Study: NCT01331304

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 240 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 18 affected / 240 at risk

Adverse event: Car/Bike Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 240 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 240 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 240 at risk

Adverse event: Laparoscopic Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 240 at risk

Adverse event: Alcoholism Treatment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 240 at risk

Adverse event: Gastrointestinal Issues
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 240 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 240 at risk

Adverse event: Heroin Overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 240 at risk

Adverse event: Eczema Outbreak
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 240 at risk

Adverse event: Muscle Spasms Hospitalization
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 240 at risk

Adverse event: Biliary cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 240 at risk

Adverse event: Study Medication Overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 240 at risk

Adverse event: Psychogenic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 240 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Notes: Adverse reaction to study medication: dizziness, disturbance in gait
Frequency: 1 affected / 240 at risk

Adverse event: Excessive sleepiness/daytime somnolence
Serious: no
Organ System: General disorders
Frequency: 68 affected / 240 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 240 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 29 affected / 240 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 240 at risk

Adverse event: Increased Weight
Serious: no
Organ System: General disorders
Frequency: 25 affected / 240 at risk

Adverse event: Tremor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 240 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 20 affected / 240 at risk

Adverse event: Memory/concentration problems
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 240 at risk

Adverse event: Dizziness/Lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 240 at risk

Adverse event: Upset stomach/stomach pain/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 240 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 240 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 240 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 29 affected / 240 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 240 at risk

Adverse event: Stiffness/muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 240 at risk

Adverse event: Weakness/muscle fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 240 at risk

Adverse event: Restless/fidgety (akathisia)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 240 at risk

Adverse event: Respiratory infection or other cold-like symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 240 at risk

Adverse event: Muscle twitching (myoclonus)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 240 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 240 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 240 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 240 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 242 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 242 at risk

Adverse event: Car/Bike Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 242 at risk

Adverse event: Hospitalization reason unknown
Serious: yes
Organ System: General disorders
Notes: Hospitalization reason unknown; unable to re-contact study participant
Frequency: 1 affected / 242 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 242 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 242 at risk

Adverse event: Flu Hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Extreme Sedation Hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 242 at risk

Adverse event: Study Medication Overdose
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 242 at risk

Adverse event: Cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 242 at risk

Adverse event: Staph Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Excessive sleepiness/daytime somnolence
Serious: no
Organ System: General disorders
Frequency: 186 affected / 242 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 242 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 51 affected / 242 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 242 at risk

Adverse event: Increased Weight
Serious: no
Organ System: General disorders
Frequency: 45 affected / 242 at risk

Adverse event: Tremor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 242 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 55 affected / 242 at risk

Adverse event: Memory/concentration problems
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 242 at risk

Adverse event: Dizziness/Lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 242 at risk

Adverse event: Upset stomach/stomach pain/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 242 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 242 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 242 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 4 affected / 242 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 242 at risk

Adverse event: Stiffness/muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 242 at risk

Adverse event: Weakness/muscle fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 242 at risk

Adverse event: Restless/fidgety (akathisia)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 242 at risk

Adverse event: Respiratory infection or other cold-like symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 242 at risk

Adverse event: Muscle twitching (myoclonus)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 242 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 242 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 242 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 242 at risk