Study: NCT01800916

Adverse event: obstipation due to parastomal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 42 at risk

Adverse event: diarre
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: not related to product
Frequency: 1 affected / 42 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: bleeding from rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: otitis left ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 42 at risk

Adverse event: Gout
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: dehydration due to diarre
Frequency: 1 affected / 42 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 42 at risk

Adverse event: diarre
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: not related to product
Frequency: 1 affected / 42 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 42 at risk

Adverse event: diarre
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: active colitis ulcerosa in remaining bowl
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: small blister on peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: not related to product
Frequency: 1 affected / 42 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 62 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: bleeding from rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: gastroenterotitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: skin injury on forehead and nose
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: caused by a mountain bike accident
Frequency: 1 affected / 62 at risk

Adverse event: Pertussis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk