Study: NCT02291432

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Study Product-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Study Product-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Post procedural contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Biopsy Procedure-Related Adverse Event, AEs with ≥5% Frequency
Frequency: 2 affected / 25 at risk

Adverse event: Post procedural swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Biopsy Procedure-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Biopsy Procedure-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Biopsy Procedure-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Biopsy Procedure-Related Adverse Event, AEs with ≥5% Frequency
Frequency: 3 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 Event Biopsy Procedure-Related Adverse Event, 1 Event Not Related to Study Product or Procedures, AEs with ≥5% Frequency
Frequency: 2 affected / 25 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Biopsy Procedure-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Biopsy Procedure-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Biopsy Procedure-Related Adverse Event
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: AEs Not Related to Study Product or Procedures with ≥5% Frequency
Frequency: 2 affected / 25 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: AEs Not Related to Study Product or Procedures with ≥5% Frequency
Frequency: 2 affected / 25 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: AEs Not Related to Study Product or Procedures with ≥5% Frequency
Frequency: 2 affected / 25 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Infections and infestations
Notes: AEs Not Related to Study Product or Procedures with ≥5% Frequency
Frequency: 2 affected / 25 at risk