Study: NCT00393042

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: Talk less
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 53 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 53 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Sadness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 53 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Subject shaking in bed,unresponsive,eyes rolled upward. Taken to ER. ECG showed possible prolonged QTc. Subject evaluated overnight. No other events. Diagnosed on 12/29 with "benign rolandic seizures." No further cardiac evaluation recommended.
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 47 at risk

Adverse event: Talk less
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 47 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 47 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Sadness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 47 at risk

Adverse event: Talk less
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 47 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 47 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 54 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 54 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 54 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Stares
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 55 at risk

Adverse event: Talk less
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 55 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 55 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 55 at risk

Adverse event: Stares
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 52 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 52 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 52 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Stares
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Insomnia or trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 51 at risk

Adverse event: Talk less
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 51 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Onychophagia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Stares
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Uninterested
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Sadness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk