TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02586896

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Death (cause unknown)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 150 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Hepatobiliary disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 150 at risk

Adverse event: Withdrawal of life support
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 150 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Angiopathy
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Cardiac disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Death (cause unknown)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 150 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: Musculoskeletal disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 150 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Musculoskeletal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk
Study: NCT02587065

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 28 affected / 193 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Frequency: 10 affected / 193 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 193 at risk
Study: NCT02587117

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Flatulency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 13 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Puffiness of face
Serious: no
Organ System: General disorders
Frequency: 13 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 15 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 15 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT02587143

Adverse event: Dizziness after puncture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 66 at risk
Study: NCT02587234

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject sustained a fall at home during the intervention period of the study. The subject was evaluated by a doctor not associated with the study and no fractures or major trauma was detected. The event was determined to not be related to the study.
Frequency: 1 affected / 11 at risk
Study: NCT02587637

Adverse event: Increased Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Pain at pocket
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk
Study: NCT02587650

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

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

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

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

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

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

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

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

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1 at risk
Study: NCT02587819

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Subject 01-007 experienced a myocardial infarction from 9 September 2013 (Study Day 49) to 11 September 2013 (Study Day 51), which was moderate and was considered to be unrelated to study medication.
Frequency: 1 affected / 21 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 21 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 21 at risk

Adverse event: Application site exfoliation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk
Study: NCT02588248

Adverse event: bloating and cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: bumps
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: bloating and cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

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

Adverse event: constipation and bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk
Study: NCT02588586

Adverse event: Acute psychotic episode
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization for an acute psychotic episode 6 days after the second 3BNC117 infusion. Deemed not related to study drug but to underlying bipolar disorder.
Frequency: 1 affected / 17 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Malaise or fatigue
Frequency: 4 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk
Study: NCT02588950

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

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eye laser surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 11 at risk

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

Adverse event: Medical device site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Priapism
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk
Study: NCT02589067

Adverse event: other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient experienced vomiting
Frequency: 1 affected / 33 at risk

Adverse event: other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient experienced vomiting
Frequency: 1 affected / 34 at risk
Study: NCT02589275

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 170 at risk

Adverse event: Parasthesia Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 170 at risk

Adverse event: Tongue discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 170 at risk

Adverse event: Product taste abnormal
Serious: no
Organ System: Product Issues
Frequency: 9 affected / 170 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 186 at risk

Adverse event: Parasthesia Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 186 at risk

Adverse event: Tongue discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 186 at risk

Adverse event: Product taste abnormal
Serious: no
Organ System: Product Issues
Frequency: 20 affected / 186 at risk
Study: NCT02589392

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 60 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk
Study: NCT02589405

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk
Study: NCT02589496

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: elevated liver enzyme
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 61 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk
Study: NCT02589626

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 32 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 33 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 33 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 33 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 33 at risk
Study: NCT02589795

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Occurred 5 months after the affected subject's final vaccination
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk
Study: NCT02589938

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 86 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 86 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Flu like systoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 86 at risk
Study: NCT02590068

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Notes: The incident of dyspenia occurred during the screening visits prior to receipt of the Zoster vaccine. Not related to the test article.
Frequency: 1 affected / 14 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: This volunteer has a history of previously uncontrolled hypertension of several years,with a recent history of intermittent dyspnea on exertion.He had a cardiac catheterization performed prior to the administration of Zoster vaccine in this study.
Frequency: 1 affected / 14 at risk

Adverse event: Mild Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: The decrease in the hemoglobin level not believed to be related to the administration of the Zoster vaccine.
Frequency: 1 affected / 14 at risk

Adverse event: Mild Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: This volunteer has had intermittent chronic back pain for the past 10 years and takes Baclofen 10 mg po h.s. for pain relief. Use of Baclofen was during the screening period prior to the administration of the Zoster vaccine and therefore not related.
Frequency: 1 affected / 14 at risk

Adverse event: Dental Filling Fell Out
Serious: no
Organ System: Gastrointestinal disorders
Notes: The volunteer had a dental filling that fell out which caused a moderate amount of dental pain (one month after administration of Zoster vaccination).
Frequency: 1 affected / 14 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: This episode was precipitated by psychosocial stressors at home. He has a history of bipolar disorder.
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Zoster vaccination was given on 8/8/16 and lightheadedness occurred on 8/11/16.
Frequency: 1 affected / 14 at risk