Study: NCT01285960

Adverse event: Acute Bowel Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Device-Treatment Related AE
Frequency: 1 affected / 108 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 108 at risk

Adverse event: Skin burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 108 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Small bruise at IV Site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Edema/Hypo-intense tissu
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 108 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 108 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Generalized GI upset and decreased activity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Stomach cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Bloody mucus in stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 108 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 108 at risk

Adverse event: Menstrual cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 108 at risk

Adverse event: Back pain during period
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 108 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 108 at risk

Adverse event: Vaginal bleeding between periods
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 108 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 108 at risk

Adverse event: Leg/calf pain
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Dizziness/vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Tingling sensation in spine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Left leg anterior compartment tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Decreased sensation in right foot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: IV infiltration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Position Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 23 affected / 108 at risk

Adverse event: Sonication Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 55 affected / 108 at risk

Adverse event: Sonication-related epidermal pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 49 affected / 108 at risk

Adverse event: Sonication related neuromuscular pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 81 affected / 108 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: Fever/chills
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 108 at risk

Adverse event: Post-embolization like symptoms
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 108 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pain or burning at urinary catheter site
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 108 at risk

Adverse event: Difficulty initiating urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Urinary tract infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 108 at risk