Study: NCT04205643

Adverse event: Anaemia (Study drug unrelated)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 548 at risk

Adverse event: Iron deficiency anaemia (study drug unrelated)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 548 at risk

Adverse event: Colitis ulcerative (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 548 at risk

Adverse event: Duodenal ulcer (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Intestinal obstruction (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Intestinal strangulation (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Large intestine perforation (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Pancreatitis acute (study drug related)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 548 at risk

Adverse event: Appendicitis (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: COVID-19 (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: COVID-19 pneumonia (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 548 at risk

Adverse event: Cellulitis (study drug related)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: Cytomegalovirus infection (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 548 at risk

Adverse event: Peritonitis (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: Urosepsis (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 548 at risk

Adverse event: Anastomic leak (study drug unrelated)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 548 at risk

Adverse event: Infusion related reaction (study drug related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 548 at risk

Adverse event: Ureterolithiasis (study drug unrelated)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 548 at risk

Adverse event: Cervical dysplasia (study drug unrelated)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 548 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 548 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 548 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 548 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 548 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 548 at risk

Adverse event: Anaemia (Study drug unrelated)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 296 at risk

Adverse event: Iron deficiency anaemia (study drug unrelated)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 296 at risk

Adverse event: Aortic valve incompetence (study drug unrelated)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 296 at risk

Adverse event: Cardiac failure (study drug unrelated)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 296 at risk

Adverse event: Colitis ulcerative (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 296 at risk

Adverse event: Duodenal ulcer perforation (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 296 at risk

Adverse event: COVID-19 (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 296 at risk

Adverse event: COVID-19 pneumonia (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 296 at risk

Adverse event: Cystitis (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 296 at risk

Adverse event: Pneumonia (study drug related)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 296 at risk

Adverse event: Salpingitis (study drug unrelated)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 296 at risk

Adverse event: Urinary tract infection (study drug related)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 296 at risk

Adverse event: Clavicle fracture (study drug unrelated)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 296 at risk

Adverse event: Arthritis (study drug unrelated)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 296 at risk

Adverse event: Colorectal adenoma (study drug unrelated)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 296 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 296 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 296 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 296 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 296 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 296 at risk

Adverse event: Colitis ulcerative (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 140 at risk

Adverse event: Rectal haemorrhage (study drug unrelated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 140 at risk

Adverse event: Cellulitis (study drug related)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 140 at risk

Adverse event: Neuromyopathy (study drug unrelated)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 140 at risk

Adverse event: Deep vein thrombosis (study drug unrelated)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 140 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 140 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 140 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 140 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 140 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 140 at risk