Study: NCT02697734

Adverse event: Erosive duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 48 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 48 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 48 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 48 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 48 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Blood testosterone increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 48 at risk

Adverse event: Renin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 48 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 48 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 48 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 48 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 48 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 48 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 48 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 48 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 48 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 25 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 25 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 48 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Erosive duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Conjunctival laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Retinal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Cerebral vascular occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 48 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 48 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 48 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 48 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 48 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 12 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 48 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 48 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 48 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 48 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 48 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Blood testosterone increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 48 at risk

Adverse event: Renin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 48 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 48 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 48 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 48 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 48 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 48 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 48 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 48 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 48 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 48 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 48 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 48 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 48 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 48 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 48 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 48 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 25 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Blood testosterone increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 25 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Renin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 25 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 25 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 25 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 25 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 25 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 73 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Erosive duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Conjunctival laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Retinal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 73 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 73 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 73 at risk

Adverse event: Cerebral vascular occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 73 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 73 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 73 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 73 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 73 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 18 affected / 73 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 73 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 73 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 73 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 73 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 73 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 73 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 12 affected / 73 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 73 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 73 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 73 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 73 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 73 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 73 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 73 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 73 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 73 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 73 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 73 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 73 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 73 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 73 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 73 at risk

Adverse event: Blood testosterone increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 73 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: no
Organ System: Investigations
Frequency: 2 affected / 73 at risk

Adverse event: Renin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 73 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 73 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 73 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 73 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 73 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 73 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 73 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 73 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 73 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 73 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 73 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 73 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 73 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 73 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 73 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 73 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 73 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 73 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 73 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 73 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 73 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 73 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 73 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 73 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 73 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 73 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 73 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 73 at risk