TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00728754

Adverse event: Loss of integration of implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 29 at risk

Adverse event: Loss of integration of implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 32 at risk
Study: NCT00728819

Adverse event: Purelence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 171 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 171 at risk

Adverse event: Purelence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 168 at risk
Study: NCT00728910

Adverse event: Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk
Study: NCT00728962

Adverse event: Loss of integration of implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 11 affected / 75 at risk
Study: NCT00729430

Adverse event: Allergic Reaction (Tongue Swelling)
Serious: yes
Organ System: Immune system disorders
Notes: One omega-3 fatty acid treated patient experienced tongue swelling 1 month after enrollment that necessitated study drug termination, which resulted in resolution of the patient's symptoms.
Frequency: 1 affected / 180 at risk

Adverse event: Fishy Taste in Mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 180 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 180 at risk

Adverse event: Fishy Taste in Mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 178 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 178 at risk
Study: NCT00729612

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: NOS=not otherwise specified
Frequency: 1 affected / 63 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 63 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 63 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 63 at risk

Adverse event: Leukopenia/Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 63 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 63 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 63 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 63 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 63 at risk
Study: NCT00729690

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 16 at risk
Study: NCT00729781

Adverse event: Temporary pain implant site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 45 at risk

Adverse event: Partial extrusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 45 at risk

Adverse event: Foreign body sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 45 at risk

Adverse event: Upper respiratory infection/viral cold
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Cosmetic contour deformity
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 45 at risk

Adverse event: Swelling/edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 45 at risk

Adverse event: Minimal bleeding
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 45 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk
Study: NCT00729924

Adverse event: post-lumbar puncture headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk
Study: NCT00730015

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 217 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 217 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 217 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 217 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 217 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 217 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 209 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 209 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 209 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 209 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 209 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 209 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 177 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk
Study: NCT00730041

Adverse event: Sore or scratchy throat at site of needle insertion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Note that these reported adverse events occurred shortly after the procedure and were not associated with cold or flu symptoms. All resolved on their own or with the short-term use of pain medication.
Frequency: 13 affected / 26 at risk

Adverse event: Mild bleeding at the site of needle insertion during the procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All occurrences resolved the same day with minimal or no intervention by the study physician.
Frequency: 2 affected / 26 at risk

Adverse event: Medication reaction (non-study related, non-life threatening)
Serious: no
Organ System: General disorders
Notes: These reactions were caused by medications the subjects took outside of the study related treatment and resulted in 2 cases of hives and 1 headache with hypertension and lasted briefly.
Frequency: 2 affected / 26 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Not related to the subject's participation in this study.
Frequency: 2 affected / 26 at risk

Adverse event: Sore or scratchy throat at site of needle insertion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Note that these reported adverse events occurred shortly after the procedure and were not associated with cold or flu symptoms. All resolved on their own or with the short-term use of pain medication.
Frequency: 7 affected / 25 at risk

Adverse event: Mild bleeding at the site of needle insertion during the procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All occurrences resolved the same day with minimal or no intervention by the study physician.
Frequency: 1 affected / 25 at risk

Adverse event: Medication reaction (non-study related, non-life threatening)
Serious: no
Organ System: General disorders
Notes: These reactions were caused by medications the subjects took outside of the study related treatment and resulted in 2 cases of hives and 1 headache with hypertension and lasted briefly.
Frequency: 1 affected / 25 at risk
Study: NCT00730132

Adverse event: Cardiac asthma
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 712 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 712 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 712 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 712 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 712 at risk

Adverse event: Vascular graft
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 712 at risk
Study: NCT00730275

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

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

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

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

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

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

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

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT00730730

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dissection - Target Vessel
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: NSTEMI - Acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pseudoaneurysm Left Femoral Artery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

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

Adverse event: Right Lower Extremity Gangrene
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Right Toe Gangrene
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Shock Liver
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 50 at risk
Study: NCT00730756

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nasal ulcer
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Nasal ulcer
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk
Study: NCT00730886

Adverse event: perinatal fever
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Subject experienced post delivery fever reported to be unrelated to ExAblate treatment. The fever resulted from prolonged ruptured membranes prior to admission for labor and delivery.
Frequency: 1 affected / 2 at risk

Adverse event: blood tinged mucus peri-rectum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT00730912

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 53 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 53 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

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

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

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 104 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 104 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 104 at risk

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

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 104 at risk
Study: NCT00730964

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1039 at risk

Adverse event: Left Ventricular thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1039 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1039 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1039 at risk

Adverse event: Left Ventricular Mass Requiring Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1039 at risk

Adverse event: Episodes of Sustained Ventricular Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1039 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 69 affected / 1039 at risk
Study: NCT00731133

Adverse event: Nausea/Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Stomach Bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Anxiety/Racing Heart
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Metallic Taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT00731341

Adverse event: Burning sensation in lower abdomen
Serious: no
Organ System: Reproductive system and breast disorders
Notes: This AE occurred in one subject and lasted 6 days before self-resolving. The severity was reported as MILD.
Frequency: 1 affected / 3 at risk
Study: NCT00731614

Adverse event: Admission for urinary tract infection (UTI)/urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Participant had a history of chronic renal disease secondary to diabetes prior to study entry, s/p renal transplant, experienced UTI and was admitted for treatment. Symptoms were deemed unrelated to study intervention.
Frequency: 1 affected / 23 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: Participant withdrew from study due to deteriorating health (peripheral arterial disease). Disease progression was unrelated to study procedures.
Frequency: 1 affected / 23 at risk

Adverse event: Pain exacerbation
Serious: no
Organ System: General disorders
Notes: Participant reported increase in pain while using visual feedback for treatment of phantom limb pain.
Frequency: 1 affected / 23 at risk

Adverse event: Fall/ broken femur
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pt fell and broke femur, requiring hospitalization and withdrawal from study. Fall was unrelated to study procedures.
Frequency: 1 affected / 31 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: Participant had stroke while driving, necessitating withdrawal from study. Stroke was unrelated to the study procedures.
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Participant admitted to hospital for exacerbation of congestive heart failure due to upper respiratory infection. Hospitalization unrelated to study procedures.
Frequency: 1 affected / 31 at risk
Study: NCT00731653

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 81 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 81 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 81 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 81 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 81 at risk
Study: NCT00731666

Adverse event: Infection
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedure-related infection.
Frequency: 1 affected / 40 at risk
Study: NCT00731783

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 85 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 85 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 77 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 77 at risk