TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03480152

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

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

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, excoriation to the head of penis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possibly related to research.
Frequency: 1 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possibly related to research.
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT03480243

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 28 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 28 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 28 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 27 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 27 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk
Study: NCT03480360

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Notes: Probably related to pseudo-gout
Frequency: 1 affected / 20 at risk

Adverse event: GI GVHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Liver GVHD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Skin GVHD
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 20 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

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

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

Adverse event: Dysrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: C. Diff
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT03480386

Adverse event: Hospitalization- COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 188 at risk

Adverse event: Hospitalization: Aortic Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 188 at risk

Adverse event: Hospitalization: Opioid Hyperalgesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 188 at risk

Adverse event: Hospitalization- left Carotid Artery Stent
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 188 at risk

Adverse event: Hospitalization: Debridement of Metatarsal ulcer
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 188 at risk

Adverse event: Hospitalization: Endobronchial valve lung volume reduction sugery
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Hospitalization: Obstruction Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Hospitalization- COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 187 at risk

Adverse event: Hospitalization: Prostate Cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 187 at risk

Adverse event: Hospitalization: Neoplasm of Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Hospitalization: Malignant Neoplasm Brain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 187 at risk

Adverse event: Hospitalization: Acute Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 187 at risk

Adverse event: Hospitalization: Pacemaker Cardiac Status Post
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 187 at risk
Study: NCT03481725

Adverse event: Lead fracture during purposeful removal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The electrical lead fractured during purposeful removal. The remaining lead fragment is always left in situ and there were no adverse sequelae due to the fragments in the 4-month follow-up period.
Frequency: 1 affected / 31 at risk

Adverse event: Adhesive reaction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Erythema and irritation developed under the occlusive dressing holding the lead. The dressing and lead were removed and the erythema and irritation resolved without requiring treatment.
Frequency: 1 affected / 31 at risk

Adverse event: Lead fracture during purposeful removal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The electrical lead fractured during purposeful removal. The remaining lead fragment is always left in situ and there were no adverse sequelae due to the fragments in the 4-month follow-up period.
Frequency: 1 affected / 34 at risk
Study: NCT03481777

Adverse event: SAE
Serious: yes
Organ System: Cardiac disorders
Notes: All cause mortality
Frequency: 335 affected / 713 at risk

Adverse event: Upper extremity pain during treatment and/or skin petechia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Upper extremity pain during treatment and/or skin petechia for ALL randomized (Target diagnosis, non-target diagnosis and post-randomization exlcuded patients)
Frequency: 54 affected / 713 at risk

Adverse event: SAE
Serious: yes
Organ System: Cardiac disorders
Notes: All cause mortality
Frequency: 325 affected / 720 at risk

Adverse event: Upper extremity pain during treatment and/or skin petechia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Upper extremity pain during treatment and/or skin petechia for ALL randomized (Target diagnosis, non-target diagnosis and post-randomization exlcuded patients)
Frequency: 11 affected / 720 at risk
Study: NCT03482024

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk
Study: NCT03482713

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oral discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 11 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 12 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT03482752

Adverse event: Alveolar proteinosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: HIV infection CDC Group IV subgroup A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 59 at risk

Adverse event: Alveolar proteinosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 59 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 59 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 59 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 59 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 59 at risk
Study: NCT03482973

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk
Study: NCT03483051

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

Adverse event: Stomach Ache, diarrhea, nausea or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Drop in blood pressure when standing up
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk
Study: NCT03483077

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

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

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk
Study: NCT03483506

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Listless
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT03484429

Adverse event: PNS Lead Reimplantation
Serious: no
Organ System: Surgical and medical procedures
Notes: Two subjects in the PNS group required reimplantation of PNS leads due to dislodgement. No suspected lead fractures were observed during the treatment period or lead removal.
Frequency: 2 affected / 8 at risk
Study: NCT03484533

Adverse event: Hospitalisation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hospitalization due to pregnancy complications.
Frequency: 5 affected / 332 at risk

Adverse event: Social Harm
Serious: no
Organ System: Social circumstances
Notes: Social harm related to HIV disclosure by male partner testing
Frequency: 5 affected / 332 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Hospitalization due to pregnancy complications.
Frequency: 1 affected / 168 at risk

Adverse event: Social Harm
Serious: no
Organ System: Social circumstances
Notes: Social harm related to HIV disclosure by male partner testing
Frequency: 1 affected / 168 at risk
Study: NCT03485222

Adverse event: Malignant Ventricular Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: New ICD Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: New Cardiomems Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 40 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Worsening Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: New ICD Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hepatic Injury
Serious: no
Organ System: Hepatobiliary disorders
Notes: ALT and/or AST ≥ 5 fold ULN
Frequency: 1 affected / 40 at risk