TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02308371

Adverse event: Death
Serious: yes
Organ System: Investigations
Notes: Patients that died during the time enrolled in the study or until discharge from the pediatric critical care unit.
Frequency: 5 affected / 50 at risk

Adverse event: Extracorporeal Life Support
Serious: yes
Organ System: Investigations
Notes: Subjects requiring extracorporeal life support during time of study or during enrolled admission to the pediatric critical care unit.
Frequency: 2 affected / 50 at risk

Adverse event: Prolonged Intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject requiring intubation longer that expected course during enrolled admission in the pediatric critical care unit
Frequency: 14 affected / 50 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: Subjects that had significant fluid overload requiring significant, unexpected diuresis or hemodialysis
Frequency: 3 affected / 50 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Subject with renal failure significant enough to require hemodialysis or peritoneal dialysis.
Frequency: 2 affected / 50 at risk
Study: NCT02308475

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: ED visit for chest pain radiating to the shoulder and abdomen
Frequency: 1 affected / 2 at risk
Study: NCT02308501

Adverse event: filmy sensation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: decreased visual acuity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: filmy sensation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: decreased visual acuity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk
Study: NCT02308748

Adverse event: Dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk
Study: NCT02308787

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 12 at risk

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

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

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk
Study: NCT02308839

Adverse event: Device Related
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 181 at risk

Adverse event: Procedure Related
Serious: yes
Organ System: General disorders
Notes: Procedure Related but not Device Related
Frequency: 10 affected / 181 at risk

Adverse event: Aneurysm Related
Serious: yes
Organ System: General disorders
Notes: Aneurysm Related but not Device Related or Procedure Related
Frequency: 17 affected / 181 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 46 affected / 181 at risk

Adverse event: Device Related
Serious: no
Organ System: General disorders
Frequency: 5 affected / 181 at risk

Adverse event: Procedure Related
Serious: no
Organ System: General disorders
Notes: Procedure Related but not Device Related
Frequency: 17 affected / 181 at risk

Adverse event: Aneurysm Related
Serious: no
Organ System: General disorders
Notes: Aneurysm Related but not Device Related or Procedure Related
Frequency: 63 affected / 181 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 181 at risk
Study: NCT02309099

Adverse event: Unsuccessful Initial Activation
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Participant denied auditory percept on all electrodes during initial activation of the study device.
Frequency: 2 affected / 7 at risk

Adverse event: Facial nerve weakness
Serious: no
Organ System: Nervous system disorders
Notes: Participants reported facial weakness on the implanted side.
Frequency: 3 affected / 7 at risk

Adverse event: Metallic taste on tongue on implanted side
Serious: no
Organ System: Nervous system disorders
Notes: Participants reported a metallic taste on their tongue on the side of the implant following surgery.
Frequency: 1 affected / 7 at risk

Adverse event: Migration of receiver/stimulator portion of cochlear implant
Serious: no
Organ System: Product Issues
Notes: Participant reported the cochlear implant's receiver/stimulator migrating.
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Participant reported constant dizziness following surgery; participant previously reported a history of dizziness prior to enrollment.
Frequency: 1 affected / 7 at risk

Adverse event: Aural pressure
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Participant reported feeling aural pressure around the external portion of the ear that was implanted following surgery.
Frequency: 1 affected / 7 at risk

Adverse event: Fever and congestion
Serious: no
Organ System: General disorders
Notes: Participant reported onset of fever and congestion during cochlear implant device use.
Frequency: 1 affected / 3 at risk

Adverse event: "Unsettling feelings" reported
Serious: no
Organ System: Psychiatric disorders
Notes: Participant reported "unsettling feelings"; specifically, participant reported having a hard time concentrating and thinking clearly. Participant reported a history of depression before enrollment.
Frequency: 1 affected / 3 at risk

Adverse event: Nasal drainage and itching in noise
Serious: no
Organ System: Immune system disorders
Notes: Participant reported bilateral nasal drainage and sneezing/itching nostrils; participant reported a history of allergies prior to enrollment.
Frequency: 1 affected / 3 at risk
Study: NCT02309138

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \< 40-30 mg/dl; \<2.2-1.7 mol/L
Frequency: 12 affected / 460 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \< 30 mg/dl; \<1.7 mol/L, life threatening consequences; seizures
Frequency: 4 affected / 460 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: went to Emergency room and as tx and released.
Frequency: 1 affected / 460 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pt had spontaneous premature rupture of members right during study visit
Frequency: 1 affected / 460 at risk

Adverse event: Nausea
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 460 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 460 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 460 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 8 affected / 460 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 460 at risk

Adverse event: Other
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 460 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 70 affected / 460 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \< 40-30 mg/dl; \<2.2-1.7 mol/L
Frequency: 1 affected / 461 at risk

Adverse event: heavy vaginal bleeding
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Admitted to hospital with vaginal bleeding due to placenta previa
Frequency: 1 affected / 461 at risk

Adverse event: Nausea
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 461 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 461 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 461 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 461 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 461 at risk

Adverse event: Other
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 461 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 461 at risk
Study: NCT02309372

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Elevated creatine kinase
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Alcohol abuse
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Arthroplasty of toe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT02309515

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk
Study: NCT02309944

Adverse event: postop ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Postop hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hospital-acquired pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Postop hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Genital yeast infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Superficial wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: postop ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 43 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Anastomotic leak
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Vaginal cuff dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Postop hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 43 at risk

Adverse event: Malignant ascites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Superficial wound infection, requiring readmission
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Paraneoplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 43 at risk

Adverse event: Superficial wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk
Study: NCT02310100

Adverse event: Vascular access complication
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 173 at risk

Adverse event: Cardiac perforation/tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 173 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 173 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 173 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 173 at risk

Adverse event: Allergic drug reaction that required intubation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 173 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 173 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 14 affected / 173 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 173 at risk
Study: NCT02310646

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 109 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Ligament rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 109 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 109 at risk

Adverse event: Arthroscopy
Serious: no
Organ System: Investigations
Frequency: 1 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 109 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 109 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 104 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 104 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 104 at risk
Study: NCT02310789

Adverse event: Subcutaneous induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02310919

Adverse event: Severe OHSS
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Severe Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: 1 affected / 51 at risk

Adverse event: Mild OHSS
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Mild Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: 1 affected / 51 at risk
Study: NCT02311894

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 82 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 7 affected / 82 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 82 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 82 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 82 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 82 at risk
Study: NCT02312063

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk
Study: NCT02312154

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema developed right after the treatment and maintained until 5days after the treatment
Frequency: 24 affected / 24 at risk
Study: NCT02312245

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neoplasms benign, mal, uncpec - Oth spec
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

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

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

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

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