TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00113321

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 16 at risk

Adverse event: Elevated Cardiac Triponin
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Blood/Bone Marrow (Other) - Spleen
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient had history of splenomegaly
Frequency: 1 affected / 16 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Elevated Alanine transaminase (ALT)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 16 at risk

Adverse event: Elevated aspartate aminotransferase (AST)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 16 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 16 at risk

Adverse event: Metabolic/Laboratory (0ther)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk
Study: NCT00113334

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

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

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

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

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

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk
Study: NCT00113425

Adverse event: Mild Peeling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Transient Postinflammatory Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk
Study: NCT00113555

Adverse event: port erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 163 at risk

Adverse event: Other (non-pelvic)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 163 at risk

Adverse event: Pain/Discomfort
Serious: no
Organ System: General disorders
Frequency: 51 affected / 163 at risk

Adverse event: Balloon Migration
Serious: no
Organ System: General disorders
Notes: Balloon device moves from implantation site
Frequency: 27 affected / 163 at risk

Adverse event: Balloon Erosion
Serious: no
Organ System: General disorders
Notes: Balloon Erodes into Vagina, Urethra, or Bladder
Frequency: 10 affected / 163 at risk

Adverse event: Port Migration
Serious: no
Organ System: General disorders
Notes: Port moves from implantation site
Frequency: 7 affected / 163 at risk

Adverse event: Port Erosion
Serious: no
Organ System: General disorders
Notes: Port erodes out of implantation site
Frequency: 21 affected / 163 at risk

Adverse event: Perforation
Serious: no
Organ System: General disorders
Notes: Implantation tools perforate the vagina, urethra, or bladder during implantation procedure
Frequency: 14 affected / 163 at risk

Adverse event: Worsening Incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Patient has worsening incontinence symptoms
Frequency: 35 affected / 163 at risk

Adverse event: Device failure
Serious: no
Organ System: Product Issues
Notes: ACT device failure
Frequency: 3 affected / 163 at risk

Adverse event: Procedure Failure
Serious: no
Organ System: General disorders
Notes: Procedure is not able to be completed
Frequency: 5 affected / 163 at risk

Adverse event: Infected Device
Serious: no
Organ System: Infections and infestations
Notes: Infection of ACT Device
Frequency: 1 affected / 163 at risk

Adverse event: Other (Pelvic)
Serious: no
Organ System: General disorders
Frequency: 75 affected / 163 at risk

Adverse event: Other (non-Pelvic)
Serious: no
Organ System: General disorders
Frequency: 112 affected / 163 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary Tract Infection
Frequency: 75 affected / 163 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 163 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 163 at risk
Study: NCT00113841

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

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

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

Adverse event: Queasy feeling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Yellow discoloration of finger tips
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Yellow discoloration of sweat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Yellow discoloration of urine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Appetite decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Burning in the eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Feeling of fullness with capsules
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 17 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Yellow discoloration of urine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk
Study: NCT00113919

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: acute respiratory distress due to fluid overload
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: blood clot in Arteriovenous fistula
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: catheter related septecemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: colitis, diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: febrile neutropenia with hypotention
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: hypotension, edema and depression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: inflammation syndrome, cellulitis, pansinusitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nephrogenic systemic fibrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Septic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: shortness of breath and tachcardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk
Study: NCT00114114

Adverse event: Increased Prostate Specific Antigen (PSA)
Serious: no
Organ System: Renal and urinary disorders
Notes: PSA \>=4 ng/mL or whose PSA increased by \>= 1 ng/mL
Frequency: 3 affected / 26 at risk

Adverse event: Increased Prostate Specific Antigen (PSA)
Serious: no
Organ System: Renal and urinary disorders
Notes: PSA \>=4 ng/mL or whose PSA increased by \>= 1 ng/mL
Frequency: 1 affected / 35 at risk

Adverse event: Increased Prostate Specific Antigen (PSA)
Serious: no
Organ System: Renal and urinary disorders
Notes: PSA \>=4 ng/mL or whose PSA increased by \>= 1 ng/mL
Frequency: 2 affected / 29 at risk
Study: NCT00114127

Adverse event: Elevated Liver Function Tests
Serious: yes
Organ System: General disorders
Notes: The elevated LFTs were later diagnosed by primary care physician on evaluation as unrelated to study medication and a result of rhabdomyolysis from a week of intensive weight lifting and exercises.
Frequency: 1 affected / 13 at risk

Adverse event: Study medication overdose
Serious: yes
Organ System: General disorders
Notes: The study medication overdose was in the context of alcohol use and suicidal ideation and had no medical consequences: this was deemed possibly related to duloxetine and the participant was transferred to clinical care.
Frequency: 1 affected / 13 at risk

Adverse event: Sedation and other side effects
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased drinking
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT00115076

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk
Study: NCT00115336

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

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Acute chest syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk
Study: NCT00115778

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: E. coli pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hospital admission for thymoglobulin infusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk
Study: NCT00115804

Adverse event: Viral Adenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT00116207

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Non-Serious Adverse Events
Serious: no
Organ System: General disorders
Notes: General complaints or concerns reported by participants that were non-serious, and mild to moderate in nature
Frequency: 18 affected / 22 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Liver cancer resulting in death
Frequency: 1 affected / 22 at risk

Adverse event: Non-Serious Adverse Events
Serious: no
Organ System: General disorders
Notes: General complaints or concerns reported by participants that were non-serious, and mild to moderate in nature
Frequency: 21 affected / 22 at risk
Study: NCT00116337

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: There were no postoperative infections.
Frequency: 1 affected / 17 at risk

Adverse event: Hemodynamic effects: Decreases in pulse rate
Serious: no
Organ System: Nervous system disorders
Notes: Hemodynamic effects: Decreases in pulse rate in association with the initial application of SCS. With the application of chronic daily stimulation, these changes gradually diminished.
Frequency: 3 affected / 17 at risk
Study: NCT00116428

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 139 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 139 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 139 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 139 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 139 at risk

Adverse event: Tearing of atrial septum
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 139 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Hemoptysis/Right Kidney Stone
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Neoplasm/Kidney Nodule
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 139 at risk

Adverse event: Emergency Department Visit
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 139 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 139 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 139 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 139 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 139 at risk

Adverse event: Nausea, Vomiting/Rigors
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 139 at risk

Adverse event: Neurologic Side Effects
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 139 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 139 at risk

Adverse event: Hematoma/Bleeding/groin pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 139 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 139 at risk
Study: NCT00117585

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death is not an unexpected SAE in this nursing home population.
Frequency: 6 affected / 341 at risk