Study: NCT01441492

Adverse event: Grade 3 intra-abdominal infection and pancreatic leak/fistula
Serious: yes
Organ System: Surgical and medical procedures
Notes: Both SAEs were categorized as grade 3 or higher complications. Both patients were assigned to the "No Drain Group" and developed a grade 3 intra-abdominal infection and pancreatic leak/fistula.
Frequency: 2 affected / 170 at risk

Adverse event: Pancreatic_leak_fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 170 at risk

Adverse event: Postoperative_Abdominal_FluidCollection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 170 at risk

Adverse event: Biliary_leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Enteric_leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Lymph_Leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 170 at risk

Adverse event: Gastroparesis_DelayedGastricEmptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 170 at risk

Adverse event: SmallBowelObstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Seroma
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 170 at risk

Adverse event: Intra_abd_abscess
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 170 at risk

Adverse event: Wound_Dehiscence
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 170 at risk

Adverse event: Wound_Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 170 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 170 at risk

Adverse event: Pancreatic_leak_fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 88 affected / 174 at risk

Adverse event: Postoperative_Abdominal_FluidCollection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 174 at risk

Adverse event: Biliary_leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Enteric_leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Lymph_Leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 174 at risk

Adverse event: Gastroparesis_DelayedGastricEmptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 174 at risk

Adverse event: SmallBowelObstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 174 at risk

Adverse event: Seroma
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 174 at risk

Adverse event: Intra_abd_abscess
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 174 at risk

Adverse event: Wound_Dehiscence
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 174 at risk

Adverse event: Wound_Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 174 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 174 at risk