Study: NCT02043782

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unlikely related to the product
Frequency: 1 affected / 37 at risk

Adverse event: Peristomal skin irritation/ broken skin/ stomal bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely, probably or possibly related to the product
Frequency: 20 affected / 37 at risk

Adverse event: Influenza/ cold/ sore throat, Pneumonia, vomiting, infected wounds
Serious: no
Organ System: Infections and infestations
Notes: all AEs except one were unlikely or not related to the product. One AE (wound due to lower corner at hideaway scratching against leg) was definitely related to the product.
Frequency: 3 affected / 37 at risk

Adverse event: headache, pain in right hand
Serious: no
Organ System: Nervous system disorders
Notes: unlikely and not related to product
Frequency: 2 affected / 37 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Immune system disorders
Notes: not related to product
Frequency: 1 affected / 37 at risk

Adverse event: N/A
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Its written in the AE description: drainage is something mess, due to missing flap which is on the coloplast product.
Frequency: 1 affected / 37 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unlikely related to the product
Frequency: 1 affected / 38 at risk

Adverse event: Peristomal skin irritation/ broken skin/ stomal bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely, probably or possibly related to the product
Frequency: 5 affected / 38 at risk

Adverse event: Influenza/ cold/ sore throat, Pneumonia, vomiting, infected wounds
Serious: no
Organ System: Infections and infestations
Notes: all AEs except one were unlikely or not related to the product. One AE (wound due to lower corner at hideaway scratching against leg) was definitely related to the product.
Frequency: 4 affected / 38 at risk

Adverse event: control of fistula, pain after control of fistula, constipation, sub ileus
Serious: no
Organ System: Gastrointestinal disorders
Notes: unlikely or not related to the product
Frequency: 2 affected / 38 at risk

Adverse event: Cataract
Serious: no
Organ System: Surgical and medical procedures
Notes: unlikely related to product
Frequency: 1 affected / 38 at risk

Adverse event: Peristomal skin irritation/ broken skin/ stomal bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely, probably or possibly related to the product
Frequency: 21 affected / 37 at risk

Adverse event: Influenza/ cold/ sore throat, Pneumonia, vomiting, infected wounds
Serious: no
Organ System: Infections and infestations
Notes: all AEs except one were unlikely or not related to the product. One AE (wound due to lower corner at hideaway scratching against leg) was definitely related to the product.
Frequency: 3 affected / 37 at risk

Adverse event: control of fistula, pain after control of fistula, constipation, sub ileus
Serious: no
Organ System: Gastrointestinal disorders
Notes: unlikely or not related to the product
Frequency: 1 affected / 37 at risk

Adverse event: Gash on the riight Tibia (tipped on bike)
Serious: no
Organ System: Social circumstances
Notes: not related to product
Frequency: 1 affected / 37 at risk