Study: NCT00205699

Adverse event: Injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 49 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 49 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 49 at risk

Adverse event: Drowsiness/Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 49 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 49 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 49 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 49 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 49 at risk

Adverse event: Thirst
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 49 at risk

Adverse event: Trouble Sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 49 at risk

Adverse event: Weight increased
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 49 at risk

Adverse event: Injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 46 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 46 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 46 at risk

Adverse event: Constipation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 46 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 46 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 46 at risk

Adverse event: Drowsiness/Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 46 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 46 at risk

Adverse event: Involuntary Movements
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 46 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 46 at risk

Adverse event: Thirst
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 46 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 46 at risk

Adverse event: Trouble Sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 46 at risk

Adverse event: Weight increased
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 46 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: About 2 months after starting Risperidone, participant had a complex partial seizure, later determined by a neurologist to be unrelated to study medication. Participant was restarted on the Risperidone.
Frequency: 1 affected / 49 at risk

Adverse event: Injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 49 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 49 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 49 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 49 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 49 at risk

Adverse event: Drowsiness/Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 49 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 49 at risk

Adverse event: Involuntary Movements
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 49 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 49 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 49 at risk

Adverse event: Thirst
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 49 at risk

Adverse event: Trouble Sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 49 at risk

Adverse event: Weight increased
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 49 at risk