Study: NCT01585584

Adverse event: Emergency room visit due to suspected celulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Pregnancy in spouse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Subject was instructed to use 2 methods of birth control for duration of study. however subject's partner had an unplanned pregnancy shortly after discontinuing study drug. Subject's spouse chose to terminate the pregnancy
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 10 at risk

Adverse event: Anisocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Apthous ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 10 at risk

Adverse event: Onychoclasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 10 at risk

Adverse event: Chest pain on inspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Delayed healing
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Despressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Difficulty concentrating
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 6 affected / 10 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 10 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 10 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Exerional dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 10 at risk

Adverse event: Feeling overwhlemed
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Hypoalbuminema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Hypochloraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hypochromasia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 10 at risk

Adverse event: Increased INR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Increased leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Increased neutrophils
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Local injection site reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 10 at risk

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

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 10 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 10 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 10 at risk

Adverse event: High density lipoprotein decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 10 at risk

Adverse event: Non-productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: Polychromasia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Worsening of psoriasis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 10 at risk

Adverse event: Resltess legs
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Acrochordon
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Irritated eyes
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tender gums
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 10 at risk

Adverse event: Tongue discolouration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Transient heart rate increase
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Low density lipoprotein decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk