TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01829464

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk
Study: NCT01829477

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Episcleritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Electrocardiogram (ECG) abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasal polyps
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT01829919

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 24 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk
Study: NCT01829997

Adverse event: Continued leg pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Increased bilateral leg pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Right iliac implant pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Right leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 22 at risk

Adverse event: Bilateral leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

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

Adverse event: Lower back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

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

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

Adverse event: Arm tingling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

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

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

Adverse event: CSF Leak
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk
Study: NCT01830140

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 233 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Monoplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 233 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 42 affected / 233 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 233 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 233 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 53 affected / 233 at risk
Study: NCT01830205

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk
Study: NCT01830699

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: One subject in the rilonacept arm was hospitalized for diarrhea, heme-occult positive stool, and an INR of 3.4. One subject in the triamcinolone arm was hospitalized for shortness of breath for which an etiology was never identified.
Frequency: 1 affected / 12 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: One subject in the rilonacept arm was hospitalized for diarrhea, heme-occult positive stool, and an INR of 3.4. One subject in the triamcinolone arm was hospitalized for shortness of breath for which an etiology was never identified.
Frequency: 1 affected / 20 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Required antibiotics
Frequency: 1 affected / 20 at risk

Adverse event: Generalized Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hand Tingling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT01830881

Adverse event: Reaspiration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 62 at risk

Adverse event: Reaspiration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 62 at risk

Adverse event: Uterine cervical laceration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 62 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 62 at risk
Study: NCT01831154

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 15 at risk

Adverse event: Cerebral vascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Viral gastrointestinal-dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: death
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cerebral vascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Deep sternal wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain, restenosis of cardiac bypass graft
Frequency: 1 affected / 11 at risk

Adverse event: Feet Ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Bilateral Feet blisters and ulceration
Frequency: 1 affected / 11 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Peripheral edema, dyspnea, fluid overload
Frequency: 1 affected / 11 at risk
Study: NCT01831232

Adverse event: Multi organ failure secondary to sepsis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Febrile neutropenia Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 24 at risk

Adverse event: Febrile neutropenia Grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash Grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hand-foot syndrome Grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Septic shock (Grade 4)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhea Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 24 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Transaminitis Grade 3
Serious: no
Organ System: Investigations
Frequency: 2 affected / 24 at risk

Adverse event: Colon pneumatosis Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: GI bleeding Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Tumor lysis syndrome Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk
Study: NCT01831258

Adverse event: Mask related issues
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 11 events were related to the mask, it was not related to the device. There were sore on nose, skin breakdown from mask and mask irritations
Frequency: 5 affected / 70 at risk

Adverse event: Cold or Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cold or Upper Respiratory Infections. They were not related to the device
Frequency: 3 affected / 70 at risk

Adverse event: Dizziness upon Arousal
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not related to the device
Frequency: 1 affected / 70 at risk

Adverse event: Pressure related problems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Feeling higher pressure from the device
Frequency: 2 affected / 70 at risk

Adverse event: High Blood Pressure
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Participant was hospitalized with symptoms of extremely high blood pressure. No formal diagnosis was given prior to discharge however subjects were placed on hypertension medication. PI deemed as not related to the device
Frequency: 1 affected / 70 at risk

Adverse event: Mask related issues
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 11 events were related to the mask, it was not related to the device. There were sore on nose, skin breakdown from mask and mask irritations
Frequency: 7 affected / 70 at risk

Adverse event: Cold or Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cold or Upper Respiratory Infections. They were not related to the device
Frequency: 5 affected / 70 at risk

Adverse event: Broken Arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Broken Arm not related to the device
Frequency: 1 affected / 70 at risk

Adverse event: Pressure related problems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Feeling higher pressure from the device
Frequency: 2 affected / 70 at risk

Adverse event: Scheduled Achilles Tendon Surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to the device
Frequency: 1 affected / 70 at risk
Study: NCT01831544

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 11 at risk

Adverse event: Device Malfunction/Failure
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 11 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 11 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 11 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 11 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 11 at risk

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

Adverse event: Device malfunction/failure
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 11 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 11 at risk
Study: NCT01831596

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Mild surgical infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Congestive Heart Failure exacerbation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Stitch granuloma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: Minor dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Lymphocele
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk
Study: NCT01831791

Adverse event: Stress fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Post-traumatic neck syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 120 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 120 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 120 at risk
Study: NCT01831804

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

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infected skin ulcer
Serious: no
Organ System: Infections and infestations
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: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

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