Study: NCT03545165

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: The patient experienced grade 3 dehydration from vomiting, requiring hospitalization for intravenous fluids. The event was not attributed to the study drug. The event was deemed unrelated. Patient's vomiting pre-dated enrollment on the study.
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The patient experienced grade 3 back pain, requiring hospitalization. The adverse event was not related to the study drug.
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 3 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1-2
Frequency: 2 affected / 6 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 4 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 4 affected / 6 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1-2
Frequency: 3 affected / 6 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1-2
Frequency: 2 affected / 6 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1-2
Frequency: 2 affected / 6 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 1-2
Frequency: 2 affected / 6 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 2 affected / 6 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 2 affected / 6 at risk

Adverse event: Osteonecrosis of jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 3
Frequency: 1 affected / 6 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1-2
Frequency: 2 affected / 6 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: grade 1-2
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 1 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 1-2
Frequency: 3 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 2 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: grade 1-2
Frequency: 2 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 1 affected / 6 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 1 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: grade 1-2
Frequency: 3 affected / 6 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 3 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: grade 1-2
Frequency: 3 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 2 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: grade 1-2
Frequency: 3 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 1 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 1 affected / 6 at risk