Study: NCT00483119

Adverse event: Elevated blood pressure; blurred vision, nausea and tearing
Serious: yes
Organ System: Cardiac disorders
Notes: Day 3 of IVIG infusion cycle 3; At the infusion suite his blood pressure was 160/106 mmHg and the headache was still persistent. IVIG was not infused. Patient was sent to NYULMC ER for evaluation. Brain CT was normal. Patient withdrawn from study.
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Notes: Intermittant following infusion for 2 hours
Frequency: 1 affected / 5 at risk

Adverse event: Increased Creatine Levels
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 5 at risk

Adverse event: Mild Muscle Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Elevated Urine Protein Levels
Serious: no
Organ System: Renal and urinary disorders
Notes: Creatine levels remained normal throughout event.
Frequency: 2 affected / 5 at risk

Adverse event: Localized minor inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: At infusion site.
Frequency: 1 affected / 5 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Mild Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Mild skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Penile ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vasovega
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Atrial Fibrillation not considered related to treatment
Serious: yes
Organ System: Cardiac disorders
Notes: event occurred 5 days post infusion
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mild Muscle Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pulmanary Adema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oral Candida Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk