Study: NCT00935818

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: sustained trauma during a motor vehicle collision
Frequency: 1 affected / 249 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 249 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 249 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: new diagnosis
Frequency: 1 affected / 249 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 100 affected / 249 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 249 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 249 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 249 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 21 affected / 249 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 18 affected / 249 at risk

Adverse event: difficulty concentrating
Serious: no
Organ System: General disorders
Frequency: 14 affected / 249 at risk

Adverse event: mood disturbance
Serious: no
Organ System: General disorders
Frequency: 13 affected / 249 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 249 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 9 affected / 249 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 249 at risk

Adverse event: depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 249 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 249 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 7 affected / 249 at risk

Adverse event: dispepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 249 at risk

Adverse event: flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: food poisining
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 257 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 257 at risk

Adverse event: Death
Serious: yes
Organ System: Immune system disorders
Notes: death due to complications from human immunodeficiency virus 6 months after the study drug was discontinued
Frequency: 1 affected / 257 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: 9 months after the study drug was discontinued
Frequency: 1 affected / 257 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 257 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 91 affected / 257 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 257 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 257 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 257 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 12 affected / 257 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 8 affected / 257 at risk

Adverse event: difficulty concentrating
Serious: no
Organ System: General disorders
Frequency: 10 affected / 257 at risk

Adverse event: mood disturbance
Serious: no
Organ System: General disorders
Frequency: 7 affected / 257 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 257 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 19 affected / 257 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 257 at risk

Adverse event: depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 257 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 257 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 9 affected / 257 at risk

Adverse event: dispepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 257 at risk