Study: NCT01238822

Adverse event: Parent-reported buccal-lingual movements
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported picking at skin or fingers, nail-biting, or cheek chewing
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 3 affected / 96 at risk

Adverse event: Parent-reported worried/anxious
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 2 affected / 96 at risk

Adverse event: Parent-reported dull, tired, listless
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 4 affected / 96 at risk

Adverse event: Parent-reported hallucinations
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent reported tics
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported picking at skin or fingers, nail-biting, or cheek chewing
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported worried/anxious
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 3 affected / 96 at risk

Adverse event: Parent-reported dull, tired, listless
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 3 affected / 96 at risk

Adverse event: Parent-reported stomachache
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 3 affected / 96 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Parent reported tics
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported buccal-lingual movements
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 2 affected / 96 at risk

Adverse event: Parent-reported picking at skin or fingers, nail-biting, or cheek chewing
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 3 affected / 96 at risk

Adverse event: Parent-reported worried/anxious
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 5 affected / 96 at risk

Adverse event: Parent-reported dull, tired, listless
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 2 affected / 96 at risk

Adverse event: Parent-reported crabby, irritable
Serious: no
Organ System: General disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported socially withdrawn
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported hallucinations
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent reported tics
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 2 affected / 96 at risk

Adverse event: Parent-reported buccal-lingual movements
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 2 affected / 96 at risk

Adverse event: Parent-reported picking at skin or fingers, nail-biting, or cheek chewing
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 7 affected / 96 at risk

Adverse event: Parent-reported worried/anxious
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 9 affected / 96 at risk

Adverse event: Parent-reported dull, tired, listless
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 7 affected / 96 at risk

Adverse event: Parent-reported headaches
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported stomachache
Serious: no
Organ System: Nervous system disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported crabby, irritable
Serious: no
Organ System: General disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported tearful, sad, depressed
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported socially withdrawn
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 2 affected / 96 at risk

Adverse event: Parent-reported hallucinations
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk

Adverse event: Parent-reported loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Number rated 4 (severe)
Frequency: 2 affected / 96 at risk

Adverse event: Parent-reported trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: Number rated 4 (severe)
Frequency: 1 affected / 96 at risk