Study: NCT02351167

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 275 at risk

Adverse event: Death due to cardiorespiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 275 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 275 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 275 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 275 at risk

Adverse event: Death due to natural causes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 275 at risk

Adverse event: Ammonia poisoning of liver
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 275 at risk

Adverse event: Cellulitis, right hand
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 275 at risk

Adverse event: Infection of second toe on left foot
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 275 at risk

Adverse event: Severe sinus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 275 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 275 at risk

Adverse event: Broken ribs
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 275 at risk

Adverse event: Cervical disc fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 275 at risk

Adverse event: Gunshot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 275 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 275 at risk

Adverse event: Death due to brain tumor complications
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 275 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 275 at risk

Adverse event: Alcohol dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 275 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 275 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 275 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 275 at risk

Adverse event: Asthmatic episode
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 275 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 275 at risk

Adverse event: Chronic sinus necrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 275 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 275 at risk

Adverse event: Trouble breathing due to COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 275 at risk

Adverse event: Foot surgery to fix broken toes on right foot
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 275 at risk

Adverse event: Hip replacement surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 275 at risk

Adverse event: Hysterectomy due to enlarged fallopian tubes
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 275 at risk

Adverse event: Left knee replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 275 at risk

Adverse event: Minor procedure to clean wound on right foot
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 275 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 275 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 275 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 275 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 275 at risk

Adverse event: Rapid, slow, pounding, or irregular heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 275 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 49 affected / 275 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 63 affected / 275 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 275 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 275 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 275 at risk

Adverse event: Itching/hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 275 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 275 at risk

Adverse event: Swelling in face or hands
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 275 at risk

Adverse event: Swelling or tingling in mouth or throat
Serious: no
Organ System: Immune system disorders
Frequency: 20 affected / 275 at risk

Adverse event: Mouth problems (e.g. pain or sore)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 275 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 275 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 275 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 275 at risk

Adverse event: Trouble breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 275 at risk

Adverse event: Feeling worried, nervous, scared, or anxious
Serious: no
Organ System: Psychiatric disorders
Frequency: 50 affected / 275 at risk

Adverse event: Feeling panicky or having panic attacks
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 275 at risk

Adverse event: Feeling agitated and restless
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 275 at risk

Adverse event: Feeling hostile or angry towards others
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 275 at risk

Adverse event: Feeling significantly down, depressed, or hopeless
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 275 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 274 at risk

Adverse event: Hemorrhoid
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Death, unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 274 at risk

Adverse event: Antibiotic spacer for MRSA infection in knee
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: MRSA infection in knee
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Homicide by gunshot
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Motor vehicle accident (injury of intervertebral discs T10-12)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Partial amputation of leg due to MRSA infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Struck by vehicle
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 274 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Unspecified mood disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 274 at risk

Adverse event: Stage 4 endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 274 at risk

Adverse event: Thoracic outlet syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 274 at risk

Adverse event: Abdominal hysterectomy due to endometriosis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 274 at risk

Adverse event: Hysterectomy due to cervical cancer
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 274 at risk

Adverse event: Urethral sling surgery due to urinary incontinence
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 274 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 274 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 92 affected / 274 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 274 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 274 at risk

Adverse event: Rapid, slow, pounding, or irregular heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 274 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 55 affected / 274 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 100 affected / 274 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 274 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 274 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 274 at risk

Adverse event: Itching/hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 274 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 274 at risk

Adverse event: Swelling in face or hands
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 274 at risk

Adverse event: Swelling or tingling in mouth or throat
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 274 at risk

Adverse event: Mouth problems (e.g. pain or sore)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 274 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 274 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 274 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 274 at risk

Adverse event: Trouble breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 274 at risk

Adverse event: Feeling worried, nervous, scared, or anxious
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 274 at risk

Adverse event: Feeling panicky or having panic attacks
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 274 at risk

Adverse event: Feeling agitated and restless
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 274 at risk

Adverse event: Feeling hostile or angry towards others
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 274 at risk

Adverse event: Feeling significantly down, depressed, or hopeless
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 274 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 273 at risk

Adverse event: Death due to congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 273 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 273 at risk

Adverse event: Death due to diabetic coma
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 273 at risk

Adverse event: Type 2 Diabetes
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 273 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 273 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 273 at risk

Adverse event: Surgical incision site infection (post-surgery)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 273 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 273 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 273 at risk

Adverse event: Severe tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 273 at risk

Adverse event: Broken arm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Broken ribs
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Complication from gastric bypass surgery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Death due to heroin overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Gunshot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Sternum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Inter-vertebral dis herniation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 273 at risk

Adverse event: Death due to Lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Lung cancer (stage 4)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Bell's palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 273 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 273 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 273 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 273 at risk

Adverse event: Death due to kidney failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 273 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 273 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 273 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 273 at risk

Adverse event: Hip replacement surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 273 at risk

Adverse event: Knee surgery for osteoarthritis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 273 at risk

Adverse event: Surgery for aortic valve stenosis and cardiac bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 273 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 273 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 273 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 71 affected / 273 at risk

Adverse event: Rapid, slow, pounding, or irregular heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 273 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 42 affected / 273 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 60 affected / 273 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 273 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 32 affected / 273 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 273 at risk

Adverse event: Itching/hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 273 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 273 at risk

Adverse event: Swelling in face or hands
Serious: no
Organ System: Immune system disorders
Frequency: 16 affected / 273 at risk

Adverse event: Swelling or tingling in mouth or throat
Serious: no
Organ System: Immune system disorders
Frequency: 12 affected / 273 at risk

Adverse event: Mouth problems (e.g. pain or sore)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 273 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 273 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 273 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 273 at risk

Adverse event: Trouble breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 273 at risk

Adverse event: Feeling worried, nervous, scared, or anxious
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 273 at risk

Adverse event: Feeling panicky or having panic attacks
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 273 at risk

Adverse event: Feeling agitated and restless
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 273 at risk

Adverse event: Feeling hostile or angry towards others
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 273 at risk

Adverse event: Feeling significantly down, depressed, or hopeless
Serious: no
Organ System: Psychiatric disorders
Frequency: 44 affected / 273 at risk