Study: NCT03234907

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Gastrointestinal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Intestinal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 70 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 70 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 5 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 70 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 70 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 144 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 144 at risk

Adverse event: Hyperpyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Bartholin's abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 144 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 144 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 144 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 13 affected / 144 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 144 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 144 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 144 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Gastrointestinal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 38 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 38 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 5 affected / 38 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 38 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 46 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Arthropod sting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 46 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 46 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 4 affected / 46 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 46 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 46 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 46 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 46 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 46 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 46 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 46 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 46 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 88 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Gastrointestinal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 88 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Ileal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Large intestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Granuloma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Anal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Mumps
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Foreign body in throat
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 88 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 88 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 88 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 10 affected / 88 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 88 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 88 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 88 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 88 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 88 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 88 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 88 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 88 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 88 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 8 affected / 88 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 88 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 88 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 88 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 88 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 88 at risk