TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03192137

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 158 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 158 at risk

Adverse event: Blood magnesium decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 158 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 158 at risk

Adverse event: Pulmonary thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 158 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 158 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 158 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 158 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 158 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 158 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 158 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 158 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 158 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 158 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 80 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 80 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 80 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 80 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 80 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 80 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 80 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 80 at risk
Study: NCT03192202

Adverse event: G3/4 Infection and skin rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: G1 IRR
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Death, G3 infection, IRR
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infusion related reaction (IRR)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 3 at risk
Study: NCT03192306

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Seborrhoeic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Diahrrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Sialoadenitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk
Study: NCT03192475

Adverse event: Inguinal hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 162 at risk

Adverse event: knee strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 162 at risk

Adverse event: aggravated spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: tendon tear from a fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: leg cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 160 at risk
Study: NCT03192488

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Lightheadedness and fainting episode with blood draw procedure.
Frequency: 1 affected / 11 at risk
Study: NCT03192904

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk
Study: NCT03192995

Adverse event: Abscess of Hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The other SAE was observed in a participant in the lorcaserin group who developed an abscess on his left hip that resolved after a course of antibiotics and was determined to not be related to lorcaserin.
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea SNOMED CT 409966000
Frequency: 3 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: abdominal pain in the stomach SNOMED CT 21522001
Frequency: 2 affected / 16 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypoglycemia SNOWMED CT 302866003
Frequency: 1 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Plasma Alanine aminotransferase level and plasma aspartate aminotransferase levels
Serious: yes
Organ System: Hepatobiliary disorders
Notes: One Severe Adverse Event (SAE) occurred with a participant from the placebo group and involved increased AST (Grade 3 AE) and increased ALT (Grade 2 AE) at month 1 of treatment (resolving to Grade 2 and Grade 1 AEs at the end of study participation).
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: abdominal pain in the stomach SNOMED CT 21522001
Frequency: 1 affected / 6 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypoglycemia SNOWMED CT 302866003
Frequency: 1 affected / 6 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Malaise and fever
Frequency: 2 affected / 6 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT03193021

Adverse event: POST ABLATION -SVT/ AFLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: ACUTE KIDNEY INSUFFICIENCY
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: ACUTE DIASTOLIC HEART FAILURE EXACERBATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Arterial Perforation - non-access site-related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 100 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: NEW ONSET A-FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: POST ABLATION FEVER
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedural Complication
Frequency: 1 affected / 100 at risk

Adverse event: Pseudoaneurysm requiring thrombin/fibrin adhesive injection or ultrasound-guided compression
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 100 at risk

Adverse event: Access site hematoma < 6 cm
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 100 at risk

Adverse event: CHF EXACERBATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk
Study: NCT03193047

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyelonephritis acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ejaculation failure
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk
Study: NCT03193619

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Notes: Arteriovenous fistula Embolism arterial Femoral artery dissection Femoral artery perforation Peripheral artery dissection Vasospasm
Frequency: 44 affected / 350 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 350 at risk

Adverse event: Peripheral arterial reocclusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 350 at risk
Study: NCT03193684

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 36 at risk
Study: NCT03193736

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: death during sleep from unknown cause
Frequency: 1 affected / 26 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: pancreatic carcinoma resulting in death
Frequency: 1 affected / 26 at risk

Adverse event: Anterior chamber inflammation
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 26 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 26 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Notes: \>3dB (decibel) worsening from baseline value, even if transient, reported
Frequency: 7 affected / 26 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: \*Only one patient had a mean intraocular pressure (IOP) increase, which fulfilled the protocol definition of substantial IOP increase (≥10 mmHg higher than screening IOP after the 1-month postoperative visit).
Frequency: 5 affected / 26 at risk

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 26 at risk

Adverse event: Hyphaema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 26 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk
Study: NCT03194321

Adverse event: Bacteraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diabetic ketoacidosis (DKA)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Incisional abscess and acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Perinephric collection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: BKAN Grade 2 with stable Serum Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk
Study: NCT03194490

Adverse event: Developed specific neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: paresthesia on pinna both side L\>R
Frequency: 1 affected / 20 at risk
Study: NCT03194555

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Heavy Breathing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Heavy Breathing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT03194568

Adverse event: Grade IIIB
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Requiring surgical, endoscopic or radiological intervention under general anesthesia
Frequency: 6 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 20 affected / 20 at risk

Adverse event: Grade II
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

Blood transfusions and total parenteral nutrition are also included.
Frequency: 1 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: Gastrointestinal disorders
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 12 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 6 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 16 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: General disorders
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 3 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: Cardiac disorders
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 1 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: Psychiatric disorders
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 1 affected / 20 at risk

Adverse event: Grade I
Serious: no
Organ System: Product Issues
Notes: Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Also includes wound infections opened at the bedside.
Frequency: 3 affected / 20 at risk