TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00578552

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject became intoxicated and had to be hospitalized while in the study medication phase of the study. The attending physician and PI did not determine this to be related to study medication.
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Decreased Concentration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Ataxia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Increased Energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Study participant reported having a Heart Attack during the follow up phase of the study (post medication phase). This was determined NOT to be related to the study drug.
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Ataxia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hand Tremors
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Polyuria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk
Study: NCT00578565

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: One patient was hospitalized for congestive heart failure at week 5, considered to be unrelated to study drug, and later died at week 32 of complications following a traumatic hip fracture.
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia and Adult Respiratory Distress Syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient died at week 6 of possible pneumonia and adult respiratory distress syndrome; a causative organism was not recovered.
Frequency: 1 affected / 10 at risk

Adverse event: Traumatic Hip Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One patient was hospitalized for congestive heart failure at week 5, considered to be unrelated to study drug, and later died at week 32 of complications following a traumatic hip fracture.
Frequency: 1 affected / 10 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: One patient had an infusion reaction with the first infusion, and withdrew from the study.
Frequency: 1 affected / 10 at risk
Study: NCT00578617

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Adverse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vascular injury
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vascular injury
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 29 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 29 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 29 at risk
Study: NCT00578669

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk
Study: NCT00578721

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT00578877

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 137 at risk

Adverse event: Abnormal vaginal bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 137 at risk

Adverse event: Pain, irritation, pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 48 affected / 137 at risk

Adverse event: Symptomatic vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 16 affected / 137 at risk

Adverse event: Intentional Suicide
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 278 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 278 at risk

Adverse event: Post Surgical Infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 278 at risk

Adverse event: Abnormal vaginal bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 38 affected / 278 at risk

Adverse event: Pain, irritation, pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 104 affected / 278 at risk

Adverse event: Symptomatic vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 37 affected / 278 at risk
Study: NCT00578929

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 298 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 298 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 297 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 297 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 296 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 296 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 297 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2388 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 2388 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 2388 at risk
Study: NCT00578942

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 48 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: e.g. thrombotic thrombocytopenic purpura \[TTP\] or hemolytic uremic syndrome \[HUS\]
Frequency: 1 affected / 48 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 48 at risk

Adverse event: Allergic reaction / hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C
Frequency: 16 affected / 48 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: shortness of breath
Frequency: 2 affected / 48 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: lack of oxygen
Frequency: 5 affected / 48 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Failure to engraft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 48 at risk

Adverse event: Infection with normal ANC or Grade 1/2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 48 at risk
Study: NCT00579098

Adverse event: Puncture of the subclavian artery during ablation procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: The puncture was repaired surgically.
Frequency: 1 affected / 62 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain resolved two days after stopping Lipitor.
Frequency: 1 affected / 62 at risk

Adverse event: Elevated liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache resolved within 24 hours of stopping atorvastatin.
Frequency: 1 affected / 62 at risk

Adverse event: Clot formation in left atrium during ablation procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 63 at risk

Adverse event: Elevated liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk
Study: NCT00579111

Adverse event: Blood/Bone Marrow - Other: Engraftment Failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk
Study: NCT00579124

Adverse event: Non-relapsed mortality
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 87 at risk

Adverse event: Non-relapsed mortality
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 6 at risk
Study: NCT00579254

Adverse event: High density lipoprotein decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk
Study: NCT00579826

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 5 affected / 29 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Acute cholecystitis necrotic
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Vomiting/nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Vaginal mucositis/ cervical infection
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 29 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 3 affected / 26 at risk

Adverse event: Renal pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 3
Frequency: 1 affected / 26 at risk
Study: NCT00579878

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: It was felt lung cancer was probably a result of her long smoking history; however, as she required hospitalization.
Frequency: 1 affected / 22 at risk

Adverse event: GI distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: GI distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Keratitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: GI distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk
Study: NCT00580034

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 71 affected / 88 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 88 at risk

Adverse event: Failure to Engraft
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 88 at risk

Adverse event: Cardiac Left Ventricular Function
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 88 at risk

Adverse event: Rash / desquamation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 88 at risk

Adverse event: Vomiting
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 88 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 88 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 88 at risk

Adverse event: Infection - with grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 35 affected / 88 at risk

Adverse event: Infection - grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Infection with Grade1 or 2 neutrophils (normal ANC)
Frequency: 12 affected / 88 at risk

Adverse event: Infection - without febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 88 at risk

Adverse event: Metabolic - Creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 88 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 88 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 6 affected / 88 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 88 at risk
Study: NCT00580047

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk
Study: NCT00580073

Adverse event: Grade 3/4 neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Grade 3/4 potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Grade 3/4 neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3/4 fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3/4 aspartate aminotransferase (AST)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3/4 alanine aminotransferase (ALT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Grade 1/2 rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 6 at risk

Adverse event: Grade 1/2 neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Grade 1/2 neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Grade 1/2 fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Grade 1/2 mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Grade 1/2 nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Grade 1/2 diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Grade 1/2 potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Grade 1/2 aspartate aminotransferase (AST)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Grade 1/2 alanine transaminase (ALT)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk