TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01992523

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular and non cardiovascular death
Frequency: 1 affected / 41 at risk

Adverse event: Re-infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: TIMI minor bleeding (TIMI criteria)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Serum creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 41 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular and non cardiovascular death
Frequency: 1 affected / 41 at risk

Adverse event: Major bleeding (TIMI criteria)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: TIMI minor bleeding (TIMI criteria)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Ventricular pauses >= 3 sec
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Serum creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk
Study: NCT01992549

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Neuroblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 48 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 48 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

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

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

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

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 48 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 48 at risk
Study: NCT01992913

Adverse event: Inpatient psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: admission to a psychiatric unit for reasons of increased psychiatric symptoms, including substance abuse
Frequency: 12 affected / 37 at risk

Adverse event: Inpatient surgical hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: Inpatient hospitalization for reasons of planned or unplanned surgical procedure
Frequency: 1 affected / 37 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Rectal bleeding
Frequency: 1 affected / 37 at risk

Adverse event: Observation
Serious: yes
Organ System: General disorders
Notes: Admitted for observation due to fluid restriction
Frequency: 1 affected / 37 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Weakness in legs, unknown origin
Frequency: 1 affected / 37 at risk

Adverse event: Colonscopy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Admitted for colonoscopy
Frequency: 1 affected / 37 at risk

Adverse event: UTI/blood infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood infection that began with a urinary tract infection
Frequency: 1 affected / 37 at risk

Adverse event: Inpatient psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: admission to a psychiatric unit for reasons of increased psychiatric symptoms, including substance abuse
Frequency: 9 affected / 30 at risk

Adverse event: Inpatient surgical hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: Inpatient hospitalization for reasons of planned or unplanned surgical procedure
Frequency: 1 affected / 30 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Admitted for hand injury
Frequency: 1 affected / 30 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: General Medical
Serious: yes
Organ System: Surgical and medical procedures
Notes: Admitted for "general medical purposes"--no other information availably
Frequency: 2 affected / 30 at risk
Study: NCT01993030

Adverse event: Empyema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Excessive fluid leakage with odors
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk
Study: NCT01993238

Adverse event: Car Accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient admitted to hospital following car accident for lower back pain. Unrelated to treatment
Frequency: 1 affected / 11 at risk

Adverse event: Pain during treatment
Serious: no
Organ System: General disorders
Frequency: 11 affected / 11 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 11 at risk

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

Adverse event: Tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Soreness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Tingling/Altered Sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Dizziness/Feeling Faint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Warm sensation on treatment area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Surface sensitivity/soreness at treatment site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

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

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

Adverse event: Bruising at attempted IV site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Burning sensation to touch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain with movement
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sense of pressure at treatment site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk
Study: NCT01993329

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 19 at risk

Adverse event: Hypogeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 19 at risk

Adverse event: Hypogeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Macule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Hypogeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk
Study: NCT01993615

Adverse event: Surgical complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Heterotopic ossification or femur fracture
Frequency: 2 affected / 40 at risk

Adverse event: Surgical complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Heterotopic ossification or femur fracture
Frequency: 2 affected / 40 at risk
Study: NCT01993836

Adverse event: Vagal Event
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Leg Pain and Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 72 at risk

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

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

Adverse event: Vagal Event
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 68 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Post-dural puncture headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

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

Adverse event: Elevated PTT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

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

Adverse event: Vagal Event
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Post-dural puncture headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 51 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk
Study: NCT01993849

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk
Study: NCT01993875

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 82 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 82 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 82 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 82 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 82 at risk
Study: NCT01993927

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 713 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 713 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 713 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 713 at risk

Adverse event: Thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 713 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 713 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 713 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 713 at risk
Study: NCT01994226

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Non Cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Complication of TAVI procedure
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk
Study: NCT01994538

Adverse event: Any adverse event
Serious: no
Organ System: General disorders
Notes: Adverse events assessed were: C difficile, nausea, vomiting, diarrhea, dizziness, headache, allergic reaction, thrush, muscle/joint aches, abnormal blood sugars, and changes in warfarin dosing. Subjects may have more than one adverse event.
Frequency: 33 affected / 136 at risk

Adverse event: Any adverse event
Serious: no
Organ System: General disorders
Notes: Adverse events assessed were: C difficile, nausea, vomiting, diarrhea, dizziness, headache, allergic reaction, thrush, muscle/joint aches, abnormal blood sugars, and changes in warfarin dosing. Subjects may have more than one adverse event.
Frequency: 28 affected / 136 at risk
Study: NCT01994863

Adverse event: Peristomal skin problem/pain/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Possibly related to the product
Frequency: 8 affected / 20 at risk

Adverse event: Peristomal skin problem/pain/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Possibly related to the product
Frequency: 6 affected / 20 at risk
Study: NCT01994876

Adverse event: Redness skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Peristomal skin irritaion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk
Study: NCT01994902

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: unlikely related to the device
Frequency: 1 affected / 125 at risk

Adverse event: gastrientitis
Serious: yes
Organ System: Infections and infestations
Notes: not related to product
Frequency: 1 affected / 125 at risk

Adverse event: stoma operation (revision of stome)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: not related to product
Frequency: 1 affected / 125 at risk

Adverse event: obstruction of stoma
Serious: yes
Organ System: Gastrointestinal disorders
Notes: not related to product
Frequency: 1 affected / 125 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: not related to product
Frequency: 1 affected / 125 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: not related to product
Frequency: 1 affected / 125 at risk

Adverse event: Skin irritations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 125 at risk

Adverse event: acute abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: unlikely related to the device
Frequency: 1 affected / 120 at risk

Adverse event: Blocked stoma
Serious: yes
Organ System: Gastrointestinal disorders
Notes: not related to product
Frequency: 1 affected / 120 at risk

Adverse event: Severe sepsis in contex of intra abdominal infection
Serious: yes
Organ System: Infections and infestations
Notes: not related to product
Frequency: 1 affected / 120 at risk

Adverse event: Skin irritations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 120 at risk
Study: NCT01994954

Adverse event: Viral Respiratory Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Former preterm infants are at an increased risk for respiratory adverse events and morbidity.
Frequency: 16 affected / 99 at risk

Adverse event: Feeding Issue/G-Tube Complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 99 at risk

Adverse event: Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other serious adverse events related to prematurity
Frequency: 4 affected / 99 at risk

Adverse event: Respiratory Related Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 99 at risk

Adverse event: Viral Respiratory Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Former preterm infants are at an increased risk for respiratory adverse events and morbidity.
Frequency: 18 affected / 97 at risk

Adverse event: Feeding Issue/G-Tube Complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Respiratory Related Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 97 at risk
Study: NCT01995045

Adverse event: Intraocular pressure test
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Intraocular pressure test
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk