Study: NCT01314001

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 215 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Broken bones due to accidents
Frequency: 2 affected / 215 at risk

Adverse event: Suicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: COPD diagnosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization; COPD diagnosis
Frequency: 1 affected / 215 at risk

Adverse event: Brain aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 215 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 215 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 215 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 215 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 215 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 215 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 215 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 215 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 215 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 215 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 215 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 215 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 28 affected / 215 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 89 affected / 215 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 73 affected / 215 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 95 affected / 215 at risk

Adverse event: Body Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 215 at risk

Adverse event: Feel Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 215 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 68 affected / 215 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 103 affected / 215 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 74 affected / 215 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 51 affected / 215 at risk

Adverse event: Disturbed Attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 54 affected / 215 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 54 affected / 215 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 215 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 125 affected / 215 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 109 affected / 215 at risk

Adverse event: Suicidal Thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 215 at risk

Adverse event: Skin Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 215 at risk

Adverse event: Skin Swelling/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 215 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Episode of atrial fibrillation that required hospitalization
Frequency: 1 affected / 193 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 193 at risk

Adverse event: Gall bladder issues
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hospitalized due to surgery or issues of the gall bladder
Frequency: 1 affected / 193 at risk

Adverse event: Suicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 193 at risk

Adverse event: Severe asthma attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Required hospitalization
Frequency: 1 affected / 193 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 193 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 193 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 193 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 193 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 193 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 193 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 193 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 193 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 101 affected / 193 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 193 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 193 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 193 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 28 affected / 193 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 71 affected / 193 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 71 affected / 193 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 74 affected / 193 at risk

Adverse event: Body Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 193 at risk

Adverse event: Feel Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 193 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 193 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 95 affected / 193 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 87 affected / 193 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 52 affected / 193 at risk

Adverse event: Disturbed Attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 50 affected / 193 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 44 affected / 193 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 63 affected / 193 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 123 affected / 193 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 81 affected / 193 at risk

Adverse event: Suicidal Thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 193 at risk

Adverse event: Skin Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 193 at risk

Adverse event: Skin Swelling/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 193 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Episodes of heart attack or heart attack-like symptoms
Frequency: 1 affected / 227 at risk

Adverse event: Severe nausea/vomiting/abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Symptoms severe enough to require hospitalization.
Frequency: 1 affected / 227 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization due to pneumonia
Frequency: 1 affected / 227 at risk

Adverse event: Knee injuries
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee injuries; may require surgery
Frequency: 1 affected / 227 at risk

Adverse event: Cancer; colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Diagnosis of colon cancer
Frequency: 1 affected / 227 at risk

Adverse event: Cancer; lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Diagnosis of lung cancer
Frequency: 1 affected / 227 at risk

Adverse event: Cancer; oral
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Diagnosis of oral cancer
Frequency: 1 affected / 227 at risk

Adverse event: Sleep problems
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 227 at risk

Adverse event: Suicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 227 at risk

Adverse event: Kidney stone procedure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 227 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 227 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 227 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 227 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 227 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 227 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 227 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 227 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 108 affected / 227 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 227 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 227 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 227 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 26 affected / 227 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 99 affected / 227 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 88 affected / 227 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 75 affected / 227 at risk

Adverse event: Body Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 227 at risk

Adverse event: Feel Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 227 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 94 affected / 227 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 105 affected / 227 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 84 affected / 227 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 66 affected / 227 at risk

Adverse event: Disturbed Attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 46 affected / 227 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 227 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 72 affected / 227 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 130 affected / 227 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 103 affected / 227 at risk

Adverse event: Suicidal Thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 227 at risk

Adverse event: Skin Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 227 at risk

Adverse event: Skin Swelling/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 227 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Episodes of heart attack or heart attack-like symptoms
Frequency: 1 affected / 191 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Tongue Swelling
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization due to swelling of the tongue
Frequency: 1 affected / 191 at risk

Adverse event: Gall bladder issues
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hospitalized due to surgery or issues of the gall bladder
Frequency: 1 affected / 191 at risk

Adverse event: Cancer; colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Diagnosis of colon cancer
Frequency: 1 affected / 191 at risk

Adverse event: Cancer; throat
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Diagnosis of throat cancer
Frequency: 1 affected / 191 at risk

Adverse event: Moderate cervical dysplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unknown whether benign or malignant
Frequency: 1 affected / 191 at risk

Adverse event: Seizures; cause unknown
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 191 at risk

Adverse event: Suicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 191 at risk

Adverse event: Skin/bone biopsy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 191 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 191 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 191 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 191 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 191 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 191 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 191 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 191 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 91 affected / 191 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 191 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 191 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 191 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 16 affected / 191 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 74 affected / 191 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 65 affected / 191 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 64 affected / 191 at risk

Adverse event: Body Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 191 at risk

Adverse event: Feel Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 191 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 88 affected / 191 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 96 affected / 191 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 86 affected / 191 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 52 affected / 191 at risk

Adverse event: Disturbed Attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 191 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 191 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 64 affected / 191 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 119 affected / 191 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 100 affected / 191 at risk

Adverse event: Skin Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 191 at risk

Adverse event: Skin Swelling/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 191 at risk

Adverse event: Diabetes diagnosis
Serious: yes
Organ System: Endocrine disorders
Notes: Diagnosis made during hospitalization following heart attack-like symptoms
Frequency: 1 affected / 220 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization due to pneumonia
Frequency: 1 affected / 220 at risk

Adverse event: Knee injuries
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee injuries; may require surgery
Frequency: 1 affected / 220 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 220 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 220 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 220 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 220 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 71 affected / 220 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 220 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 220 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 111 affected / 220 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 220 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 220 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 220 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 39 affected / 220 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 111 affected / 220 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 88 affected / 220 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 88 affected / 220 at risk

Adverse event: Body Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 220 at risk

Adverse event: Feel Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 220 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 97 affected / 220 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 90 affected / 220 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 71 affected / 220 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 220 at risk

Adverse event: Disturbed Attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 220 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 42 affected / 220 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 83 affected / 220 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 128 affected / 220 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 118 affected / 220 at risk

Adverse event: Suicidal Thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 220 at risk

Adverse event: Skin Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 220 at risk

Adverse event: Skin Swelling/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 220 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Episodes of heart attack or heart attack-like symptoms
Frequency: 1 affected / 200 at risk

Adverse event: Severe nausea/vomiting/abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Symptoms severe enough to require hospitalization.
Frequency: 1 affected / 200 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Knee injuries
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee injuries; may require surgery
Frequency: 1 affected / 200 at risk

Adverse event: Mood changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 200 at risk

Adverse event: Suicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 200 at risk

Adverse event: Abscess drainage; surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 200 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 200 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 200 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 200 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 200 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 200 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 200 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 200 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 98 affected / 200 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 200 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 200 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 200 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 19 affected / 200 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 62 affected / 200 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 79 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 60 affected / 200 at risk

Adverse event: Body Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 200 at risk

Adverse event: Feel Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 200 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 89 affected / 200 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 84 affected / 200 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 73 affected / 200 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 49 affected / 200 at risk

Adverse event: Disturbed Attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 200 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 200 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 60 affected / 200 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 114 affected / 200 at risk

Adverse event: Sleep Problems
Serious: no
Organ System: Psychiatric disorders
Frequency: 109 affected / 200 at risk

Adverse event: Suicidal Thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 200 at risk

Adverse event: Skin Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 200 at risk

Adverse event: Skin Swelling/Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 200 at risk