Study: NCT01109849

Adverse event: Self-destructive behaviour
Serious: yes
Organ System: Psychiatric disorders
Notes: child tried to open door in moving car in attempt to harm self. Did lead to psychiatric hospitalization with no further self harm events.
Frequency: 1 affected / 41 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Notes: child became defiant towards staff at school and responded with physical aggression when redirected. led to brief psychiatric hospitalization. Event did not recur over course of the study.
Frequency: 1 affected / 41 at risk

Adverse event: skin picking
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 20 affected / 41 at risk

Adverse event: buccal movements
Serious: no
Organ System: Nervous system disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 10 affected / 41 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 24 affected / 41 at risk

Adverse event: dull, listless
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 10 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 12 affected / 41 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 11 affected / 41 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 14 affected / 41 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 9 affected / 41 at risk

Adverse event: socially withdrawn
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 9 affected / 41 at risk

Adverse event: loss of appetite
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 16 affected / 41 at risk

Adverse event: trouble sleeping
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 11 affected / 41 at risk

Adverse event: motor/verbal tics
Serious: no
Organ System: Nervous system disorders
Notes: not including buccal movements
Frequency: 8 affected / 41 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hospitalized for appendectomy
Frequency: 1 affected / 171 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: diagnosed with gastroenteritis and hospitalized for one day
Frequency: 1 affected / 171 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: diagnosed with pneumonia and hospitalized for treatment
Frequency: 1 affected / 171 at risk

Adverse event: skin picking
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 81 affected / 171 at risk

Adverse event: buccal movements
Serious: no
Organ System: Nervous system disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 29 affected / 171 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 104 affected / 171 at risk

Adverse event: dull, listless
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 51 affected / 171 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 45 affected / 171 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 52 affected / 171 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 80 affected / 171 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 55 affected / 171 at risk

Adverse event: socially withdrawn
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 35 affected / 171 at risk

Adverse event: loss of appetite
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 85 affected / 171 at risk

Adverse event: trouble sleeping
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 74 affected / 171 at risk

Adverse event: motor/verbal tics
Serious: no
Organ System: Nervous system disorders
Notes: not including buccal movements
Frequency: 30 affected / 171 at risk

Adverse event: Self-destructive behaviour
Serious: yes
Organ System: Psychiatric disorders
Notes: child tried to open door in moving car in attempt to harm self. Did lead to psychiatric hospitalization with no further self harm events.
Frequency: 1 affected / 136 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hospitalized for appendectomy
Frequency: 1 affected / 136 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: diagnosed with gastroenteritis and hospitalized for one day
Frequency: 1 affected / 136 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: diagnosed with pneumonia and hospitalized for treatment
Frequency: 1 affected / 136 at risk

Adverse event: skin picking
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 57 affected / 136 at risk

Adverse event: buccal movements
Serious: no
Organ System: Nervous system disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 20 affected / 136 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 65 affected / 136 at risk

Adverse event: dull, listless
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 36 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 40 affected / 136 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 43 affected / 136 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 66 affected / 136 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 48 affected / 136 at risk

Adverse event: socially withdrawn
Serious: no
Organ System: Psychiatric disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 27 affected / 136 at risk

Adverse event: loss of appetite
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 85 affected / 136 at risk

Adverse event: trouble sleeping
Serious: no
Organ System: General disorders
Notes: measured on Pittsburgh Side Effect Rating Scale
Frequency: 56 affected / 136 at risk

Adverse event: motor/verbal tics
Serious: no
Organ System: Nervous system disorders
Notes: not including buccal movements
Frequency: 25 affected / 136 at risk