Study: NCT03023722

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Fever
Frequency: 1 affected / 18 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Cognitive Disturbance
Frequency: 1 affected / 18 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke
Frequency: 1 affected / 18 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute Kidney Injury
Frequency: 1 affected / 18 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Hypotension
Frequency: 1 affected / 18 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Obstruction Gastric
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal Pain
Frequency: 1 affected / 18 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ascites
Frequency: 1 affected / 18 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis
Frequency: 1 affected / 18 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea
Frequency: 1 affected / 18 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypoxia
Frequency: 1 affected / 18 at risk

Adverse event: Palmar Plantar Erythrodysesthes
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Palmar Plantar Erythrodysesthes
Frequency: 1 affected / 18 at risk

Adverse event: Blood and Lymphatic System Disorders-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Febrile Neutropenia
Frequency: 1 affected / 18 at risk

Adverse event: Infections and Infestations-other
Serious: yes
Organ System: Infections and infestations
Notes: Elevated White Blood Count
Frequency: 1 affected / 18 at risk

Adverse event: Respiratory Failure (Pleural metastatic PD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory Failure (Pleural metastatic PD)
Frequency: 1 affected / 18 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 1 affected / 18 at risk

Adverse event: General Disorders and administration-other specify Failure to Thrive
Serious: yes
Organ System: General disorders
Notes: Failure to thrive
Frequency: 1 affected / 18 at risk

Adverse event: General Disorders and administration-other specify Death NOS
Serious: yes
Organ System: General disorders
Notes: Death NOS
Frequency: 1 affected / 18 at risk

Adverse event: Infections and Infestations-Other, specify-Rhinovirus
Serious: yes
Organ System: Infections and infestations
Notes: Rhino virus
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distention
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal Pain
Frequency: 12 affected / 18 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Cardiac disorders
Notes: PTT Prolonged
Frequency: 3 affected / 18 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Aacute kidney injury
Frequency: 2 affected / 18 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Alanine Aminotransferase Elevated
Frequency: 3 affected / 18 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Alkaline Phosphatase Increase
Frequency: 6 affected / 18 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Allergic Rhinitis
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 8 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Anorexia
Frequency: 11 affected / 18 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 5 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthralgias
Frequency: 1 affected / 18 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthritis - knees / hands
Frequency: 2 affected / 18 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ascites
Frequency: 2 affected / 18 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: AST Increase
Frequency: 2 affected / 18 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Atrial fibrillation
Frequency: 3 affected / 18 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Atrial flutter
Frequency: 1 affected / 18 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain
Frequency: 1 affected / 18 at risk

Adverse event: Basal Cell Carcinoma of Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Basal Cell Carcinoma of Skin
Frequency: 1 affected / 18 at risk

Adverse event: Bladder cancer
Serious: no
Organ System: Renal and urinary disorders
Notes: Bladder Cancer
Frequency: 1 affected / 18 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Elevated bilirubin
Frequency: 3 affected / 18 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Blurred Vison
Frequency: 3 affected / 18 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Investigations
Notes: cardiac troponin i increased
Frequency: 1 affected / 18 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Cataracts
Frequency: 1 affected / 18 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Chills
Frequency: 3 affected / 18 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Notes: High Cholesterol
Frequency: 1 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 11 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dry Cough
Frequency: 1 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 2 affected / 18 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Creatinine Increase
Frequency: 1 affected / 18 at risk

Adverse event: Decreased Platelet Count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Decreased Platelet Count
Frequency: 1 affected / 18 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dehydration
Frequency: 5 affected / 18 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Depression
Frequency: 4 affected / 18 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: diabetes
Frequency: 3 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 10 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 3 affected / 18 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Dry Eyes
Frequency: 7 affected / 18 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dry Mouth
Frequency: 2 affected / 18 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Dysgeusia
Frequency: 1 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dyspepsia
Frequency: 3 affected / 18 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea
Frequency: 2 affected / 18 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Edema limbs
Frequency: 5 affected / 18 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Cardiac disorders
Notes: Prolonged QTC
Frequency: 2 affected / 18 at risk

Adverse event: Dermatitis exfoliative generalised
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Facial Erythema
Frequency: 1 affected / 18 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Colorblindness
Frequency: 1 affected / 18 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Right eye pain
Frequency: 1 affected / 18 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 14 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: fevers
Frequency: 2 affected / 18 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Flatulence
Frequency: 1 affected / 18 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: GERD
Frequency: 3 affected / 18 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Partial gastric outlet obstruction
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal hernia
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mouth sores
Frequency: 1 affected / 18 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Generalized muscle weakness
Frequency: 1 affected / 18 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: GGT increased
Frequency: 1 affected / 18 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Notes: Glaucoma
Frequency: 1 affected / 18 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: GOUT
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 18 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Hearing impaired
Frequency: 1 affected / 18 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Hematuria
Frequency: 1 affected / 18 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hiccups
Frequency: 1 affected / 18 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hoarseness
Frequency: 1 affected / 18 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Notes: Hypercholesterolemia
Frequency: 1 affected / 18 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: hyperglycemia
Frequency: 1 affected / 18 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypokalemia
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 7 affected / 18 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hyperlipidemia
Frequency: 1 affected / 18 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperuricemia
Frequency: 2 affected / 18 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypoalbuminemia
Frequency: 3 affected / 18 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypocalcemia
Frequency: 3 affected / 18 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypokalemia
Frequency: 3 affected / 18 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypomagnesemia
Frequency: 2 affected / 18 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia
Frequency: 4 affected / 18 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypophosphatemia
Frequency: 2 affected / 18 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Orthostatic Hypotension
Frequency: 1 affected / 18 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypoxia
Frequency: 1 affected / 18 at risk

Adverse event: Increased LDH
Serious: no
Organ System: Investigations
Notes: Increased LDH
Frequency: 1 affected / 18 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Oral Thrush
Frequency: 1 affected / 18 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: inguinal hernia
Frequency: 1 affected / 18 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Notes: Elevated INR
Frequency: 4 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Insomnia
Frequency: 9 affected / 18 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Tremors
Frequency: 1 affected / 18 at risk

Adverse event: Investigations- other, specify
Serious: no
Organ System: Investigations
Notes: Elevated LDH
Frequency: 1 affected / 18 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: Irritability
Frequency: 1 affected / 18 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Left Ventricular Systolic Dysfunction
Frequency: 1 affected / 18 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Notes: Lipase
Frequency: 1 affected / 18 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: lymphocyte count decrease
Frequency: 5 affected / 18 at risk

Adverse event: Malabsorption
Serious: no
Organ System: Gastrointestinal disorders
Notes: Malabsorption
Frequency: 1 affected / 18 at risk

Adverse event: Metabolism and nutrition disorders - Other, specify
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 1 affected / 18 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mucositis
Frequency: 1 affected / 18 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: myalgia
Frequency: 2 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 9 affected / 18 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Neuropathy
Frequency: 1 affected / 18 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Non cardiac chest pain
Frequency: 1 affected / 18 at risk

Adverse event: Occasional Epigastric Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Occasional Epigastric Pain
Frequency: 1 affected / 18 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: Orthostatic Hypotension
Frequency: 1 affected / 18 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain (back/neck)
Frequency: 1 affected / 18 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Bilateral Hands
Frequency: 1 affected / 18 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Peripheral Sensory Neuropathy
Frequency: 8 affected / 18 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: platelet count decrease
Frequency: 4 affected / 18 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural effusion
Frequency: 2 affected / 18 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Proteinuria
Frequency: 5 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritis
Frequency: 1 affected / 18 at risk

Adverse event: Psychiatric disorders - Other, specify
Serious: no
Organ System: Psychiatric disorders
Notes: Mood Swings
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 1 affected / 18 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Kidney stone
Frequency: 2 affected / 18 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Notes: Serum Amylase Increased
Frequency: 1 affected / 18 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Sick Sinus Syndrome
Frequency: 1 affected / 18 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Sinus Tachycardia
Frequency: 2 affected / 18 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sleep apnea
Frequency: 1 affected / 18 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Notes: small intestinal obstruction
Frequency: 1 affected / 18 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sore Throat
Frequency: 1 affected / 18 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia
Frequency: 2 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: General disorders
Notes: Cold
Frequency: 1 affected / 18 at risk

Adverse event: URI/ Sinus Symptoms
Serious: no
Organ System: Infections and infestations
Notes: URI/ Sinus Symptoms
Frequency: 1 affected / 18 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary Frequency
Frequency: 1 affected / 18 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: urinary retention
Frequency: 1 affected / 18 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary tract infection
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting
Frequency: 9 affected / 18 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Watering Eyes
Frequency: 1 affected / 18 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Notes: Weight Loss
Frequency: 4 affected / 18 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: WBC Count Decrease
Frequency: 1 affected / 18 at risk