TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02363478

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk
Study: NCT02363621

Adverse event: Anterior chamber inflammation
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 51 at risk

Adverse event: Anterior chamber inflammation
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 50 at risk
Study: NCT02363686

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject vomited the night of the BSE and FEES
Frequency: 2 affected / 248 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: subject re-intubated same day after GI bleed
Frequency: 1 affected / 248 at risk

Adverse event: penetration
Serious: no
Organ System: Gastrointestinal disorders
Notes: stopped study due to penetration combined with vomiting
Frequency: 1 affected / 248 at risk
Study: NCT02363738

Adverse event: Mortality
Serious: yes
Organ System: Nervous system disorders
Notes: A participant who received infliximab at the Stanford site died due to anoxic brain injury approximately 4 weeks after the third infusion.
Frequency: 1 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Arthritis reactive
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abnormal liver function enzymes
Serious: no
Organ System: Hepatobiliary disorders
Notes: Replicated abnormalities in laboratory assessments of liver function (ie, alanine aminotransferase and aspartate aminotransferase levels) without associated symptoms after 2 infusions of infliximab, patient dismissed from study before third infusion.
Frequency: 1 affected / 29 at risk

Adverse event: Mortality
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 31 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 31 at risk
Study: NCT02363803

Adverse event: Dry mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 33 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 33 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 34 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 34 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 34 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk
Study: NCT02363959

Adverse event: Repeat bronchoscopy due to bleeding during biopsy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT02363972

Adverse event: Cardiac serious adverse events
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 103 at risk

Adverse event: Endocrine, metabolic nutritional serious adverse events
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 103 at risk

Adverse event: Gastrointestinal serious adverse events
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Musculoskeletal serious adverse events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Nervous system serious adverse events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Respiratory serious adverse events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Skin and subcutaneous serious adverse events
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Vascular, blood and lymphatic serious adverse events
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 103 at risk

Adverse event: Uncoded
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 103 at risk

Adverse event: Eye, ear nonserious events
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 103 at risk

Adverse event: Immune, infection nonserious events
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 103 at risk

Adverse event: musculoskeletal nonserious adverse events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 103 at risk

Adverse event: Skin nonserious adverse events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Surgical procedure nonserious adverse events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 103 at risk

Adverse event: Vascular, blood nonserious adverse events
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 103 at risk

Adverse event: Drug effect nonserious adverse events
Serious: no
Organ System: Investigations
Frequency: 1 affected / 103 at risk
Study: NCT02363998

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 286 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 286 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 144 affected / 286 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 107 affected / 286 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 96 affected / 286 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 84 affected / 286 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 72 affected / 286 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 286 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 286 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 286 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 286 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 286 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 286 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 286 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 286 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 286 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 286 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 286 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 286 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 286 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 286 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 286 at risk
Study: NCT02364271

Adverse event: Safety MACE (STEMI)
Serious: yes
Organ System: Cardiac disorders
Notes: Patients had STEMI and survived. 7 had percutaneous coronary intervention or coronary artery bypass grafting
Frequency: 10 affected / 479 at risk

Adverse event: Safety MACE (NSTEMI)
Serious: yes
Organ System: Cardiac disorders
Notes: Patients had NSTEMI and survived. 10 had percutaneous coronary intervention or coronary artery bypass grafting
Frequency: 16 affected / 479 at risk

Adverse event: Effectiveness MACE (PCI)
Serious: no
Organ System: Surgical and medical procedures
Notes: Percutaneous coronary intervention without prior serious adverse cardiac event.
Frequency: 7 affected / 479 at risk

Adverse event: Effectiveness MACE (CABG)
Serious: no
Organ System: Surgical and medical procedures
Notes: Coronary artery bypass grafting without prior serious adverse cardiac event
Frequency: 2 affected / 479 at risk
Study: NCT02364388

Adverse event: Post procedural haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 217 at risk
Study: NCT02364700

Adverse event: mild skin rubbing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 7 subjects reported mild skin rubbing/pinching on proximal interphalangeal joint related to changes in fit of the device during training. Symptoms resolved with positional re-adjustment and/or added padding to hand (padding on finger joint or glove)
Frequency: 7 affected / 12 at risk

Adverse event: fatigue (cognitive)
Serious: no
Organ System: General disorders
Notes: 3 participants experienced feeling tired (attention) toward end of hand training sessions. Short rest breaks used to alleviate symptoms. Did not interfere with participation
Frequency: 3 affected / 12 at risk

Adverse event: shoulder fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 6 subjects reported muscle fatigue at shoulder during training as a results of active use. Did not interfere with study participation
Frequency: 6 affected / 12 at risk
Study: NCT02365207

Adverse event: Abdominal fluid collection
Serious: yes
Organ System: Surgical and medical procedures
Notes: Unanticipated: Subject was hospitalized with symptoms unrelated to study intervention: Abdominal fluid collection, body ache, chills, leg pain and surgical wound skin dehiscence
Frequency: 2 affected / 5 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unanticipated: unrelated to study intervention (subject hospitalized post surgery)
Frequency: 1 affected / 5 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unanticipated: related to surgical procedure, not study intervention
Frequency: 1 affected / 5 at risk

Adverse event: Gross hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 5 at risk

Adverse event: Exploratory laparotomy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unanticipated: unrelated to study drug: diagnosis of anemia prompted an exploratory laparotomy
Frequency: 1 affected / 5 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Painful and frequent urination which resolved within 24 hours
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal cramps
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT02365285

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Lightheadness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lightheadness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk
Study: NCT02365298

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Not Study Related
Frequency: 2 affected / 28 at risk
Study: NCT02365480

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk
Study: NCT02365506

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

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

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

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

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

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

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT02365519

Adverse event: Extradural abscess
Serious: yes
Organ System: Infections and infestations
Notes: The subject who presented extradural abscess discontinued the study due to this AE, which was not related to the investigational product.
Frequency: 1 affected / 213 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Not related to investigational product
Frequency: 1 affected / 65 at risk
Study: NCT02365558

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk
Study: NCT02365584

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 21 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 22 at risk
Study: NCT02365636

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 100 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk
Study: NCT02365688

Adverse event: Hypertension
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hypertensive event during open abdominal procedure
Frequency: 1 affected / 18 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Surgical and medical procedures
Notes: Excessive blood loss during the open abdominal procedure managed by fluid resuscitation
Frequency: 1 affected / 18 at risk
Study: NCT02365714

Adverse event: RT dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2 at risk
Study: NCT02365870

Adverse event: Excessive Somnolence
Serious: no
Organ System: General disorders
Notes: Mild severity recovered without treatment
Frequency: 1 affected / 3 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Notes: mild severity, not distressing
Frequency: 1 affected / 3 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Notes: mild severity
Frequency: 1 affected / 3 at risk
Study: NCT02365961

Adverse event: Hospital readmission
Serious: no
Organ System: General disorders
Notes: 2 patients were readmitted for postoperative pain control.
Frequency: 1 affected / 41 at risk

Adverse event: Hospital readmission
Serious: no
Organ System: General disorders
Notes: 2 patients were readmitted for postoperative pain control.
Frequency: 1 affected / 43 at risk
Study: NCT02366130

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 36 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 36 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 36 at risk

Adverse event: AST/ALT elevation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 36 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 36 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 36 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 36 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 36 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Hot flush
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 36 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 36 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 36 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 36 at risk
Study: NCT02366403

Adverse event: Admission to inpatient psychiatry
Serious: yes
Organ System: Psychiatric disorders
Notes: One participant presented to the emergency room with suicidal ideation and was admitted to inpatient psychiatry.
Frequency: 1 affected / 44 at risk

Adverse event: Distressed and lost to follow up
Serious: no
Organ System: Psychiatric disorders
Notes: One participant reported being distressed by the written assignments and was lost to follow up. The study's safety protocol was followed and the participant was determined to not be at imminent risk of harm.
Frequency: 1 affected / 44 at risk