0%)1 (4%)1 (4%)
Side EffectPooled placebo (n=25)Pooled active (n=25)1.4 mg (n=3)2.8 mg (n=5)4.6 mg (n=5)6.8 mg (n=6)9.6 mg (n=6)
n(%)n(%)n(%)n(%)n(%)n(%)n(%)
Autonomic
Tachycardia1 (4%)0 (0%)
Bradycardia0 (0%)1 (4%)1 (4%)
Chest tightness2 (8%)0 (0%)
CNS/psychiatric
Headache2 (8%)1 (4%)1 (4%)
Dizziness3 (12%)0 (0%)
Irritability0 (0%)1 (4%)1 (4%)
Lightheadedness3 (12%)0 (0%)
Blurry vision1 (4%)0 (0%)
Fatigue1 (4%)0 (0%)
Sleepiness2 (8%)0 (0%)
Gastrointestinal
Nausea0 (0%)1 (4%)1 (4%)
Skin disorders
Itchiness1 (4%)0 (0%)
Other
Flu-like symptoms1 (4%)0 (0%)
Fever1 (4%)0 (0%)
Nasal congestion0 (0%)1 (4%)1 (4%)

n=24 subjects overlapped in both the pooled placebo and pooled active groups, but one subject dropped out after participating in a placebo condition and did not complete an active condition, and another subject dropped out after participating in an active condition and did not complete a placebo condition.

Number of subjects experiencing an adverse event: only events rated “possibly,” “probably,” or “definitely” related to drug were included.

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