Study: NCT01827904

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Numbness and Tingling
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Syncopal episode
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 56 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 56 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 56 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 56 at risk

Adverse event: Hypertentsion
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 56 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 56 at risk

Adverse event: Vision problems
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 56 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 56 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Impatience
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Dysergia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 56 at risk

Adverse event: Imbalance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 56 at risk

Adverse event: Musculoskeletal weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Positional pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 56 at risk

Adverse event: Unsteady
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 56 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 56 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Dysgnosia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Dysmetria
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Involuntary movements-UE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Memory deterioration
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Numbness/Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 56 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Ankle pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 56 at risk

Adverse event: Sonication-related head pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 56 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame / Pin site related
Frequency: 2 affected / 56 at risk

Adverse event: Facial edema
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame / pin site related
Frequency: 1 affected / 56 at risk

Adverse event: Numbness / Tingling
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame / pin site related
Frequency: 1 affected / 56 at risk

Adverse event: Pin site edema
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 1 affected / 56 at risk

Adverse event: Pin site pain
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 8 affected / 56 at risk

Adverse event: Pin site abrasion
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 2 affected / 56 at risk

Adverse event: Contusion
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 2 affected / 56 at risk

Adverse event: Catheter irritation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 56 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 56 at risk

Adverse event: Paroxysmal vertigo issues
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypertentsion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Imbalance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Positional pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Numbness/Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Numbness / Tingling
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame / pin site related
Frequency: 2 affected / 20 at risk

Adverse event: Pin site bleeding
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 1 affected / 20 at risk

Adverse event: Pin site edema
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 2 affected / 20 at risk

Adverse event: Pin site pain
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 3 affected / 20 at risk

Adverse event: Hypertentsion
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 21 at risk

Adverse event: Preventricular contractions
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Dysmetria
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Imbalance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Musculoskeletal weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Unsteady
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Dysmnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Grogginess
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hand tremor (untreated side)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Numbness/Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 21 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Slow movements
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 21 at risk

Adverse event: Sonication-related head pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 21 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame / Pin site related
Frequency: 1 affected / 21 at risk

Adverse event: Pin site bleeding
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 1 affected / 21 at risk

Adverse event: Pin site edema
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 1 affected / 21 at risk

Adverse event: Pin site pain
Serious: no
Organ System: Product Issues
Notes: Stereotactic frame related
Frequency: 4 affected / 21 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 21 at risk