Study: NCT03829475

Adverse event: Colectomy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was admitted due to IBD complications, and surgical laparoscopy with complete colectomy and ileostomy by abdominal approach was performed. Post-op was uncomplicated, and subject was discharged.
Frequency: 1 affected / 30 at risk

Adverse event: IBD Flare
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was admitted to the hospital for increased abdominal pain due to an IBD flare, the adverse event was resolved. The IBD flare occurred prior to administration of study drug, the subject continued in the study with no further issues.
Frequency: 1 affected / 30 at risk

Adverse event: IBD flare
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject experienced flare symptoms, which was treated by switching their IBD medications. The patient's symptoms improved with the treatment.
Frequency: 1 affected / 30 at risk

Adverse event: Colectomy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was admitted to the hospital for pain and nausea. They underwent total abdominal colectomy and end ileostomy and were discharged with antibiotics.
Frequency: 1 affected / 30 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was admitted for abdominal pain, diarrhea, and vomiting. They received IV steroids and antibiotics prior to discharged which resolved symptoms.
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 30 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fecal urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: COVID-19 Infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: IBD Flare
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was hospitalized due to a UC flare, the study team determined it not to be related to FMT procedure. The adverse event resolved, and the subject continued in the study.
Frequency: 1 affected / 31 at risk

Adverse event: IBD Flare
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was hospitalized due to a UC flare causing abdominal pain, the subject was discontinued from the trial prior to receiving study drug.
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject was hospitalized for worsening of ongoing baseline symptoms of rectal bleeding, diarrhea, and abdominal pain. The patient was treated for these symptoms and this adverse event was resolved.
Frequency: 1 affected / 31 at risk

Adverse event: IBD flare
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject experienced an IBD flare for which they were hospitalized. Patient was started on biologic treatment and deemed clinically stable for discharge.
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Chest Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Herpes simplex reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk