TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01499134

Adverse event: Decrease in hemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The patient had a decrease in hemoglobin and was sent to outside hospital where upper endoscopy and colonoscopy found no bleeding. The patient received 2 units of packed red blood cells started on a regimen of ferrous sulfate 320 mg PO BID.
Frequency: 1 affected / 9 at risk

Adverse event: Peripheral stent placed
Serious: yes
Organ System: Vascular disorders
Notes: The patient had elective left femoral and popliteal artery angioplasty with stent placed in left leg due to disabling claudication.
Frequency: 1 affected / 9 at risk
Study: NCT01499147

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: CMV reactivation
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: CMV reactivation
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: CMV reactivation
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 12 at risk
Study: NCT01499511

Adverse event: Injuries
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: after fall from bicycle
Frequency: 1 affected / 885 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: Bronchiectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 885 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 885 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 885 at risk

Adverse event: Alcohol dependence withdrawal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 885 at risk

Adverse event: Circulatory collapse
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 833 at risk
Study: NCT01499576

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 105 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk
Study: NCT01499810

Adverse event: Pospunctional pseudoaneurysm of femoral artery
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Small hematoma communicating with the lumen of femoral artery occurred as a result of percutaneous punction of the femoral artery in course the procedure
Frequency: 3 affected / 53 at risk
Study: NCT01499953

Adverse event: Diabetic foot syndrome with tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 235 at risk

Adverse event: Hospitalisation for COPD exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 235 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 235 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 235 at risk

Adverse event: Suspected infection-associated seizure
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 236 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 236 at risk

Adverse event: Mucosal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 236 at risk

Adverse event: New onset of atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 236 at risk

Adverse event: Worsening of arterial hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 236 at risk

Adverse event: Hemorrhagic allergic skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 236 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 236 at risk
Study: NCT01500057

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Urethral stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 35 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk
Study: NCT01500317

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk
Study: NCT01500629

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 21 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Pregnancy of partner
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 20 at risk
Study: NCT01500772

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT01501955

Adverse event: Stem revision
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Notes: ST depression and Myocard Infarction
Frequency: 1 affected / 11 at risk

Adverse event: Cup revision
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cortical Erosion/Osteolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Superficial Infection Wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Stem revision
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 9 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Notes: ST depression and Myocard Infarction
Frequency: 1 affected / 9 at risk

Adverse event: Pain in groin During Weigth Bearing
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk
Study: NCT01502033

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One participant had scalp pain with the initial session and discontinued treatment.
Frequency: 1 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety (related to school expectations)
Frequency: 1 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Worsening depression
Frequency: 1 affected / 10 at risk
Study: NCT01502072

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Worsening oral ulcer
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 13 at risk

Adverse event: Shortness of breath/hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Alveolar hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

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

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

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

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

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk
Study: NCT01502228

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 14 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 14 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 14 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk
Study: NCT01502371

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 120 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 120 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 113 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 113 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 108 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 108 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 108 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 125 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 125 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 112 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 112 at risk
Study: NCT01502423

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

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk

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

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

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

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

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Traumatic pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk
Study: NCT01502709

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, transient
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk
Study: NCT01502761

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Parotiditis with sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ischemic change on brain imaging
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hemorrhagic Transformation of stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: increased blood glucose
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk
Study: NCT01503749

Adverse event: ascties tapping
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: percutaneous vertebroplasty
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: ascties tapping
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Liver transplant
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hepatic encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk
Study: NCT01504204

Adverse event: Dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dry skin
Frequency: 3 affected / 10 at risk

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

Adverse event: Dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dry skin
Frequency: 3 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin itching
Frequency: 2 affected / 10 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: red skin
Frequency: 1 affected / 10 at risk
Study: NCT01504438

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unrelated to study
Frequency: 1 affected / 50 at risk
Study: NCT01504477

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS
Frequency: 2 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Electrolyte
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk