Study: NCT00194012

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 15 affected / 31 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 11 affected / 31 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Notes: One case in the placebo group had a dosing reduction
Frequency: 7 affected / 31 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: Per study protocol as previously outlined
Frequency: 7 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee Pain, back ache
Frequency: 5 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Runny nose, Sneezing
Frequency: 2 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 12 affected / 31 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 7 affected / 31 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Notes: One case in the placebo group had a dosing reduction
Frequency: 2 affected / 31 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: Per study protocol as previously outlined
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee Pain, back ache
Frequency: 2 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Runny nose, Sneezing
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 8 affected / 22 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 3 affected / 22 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Notes: One case in the placebo group had a dosing reduction
Frequency: 1 affected / 22 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: Per study protocol as previously outlined
Frequency: 8 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee Pain, back ache
Frequency: 4 affected / 22 at risk

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

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Runny nose, Sneezing
Frequency: 3 affected / 22 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinus infection
Frequency: 1 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Broken leg, broken nose, heel injury
Frequency: 6 affected / 22 at risk

Adverse event: Athletes Foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 5 affected / 21 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: One case in the abilify group had a dosing reduction
Frequency: 6 affected / 21 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Notes: One case in the placebo group had a dosing reduction
Frequency: 4 affected / 21 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: Per study protocol as previously outlined
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee Pain, back ache
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinus infection
Frequency: 3 affected / 21 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Broken leg, broken nose, heel injury
Frequency: 2 affected / 21 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 21 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: Tired, Tiredness, Fatigue, Going to bed early
Frequency: 11 affected / 21 at risk

Adverse event: Allergies
Serious: no
Organ System: General disorders
Notes: including nickel allergy
Frequency: 5 affected / 21 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Increased heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Notes: Flu
Frequency: 1 affected / 21 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Can't remember music
Frequency: 1 affected / 21 at risk