Study: NCT04319224

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Renal and urinary disorders
Notes: New primary malignancy: bladder transitional cell carcinoma
Frequency: 1 affected / 1 at risk

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

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

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

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 2 affected / 3 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Papilloma viral infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 3 at risk

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk