Study: NCT01934556

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Arrhythmia
Frequency: 1 affected / 30 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hematoma
Frequency: 1 affected / 30 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Allergy
Frequency: 1 affected / 30 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Appendicitis
Frequency: 1 affected / 30 at risk

Adverse event: Skin/Soft Tissue Infection
Serious: yes
Organ System: Infections and infestations
Notes: Skin/Soft Tissue Infection
Frequency: 1 affected / 30 at risk

Adverse event: Hyperammonaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Hyperammonemia
Frequency: 1 affected / 30 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Osteoarthritis
Frequency: 1 affected / 30 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lung Cancer
Frequency: 1 affected / 30 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urolithiasis
Frequency: 1 affected / 30 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute Respiratory Failure
Frequency: 1 affected / 30 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 1 affected / 30 at risk

Adverse event: Blurred Vision/Vision Loss
Serious: no
Organ System: Eye disorders
Notes: Blurred Vision/Vision Loss
Frequency: 1 affected / 30 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Notes: Cataract Progression
Frequency: 1 affected / 30 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Notes: Chalazion
Frequency: 2 affected / 30 at risk

Adverse event: Elevated Intraocular Pressure
Serious: no
Organ System: Eye disorders
Notes: Elevated Intraocular Pressure
Frequency: 3 affected / 30 at risk

Adverse event: Eye Discomfort/Discharge
Serious: no
Organ System: Eye disorders
Notes: Eye Discomfort/Discharge
Frequency: 6 affected / 30 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: Secondary Cataract
Frequency: 3 affected / 30 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Vitreous Floaters
Frequency: 7 affected / 30 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Punctate Keratitis
Frequency: 2 affected / 30 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac Arrhythmia
Frequency: 2 affected / 30 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Notes: Peripheral Edema
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 2 affected / 30 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Gallstones
Frequency: 1 affected / 30 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Esophageal Reflux
Frequency: 2 affected / 30 at risk

Adverse event: Poor Dentition
Serious: no
Organ System: General disorders
Notes: Poor Dentition
Frequency: 2 affected / 30 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Throat Irritation
Frequency: 3 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 30 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergy
Frequency: 5 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Notes: Gastrointestinal Infection
Frequency: 1 affected / 30 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Skin Infection
Frequency: 6 affected / 30 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory Infection
Frequency: 12 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinusitis
Frequency: 5 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary Tract Infection
Frequency: 4 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 3 affected / 30 at risk

Adverse event: Hypo/Hyperglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypo/Hyperglycemia
Frequency: 7 affected / 30 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperlipidemia
Frequency: 5 affected / 30 at risk

Adverse event: Androgen deficiency
Serious: no
Organ System: Endocrine disorders
Notes: Testosterone Deficiency
Frequency: 2 affected / 30 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Vitamin D Deficiency
Frequency: 1 affected / 30 at risk

Adverse event: Fractured Bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fractured Bone
Frequency: 2 affected / 30 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal Pain
Frequency: 12 affected / 30 at risk

Adverse event: Skin Burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin Burn
Frequency: 2 affected / 30 at risk

Adverse event: Colon cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Colon Cancer
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Dizziness
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Headache
Frequency: 6 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Insomnia
Frequency: 7 affected / 30 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Paresthesia
Frequency: 2 affected / 30 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal Insufficiency
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 2 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 2 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 10 affected / 30 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Vitreous Hemorrhage
Frequency: 1 affected / 60 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial Infarction
Frequency: 4 affected / 60 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiomyopathy
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Congestive Heart Failure
Frequency: 2 affected / 60 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Coronary Artery Disease
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Notes: Gastrointestinal Infection
Frequency: 1 affected / 60 at risk

Adverse event: Skin/Soft Tissue Infection
Serious: yes
Organ System: Infections and infestations
Notes: Skin/Soft Tissue Infection
Frequency: 3 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Urinary Tract Infection
Frequency: 1 affected / 60 at risk

Adverse event: Hypo/Hyperglycemia
Serious: yes
Organ System: Endocrine disorders
Notes: Hypo/Hyperglycemia
Frequency: 2 affected / 60 at risk

Adverse event: Fractured Bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fractured Bone
Frequency: 1 affected / 60 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Colon Cancer
Frequency: 1 affected / 60 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Prostate Cancer
Frequency: 1 affected / 60 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope
Frequency: 1 affected / 60 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urolithiasis
Frequency: 1 affected / 60 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal Failure
Frequency: 1 affected / 60 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute Respiratory Failure
Frequency: 1 affected / 60 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 4 affected / 60 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Orthostatic Hypotension
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 2 affected / 60 at risk

Adverse event: Blurred Vision/Vision Loss
Serious: no
Organ System: Eye disorders
Notes: Blurred Vision/Vision Loss
Frequency: 6 affected / 60 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Notes: Cataract Progression
Frequency: 5 affected / 60 at risk

Adverse event: Elevated Intraocular Pressure
Serious: no
Organ System: Eye disorders
Notes: Elevated Intraocular Pressure
Frequency: 4 affected / 60 at risk

Adverse event: Eye Discomfort/Discharge
Serious: no
Organ System: Eye disorders
Notes: Eye Discomfort/Discharge
Frequency: 9 affected / 60 at risk

Adverse event: Eyelid Swelling
Serious: no
Organ System: Eye disorders
Notes: Eyelid Swelling
Frequency: 3 affected / 60 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: Secondary Cataract
Frequency: 2 affected / 60 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Vitreous Floaters
Frequency: 6 affected / 60 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Punctate Keratitis
Frequency: 3 affected / 60 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Vitreous Hemorrhage
Frequency: 4 affected / 60 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Notes: Myocardial Infarction
Frequency: 5 affected / 60 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac Arrhythmia
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: Congestive Heart Failure
Frequency: 2 affected / 60 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Notes: Peripheral Edema
Frequency: 6 affected / 60 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Gallstones
Frequency: 1 affected / 60 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Esophageal Reflux
Frequency: 4 affected / 60 at risk

Adverse event: Poor Dentition
Serious: no
Organ System: General disorders
Notes: Poor Dentition
Frequency: 3 affected / 60 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Throat Irritation
Frequency: 1 affected / 60 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 4 affected / 60 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergy
Frequency: 9 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Notes: Gastrointestinal Infection
Frequency: 3 affected / 60 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Skin Infection
Frequency: 18 affected / 60 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory Infection
Frequency: 22 affected / 60 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinusitis
Frequency: 9 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary Tract Infection
Frequency: 2 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 1 affected / 60 at risk

Adverse event: Hypo/Hyperglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypo/Hyperglycemia
Frequency: 12 affected / 60 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperlipidemia
Frequency: 4 affected / 60 at risk

Adverse event: Hypo/Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypo/Hyperkalemia
Frequency: 1 affected / 60 at risk

Adverse event: Androgen deficiency
Serious: no
Organ System: Endocrine disorders
Notes: Testosterone Deficiency
Frequency: 1 affected / 60 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Vitamin D Deficiency
Frequency: 3 affected / 60 at risk

Adverse event: Fractured Bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fractured Bone
Frequency: 3 affected / 60 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal Pain
Frequency: 16 affected / 60 at risk

Adverse event: Skin Burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin Burn
Frequency: 2 affected / 60 at risk

Adverse event: Colon cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Colon Cancer
Frequency: 3 affected / 60 at risk

Adverse event: Depression/Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Depression/Anxiety
Frequency: 1 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Dizziness
Frequency: 3 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Headache
Frequency: 1 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Insomnia
Frequency: 7 affected / 60 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Paresthesia
Frequency: 1 affected / 60 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal Insufficiency
Frequency: 1 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 5 affected / 60 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 4 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 21 affected / 60 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial Infarction
Frequency: 2 affected / 60 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Angina Pectoris
Frequency: 1 affected / 60 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Arrhythmia
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Congestive Heart Failure
Frequency: 4 affected / 60 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Coronary Artery Disease
Frequency: 1 affected / 60 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Pericardial Effusion
Frequency: 1 affected / 60 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Gallstones
Frequency: 1 affected / 60 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Notes: Gastrointestinal Infection
Frequency: 1 affected / 60 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Notes: Parotitis
Frequency: 1 affected / 60 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Respiratory Infection
Frequency: 1 affected / 60 at risk

Adverse event: Skin/Soft Tissue Infection
Serious: yes
Organ System: Infections and infestations
Notes: Skin/Soft Tissue Infection
Frequency: 4 affected / 60 at risk

Adverse event: Elevated Creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Elevated Creatinine
Frequency: 1 affected / 60 at risk

Adverse event: Hypo/Hyperglycemia
Serious: yes
Organ System: Endocrine disorders
Notes: Hypo/Hyperglycemia
Frequency: 2 affected / 60 at risk

Adverse event: Fractured Bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fractured Bone
Frequency: 2 affected / 60 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal Pain
Frequency: 1 affected / 60 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Colon Cancer
Frequency: 1 affected / 60 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lung Cancer
Frequency: 1 affected / 60 at risk

Adverse event: Cranial nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Notes: Cranial Nerve Palsy
Frequency: 1 affected / 60 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Cerebrovascular Accident
Frequency: 3 affected / 60 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope
Frequency: 1 affected / 60 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Transient Ischemic Attack
Frequency: 1 affected / 60 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal Failure
Frequency: 2 affected / 60 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute Respiratory Failure
Frequency: 1 affected / 60 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea
Frequency: 1 affected / 60 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 3 affected / 60 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 6 affected / 60 at risk

Adverse event: Blurred Vision/Vision Loss
Serious: no
Organ System: Eye disorders
Notes: Blurred Vision/Vision Loss
Frequency: 5 affected / 60 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Notes: Cataract Progression
Frequency: 7 affected / 60 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Notes: Chalazion
Frequency: 1 affected / 60 at risk

Adverse event: Elevated Intraocular Pressure
Serious: no
Organ System: Eye disorders
Notes: Elevated Intraocular Pressure
Frequency: 3 affected / 60 at risk

Adverse event: Eye Discomfort/Discharge
Serious: no
Organ System: Eye disorders
Notes: Eye Discomfort/Discharge
Frequency: 15 affected / 60 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: Secondary Cataract
Frequency: 2 affected / 60 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Vitreous Floaters
Frequency: 7 affected / 60 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Punctate Keratitis
Frequency: 6 affected / 60 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Vitreous Hemorrhage
Frequency: 1 affected / 60 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Notes: Myocardial Infarction
Frequency: 2 affected / 60 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Angina Pectoris
Frequency: 5 affected / 60 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac Arrhythmia
Frequency: 3 affected / 60 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: Congestive Heart Failure
Frequency: 4 affected / 60 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Notes: Peripheral Edema
Frequency: 8 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 1 affected / 60 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Gallstones
Frequency: 3 affected / 60 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Esophageal Reflux
Frequency: 3 affected / 60 at risk

Adverse event: Poor Dentition
Serious: no
Organ System: General disorders
Notes: Poor Dentition
Frequency: 3 affected / 60 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Throat Irritation
Frequency: 1 affected / 60 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 7 affected / 60 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergy
Frequency: 5 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Notes: Gastrointestinal Infection
Frequency: 4 affected / 60 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Skin Infection
Frequency: 20 affected / 60 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory Infection
Frequency: 14 affected / 60 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinusitis
Frequency: 3 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary Tract Infection
Frequency: 1 affected / 60 at risk

Adverse event: Hypo/Hyperglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypo/Hyperglycemia
Frequency: 14 affected / 60 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperlipidemia
Frequency: 6 affected / 60 at risk

Adverse event: Hypo/Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypo/Hyperkalemia
Frequency: 5 affected / 60 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Vitamin D Deficiency
Frequency: 2 affected / 60 at risk

Adverse event: Fractured Bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fractured Bone
Frequency: 9 affected / 60 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal Pain
Frequency: 18 affected / 60 at risk

Adverse event: Skin Burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin Burn
Frequency: 1 affected / 60 at risk

Adverse event: Colon cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Colon Cancer
Frequency: 1 affected / 60 at risk

Adverse event: Depression/Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Depression/Anxiety
Frequency: 3 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Dizziness
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Headache
Frequency: 3 affected / 60 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Paresthesia
Frequency: 1 affected / 60 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal Insufficiency
Frequency: 6 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 5 affected / 60 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 3 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 26 affected / 60 at risk