TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03028363

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 485 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 485 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 485 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 485 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 13 affected / 485 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 485 at risk

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

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 258 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 258 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 258 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 258 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 258 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 258 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 258 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 258 at risk
Study: NCT03028870

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 74 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 74 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 74 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 67 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 67 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 67 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 67 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 67 at risk

Adverse event: Delerium tremens
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 76 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 76 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 74 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 74 at risk
Study: NCT03028974

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash with erythema below injection site
Frequency: 1 affected / 7 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Surgical and medical procedures
Notes: Ecchymosis at phlebotomy site
Frequency: 1 affected / 7 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Mild Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Post procedure bleeding
Serious: no
Organ System: Surgical and medical procedures
Notes: A small amount of blood noted on the swab when the NP sample was obtained.
Frequency: 1 affected / 25 at risk

Adverse event: Nasal mucous drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

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

Adverse event: Injection site pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 56 at risk
Study: NCT03029000

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

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

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

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

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk
Study: NCT03029104

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: Subject developed diverticulitis 208 days post-procedure; not related; treated and resolved.
Frequency: 1 affected / 752 at risk
Study: NCT03029598

Adverse event: Disease progression leading to hospice
Serious: yes
Organ System: General disorders
Notes: For this study disease progression was not defined as an SAE, unless it led to hospitalization or death
Frequency: 1 affected / 29 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: 3 reported adverse events were deemed unrelated to study treatment
Frequency: 19 affected / 29 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 31 reported adverse events were deemed unrelated to study treatment
Frequency: 25 affected / 29 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 18 reported adverse events were deemed unrelated to study treatment
Frequency: 14 affected / 29 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Notes: 4 reported adverse events were deemed unrelated to study treatment
Frequency: 13 affected / 29 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: 2 reported adverse events were deemed unrelated to study treatment
Frequency: 14 affected / 29 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 24 reported adverse events were deemed unrelated to study treatment
Frequency: 14 affected / 29 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 23 reported adverse events were deemed unrelated to study treatment
Frequency: 14 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 5 reported adverse events were deemed unrelated to study treatment
Frequency: 13 affected / 29 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 29 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 6 reported adverse events were deemed unrelated to study treatment
Frequency: 14 affected / 29 at risk
Study: NCT03029624

Adverse event: Cellulitis Secondary to Ankle Wrap
Serious: yes
Organ System: Infections and infestations
Notes: One participant experienced cellulitis secondary to an ankle wrap that was part of the specified wound care but with no involvement of the incision or implant site. Cellulitis resolved with intravenous antibiotics.
Frequency: 1 affected / 46 at risk

Adverse event: Hip Bursitis & Edema
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant presented with limp and pain determined to be related to hip bursitis and edema, which were noted at screening.
Frequency: 1 affected / 46 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Participant contracted pneumonia determined to be unrelated to the device and resolved with treatment
Frequency: 1 affected / 46 at risk

Adverse event: Mild swelling, bruising, discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 46 at risk

Adverse event: Possible incision site infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Blister secondary to ankle wrap
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 46 at risk

Adverse event: Moderate implant site discomfort, swelling, pain, bruising
Serious: no
Organ System: General disorders
Frequency: 5 affected / 46 at risk

Adverse event: Stimulation pain
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 46 at risk

Adverse event: Device migration about 1 cm posterior
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 46 at risk
Study: NCT03029650

Adverse event: Decreased Blood Pressure
Serious: no
Organ System: General disorders
Frequency: 10 affected / 24 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Decreased Heart Rate
Serious: no
Organ System: General disorders
Frequency: 11 affected / 24 at risk

Adverse event: Increased Heart Rate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 14 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Mydriasis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 8 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 24 at risk

Adverse event: Decreased Blood Pressure
Serious: no
Organ System: General disorders
Frequency: 13 affected / 25 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Decreased Heart Rate
Serious: no
Organ System: General disorders
Frequency: 15 affected / 25 at risk

Adverse event: Increased Heart Rate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Mydriasis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 18 affected / 25 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 25 at risk
Study: NCT03029819

Adverse event: Mild nicotine patch side effects
Serious: no
Organ System: General disorders
Notes: Mild nicotine patch side effects (itching, nausea, abnormal dreams, nervousness)
Frequency: 7 affected / 33 at risk

Adverse event: Mild nicotine patch side effects
Serious: no
Organ System: General disorders
Notes: Mild nicotine patch side effects (itching, nausea, abnormal dreams, nervousness)
Frequency: 5 affected / 39 at risk
Study: NCT03029884

Adverse event: Haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Suicidal Ideation (passive)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk
Study: NCT03029988

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Subject 25-01-005 experienced an adverse event (AE) of leukocytosis during their Follow-Up Visit laboratory evaluations
Frequency: 1 affected / 3 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject 25-01-002 reported an AE of hives after the Tc 99m tilmanocept administration (Visit 2, Day 1).
Frequency: 1 affected / 3 at risk
Study: NCT03030183

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk
Study: NCT03030599

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 201 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 201 at risk

Adverse event: Peripheral nerve paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 201 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 201 at risk

Adverse event: Viral cardiomyopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 201 at risk

Adverse event: Cataplexy
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 201 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 201 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 201 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 201 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 201 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 201 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 201 at risk

Adverse event: Muscle enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Cataplexy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 65 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk
Study: NCT03030625

Adverse event: Acute rectal toxicity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Acute urinary toxicity
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 30 at risk

Adverse event: Late rectal toxicity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Late urinary toxicity
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 30 at risk
Study: NCT03030989

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk
Study: NCT03031301

Adverse event: Traumatic Fracture Of Pelvis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Traumatic Fracture Of Pelvis, not related to the device
Frequency: 1 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 7 affected / 89 at risk

Adverse event: Sensation of vibration
Serious: no
Organ System: Product Issues
Notes: Sensation of vibration
Frequency: 15 affected / 89 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Anxiety Attack, not related to the device
Frequency: 1 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 2 affected / 93 at risk

Adverse event: Sensation of vibration
Serious: no
Organ System: Product Issues
Notes: Sensation of vibration
Frequency: 2 affected / 93 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 93 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 93 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Decrease In The Frequency In Bm
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 93 at risk

Adverse event: Extreme Lower Abdominal Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Uncomfortable Bm
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 93 at risk
Study: NCT03031340

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1 at risk
Study: NCT03031496

Adverse event: Crystal urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk
Study: NCT03031678

Adverse event: Loss of Residual Hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 50 at risk

Adverse event: Internal Device Failure
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 50 at risk