Study: NCT01942720

Adverse event: Worsening of IBD, Nausea, vomiting, diarrhea, abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unanticipated serious adverse event not related to study device
Frequency: 2 affected / 74 at risk

Adverse event: Asthma Excerbation, Shortness of Breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unanticipated serious adverse event not related to study device
Frequency: 1 affected / 74 at risk

Adverse event: Pancreatitis, Acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Unanticipated serious adverse event not related to study device
Frequency: 1 affected / 74 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious AE
Frequency: 2 affected / 74 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Athralgia Of Hands And Elbows, Arthritis Flare
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: non-serious AE
Frequency: 2 affected / 74 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Bilateral Bursitis In Hips
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Blolating
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Bruise At Venipucture Site. Right Anticubital Space
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Bruised Coccyx Due To Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: C-Difficile
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: non-serious ae
Frequency: 1 affected / 74 at risk

Adverse event: Common Cold, cough
Serious: no
Organ System: Infections and infestations
Notes: non-serious
Frequency: 2 affected / 74 at risk

Adverse event: Crohn's Flare
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Cyst Right Great Toe
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Notes: non-serious
Frequency: 1 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious
Frequency: 4 affected / 74 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: non-serious
Frequency: 1 affected / 74 at risk

Adverse event: fell
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: non-serious
Frequency: 1 affected / 74 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: non-serious
Frequency: 2 affected / 74 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Cardiac disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Incontinence a Little Worse And More Often
Serious: no
Organ System: Renal and urinary disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: non-serious AE
Frequency: 2 affected / 74 at risk

Adverse event: Light Headed
Serious: no
Organ System: General disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Mild Perianal Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Infections and infestations
Notes: non-serious AE
Frequency: 2 affected / 74 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious AE
Frequency: 3 affected / 74 at risk

Adverse event: Pulled Upper Back Muscle Left Side
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Questionable Right Lower Quadrant Mass
Serious: no
Organ System: General disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: non-serious AE
Frequency: 4 affected / 74 at risk

Adverse event: Rectal Urgency
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: non-serious AE
Frequency: 2 affected / 74 at risk

Adverse event: Right Leg Bruising Secondary To Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Superficial Blood Clot Left Axilla Area
Serious: no
Organ System: General disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: non-serious AE
Frequency: 6 affected / 74 at risk

Adverse event: Worsening Diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: non-serious AE
Frequency: 1 affected / 74 at risk