Study: NCT02235870

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Device or Procedure Related
Frequency: 1 affected / 336 at risk

Adverse event: Abnormal Pap Smear
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 336 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 336 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 336 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: NOT Device or Procedure Related
Frequency: 2 affected / 336 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 336 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 244/336 (76.62%) / 494 Events
Frequency: 246 affected / 336 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 188/336 (55.95%) / 311 Events
Frequency: 191 affected / 336 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 58/336 (17.26%) / 71 Events
Frequency: 61 affected / 336 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 57/336 (16.96%) / 69 Events
Frequency: 60 affected / 336 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 49/336 (14.58%) / 54 Events
Frequency: 49 affected / 336 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 31/336 (9.23%) / 37 Events
Frequency: 31 affected / 336 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 28/336 (8.33%) / 30 Events
Frequency: 41 affected / 336 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 24/336 (7.14%) / 25 Events
Frequency: 24 affected / 336 at risk

Adverse event: Gastric Bleeding/Abrasion
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 17/336 (5.06%) / 17 Events
Frequency: 17 affected / 336 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 9/336 (2.68%) / 10 Events
Frequency: 51 affected / 336 at risk

Adverse event: Common Cold/Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 0/336 (0.00%) / 0 Events
Frequency: 46 affected / 336 at risk

Adverse event: Stomach/Seasonal Flu
Serious: no
Organ System: Infections and infestations
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 0/336 (0.00%) / 0 Events
Frequency: 29 affected / 336 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 6/336 (1.79%) / 7 Events
Frequency: 22 affected / 336 at risk

Adverse event: Synovectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 359 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 359 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 359 at risk

Adverse event: Arnold-Chiari malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 359 at risk

Adverse event: Exostosis
Serious: yes
Organ System: General disorders
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 359 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: NOT Device or Procedure Related
Frequency: 1 affected / 359 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 244/336 (76.62%) / 494 Events
Frequency: 51 affected / 359 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 188/336 (55.95%) / 311 Events
Frequency: 37 affected / 359 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 58/336 (17.26%) / 71 Events
Frequency: 16 affected / 359 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 57/336 (16.96%) / 69 Events
Frequency: 10 affected / 359 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 49/336 (14.58%) / 54 Events
Frequency: 10 affected / 359 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 28/336 (8.33%) / 30 Events
Frequency: 15 affected / 359 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 9/336 (2.68%) / 10 Events
Frequency: 37 affected / 359 at risk

Adverse event: Common Cold/Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 0/336 (0.00%) / 0 Events
Frequency: 44 affected / 359 at risk

Adverse event: Stomach/Seasonal Flu
Serious: no
Organ System: Infections and infestations
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 0/336 (0.00%) / 0 Events
Frequency: 25 affected / 359 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 6/336 (1.79%) / 7 Events
Frequency: 26 affected / 359 at risk