Study: NCT01556347

Adverse event: Hospitalized with Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Facial swelling, nausea and vomitting.
Frequency: 1 affected / 2 at risk

Adverse event: Hospitalized with Fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hospitalized with LVAD Device Malfunction
Serious: yes
Organ System: Cardiac disorders
Notes: LVAD Device malfunction was device stopped.
Frequency: 1 affected / 2 at risk

Adverse event: Hospitalization for Nausea/Vomiting/Diarrhea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hospitalized with Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Bruising-Abdominal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Abdominal Distention
Serious: no
Organ System: Gastrointestinal disorders
Notes: Increased abdominal girth.
Frequency: 1 affected / 2 at risk

Adverse event: Pain-Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Pain-Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Chest/Thorax NOS Pain
Serious: no
Organ System: Cardiac disorders
Notes: Patient complained of chest pain during a device malfunction that resolved upon resolution of the malfunction.
Frequency: 1 affected / 2 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Decreased Bicarb
Serious: no
Organ System: Investigations
Notes: Decreased Bicarb on study required lab work.
Frequency: 1 affected / 2 at risk

Adverse event: Decreased Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 2 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: Decreased Hemoglobin noted on study required lab work
Frequency: 2 affected / 2 at risk

Adverse event: Decreased Phosphate
Serious: no
Organ System: Investigations
Notes: Decreased Phosphate on study required lab work.
Frequency: 2 affected / 2 at risk

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

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

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

Adverse event: Dyspnes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Elevated Uric Acid
Serious: no
Organ System: Investigations
Notes: Elevated Uric Acid on study required lab work.
Frequency: 1 affected / 2 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Elevated temperature with medication administration.
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperreaction to IVIG
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Notes: Decreased Calcium levels on study lab work.
Frequency: 1 affected / 2 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Notes: Decreased Blood Glucose on study required lab work
Frequency: 1 affected / 2 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Notes: Decreased Potassium levels on study required lab work
Frequency: 2 affected / 2 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Notes: Decreased Magnesium levels on study required lab work.
Frequency: 2 affected / 2 at risk

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

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

Adverse event: Increased Creatinine
Serious: no
Organ System: Investigations
Notes: Increased Creatinine on study required lab work.
Frequency: 1 affected / 2 at risk

Adverse event: Infection-Oral Cavity (Thrush)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

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

Adverse event: Lower Extremity/Limb Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Foot cramping
Frequency: 1 affected / 2 at risk

Adverse event: Muscle cramps/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Neuralgia/Peripheral Nerve Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Lower Extremity/Limb Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Leg Pain
Frequency: 1 affected / 2 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Serum sickness
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 2 at risk

Adverse event: Upper Extremity/Limb Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Shoulder Pain
Frequency: 1 affected / 2 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Difficulty Walking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Weakness of left hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Bleeding from LVAD driveline site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Pull on LVAD driveline that caused bleeding
Frequency: 1 affected / 2 at risk