TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01759446

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Burning in nasal \& throat
Frequency: 6 affected / 44 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 44 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Burning in nasal \& throat
Frequency: 10 affected / 44 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 44 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Burning in nasal \& throat
Frequency: 3 affected / 44 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk
Study: NCT01759537

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Note: Cause of death is unknown and therefore "General disorders" was selected.
Frequency: 1 affected / 48 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: An accident involving a fractured upper and lower jaw (trauma adjacent to a study implant)
Frequency: 1 affected / 48 at risk

Adverse event: Healing abutment lost
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 48 at risk

Adverse event: Provisional crown loosened/lost
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 48 at risk

Adverse event: Final crown loosened/lost
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 48 at risk

Adverse event: Final crown chipped/fractured
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 48 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Note: Cause of death is unknown and therefore "General disorders" was selected.
Frequency: 1 affected / 48 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: An accident involving a fractured upper and lower jaw (trauma adjacent to a study implant)
Frequency: 1 affected / 48 at risk

Adverse event: Healing abutment lost
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 48 at risk

Adverse event: Provisional crown loosened/lost
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 48 at risk

Adverse event: Provisional crown chipped/fractured
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 48 at risk

Adverse event: Final crown loosened/lost
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 48 at risk

Adverse event: Final crown chipped/fractured
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 48 at risk
Study: NCT01759862

Adverse event: tachycardia at day 1 post transplant
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 23 at risk

Adverse event: tacrolimus toxicity
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 23 at risk

Adverse event: Rejection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 23 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: tachycardia at day 1 post transplant
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 27 at risk

Adverse event: tacrolimus toxicity
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 27 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rejection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 27 at risk
Study: NCT01760239

Adverse event: Very high blood pressure
Serious: yes
Organ System: Vascular disorders
Notes: Blood pressure greater than 160/100 at any point in the intervention period.
Frequency: 2 affected / 296 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 296 at risk

Adverse event: Echocardiogram conducted
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 296 at risk

Adverse event: Renal ultrasound conducted
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 296 at risk

Adverse event: New medication for hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 296 at risk

Adverse event: Hospitalization for any cause
Serious: no
Organ System: General disorders
Frequency: 11 affected / 296 at risk

Adverse event: Very high blood pressure
Serious: yes
Organ System: Vascular disorders
Notes: Blood pressure greater than 160/100 at any point in the intervention period.
Frequency: 1 affected / 226 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 226 at risk

Adverse event: Echocardiogram conducted
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 226 at risk

Adverse event: Renal ultrasound conducted
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 226 at risk

Adverse event: New medication for hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 226 at risk

Adverse event: Hospitalization for any cause
Serious: no
Organ System: General disorders
Frequency: 8 affected / 226 at risk
Study: NCT01760473

Adverse event: Elevated liver function test (AST/ALT)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Liver function rose to greater than 3 x the upper limit of normal. Blood chemistry was performed on a weekly basis throughout the 9 weeks. As multiple doses were tested during the week, we cannot attribute this AE to any individual drug condition.
Frequency: 2 affected / 27 at risk
Study: NCT01760733

Adverse event: Graft loss
Serious: yes
Organ System: Renal and urinary disorders
Notes: Loss of function of kidney transplant
Frequency: 7 affected / 217 at risk

Adverse event: Removed from the transplantation wait-list
Serious: yes
Organ System: General disorders
Notes: Patients who are removed from the transplantation waiting list because of medical conditions making the ineligible for the procedure
Frequency: 41 affected / 289 at risk
Study: NCT01761019

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT01761162

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Arterial stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 229 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 229 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 229 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 229 at risk

Adverse event: Mild to moderate post-operative risks
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 229 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 229 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 229 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 229 at risk

Adverse event: Syncope/Pre-Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 229 at risk

Adverse event: Arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 229 at risk

Adverse event: MRI Incidental Finding
Serious: no
Organ System: General disorders
Frequency: 17 affected / 229 at risk
Study: NCT01761175

Adverse event: Horner syndrome
Serious: no
Organ System: Nervous system disorders
Notes: Ptosis, miosis, and anhidrosis of the side of the face ipsilateral to the block performed
Frequency: 2 affected / 112 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Hematoma at the puncture site
Frequency: 1 affected / 112 at risk

Adverse event: Local anesthetic toxicity
Serious: no
Organ System: Nervous system disorders
Notes: Mild signs of local anesthetic toxicity including tinnitus, circumoral numbness, drowsiness, lightheadedness or metallic taste.
Frequency: 1 affected / 112 at risk
Study: NCT01761565

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 39 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 39 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 39 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: All adverse events listed in the above table are included regardless of relationship to study drug
Frequency: 1 affected / 39 at risk
Study: NCT01761643

Adverse event: Fanconi syndrome
Serious: yes
Organ System: Renal and urinary disorders
Notes: Related to study drug
Frequency: 1 affected / 198 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea, diarrhea, abdomen pain
Frequency: 7 affected / 198 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 198 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 198 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 198 at risk

Adverse event: depression with or without sucidality
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 198 at risk

Adverse event: GU symptoms and disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 198 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 198 at risk

Adverse event: tonsil lesion
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 198 at risk

Adverse event: HIV Seroconversion
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea, diarrhea, abdomen pain
Frequency: 12 affected / 200 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 200 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 200 at risk

Adverse event: GU symptoms and disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 200 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk
Study: NCT01761747

Adverse event: Pancreatits
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2 at risk
Study: NCT01761877

Adverse event: Intraparenchymal Hemorrhage associated with cerebral amyloid angiopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Transient Pancreatitis of Unclear Etiology
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: B cell Lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: upset stomach or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 50 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 50 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 50 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk
Study: NCT01762059

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Headache occurred three times on two subjects on the bionic pancreas.
Frequency: 3 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea without vomiting occurred one time each in four subjects on the bionic pancreas. In three of these cases, no glucagon dosing had occurred in over 2 hours.
Frequency: 4 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea with vomiting occurred in one subject in the setting of an intravenous catheter removal, with the last glucagon dosed approximately 1 hour earlier.
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Three insulin infusion sets and one glucagon infusion set were removed for pain or inflammation during the bionic pancreas arm.
Frequency: 3 affected / 20 at risk

Adverse event: Blood ketone body
Serious: no
Organ System: Endocrine disorders
Notes: One subject developed moderate hyperketonemia (0.8 mmol/l) on the bionic pancreas in the setting of a leaking insulin infusion set. The hyperketonemia resolved afterthe infusion set was changed.
Frequency: 1 affected / 20 at risk
Study: NCT01762345

Adverse event: urinary tract infection (UTI)
Serious: no
Organ System: Infections and infestations
Notes: UTI
Frequency: 5 affected / 83 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: vaginal bleeding
Frequency: 5 affected / 83 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 83 at risk
Study: NCT01762501

Adverse event: Infectious disease
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 359 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 62 affected / 359 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 359 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 359 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 359 at risk

Adverse event: Infectious disease
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 359 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 359 at risk
Study: NCT01762982

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 36 at risk
Study: NCT01763346

Adverse event: Ankle fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: requiring fixation, resutling from traffic accident
Frequency: 1 affected / 39 at risk

Adverse event: Gastric sleeve surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: elective
Frequency: 1 affected / 39 at risk

Adverse event: stomach pain or discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 39 at risk

Adverse event: dairrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Lack of energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: gastric band slippage requiring removal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: gastric band slippage requireing removal
Frequency: 2 affected / 38 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 38 at risk

Adverse event: acalcuous cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Requering gall bladder removal
Frequency: 1 affected / 38 at risk

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

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