Study: NCT00203203

Adverse event: Placement of AICD
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pulmonary edema within 24 hrs of treatment
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Replacement of AICD
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Staph aureus septicemia (left sternoclavicular area) leg
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: bronchitis, decompensated heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: elevated Troponin T in presence of bacteremia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: unstable angina and stent
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: urosepsis and chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: ventricular tachycardia during 6 month F/Ucath requiring cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: abcess left sternovascular joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: abcess tooth
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

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

Adverse event: abnormalities/ pain eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: albumin, increase
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: back/ hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 10 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: bone pain, extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: carpel tunnel release
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: changes in cardiac enzymes (CK-MB,BNP,CRP, troponin)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: changes in heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: changes in renal enzymes (BUN, creatinine, chloride)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: chest pain/ increased chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 10 at risk

Adverse event: cold/ congestion
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: 3 affected / 10 at risk

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

Adverse event: decrease in platelets/ hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: dizziness/ light-headedness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: edema, extremity not specified
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: eyes sensitive to light
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Gingival bleeding
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: heart palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

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

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

Adverse event: hyperglycermia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: influenza/ flu-like symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: lesion right foot
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

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

Adverse event: numbness/ tingling in extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: shortness of breath, lying down
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: shortness of breath/ increased shortness of breath/ difficulty breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: swelling/ edema lower extremities
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

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

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

Adverse event: virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Chest pain and slightly elevated Troponin I
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Confusion/disorientation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Elevated troponin,chestpain and fever with episode of cellulitis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: False positive culture on processed stem cells at day 5
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Hospitalized for chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hospitalized for heart failure at one year
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Placement of AICD
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary edema & slightly elevated Troponin I with ablation of atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Replacement of AICD
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Restenosis without symptoms at 6 months, received stent
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Troponin I elevation in presence of new onset Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: supraventricular tachycardia ablation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: abcess tooth
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: abnormalities/ pain eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: abnormality on MRI scan
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: back/ hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 20 at risk

Adverse event: bloody nose
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: bone pain, extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: carbuncles on body
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: changes in cardiac enzymes (CK-MB,BNP,CRP, troponin)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 20 at risk

Adverse event: changes in heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: changes in renal enzymes (BUN, creatinine, chloride)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 20 at risk

Adverse event: chest pain/ increased chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 20 at risk

Adverse event: Chills
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: chronic obtructive pulmonary disease, increased symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: cold/ congestion
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: crackles/ wheezes in lungs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

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

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

Adverse event: diabetes uncontrolled
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: digestive problems
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

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

Adverse event: dizziness/ light-headedness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: edema, extremity not specified
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 20 at risk

Adverse event: edema, upper extremities
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: electrocardiogram changes
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk

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

Adverse event: fatigue/ weakness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

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

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

Adverse event: gout, increased symptoms
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: heart palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: hyperglycermia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 20 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: influenza/ flu-like symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

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

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

Adverse event: muscle pain/pull
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: myocardial infaction, non-ST elevation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: numbness/ tingling in extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 20 at risk

Adverse event: pleuritic chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: probable obstructive sleep apnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sciatica
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: scrotal edema/ erythema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: shortness of breath, lying down
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: shortness of breath/ increased shortness of breath/ difficulty breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 20 at risk

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

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

Adverse event: slurred speech/ dysphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

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

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

Adverse event: swelling/ edema lower extremities
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 20 at risk

Adverse event: swelling/ edema upper extremity
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: tremors
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: urinary/ bladder problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

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

Adverse event: white blood count, elevated
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk