Study: NCT01008280

Adverse event: Dizziness, Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Subject stopped taking study medication and was discontinued from the study.
Frequency: 1 affected / 88 at risk

Adverse event: Tightness in the head and Chest
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject was hospitalized over night. Chest and head tightness was determined to be related to an epidural the patient received the day before.
Frequency: 1 affected / 88 at risk

Adverse event: GI Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was admitted for GI bleeding, needed 8 bands in the esophagus.
Frequency: 1 affected / 88 at risk

Adverse event: Altered Mental Status and Renal Failure
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject was hospitalized two times, once for altered mental status and acute renal insufficiency, then again for alcohol withdrawal, hypertension and acute renal failure.
Frequency: 1 affected / 88 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject was hospitalized for Alcohol Withdrawal
Frequency: 1 affected / 88 at risk

Adverse event: Mild Chest Pressure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject had a preexisting history of chest pressure prior to participation in this study. Subject was withdrawn from the study.
Frequency: 1 affected / 88 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 88 at risk

Adverse event: Bedwetting
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 88 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 88 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 20 affected / 88 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 14 affected / 88 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 88 at risk

Adverse event: Difficulty Breathing at Night
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 88 at risk

Adverse event: Difficulty Moving
Serious: no
Organ System: General disorders
Frequency: 10 affected / 88 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 23 affected / 88 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 88 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 34 affected / 88 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 14 affected / 88 at risk

Adverse event: Excessive Perspiration
Serious: no
Organ System: General disorders
Frequency: 13 affected / 88 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 88 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 88 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 88 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 88 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 22 affected / 88 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 88 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 7 affected / 88 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 88 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 13 affected / 88 at risk

Adverse event: Coordination abnormal
Serious: no
Organ System: General disorders
Frequency: 7 affected / 88 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 12 affected / 88 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 88 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 88 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 88 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 88 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 11 affected / 88 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 14 affected / 88 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 88 at risk

Adverse event: Problems Speaking
Serious: no
Organ System: General disorders
Frequency: 8 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 88 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 88 at risk

Adverse event: Dysarthria
Serious: no
Organ System: General disorders
Frequency: 9 affected / 88 at risk

Adverse event: Swelling in Ankles
Serious: no
Organ System: General disorders
Frequency: 4 affected / 88 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 5 affected / 88 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 6 affected / 88 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 88 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 88 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 8 affected / 88 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 88 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 11 affected / 88 at risk

Adverse event: Mental Status Change
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject had an increase in BDI-II (Beck Depression Inventory-II) depression scores and mental status change.
Frequency: 1 affected / 92 at risk

Adverse event: Substance Abuse/Intoxication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject was hospitalized after suspected mix of alcohol and opiate drugs.
Frequency: 1 affected / 92 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: subject was hospitalized for hypotension
Frequency: 1 affected / 92 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 92 at risk

Adverse event: Bedwetting
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 92 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 92 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 14 affected / 92 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 14 affected / 92 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 92 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 92 at risk

Adverse event: Difficulty Breathing at Night
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 92 at risk

Adverse event: Difficulty Moving
Serious: no
Organ System: General disorders
Frequency: 6 affected / 92 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 21 affected / 92 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 92 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 30 affected / 92 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 16 affected / 92 at risk

Adverse event: Excessive Perspiration
Serious: no
Organ System: General disorders
Frequency: 10 affected / 92 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 92 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 92 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 92 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 18 affected / 92 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 92 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 92 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 9 affected / 92 at risk

Adverse event: Coordination abnormal
Serious: no
Organ System: General disorders
Frequency: 11 affected / 92 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 17 affected / 92 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 92 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 92 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 92 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 92 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 13 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 22 affected / 92 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 92 at risk

Adverse event: Problems Speaking
Serious: no
Organ System: General disorders
Frequency: 9 affected / 92 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 92 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 92 at risk

Adverse event: Dysarthria
Serious: no
Organ System: General disorders
Frequency: 4 affected / 92 at risk

Adverse event: Swelling in Ankles
Serious: no
Organ System: General disorders
Frequency: 2 affected / 92 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 5 affected / 92 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 7 affected / 92 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 92 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 92 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 11 affected / 92 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 92 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 15 affected / 92 at risk