Study: NCT03029611

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Unrelated to study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 4 of 6 events are unrelated to study treatment
Frequency: 5 affected / 9 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Other - leg weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Other - "pulled muscle" in left upper quadrant
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: 1 of 2 events is unrelated to study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Other Infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: 1 of 2 events is unrelated to study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 1 of 3 events is unrelated to the study treatment
Frequency: 3 affected / 9 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 of 3 events is unrelated to the study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 of 3 events is unrelated to the study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 of 5 events are unrelated to the study treatment
Frequency: 4 affected / 9 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 of 12 events are unrelated to the study treatment
Frequency: 9 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: 5 of 6 events are unrelated to the study drug
Frequency: 5 affected / 9 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to study treatment
Frequency: 2 affected / 9 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Other - paracentisis
Serious: no
Organ System: Surgical and medical procedures
Notes: Unrelated to study treatment
Frequency: 4 affected / 9 at risk

Adverse event: Other - IVC filter placed due to clots
Serious: no
Organ System: Surgical and medical procedures
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Other - thoracentesis x 2 due to pleural effusion. Hospitalized
Serious: no
Organ System: Surgical and medical procedures
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk

Adverse event: Other - ex-lap, RSO, omentectomy, appendectomy, tumor debulking
Serious: no
Organ System: Surgical and medical procedures
Notes: Unrelated to study treatment
Frequency: 1 affected / 9 at risk