Study: NCT02022085

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Increase in instability of knee prosthesis
Serious: yes
Organ System: General disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Embolisation of the Splenic Artery from pancreatitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Increase of Meniere Attacks
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Progression of Hearing Loss
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Decompensated Alcoholic Liver Disease
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Cholesteatoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Pain/Discomfort
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Surgery for Baha Attract on other ear
Serious: yes
Organ System: Surgical and medical procedures
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Increase in Occlusive Arterial Disease
Serious: yes
Organ System: Vascular disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Dequervian
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Patient was addmitted to the hospital due to childbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Adverse Event Term is the Reported term
Frequency: 1 affected / 54 at risk

Adverse event: Ear and Labyrinth Disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 54 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 10 affected / 54 at risk

Adverse event: Infections and Infestation
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 54 at risk

Adverse event: Injury, Poisoning and Procedural Complications
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 54 at risk

Adverse event: Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 54 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 54 at risk

Adverse event: Respiratory, Thoracic and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 54 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 54 at risk

Adverse event: Predefined event: Pressure related Skin Complications
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 54 at risk

Adverse event: Predefined event: Pain/Discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 54 at risk