Study: NCT03254420

Adverse event: hemovhromatosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: lithiasis choledocholithiasis grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 26 at risk

Adverse event: ocular infection
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 1 affected / 26 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1 and 2
Frequency: 16 affected / 26 at risk

Adverse event: general disorders and reaction at the site of administration
Serious: no
Organ System: General disorders
Notes: grade 1 and 2
Frequency: 10 affected / 26 at risk

Adverse event: hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Notes: grade 3
Frequency: 1 affected / 26 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 1 affected / 26 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1 and 2
Frequency: 1 affected / 26 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1 and 2
Frequency: 6 affected / 26 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1 and 2
Frequency: 26 affected / 26 at risk

Adverse event: reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 1, 2 and 3
Frequency: 19 affected / 26 at risk

Adverse event: respiratory, thoracic and mediastinal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 26 at risk

Adverse event: skin and cubcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 2 affected / 26 at risk

Adverse event: vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: grade 1, 2 and 3
Frequency: 8 affected / 26 at risk

Adverse event: prostatitis grade 3
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 44 at risk

Adverse event: thrombocytopenia grade 4
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: basela cell carcinoma grade 2
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: vascular stent stenosis grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: peripheral artery stenosis grade 3
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: malignant melanoma grade 2
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: colon cancer metastatic grade 5
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: cerebral hematoma grade 3
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: large instestine polyp grade 2
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: blood and lymphatic
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 4
Frequency: 1 affected / 44 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1 and 2
Frequency: 28 affected / 44 at risk

Adverse event: general disorders and reaction at the site of administration
Serious: no
Organ System: General disorders
Notes: grade 1 and 2
Frequency: 13 affected / 44 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 44 at risk

Adverse event: investigations
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 1 affected / 44 at risk

Adverse event: musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1 and 2
Frequency: 2 affected / 44 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Notes: grade 1
Frequency: 1 affected / 44 at risk

Adverse event: psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1 and 2
Frequency: 13 affected / 44 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1 and 2
Frequency: 42 affected / 44 at risk

Adverse event: reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 1, 2 and 3
Frequency: 31 affected / 44 at risk

Adverse event: neoplasms malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: grade 2 and 5
Frequency: 4 affected / 44 at risk

Adverse event: skin and cubcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 44 at risk

Adverse event: vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: grade 1, 2 and 3
Frequency: 10 affected / 44 at risk