TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02344407

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Typhoid fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Chest injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 500 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 500 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pheumocystis jirovecii pheumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk
Study: NCT02344576

Adverse event: Neurological Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 135 at risk

Adverse event: Major Bleeding Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 64 affected / 135 at risk

Adverse event: Right Ventricular Assist Device Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 135 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 56 affected / 135 at risk

Adverse event: Endotrachael Mechanical Ventilation
Serious: yes
Organ System: Cardiac disorders
Notes: Need for endotrachael mechanical ventilation other than for the 72 hours around LVAD implant surgery.
Frequency: 36 affected / 135 at risk

Adverse event: Inotrope Support
Serious: no
Organ System: Cardiac disorders
Frequency: 107 affected / 135 at risk

Adverse event: Renal Replacement Therapy/Dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 135 at risk

Adverse event: Implantable Cardioverter Defibrillator Shocks
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 135 at risk

Adverse event: Psychiatric Episode
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 135 at risk

Adverse event: Neurological Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 113 at risk

Adverse event: Major Bleeding Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 113 at risk

Adverse event: Right Ventricular Assist Device Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 113 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 113 at risk

Adverse event: Endotrachael Mechanical Ventilation
Serious: yes
Organ System: Cardiac disorders
Notes: Need for endotrachael mechanical ventilation other than for the 72 hours around LVAD implant surgery.
Frequency: 26 affected / 113 at risk

Adverse event: Inotrope Support
Serious: no
Organ System: Cardiac disorders
Frequency: 73 affected / 113 at risk

Adverse event: Renal Replacement Therapy/Dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 113 at risk

Adverse event: Implantable Cardioverter Defibrillator Shocks
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 113 at risk

Adverse event: Psychiatric Episode
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 113 at risk
Study: NCT02344628

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 291 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 291 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 291 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 291 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 291 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 292 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 292 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 292 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 292 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 292 at risk
Study: NCT02345031

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back Pain
Frequency: 1 affected / 38 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Notes: Triglycerides increased
Frequency: 2 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhoea
Frequency: 3 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 6 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 4 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 2 affected / 38 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinus Congestion
Frequency: 1 affected / 38 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Drowsiness
Frequency: 3 affected / 38 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Tinnitus
Frequency: 4 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection
Frequency: 3 affected / 38 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Acute Alcohol Intoxication
Frequency: 1 affected / 40 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back Pain
Frequency: 3 affected / 40 at risk

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

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

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Gastroenteritis
Frequency: 2 affected / 40 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 3 affected / 40 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinus Congestion
Frequency: 2 affected / 40 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Tinnitus
Frequency: 3 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection
Frequency: 2 affected / 40 at risk
Study: NCT02345330

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4 at risk

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

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

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

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4 at risk

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

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk
Study: NCT02345512

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: bruising to buttock area following assistance of putting on Lycra splinting garment.
Frequency: 1 affected / 11 at risk
Study: NCT02345811

Adverse event: Sore Throat and Fever
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pelvic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk
Study: NCT02346136

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 77 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 77 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 77 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 77 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 77 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 77 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 67 at risk

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

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 67 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 67 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 67 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 67 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 67 at risk
Study: NCT02346526

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: hand cramp
Frequency: 1 affected / 22 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: polydipsia
Frequency: 1 affected / 22 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Spinal fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal and connective tissue disorders - other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: shaking thighs
Frequency: 1 affected / 22 at risk
Study: NCT02346643

Adverse event: Post-dural puncture headache
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: IPG Pocket Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: High Lead Impedance
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Loss of Stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 41 at risk

Adverse event: Lead Severed
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Pain at Incision Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 41 at risk

Adverse event: Arrhythmia and Irregularities
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Erythema or Drainage or Inflammation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Gluteal muscle pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Upper Extremities Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk
Study: NCT02346708

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: vasovagal syncope
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: local pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: mild blurry vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: burst vein in eye
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: mild flu
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: motor problems
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk
Study: NCT02346721

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Lymphangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 111 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 111 at risk

Adverse event: Gallbladder adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 111 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 111 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 111 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 111 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 111 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 111 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 111 at risk
Study: NCT02346877

Adverse event: Injection site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk
Study: NCT02347072

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 73 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 72 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 72 at risk
Study: NCT02347085

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Hypertenstion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypertenstion
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk
Study: NCT02347124

Adverse event: Chest pain or mild tightness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 360 at risk

Adverse event: Anxiety or stress, mild to moderate
Serious: no
Organ System: General disorders
Frequency: 4 affected / 360 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 360 at risk

Adverse event: Seizure (pre-existing disorder)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 360 at risk

Adverse event: Dizziness, mild to moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 360 at risk

Adverse event: change in heartbeat leading to ER visit. Disccontinued use of nicotien patch and resolved.
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 358 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Notes: Swelling of lips and tongue in response to nicotine replacement gum. Discontinued gum and symptoms resolved.
Frequency: 1 affected / 358 at risk

Adverse event: Unreversible blindness in right eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 358 at risk

Adverse event: Anxiety or stress, mild to moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 358 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 358 at risk

Adverse event: Dizziness, mild to moderate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 358 at risk

Adverse event: Behavior or mood change (while taking Zyban)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 358 at risk

Adverse event: Migraine, low BP, chills and nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 358 at risk