Study: NCT04602000

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 105 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 105 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 105 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 105 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 105 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 105 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 105 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 105 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 110 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 110 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 110 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 110 at risk

Adverse event: Inflammatory marker increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 110 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 110 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 110 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 110 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 110 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 110 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 110 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 110 at risk

Adverse event: Inflammatory marker increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 110 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 110 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 110 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 110 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 110 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 110 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 110 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 652 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 652 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 652 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 652 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 652 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 652 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 652 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 652 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 652 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 652 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 652 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 652 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 652 at risk

Adverse event: Inflammatory marker increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 652 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 652 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 652 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 652 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 652 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 652 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 652 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 650 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 650 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 650 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 650 at risk

Adverse event: Ocular melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 650 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 650 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 650 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 650 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 650 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 650 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 650 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 650 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 650 at risk

Adverse event: Inflammatory marker increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 650 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 650 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 650 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 650 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 650 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 650 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 650 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 650 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 650 at risk