TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01250145

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 41 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 11 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 41 at risk

Adverse event: Application site erosion
Serious: no
Organ System: General disorders
Frequency: 8 affected / 41 at risk

Adverse event: Application site vesicles
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 41 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 210 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 31 affected / 210 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 210 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 33 affected / 210 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 210 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 210 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 210 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 210 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 210 at risk
Study: NCT01250171

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 22 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk
Study: NCT01250184

Adverse event: Hematomas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: shallow hematoma after injection of lidocaine without infectious or hemorrhagic complications.
Frequency: 4 affected / 41 at risk

Adverse event: Hematomas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: shallow hematoma after injection of lidocaine without infectious or hemorrhagic complications.
Frequency: 2 affected / 43 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Minimal bleeding after injection of lidocaine.
Frequency: 1 affected / 43 at risk
Study: NCT01250717

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: defined as ANC \< 500 and fever over 100 degrees farenheit
Frequency: 4 affected / 28 at risk

Adverse event: elevated liver functions
Serious: yes
Organ System: Hepatobiliary disorders
Notes: assessment by ALT and AST levels with 3.0 common toxicity criteria
Frequency: 1 affected / 28 at risk
Study: NCT01250730

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

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT01250769

Adverse event: Left forearm deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Assessed by the PI as definitely not related to the investigational product. SAE outcome was recovered/resolved.
Frequency: 1 affected / 75 at risk

Adverse event: Apthous ulcer above tooth #7 on attached gingiva
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk
Study: NCT01250912

Adverse event: Death due to unrelated non cardiac cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT01250925

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk
Study: NCT01251042

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Wound secretion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 26 at risk

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 26 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk

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

Adverse event: Nerve contusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 23 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 23 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk
Study: NCT01251120

Adverse event: Gastointestinal Disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01251146

Adverse event: Elevated Triglyceride
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 86 at risk

Adverse event: Elevated Cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 86 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 91 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 91 at risk

Adverse event: Elevated Triglyceride
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 91 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 91 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk
Study: NCT01251276

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 96 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 96 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 96 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 107 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 107 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 107 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 107 at risk
Study: NCT01251354

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 6 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk
Study: NCT01251380

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 215 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 215 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 215 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 215 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 215 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 215 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 215 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 215 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 215 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 215 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 215 at risk
Study: NCT01251744

Adverse event: Death neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk
Study: NCT01251757

Adverse event: potential ACEI/ARB related hospitalization
Serious: yes
Organ System: Vascular disorders
Notes: organ system categorization is incomplete. this includes hospitalization for acute renal failure, angioedema, anaphylactic shock, and anaphylactic hypotension
Frequency: 24 affected / 4330 at risk

Adverse event: potential statin related hospitalization
Serious: yes
Organ System: Hepatobiliary disorders
Notes: specifically includes hospitalizations for liver failure or cirrhosis rhabdomyolysis as a primary discharge diagnosis
Frequency: 1 affected / 3980 at risk

Adverse event: potential ACEI/ARB related hospitalization
Serious: yes
Organ System: Vascular disorders
Notes: organ system categorization is incomplete. this includes hospitalization for acute renal failure, angioedema, anaphylactic shock, and anaphylactic hypotension
Frequency: 19 affected / 4370 at risk

Adverse event: potential statin related hospitalization
Serious: yes
Organ System: Hepatobiliary disorders
Notes: specifically includes hospitalizations for liver failure or cirrhosis rhabdomyolysis as a primary discharge diagnosis
Frequency: 2 affected / 3980 at risk

Adverse event: potential ACEI/ARB related hospitalization
Serious: yes
Organ System: Vascular disorders
Notes: organ system categorization is incomplete. this includes hospitalization for acute renal failure, angioedema, anaphylactic shock, and anaphylactic hypotension
Frequency: 20 affected / 4323 at risk

Adverse event: potential statin related hospitalization
Serious: yes
Organ System: Hepatobiliary disorders
Notes: specifically includes hospitalizations for liver failure or cirrhosis rhabdomyolysis as a primary discharge diagnosis
Frequency: 2 affected / 3971 at risk
Study: NCT01251770

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: serum sodium between 130-134.9 meq/L
Frequency: 2 affected / 29 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: serum sodium more than 145 mEq/L
Frequency: 1 affected / 29 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: serum sodium between 130-134.9 meq/L
Frequency: 5 affected / 29 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: serum sodium more than 145 mEq/L
Frequency: 1 affected / 29 at risk
Study: NCT01251952

Adverse event: Low BUN
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Streptococcus in urine
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk
Study: NCT01252095

Adverse event: Redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3 at risk

Adverse event: Cellulitus around umbilicus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Local reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT01252186

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 83 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Prothrombin level increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 80 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 80 at risk

Adverse event: Prothrombin level increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 80 at risk
Study: NCT01252277

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 36 at risk

Adverse event: increased bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 36 at risk

Adverse event: breast tenderness or sensitivity
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 36 at risk

Adverse event: joint pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: early awakening
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: short temper
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk
Study: NCT01252290

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: acid reflux
Serious: no
Organ System: Gastrointestinal disorders
Notes: gastric reflux, including gastroesophageal reflux disease
Frequency: 3 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Biopsy breast
Serious: no
Organ System: Reproductive system and breast disorders
Notes: One each LCIS and intraductal papilloma
Frequency: 2 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 35 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 35 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk
Study: NCT01252745

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to Study Treatment
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to the Study Treatment
Frequency: 1 affected / 8 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Treatment
Frequency: 1 affected / 7 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to the Study Treatment
Frequency: 1 affected / 7 at risk
Study: NCT01253018

Adverse event: Stent placement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Atrial Fib
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Hospitalization to r/o new CVA
Serious: yes
Organ System: Nervous system disorders
Notes: Hospital findings negative for new CVA
Frequency: 2 affected / 22 at risk

Adverse event: Fall at home with resulting fx to study arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk