Study: NCT04393454

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized, Grade 3
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized, Grade 3
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: All Grade 1
Frequency: 3 affected / 6 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Term: Hoarse Voice. Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 2 affected / 6 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Term. Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One with intermittent back pain. Other with left, lateral back pain. Other unspecified. All Grade 1
Frequency: 3 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intermittent. Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 intermittent. All Grade 1
Frequency: 3 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 6 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Both Grade 1
Frequency: 2 affected / 6 at risk

Adverse event: Mucositis, Oral
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Intermittent, Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim Term: Knee Pain
Frequency: 1 affected / 6 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Verbatim Term: Bilateral, Lower Extremity Edema
Frequency: 2 affected / 6 at risk

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 1
Frequency: 1 affected / 6 at risk

Adverse event: COVID Infection
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Term. Grade 1
Frequency: 1 affected / 6 at risk

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 1 affected / 6 at risk