Study: NCT01045499

Adverse event: Band removal due to dysphagia, reflux or heartburn
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 137 at risk

Adverse event: Hernia hiatus repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 137 at risk

Adverse event: Gastric Herniation (band slippage)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 137 at risk

Adverse event: Port site bleeding
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resulted in surgery
Frequency: 1 affected / 137 at risk

Adverse event: Malpositioned band
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resulted in surgery
Frequency: 1 affected / 137 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resulted in surgery.
Frequency: 1 affected / 137 at risk

Adverse event: Port displacement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resulted in operative port repositioning.
Frequency: 11 affected / 137 at risk

Adverse event: Band removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 33 affected / 137 at risk

Adverse event: Weight loss procedure (conversion)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 137 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 96 affected / 137 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 137 at risk

Adverse event: Port site pain
Serious: no
Organ System: General disorders
Frequency: 46 affected / 137 at risk

Adverse event: GERD/Heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 137 at risk

Adverse event: Dysphagia/food stuck
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 137 at risk

Adverse event: Upper respiratory infection (URI)
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 137 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 137 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 14 affected / 137 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 137 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 137 at risk

Adverse event: Elevated CES-D Score
Serious: no
Organ System: General disorders
Frequency: 12 affected / 137 at risk

Adverse event: Band slip/prolapse
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 137 at risk

Adverse event: Port displacement/flip
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 137 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 8 affected / 137 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 137 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 137 at risk

Adverse event: Esophageal dilation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 137 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 137 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 137 at risk