Study: NCT02716818

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Salpingitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Tonsilitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Ear infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Tonsilitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 61 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 61 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Abnormal weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 61 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 61 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Gluten sensitivity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hyperinsulinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 61 at risk

Adverse event: Impaired fasting glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 61 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 61 at risk

Adverse event: Weight fluctuation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Affect lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Burnout syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 61 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Circardian Rhythm Sleep Disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 61 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 61 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Peripheral nerve lesion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Poor quality sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 61 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hair growth abnormal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 61 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 61 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Muscle fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Fat tissue increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 61 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Influenza-like Illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 61 at risk

Adverse event: Therapeutic response unexpected
Serious: no
Organ System: General disorders
Notes: AE of unexpected therapeutic benefit
Frequency: 10 affected / 61 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 61 at risk

Adverse event: Osteocalcin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Renin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 61 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Head Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Mineralocorticoid deficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Salpingitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Adrenocortical Insufficiency (acute)
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 61 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 61 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 61 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Abnormal weight gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 61 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hyperinsulinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Impaired fasting glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 61 at risk

Adverse event: Alcohol intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 61 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 61 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 61 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Emotional distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 61 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Ear deformity acquired
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 61 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pallor
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Chloasma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 61 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 61 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 61 at risk

Adverse event: Influenza-like Illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Therapeutic response unexpected
Serious: no
Organ System: General disorders
Notes: AE of unexpected therapeutic benefit
Frequency: 1 affected / 61 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Sensation of foreign body
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Renin increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 61 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: C-telopeptide increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Auricular haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Ear injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk