Study: NCT01917968

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 225 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Infection- Other, Specify Type
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Ureteral Kink / Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Mesh Exposure in Vagina
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 225 at risk

Adverse event: Mixed incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 225 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 225 at risk

Adverse event: Bleeding Requiring Blood Transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 225 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 225 at risk

Adverse event: Constipation - NEW
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 225 at risk

Adverse event: Constipation - Worsening
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 225 at risk

Adverse event: Hematoma - Retroperitoneal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 225 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 225 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Other, Specify
Serious: no
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Pain, Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 225 at risk

Adverse event: Infection - Other, specify type
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 225 at risk

Adverse event: Pelvic Infection / Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 225 at risk

Adverse event: Urinary Tract Infection (UTI), Lower
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 225 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 225 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 225 at risk

Adverse event: Neuromuscular Disorder, specify type
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 225 at risk

Adverse event: Neuromuscular Disorder, specify type
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 225 at risk

Adverse event: Mesh Exposure in Vagina
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 225 at risk

Adverse event: Difficulty Emptying Bladder - NEW
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 225 at risk

Adverse event: Difficulty Emptying Bladder - Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Mixed Incontinence- Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 225 at risk

Adverse event: Stress Incontinence - NEW
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 225 at risk

Adverse event: Stress Incontinence - Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 225 at risk

Adverse event: Urge Incontinence - NEW
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 225 at risk

Adverse event: Urge Incontinence - Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 225 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 225 at risk

Adverse event: Dyspareunia - NEW (De Novo)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 225 at risk

Adverse event: Hematoma - Vaginal
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 225 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 225 at risk

Adverse event: Pelvic Pain - New
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 225 at risk

Adverse event: Pelvic Pain - Worsening
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 225 at risk

Adverse event: Prolapse
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 225 at risk

Adverse event: Sensation Of Bulge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 26 affected / 225 at risk

Adverse event: Vaginal Discharge, Atypical
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 225 at risk

Adverse event: Vaginal Shortening
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 225 at risk

Adverse event: Tissue Granulation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 225 at risk

Adverse event: Cardiac Event- New
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 485 at risk

Adverse event: Cardiac Event- Worsening
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 485 at risk

Adverse event: Constipation - Worsening
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 485 at risk

Adverse event: Ileus / Bowel Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 485 at risk

Adverse event: Other, Specify
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 485 at risk

Adverse event: Infection - Other, specify type
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 485 at risk

Adverse event: Pelvic Infection / Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 485 at risk

Adverse event: Pulmonary Event, Specify - NEW
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 485 at risk

Adverse event: Urinary Tract Infection (UTI), Lower
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 485 at risk

Adverse event: Ureteral Kink / Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 485 at risk

Adverse event: Visceral Organ Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 485 at risk

Adverse event: Hematoma - Retropubic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 485 at risk

Adverse event: Pelvic Pain - NEW
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 485 at risk

Adverse event: Pulmonary Event, Specify - Worsening
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 485 at risk

Adverse event: Thrombotic Event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 485 at risk

Adverse event: Cardiac Event - NEW
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 485 at risk

Adverse event: Cardiac Worsening
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 485 at risk

Adverse event: Constipation - NEW
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 485 at risk

Adverse event: Constipation - Worsening
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 485 at risk

Adverse event: Fecal Incontinence - NEW
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 485 at risk

Adverse event: Fecal Incontinence - Worsening
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 485 at risk

Adverse event: Hematoma - Retroperitoneal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 485 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 485 at risk

Adverse event: Ileus / Bowel Obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 485 at risk

Adverse event: Neuromuscular Disorder, specify type
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 485 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 485 at risk

Adverse event: Neuromuscular Disorder, specify type
Serious: no
Organ System: General disorders
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: General disorders
Frequency: 2 affected / 485 at risk

Adverse event: Pain, Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 485 at risk

Adverse event: Infection - Other, specify type
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 485 at risk

Adverse event: Pelvic Infection / Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 485 at risk

Adverse event: Pulmonary Event, Specify - NEW
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 485 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 485 at risk

Adverse event: Urinary Tract Infection (UTI), Lower
Serious: no
Organ System: Infections and infestations
Frequency: 118 affected / 485 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 485 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 485 at risk

Adverse event: Visceral Organ Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 485 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 485 at risk

Adverse event: Neuromuscular Disorder, specify type
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 485 at risk

Adverse event: Neoplasia, Non-Pelvic
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 485 at risk

Adverse event: Neuromuscular Disorder, specify type
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 485 at risk

Adverse event: Neurovascular Event
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 485 at risk

Adverse event: Suture Exposure in Vagina
Serious: no
Organ System: Product Issues
Frequency: 19 affected / 485 at risk

Adverse event: Difficulty Emptying Bladder - NEW
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 485 at risk

Adverse event: Difficulty Emptying Bladder - Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 485 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 485 at risk

Adverse event: Mixed Urinary Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 485 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 485 at risk

Adverse event: Stress Incontinence - NEW
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 485 at risk

Adverse event: Stress Incontinence - Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 485 at risk

Adverse event: Urge Incontinence - NEW
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 485 at risk

Adverse event: Urge Incontinence - Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 485 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 485 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 485 at risk

Adverse event: Urine flow decreased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 485 at risk

Adverse event: Dyspareunia - NEW (De Novo)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 485 at risk

Adverse event: Dyspareunia - Worsening
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 485 at risk

Adverse event: Hematoma - Vaginal
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 485 at risk

Adverse event: Pelvic Pain - New
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 39 affected / 485 at risk

Adverse event: Pelvic Pain - Worsening
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 485 at risk

Adverse event: Prolapse
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 88 affected / 485 at risk

Adverse event: Sensation Of Bulge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 53 affected / 485 at risk

Adverse event: Discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 485 at risk

Adverse event: Vaginal Atrophy
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 485 at risk

Adverse event: Vaginal Bleeding, De Novo
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 485 at risk

Adverse event: Vaginal Discharge, Atypical
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 485 at risk

Adverse event: Vaginal scarring
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 485 at risk

Adverse event: Vaginal Wall Dehiscence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 485 at risk

Adverse event: Vulvar Itching
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 485 at risk

Adverse event: Vulvar Lesion
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 485 at risk

Adverse event: Lichen sclerosus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 485 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 485 at risk

Adverse event: Skin Condition
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 485 at risk

Adverse event: Tissue Granulation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 485 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 485 at risk

Adverse event: Hematoma - Other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 485 at risk

Adverse event: Other, Specify
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 485 at risk