Study: NCT00587301

Adverse event: Abdominal pannus (excess skin)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Band erosion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Band slippage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 119 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Cholelithiasis (Aggravated)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Esophageal and gastric pouch dilatation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Gastric pouch dilatation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Left tibia surgery for Blount's disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Perforated appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Port leak
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Pregnancy with abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 119 at risk

Adverse event: Right tibia surgery for Blount's disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 119 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 119 at risk

Adverse event: Abdominal subcutaneous infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Abnormal EKG (junctional bradycardia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Acne
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 119 at risk

Adverse event: Acute dysphagia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Adnexa uteri mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 119 at risk

Adverse event: Adrenal Hyperplasia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Anaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 119 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: ARD (Acute Respiratory Failure)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Band erosion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Band intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Band intolerance (Chronic dysphagia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Band slippage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 119 at risk

Adverse event: Behavioural issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Bell's palsy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Chronic band intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 119 at risk

Adverse event: Chronic dysphagia with band tightening
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 119 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Depression (Aggravated)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Device malfunction (Band aneurysm)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Dilated esophagus and gastric pouch
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Dsyphagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Dyslipidemia (Aggravated)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 119 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 119 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 119 at risk

Adverse event: Dysphagia (ER visit)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Ear and throat infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 119 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 119 at risk

Adverse event: Ecchymosis (post-op site)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Elevated bilirubin level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Elevated TSH
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Elevated WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Endometriosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Erosion on antrum (endoscopy)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Oesophageal dilatation
Serious: no
Organ System: General disorders
Frequency: 23 affected / 119 at risk

Adverse event: Oesophageal irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Oesophageal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 119 at risk

Adverse event: Exacerbation of Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Excess skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 119 at risk

Adverse event: Excess skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Facial skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Flipped port
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Frozen pelvis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 119 at risk

Adverse event: Fungal infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Gastric pouch dilatation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 119 at risk

Adverse event: Gastric pouch dilation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 119 at risk

Adverse event: Gastric pouch formation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: GE Reflux
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 119 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 119 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Hiatal hernia (Esophagram)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: HTN (Aggravated)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Hyperbilirubinemia (Aggravated)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 119 at risk

Adverse event: Hypercholesterolemia (aggravated)
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 119 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Knee injury (Left)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Low Folate level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 119 at risk

Adverse event: Low Hb level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 119 at risk

Adverse event: Low iron level
Serious: no
Organ System: General disorders
Frequency: 31 affected / 119 at risk

Adverse event: Low iron level (Aggravated)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Low Vit. B12 level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Low Vit. D level
Serious: no
Organ System: General disorders
Frequency: 40 affected / 119 at risk

Adverse event: Low Vit. D level (Aggravated)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 119 at risk

Adverse event: Low Vit. D level (Baseline:24)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Major depression
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Meniscus dislocation (Left)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 3 affected / 119 at risk

Adverse event: Monocleosis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 119 at risk

Adverse event: Infectious mononucleosis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Multiple sclerosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Mumps
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Narcotic addition
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Numbness after exposing bright light
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Panic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Panic disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Port leak
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Port protrusion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Port site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Post op site infection
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 119 at risk

Adverse event: Pregnancy with abortion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 119 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 119 at risk

Adverse event: Psoriasis (Aggravated)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 119 at risk

Adverse event: Seasonal allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Self-inflicted forearm laceration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 119 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Strep throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Suicidal threats
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 119 at risk

Adverse event: Testicular torsion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 119 at risk

Adverse event: Toothache
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 119 at risk

Adverse event: Thrombocytopenia (small fat)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Vit. D Deficiency
Serious: no
Organ System: General disorders
Frequency: 5 affected / 119 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk