TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00017563

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 57 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 57 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 57 at risk

Adverse event: Dermatology-Skin Toxicity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 57 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 57 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 57 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Hyperlacrimation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 57 at risk

Adverse event: Onycholysis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 57 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 57 at risk
Study: NCT00018031

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Mild to moderate limitation in activity; some assistance may be needed; no or minimal medical intervention required.
Frequency: 1 affected / 36 at risk

Adverse event: Vision Changes
Serious: yes
Organ System: Eye disorders
Notes: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required.
Frequency: 1 affected / 36 at risk

Adverse event: Unusual affect or behavior
Serious: yes
Organ System: Psychiatric disorders
Notes: Marked limitation in activity; some assistance usually required; medical intervention/therapy required.
Frequency: 1 affected / 36 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Notes: Hemoglobin decreased
Frequency: 6 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Notes: Neutrophil count decreased
Frequency: 15 affected / 36 at risk
Study: NCT00022490

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

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

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk
Study: NCT00023322

Adverse event: Death
Serious: yes
Organ System: Hepatobiliary disorders
Notes: hepatocellular carcinoma
Frequency: 1 affected / 12 at risk

Adverse event: Death
Serious: yes
Organ System: Hepatobiliary disorders
Notes: hepatic decompensation secondary to herpes colitis
Frequency: 1 affected / 12 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: autoinflammatory syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Subarachnoid haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: subarachnoid hemorrhage from an arteriovenous malformation
Frequency: 1 affected / 12 at risk
Study: NCT00025662

Adverse event: Non relapse deaths
Serious: yes
Organ System: Immune system disorders
Frequency: 8 affected / 8 at risk

Adverse event: Relapse deaths
Serious: yes
Organ System: Immune system disorders
Frequency: 10 affected / 10 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 4 at risk
Study: NCT00027560

Adverse event: Infection with grade 3/4 neut
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Infection w.out neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Constitut symp, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 50 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 50 at risk

Adverse event: Stomatitis/BMT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 50 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 50 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 50 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 50 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 50 at risk

Adverse event: Transfusion (PLT/BMT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 50 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 50 at risk
Study: NCT00029107

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: AST elevation > grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 12 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: AST elevation > grade 3
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 12 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk
Study: NCT00029146

Adverse event: Fatal stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Non-fatal Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 97 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Epidural/subdural hematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 97 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 97 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Myocardial ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 97 at risk

Adverse event: Deep venous thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Atrial fibrillation/flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Non-fatal Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk
Study: NCT00030147

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 19 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT00030264

Adverse event: Infection - Bacterial
Serious: yes
Organ System: Infections and infestations
Notes: Fever, otitis externa, otitis media, cellulitis
Frequency: 1 affected / 23 at risk

Adverse event: Hepatic - Other - Cholecytitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Acute cholecystitis with fever, nausea and vomiting, elevated liver tests
Frequency: 1 affected / 23 at risk

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

Adverse event: Pulmonary - Other - Respiratory Distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Infection - Viral
Serious: yes
Organ System: Infections and infestations
Notes: Parainfluenza with grade 4 ANC
Frequency: 1 affected / 23 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Investigations
Notes: fever with neutropenia
Frequency: 1 affected / 23 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Investigations
Notes: Fever with upper respiratory infection symptoms
Frequency: 1 affected / 23 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Investigations
Notes: Fever NOS
Frequency: 1 affected / 23 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Chicken Pox
Frequency: 1 affected / 23 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 23 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Infection - Viral
Serious: no
Organ System: Infections and infestations
Notes: Parainfluenza
Frequency: 1 affected / 23 at risk

Adverse event: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Notes: ALT increased
Frequency: 1 affected / 23 at risk
Study: NCT00030823

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Derm, skin other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

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

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 13 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain, other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk
Study: NCT00030901

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 203 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 203 at risk

Adverse event: LVEF decrease/CHF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Abdominal pain/cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Neuro-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 203 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Pleural effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 203 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 203 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 28 affected / 203 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 203 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 203 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 202 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 202 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 202 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 18 affected / 202 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 202 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 202 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 202 at risk
Study: NCT00031551

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2 at risk
Study: NCT00031590

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 15 affected / 28 at risk

Adverse event: Creatinine renal clearance
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 28 at risk

Adverse event: thyroid dysfunction
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 28 at risk

Adverse event: Growth hormone deficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 28 at risk
Study: NCT00031694

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk

Adverse event: ALT/SGPT
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 19 at risk

Adverse event: AST/SGOT
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 19 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk
Study: NCT00032630

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 64 affected / 1099 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 1099 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 1099 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 1099 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 1099 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1099 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 1099 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 69 affected / 1104 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 1104 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 1104 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 1104 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 1104 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 1104 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1104 at risk
Study: NCT00033917

Adverse event: Necrotising colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: x-ray diagnosis
Frequency: 2 affected / 209 at risk

Adverse event: decreased urine output
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 209 at risk

Adverse event: creatinine > 1.8 mg/dL
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 209 at risk

Adverse event: excessive bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 209 at risk

Adverse event: platelets < 50,000
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 209 at risk

Adverse event: ischemic changes by ECHO
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 209 at risk

Adverse event: decreased urine output
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 222 at risk

Adverse event: creatinine > 1.8 mg/dL
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 222 at risk

Adverse event: excessive bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 222 at risk

Adverse event: platelets < 50,000
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 222 at risk

Adverse event: ischemic changes by ECHO
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 222 at risk