TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02038790

Adverse event: Drug withdrawal syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Rhinnorhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Drug withdrawal syndrome
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk
Study: NCT02038829

Adverse event: Metapneumovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 92 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 92 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 91 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 92 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 92 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 90 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 92 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 94 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 94 at risk

Adverse event: cardia failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 94 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 94 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 94 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 94 at risk
Study: NCT02038894

Adverse event: Inadequate anesthesia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Inadequate anesthesia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 58 at risk

Adverse event: Severe desaturation: SpO2 < 85%
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A recorded SpO2 \< 85% during the anesthesia
Frequency: 9 affected / 61 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 61 at risk

Adverse event: Minor desaturation < 95%
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 61 at risk

Adverse event: Inadequate anesthesia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 61 at risk
Study: NCT02039375

Adverse event: Mortality
Serious: yes
Organ System: Cardiac disorders
Notes: One patient died several weeks after discharge from a cardiovascular event unrelated to his stroke or the study.
Frequency: 1 affected / 35 at risk
Study: NCT02039778

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk
Study: NCT02040298

Adverse event: Increased trigylcerides
Serious: no
Organ System: Investigations
Frequency: 10 affected / 50 at risk

Adverse event: Increased trigylcerides
Serious: no
Organ System: Investigations
Frequency: 14 affected / 50 at risk

Adverse event: Severe fatigue
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk
Study: NCT02040532

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 26 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 26 at risk

Adverse event: Hot flush
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 26 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: Feeling tired/fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 26 at risk

Adverse event: Feeling drowsy during the day
Serious: no
Organ System: General disorders
Frequency: 8 affected / 26 at risk

Adverse event: Problems falling asleep
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Stomach/abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Tension
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 26 at risk

Adverse event: Increased interest in sex
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 26 at risk

Adverse event: Waking up too early
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Aches, pains in muscles, bones or joints
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Mild rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk
Study: NCT02040766

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 127 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 126 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 125 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 125 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 125 at risk
Study: NCT02040779

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 91 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 91 at risk
Study: NCT02040792

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 71 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 74 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 74 at risk
Study: NCT02040805

Adverse event: Voluntary hospitalization due to "alcohol detox" "possible suicidality"
Serious: no
Organ System: Psychiatric disorders
Notes: Unanticipated hospitalization due events occurring in participant's life (event possibly related to study, but alternative cause is more likely)
Frequency: 1 affected / 160 at risk

Adverse event: Suicidality
Serious: no
Organ System: Psychiatric disorders
Notes: Participant became transiently suicidal while completing a homework assignment related to study.
Frequency: 1 affected / 163 at risk

Adverse event: Participant Fell
Serious: no
Organ System: Social circumstances
Notes: During a group session, a participant unintentionally walked into an obstruction and fell onto a chair.
Frequency: 1 affected / 163 at risk
Study: NCT02041104

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: After few days of dietary trial, diarrhea appear to one participant in test group consuming bread with added beta-glucans.
Frequency: 1 affected / 28 at risk

Adverse event: Discomfort during OGTT analysis
Serious: yes
Organ System: Investigations
Notes: Participants felt dizziness or sickness during first OGTT analysis. They refused to continue diet intervention.
Frequency: 3 affected / 23 at risk
Study: NCT02041221

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT02041286

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: One subject discontinued from all testing after hypoglycemia AE. Subject's hypoglycemia was resolved at the visit.
Frequency: 4 affected / 136 at risk
Study: NCT02041325

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Myocardial Infartion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT02041377

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 134 at risk
Study: NCT02041494

Adverse event: deep space infection
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 82 at risk

Adverse event: superficial SSI
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 82 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 82 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: DVT/pumonary embolism
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 82 at risk

Adverse event: deep space infection
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 83 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: superficial SSI
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 83 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 83 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: DVT/pumonary embolism
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 83 at risk
Study: NCT02041520

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: biliar colic in patiet with cholelithiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk
Study: NCT02041702

Adverse event: Anaphylaxis, Anaphylactoid
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 140 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 140 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 140 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 140 at risk

Adverse event: Right Ventricular Lead Dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 140 at risk

Adverse event: Ventricular Tachycardia Requiring Emergent Direct Current Cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 140 at risk

Adverse event: Retracted Right Atrial Lead
Serious: no
Organ System: General disorders
Frequency: 1 affected / 140 at risk

Adverse event: Acute Non-St Elevation Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 143 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 143 at risk

Adverse event: Dressler's syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 143 at risk

Adverse event: Righ Atrial Lead Dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 143 at risk

Adverse event: System Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 143 at risk

Adverse event: New Onset Paroxysmal Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 143 at risk
Study: NCT02042014

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 8 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Device connection issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 8 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 8 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02042131

Adverse event: Death by suicide
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk
Study: NCT02042404

Adverse event: Altered mental status
Serious: yes
Organ System: Psychiatric disorders
Notes: Not device related.
Frequency: 1 affected / 48 at risk

Adverse event: Hospitalized for bike accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not device related.
Frequency: 1 affected / 48 at risk

Adverse event: Drug overdose leading to death
Serious: yes
Organ System: Psychiatric disorders
Notes: Not device related.
Frequency: 1 affected / 48 at risk

Adverse event: Bacterial pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not device related.
Frequency: 1 affected / 48 at risk

Adverse event: Hospitalized for heart issues
Serious: yes
Organ System: Cardiac disorders
Notes: Not device related.
Frequency: 1 affected / 48 at risk

Adverse event: Abrasion/Blood blister in the ear canal
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related, anticipated, mild, all resolved.
Frequency: 13 affected / 48 at risk

Adverse event: Abrasion/Blood/Blister on tympanic membrane
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related, anticipated, mild, all resolved.
Frequency: 2 affected / 48 at risk

Adverse event: Ear discomfort/pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related, anticipated, mild/moderate, all resolved.
Frequency: 5 affected / 48 at risk

Adverse event: Ear tip, other: swelling, itching
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related, anticipated, mild/moderate, all resolved.
Frequency: 2 affected / 48 at risk

Adverse event: Inflammation/Granulation tissue on tympanic membrane
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related, anticipated, mild, all resolved.
Frequency: 3 affected / 48 at risk

Adverse event: Pain upon eructation/ valsalva
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related, anticipated, mild, all resolved.
Frequency: 1 affected / 48 at risk

Adverse event: Pressure sensation of device on tympanic membrane
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related, anticipated, mild, ongoing as subject continues to wear the device..
Frequency: 1 affected / 48 at risk
Study: NCT02042924

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk