Study: NCT00936299

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant hospitalized for two days for pneumonia.
Frequency: 1 affected / 53 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant hospitalized for possible head injury due to a fight.
Frequency: 1 affected / 53 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Anger
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 53 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 53 at risk

Adverse event: Elevated blood pressure
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Elevated pulse
Serious: no
Organ System: General disorders
Frequency: 21 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 53 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 53 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Low pulse
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Muscle pain/soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 53 at risk

Adverse event: Stomache ache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 53 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 14 affected / 53 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 15 affected / 53 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant hospitalized for alleged bipolar (mania) episode.
Frequency: 1 affected / 52 at risk

Adverse event: Tonsilitis
Serious: yes
Organ System: Infections and infestations
Notes: Participant hospitalized overnight for tonsillitis.
Frequency: 1 affected / 52 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Elevated blood pressure
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Elevated pulse
Serious: no
Organ System: General disorders
Frequency: 13 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 52 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 52 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 52 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Low pulse
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: Muscle pain/soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Stomache ache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 52 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 19 affected / 52 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 14 affected / 52 at risk

Adverse event: Worse headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk