Study: NCT01396486

Adverse event: Agitated/Irritable
Serious: yes
Organ System: Psychiatric disorders
Notes: Required ER visit.
Frequency: 1 affected / 20 at risk

Adverse event: Nausea/Vomit/Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Cold/Infection/Allergy
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: Agitated/Irritable
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bet Wetting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Irregular Behavior
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Scrape
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Agitated/Irritable
Serious: yes
Organ System: Psychiatric disorders
Notes: Required ER visit.
Frequency: 1 affected / 19 at risk

Adverse event: Nausea/Vomit/Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cold/Infection/Allergy
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Agitated/Irritable
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Somnambulism
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Chewing Inside of Cheek
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nausea/Vomit/Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Cold/Infection/Allergy
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Thirsty
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizzy/Lightheaded
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 22 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Autonomic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Agitated with Homicidal Statements
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk