Study: NCT00088452

Adverse event: Generalized tonic clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 155 at risk

Adverse event: Pneumonia, diarrhea, vomiting
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 155 at risk

Adverse event: Non-epileptic movements
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 155 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 155 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 155 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 10 affected / 155 at risk

Adverse event: Nausea, vomiting, or both
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 155 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 155 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 155 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 155 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 155 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 155 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 155 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 155 at risk

Adverse event: Decrease in concentration
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 155 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 155 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 155 at risk

Adverse event: Attentional difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 155 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 155 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Infections and infestations
Notes: Due to Salmonella poisoning
Frequency: 1 affected / 149 at risk

Adverse event: Prolonged Absence Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 149 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 149 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 149 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 5 affected / 149 at risk

Adverse event: Nausea, vomiting, or both
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 149 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 149 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 149 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 149 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 149 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 149 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 149 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 149 at risk

Adverse event: Decrease in concentration
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 149 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 149 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 149 at risk

Adverse event: Attentional difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 149 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 149 at risk

Adverse event: Memory problems
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 149 at risk

Adverse event: Generalized tonic clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Acting Out
Serious: yes
Organ System: Psychiatric disorders
Notes: Voluntarily committed
Frequency: 1 affected / 147 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 147 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 147 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 14 affected / 147 at risk

Adverse event: Nausea, vomiting, or both
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 147 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 147 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 147 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 147 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 147 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 147 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 147 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 147 at risk

Adverse event: Decrease in concentration
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 147 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 147 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 147 at risk

Adverse event: Attentional difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 147 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 147 at risk

Adverse event: Memory problems
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 147 at risk