TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02724644

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Serious Adverse Events by Frequency (Safety Population)
Frequency: 1 affected / 189 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 142 affected / 189 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 112 affected / 189 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 27 affected / 189 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 21 affected / 189 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 11 affected / 189 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 14 affected / 189 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 10 affected / 189 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 25 affected / 186 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 10 affected / 186 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 1 affected / 186 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 1 affected / 186 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Notes: Administration site conditions
Frequency: 1 affected / 186 at risk
Study: NCT02724787

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Diagnosed with cancer
Frequency: 1 affected / 24 at risk

Adverse event: Increase in symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk
Study: NCT02725008

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk
Study: NCT02725177

Adverse event: Fluid retention
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 9 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 9 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 9 at risk

Adverse event: Impaired Blood Sugar
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 9 at risk
Study: NCT02725476

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chronic inflammatory demyelinating polyradiculoneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk
Study: NCT02725710

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 48 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 48 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 37 affected / 48 at risk

Adverse event: Asthenia
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 48 at risk

Adverse event: Amblyopia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 47 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 47 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 41 affected / 47 at risk

Adverse event: Asthenia
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 47 at risk

Adverse event: Amblyopia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 47 at risk
Study: NCT02725801

Adverse event: re-operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Reoperation for infection or seroma
Frequency: 1 affected / 8 at risk

Adverse event: re-operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Reoperation for infection or seroma
Frequency: 4 affected / 12 at risk
Study: NCT02725866

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 216 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 216 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 216 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Substance use
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 216 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 216 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 216 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 216 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 216 at risk

Adverse event: Hepatic encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 216 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 216 at risk

Adverse event: Acute myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 216 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Helicobacter infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Substance use
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 216 at risk
Study: NCT02726022

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 114 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 114 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 114 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 114 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 114 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 114 at risk
Study: NCT02726542

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization related to psychiatric issues (further description not available)
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 13 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Gingival hypertrophy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction to intravenous arginine administration given as part of GH stimulation testing protocol
Frequency: 1 affected / 13 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk
Study: NCT02726620

Adverse event: Acute Kidney Injury Stage I or greater
Serious: yes
Organ System: Renal and urinary disorders
Notes: KDIGO (Kidney Disease: Improving Global Outcomes) Stage I or greater within the first seven postoperative days of surgery. Only based on creatinine measurements as part of routine clinical care, not urine output (inadequate documentation).
Frequency: 1477 affected / 17463 at risk

Adverse event: Mortality
Serious: yes
Organ System: Investigations
Frequency: 534 affected / 17463 at risk

Adverse event: Acute Kidney Injury Stage I or greater
Serious: yes
Organ System: Renal and urinary disorders
Notes: KDIGO (Kidney Disease: Improving Global Outcomes) Stage I or greater within the first seven postoperative days of surgery. Only based on creatinine measurements as part of routine clinical care, not urine output (inadequate documentation).
Frequency: 435 affected / 4972 at risk

Adverse event: Mortality
Serious: yes
Organ System: Investigations
Frequency: 158 affected / 4972 at risk
Study: NCT02726789

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Notes: Nephrotic syndrome occurred at week 38 exposure secondary to facial edema presence of urine albumin . Pegasys® therapy was halted early in this patient who recovered during the follow-up with supportive therapy
Frequency: 1 affected / 5 at risk

Adverse event: ALT elevation
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transient, self resolving elevations in serum ALT not accompanied by elevation in bilirubin or INR.
Frequency: 5 affected / 5 at risk

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

Adverse event: Reduced appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 5 at risk

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

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

Adverse event: Asthenia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 5 at risk

Adverse event: Dusgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 5 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pain / tingling in periphery
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

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

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 5 at risk

Adverse event: AST elevation
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transient, self resolving elevations in serum AST not accompanied by elevation in bilirubin or INR.
Frequency: 5 affected / 5 at risk
Study: NCT02726880

Adverse event: hernia operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 17 at risk

Adverse event: ER visit for car accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk
Study: NCT02726906

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Notes: myocardial infarction, subsequent stent placement
Frequency: 1 affected / 30 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain at injection site for PET scan tracer \[12\]; skin irritation due to cleaning agent for wearable device (accelerometer) \[1\], ankle swelling
Frequency: 8 affected / 30 at risk

Adverse event: Non-Hodgkins lymphoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Falls
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One slipped on driveway, one slipped walking to car after a hike
Frequency: 2 affected / 30 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain at injection site for PET scan tracer \[12\]; skin irritation due to cleaning agent for wearable device (accelerometer) \[1\], ankle swelling
Frequency: 6 affected / 30 at risk
Study: NCT02726945

Adverse event: Possible Infection
Serious: no
Organ System: Infections and infestations
Notes: Sterility test showed 1 suspicious colony at 3 days. The patients showed no sign of infection.
Frequency: 1 affected / 13 at risk

Adverse event: Swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Swelling of the knee that resolved spontaneously
Frequency: 1 affected / 13 at risk

Adverse event: Possible Infection
Serious: no
Organ System: Infections and infestations
Notes: Sterility test showed 1 suspicious colony at 3 days. The patients showed no sign of infection.
Frequency: 1 affected / 13 at risk
Study: NCT02726971

Adverse event: nauseated and bloated
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 59 at risk

Adverse event: nauseated and bloated
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 62 at risk

Adverse event: abnormal liver function
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 62 at risk
Study: NCT02727192

Adverse event: Pacemaker implantation due to syncope and prolonged pauses
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Hospitalization due to syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hospitalization due to symptomatic atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 53 at risk

Adverse event: Hospitalization due to chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hospitalization due to symptomatic atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hospitalization due to hemorrhagic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk
Study: NCT02727322

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Voiding Dysfunction Requiring Surgery
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Lower Extremity Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 75 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 75 at risk

Adverse event: Prolonged Urinary Retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Catheter Discomfort or Obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 75 at risk

Adverse event: Infection of Incision
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 75 at risk

Adverse event: Vulvovaginal Yeast Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Infected Hematoma
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 76 at risk

Adverse event: Voiding Dysfunction Requiring Surgery
Serious: yes
Organ System: Renal and urinary 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: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 76 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 76 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Prolonged Urinary Retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 76 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Infection of Incision
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 76 at risk

Adverse event: N/A
Serious: no
Organ System: General disorders
Frequency: 2 affected / 76 at risk
Study: NCT02727478

Adverse event: Falls
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 12 non-injurious falls occurred during the training sessions
Frequency: 12 affected / 61 at risk