TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00291551

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 39 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 39 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Genital-urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hematology
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Neurology
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 39 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 39 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 32 affected / 39 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 39 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 39 at risk

Adverse event: Genital-urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 39 at risk

Adverse event: Hematology
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 39 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 39 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 39 at risk
Study: NCT00291655

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 130 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 130 at risk

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

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 130 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 130 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

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

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 130 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 130 at risk
Study: NCT00291876

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186
Frequency: 2 affected / 4 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Occurrence of the specified adverse event collected 4-days after additional dose reported by the 1 subject receiving vaccination at Month 198
Frequency: 1 affected / 1 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186
Frequency: 2 affected / 4 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186
Frequency: 1 affected / 4 at risk
Study: NCT00292162

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 22 at risk

Adverse event: heart failure hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: within 1 week of the procedure
Frequency: 1 affected / 22 at risk
Study: NCT00292370

Adverse event: Hospitalized - Suicide Ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: suicide Ideation and substance abuse
Frequency: 1 affected / 124 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension
Frequency: 2 affected / 124 at risk

Adverse event: Hospitalized - scheduled cardiac stint
Serious: yes
Organ System: Cardiac disorders
Notes: Scheduled cardiac stint
Frequency: 2 affected / 124 at risk

Adverse event: Sexual Side effects
Serious: no
Organ System: Reproductive system and breast disorders
Notes: sexual dysfunction
Frequency: 10 affected / 124 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 124 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 124 at risk

Adverse event: Sexual Side effects
Serious: no
Organ System: Reproductive system and breast disorders
Notes: sexual dysfunction
Frequency: 1 affected / 25 at risk

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

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension
Frequency: 1 affected / 25 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Sexual Side effects
Serious: no
Organ System: Reproductive system and breast disorders
Notes: sexual dysfunction
Frequency: 1 affected / 25 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Heart palpitation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 25 at risk
Study: NCT00292591

Adverse event: Pregnancy loss (miscarriage/fetal death)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 166 at risk

Adverse event: Complications of Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Examples include preterm birth or labor complications due to infection, pre-eclampsia, gestational diabetes, etc. (not reported separately due to small numbers)
Frequency: 22 affected / 166 at risk

Adverse event: Pregnancy loss (miscarriage/fetal death)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 167 at risk

Adverse event: Complications of Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Examples include preterm birth or labor complications due to infection, pre-eclampsia, gestational diabetes, etc. (not reported separately due to small numbers)
Frequency: 35 affected / 167 at risk

Adverse event: Pregnancy loss (miscarriage/fetal death)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 168 at risk

Adverse event: Complications of Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Examples include preterm birth or labor complications due to infection, pre-eclampsia, gestational diabetes, etc. (not reported separately due to small numbers)
Frequency: 27 affected / 168 at risk
Study: NCT00293059

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 119 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 119 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 119 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 119 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 119 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 119 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 119 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 119 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 119 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 66 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 66 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 66 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 66 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 66 at risk
Study: NCT00293202

Adverse event: Hematuria, chest pain, nausea and vomiting
Serious: no
Organ System: General disorders
Notes: Hematuria, chest pain, nausea and vomiting

- Not related to Study
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Nausea, vomiting, constipation, and epigastric pain initially thought to be pancreatitis, but later found to be either gastroenteritis or peptic ulcer disease

-Not related to Study
Frequency: 1 affected / 5 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke, considered related to elective catheterization to evaluate for kidney transplant, due to development of memory loss and left leg weakness (following ventricular fibrillation during catheterization)

-not related to Study
Frequency: 1 affected / 5 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Cardiac disorders
Notes: Coronary artery disease syndrome resulting in 3-vessel CABG

- not related to Study
Frequency: 1 affected / 5 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Ventricular fibrillation during elective cardiac catheterization for kidney transplant evaluation

- Not related to Study
Frequency: 1 affected / 5 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Burning pain in hands

-Not related to Study
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Fever, cough, chest congestion

-Unlikely related to Study
Frequency: 1 affected / 5 at risk
Study: NCT00293241

Adverse event: First cardiovascular hospitalization within 2 years after implant
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization (including emergency room) for cardiovascular causes: new or worsening heart failure, angina, myocardial infarction, any arrhythmia, stroke, transient ischemic attack, acute peripheral vascular emergencies, pulmonary embolism.
Frequency: 43 affected / 299 at risk

Adverse event: Cardioversion within 2 years after implant
Serious: yes
Organ System: Cardiac disorders
Notes: Cardioversion medically or electrically
Frequency: 11 affected / 299 at risk

Adverse event: Stroke within 2 years after implant
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke
Frequency: 4 affected / 299 at risk

Adverse event: Death from any cause within 2 years after implant
Serious: yes
Organ System: General disorders
Notes: All cause death
Frequency: 31 affected / 299 at risk

Adverse event: Non serious adverse events up to 2 years follow-up
Serious: no
Organ System: General disorders
Notes: All reported adverse events which were not serious
Frequency: 32 affected / 299 at risk

Adverse event: First cardiovascular hospitalization within 2 years after implant
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization (including emergency room) for cardiovascular causes: new or worsening heart failure, angina, myocardial infarction, any arrhythmia, stroke, transient ischemic attack, acute peripheral vascular emergencies, pulmonary embolism.
Frequency: 40 affected / 306 at risk

Adverse event: Cardioversion within 2 years after implant
Serious: yes
Organ System: Cardiac disorders
Notes: Cardioversion medically or electrically
Frequency: 9 affected / 306 at risk

Adverse event: Stroke within 2 years after implant
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke
Frequency: 6 affected / 306 at risk

Adverse event: Death from any cause within 2 years after implant
Serious: yes
Organ System: General disorders
Notes: All cause death
Frequency: 22 affected / 306 at risk

Adverse event: Non serious adverse events up to 2 years follow-up
Serious: no
Organ System: General disorders
Notes: All reported adverse events which were not serious
Frequency: 31 affected / 306 at risk
Study: NCT00293293

Adverse event: Sexual/Reproductive Function
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Infection/Febrile Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk
Study: NCT00293397

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 20 at risk

Adverse event: Post-embolization syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 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: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 20 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 20 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 20 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Decreased libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT00293540

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pt developed deep vein thrombosis and was successfully treated with anti-coagulants.
Frequency: 1 affected / 119 at risk
Study: NCT00295061

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk
Study: NCT00295503

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: deep venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 53 at risk

Adverse event: RPLS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: squamous cell carcinoma of the skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3/4 neutropenia only
Frequency: 6 affected / 53 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 and 4 only
Frequency: 2 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 and 4 only
Frequency: 1 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3 and 4 only
Frequency: 4 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 and 4 only
Frequency: 2 affected / 53 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: Grade 3 and 4 only
Frequency: 2 affected / 53 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3 and 4 only
Frequency: 2 affected / 53 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Grade 3 and 4 only
Frequency: 1 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: Grade 3 and 4 only
Frequency: 1 affected / 53 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 3 and 4 only
Frequency: 1 affected / 53 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 and 4 only
Frequency: 1 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 and 4 only
Frequency: 1 affected / 53 at risk