Study: NCT02744898

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Myalgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Absolute Neutrophilous Count Decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 23 at risk

Adverse event: Alkaline Phosphatase Elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 23 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Alopecia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 16 affected / 23 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Anc Decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 23 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 23 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 23 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 23 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 23 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: B/L Deep Vein Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: B/L Pleural Effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Back pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 23 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Body Aches(Myalgias)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Colitis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cough/Clear Sputum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 23 at risk

Adverse event: Decreased Anc
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Decreased Neutrolphil Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Decreased Platelet Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Decreased Sodium
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Decreased White Blood Cell Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 23 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Dry skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyseusia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Elevated Alkaline Phosphatase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Elevated Alt
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Elevated Potassium
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Elevated Total Bilirubin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 23 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gastroesophageal Reflux Disease 22
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Generalized Weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gi Distress/Abdominal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gingival pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gingivitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 23 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Increased Alkaline Phospatase Level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Increased Alkaline Phosphatase
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Intermittent Abdominal Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Anorexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Blurred Vision
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Decreased Platelets
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Diarrhea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Intermittent Hyperglycemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Myalgias
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Intermittent Nausea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 23 at risk

Adverse event: L E Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Le Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Left Arm Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Left Quadrant Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Left-Hand Neuropathy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Leukopenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Low White Blood Cell Count
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Memory impairment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nail infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 12 affected / 23 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Neuotrophil Count Decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Pain (Tooth)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: Peridontal Disease
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Platelet count
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Platelets Decresed
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Renal And Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Right Leg Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Skin And Subcutaneous Tissue Disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 23 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Embolism
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Total Bilirubin Elevated
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: White Blood Cells Decreased
Serious: no
Organ System: General disorders
Frequency: 9 affected / 23 at risk

Adverse event: Wound complication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Right Leg Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk