TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02186015

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk
Study: NCT02186509

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 17 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 17 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 17 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 17 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 17 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 17 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Hpocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 17 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 17 at risk

Adverse event: Focal seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 17 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 17 at risk

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

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 17 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 17 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk
Study: NCT02186587

Adverse event: knee stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk
Study: NCT02186600

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 93 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 91 at risk

Adverse event: Gi disturbances
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 91 at risk

Adverse event: muscle or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 91 at risk

Adverse event: Chest Pain or Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 91 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 92 at risk

Adverse event: muscle or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 92 at risk
Study: NCT02186652

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

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

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

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

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk
Study: NCT02186665

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Conjuctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Lice infestation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

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

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Urine calcium/creatinine ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

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

Adverse event: Hypercalciuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal 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: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk
Study: NCT02186808

Adverse event: Cardiac arrhytmia
Serious: yes
Organ System: Cardiac disorders
Notes: Deceased, no evidence for a device related complication is reported.
Frequency: 1 affected / 80 at risk

Adverse event: Heart disease
Serious: yes
Organ System: Cardiac disorders
Notes: Deceased, no evidence for a device related complication is reported.
Frequency: 1 affected / 80 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Deceased, no evidence for a device related complication is reported.
Frequency: 1 affected / 80 at risk

Adverse event: Porcelain fractures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 22 affected / 80 at risk

Adverse event: occlusal adjustments
Serious: no
Organ System: Surgical and medical procedures
Frequency: 14 affected / 80 at risk

Adverse event: Periodontal problems
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 80 at risk
Study: NCT02186873

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 99 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Metabolic dysfunction-associated steatohepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 105 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 105 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 105 at risk
Study: NCT02187016

Adverse event: Gingival Irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 79 at risk

Adverse event: Gingival Irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Gingival Irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk
Study: NCT02188121

Adverse event: Elevated creatine kinase level
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Classified as severe if \>2x normal range
Frequency: 2 affected / 99 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Placed on Lithium while on Losartan
Serious: yes
Organ System: General disorders
Notes: This is a relative contraindication. Patient taken off of losartan when team informed going on lithium. No sequelae
Frequency: 1 affected / 99 at risk

Adverse event: Psychiatric Hospitalization
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 99 at risk

Adverse event: Medical Hospitalization
Serious: no
Organ System: General disorders
Frequency: 6 affected / 99 at risk

Adverse event: Laboratory values outside normal range
Serious: no
Organ System: General disorders
Frequency: 43 affected / 99 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Notes: New onset
Frequency: 1 affected / 105 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 105 at risk

Adverse event: Psychiatric Hospitalization
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 105 at risk

Adverse event: Medical Hospitalization
Serious: no
Organ System: General disorders
Frequency: 7 affected / 105 at risk

Adverse event: Laboratory values outside normal range
Serious: no
Organ System: General disorders
Frequency: 23 affected / 105 at risk
Study: NCT02188147

Adverse event: Skin rash or irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin rash or irritation (no medical intervention required)
Frequency: 10 affected / 39 at risk

Adverse event: Inappropriate shock
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A defibrillation shock was delivered when the patient was not experiencing a treatable arrhythmia
Frequency: 3 affected / 39 at risk
Study: NCT02188160

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: One subject reported an SAE (cholelithiasis; KPI-121 0.25% group), which was considered unrelated to the study treatment; it was severe in intensity, led the subject to discontinue the study treatment, and ultimately resolved without sequelae.
Frequency: 1 affected / 72 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 72 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 78 at risk
Study: NCT02188485

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk
Study: NCT02188589

Adverse event: Nonsurgical implant retrieval
Serious: yes
Organ System: Investigations
Notes: 3/56 total implants placed were retrieved post implantation. Implant retrieval did not require surgical intervention and did not result in any adverse clinical sequelae.
Frequency: 3 affected / 30 at risk

Adverse event: Hernia Repair Procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hernia repair procedure occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure.
Frequency: 1 affected / 30 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchitis occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure.
Frequency: 1 affected / 30 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A non-serious device-related hematoma was observed.
Frequency: 1 affected / 30 at risk

Adverse event: Inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A non-serious device-related observation of inflammation was reported.
Frequency: 1 affected / 30 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Notes: Includes reports of rhinitis and "common cold", non-serious and not device-related
Frequency: 3 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Notes: Non-serious and not device-related
Frequency: 2 affected / 30 at risk

Adverse event: Acute hypertension
Serious: no
Organ System: Vascular disorders
Notes: Non-serious and not device-related
Frequency: 1 affected / 30 at risk

Adverse event: Injury by fallen tree
Serious: no
Organ System: Social circumstances
Notes: Non-serious and not device-related
Frequency: 1 affected / 30 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Notes: Non-serious and not device-related
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Non serious and not device-related
Frequency: 1 affected / 30 at risk

Adverse event: Normal Bleeding Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Normal bleeding epistaxis occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure.
Frequency: 1 affected / 30 at risk
Study: NCT02188849

Adverse event: Falls
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 22 at risk

Adverse event: Gastroinftestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 22 at risk

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

Adverse event: Falls
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 17 at risk

Adverse event: Gastroinftestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 17 at risk
Study: NCT02189122

Adverse event: ST T wave changes following bradykinin infusion
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 18 at risk

Adverse event: Sinus or nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: low albumin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: ST T wave changes following bradykinin infusion
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 18 at risk

Adverse event: Sinus or nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: low albumin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk
Study: NCT02189161

Adverse event: Anal stenosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Haemorrhoids thrombosed
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk
Study: NCT02189317

Adverse event: Post-operative Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk
Study: NCT02189629

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 453 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 453 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Complex regional pain syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 453 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 453 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 453 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 453 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 453 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 453 at risk

Adverse event: Application Site Pruritis
Serious: no
Organ System: General disorders
Frequency: 23 affected / 453 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 22 affected / 453 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 453 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 453 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 453 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 453 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 453 at risk

Adverse event: Infectious mononucleosis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 453 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 453 at risk