TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02199028

Adverse event: Erythema >10 mm diameter
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema at infusion set insertion site
Frequency: 16 affected / 30 at risk

Adverse event: Infection at sensor site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: abscess at Dexcom sensor insertion site
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Tape allergy from Dexcom sensor
Frequency: 1 affected / 30 at risk

Adverse event: Erythema >10 mm diameter
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema at infusion set insertion site
Frequency: 17 affected / 30 at risk

Adverse event: Infection at infusion set site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: abscess at insertion site
Frequency: 1 affected / 30 at risk

Adverse event: Infection at sensor site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: abscess at Dexcom sensor insertion site
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Tape allergy from Dexcom sensor
Frequency: 1 affected / 30 at risk
Study: NCT02199314

Adverse event: Goitre
Serious: no
Organ System: Endocrine disorders
Notes: Patient found to have enlarged thyroid gland at end of procedure - deemed unrelated to study
Frequency: 1 affected / 18 at risk
Study: NCT02199509

Adverse event: Suicide Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk
Study: NCT02199574

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT02199652

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 10 at risk
Study: NCT02199743

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Notes: Participant was monitoring glucose on his own with his PCP. Became sick with pneumonia and had his glucose increase to 315 at time of visit to ER. Was hospitalized for \~1 week. Started on medication for hypertension and insulin for DMII.
Frequency: 1 affected / 14 at risk

Adverse event: Sedation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 14 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Stiffness in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Sedation
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk
Study: NCT02200055

Adverse event: perineal wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Post-op infection leading to hospital admission
Frequency: 1 affected / 90 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: bronchospasm during surgery
Frequency: 1 affected / 90 at risk

Adverse event: upper gastrointestinal bleed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: resulted in re-admission
Frequency: 1 affected / 90 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haemoperitoneum
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pancreatic leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk
Study: NCT02201212

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: any adverse event per CTCAE v4.0
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: any adverse event per CTCAE v4.0
Frequency: 20 affected / 30 at risk
Study: NCT02201290

Adverse event: Scleral haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 9 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 9 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT02201420

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal 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
Study: NCT02201446

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 81 at risk
Study: NCT02201628

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: On insertion of nasopharyngeal temperature probe. Minor and self-resolved
Frequency: 1 affected / 59 at risk

Adverse event: Post-extubation stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Self-resolved without medical therapy. Associated with use of Microcuff endotracheal tube
Frequency: 1 affected / 59 at risk

Adverse event: Partially obstructed ETT during emergence
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Associated with use of Microcuff endotracheal tube. Required suctioning with suction catheter, thereafter no further complications
Frequency: 1 affected / 59 at risk
Study: NCT02201784

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room.Bradycardia was defined as HR\<50 beat/min
Frequency: 2 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Arterial blood pressure was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room. Hypotension was defined as systolic BP \< 90 mm Hg
Frequency: 7 affected / 30 at risk

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

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room.Bradycardia was defined as HR\<50 beat/min
Frequency: 2 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Arterial blood pressure was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room. Hypotension was defined as systolic BP \< 90 mm Hg
Frequency: 10 affected / 30 at risk
Study: NCT02202031

Adverse event: Cold/Flu
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 82 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 79 at risk
Study: NCT02202135

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE started at 12:00 pm on and resolved at 13:00 pm on 2014-08-08. It was reported as important medical event which was assessed as moderate and unrelated to study drug.
Frequency: 1 affected / 4 at risk

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

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

Adverse event: Urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

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

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

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

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk
Study: NCT02202499

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Joint range of motion decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cardiac Disorders - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gallblader Pain
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk
Study: NCT02202538

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 53 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Scrape/Cut/Abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 53 at risk

Adverse event: Skin Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 53 at risk
Study: NCT02203305

Adverse event: vertigo / dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 20 at risk

Adverse event: light-headedness & nausea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: bleeding at surgical site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: short circuit
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 20 at risk

Adverse event: vertigo / dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: imbalance
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: Drainage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: facial stimulation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT02203357

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 117 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 111 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 125 at risk
Study: NCT02203565

Adverse event: Radiation skin injury
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Radiation Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patients were evaluated for Radiation Dermatitis of all grades (1-4) as defined by CTCAE guidlines. Radiation dermatitis is an expected side effect of radiation therapy and not associated with or an expected reaction to the Dakin's solution.
Frequency: 20 affected / 20 at risk
Study: NCT02203578

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT02203591

Adverse event: Mild severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Moderate severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Probably related to product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 343 at risk

Adverse event: Anticipated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 343 at risk

Adverse event: Mild severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 344 at risk

Adverse event: Moderate severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 344 at risk

Adverse event: Not related to product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 344 at risk

Adverse event: Probably related to product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 344 at risk

Adverse event: Anticipated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 344 at risk

Adverse event: Unexpected
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 344 at risk

Adverse event: Mild severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Probably related to product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Anticipated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 347 at risk

Adverse event: Mild severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Moderate severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Possibly related to products
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Probably related to product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Anticipated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 242 at risk

Adverse event: Mild severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Moderate severity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Not related to product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 244 at risk

Adverse event: Probably related to product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 244 at risk

Adverse event: Anticipated
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 244 at risk
Study: NCT02203721

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 148 at risk

Adverse event: Pupillary capture
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 148 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 148 at risk

Adverse event: Hypopyon
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 148 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 151 at risk

Adverse event: Epiretinal membrane peel
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk

Adverse event: Optic ischaemic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk

Adverse event: Lens Fragment
Serious: yes
Organ System: Eye disorders
Notes: Requiring fragment removal
Frequency: 2 affected / 151 at risk

Adverse event: Anterior Basement Membrane Distrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 151 at risk

Adverse event: Inflammation
Serious: yes
Organ System: Eye disorders
Notes: Requiring treatment injection
Frequency: 1 affected / 151 at risk
Study: NCT02203747

Adverse event: Headache with dizziness and nausea
Serious: no
Organ System: Surgical and medical procedures
Notes: Subject reported feeling nausea with a headache and dizziness hours after astigmatism induction
Frequency: 1 affected / 34 at risk

Adverse event: Achiness and pressure
Serious: no
Organ System: Immune system disorders
Notes: Subject experienced achiness and eye pressure after experiencing a lupus flare-up, unrelated to study procedure.
Frequency: 1 affected / 34 at risk
Study: NCT02203786

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Notes: Mild restlessness which is an expected side effect of haloperidol
Frequency: 2 affected / 15 at risk
Study: NCT02203799

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 15 at risk

Adverse event: Skin Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 15 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 15 at risk

Adverse event: Sneezing/Itching
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 15 at risk

Adverse event: Stuffy Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 15 at risk

Adverse event: Throat Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 15 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Gastrointestinal, Subjective Complaints
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 15 at risk

Adverse event: Gastrointestinal, Objective Complaints
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 15 at risk
Study: NCT02203916

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 65 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 132 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 132 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 132 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 132 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 130 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 130 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 130 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 130 at risk