Study: NCT00908583

Adverse event: Generalized Weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient admitted to hospital 6 days after completing the first bortezomib cycle for generalized weakness and malaise, which subsequently spontaneously resolved.
Frequency: 1 affected / 20 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Patient admitted to the hospital with upper abdominal pain and slight elevation in lipase, but with normal amylase. Pain resolved within 48 hours and lipase returned to normal and was discharged. Event occurred during bortezomib therapy.
Frequency: 1 affected / 20 at risk

Adverse event: Elevated Liver Function Test
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Eight days after the last bortezomib dose of cycle 1, patient developed malaise, nausea, vomiting. Evaluation revealed elevated liver enzymes (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) which both spontaneously resolved.
Frequency: 1 affected / 20 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Patient developed chest pain at home with radiation to his left shoulder. Patient has a history of similar chest pain episodes. EKG was normal and troponins negative and patient was discharged from the hospital.
Frequency: 1 affected / 20 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Peripheral Sensory Neuropathy (PN)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Patient experienced atrial fibrillation during routine dialysis at his local dialysis center. Patient was transferred to a local ER where elective cardioversion was performed. The patient fully recovered in the ER.
Frequency: 1 affected / 12 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Upper Respiratory Viral Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

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

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 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: Cardiopulomonary Instability
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Superficial inflammatory dermatosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Facial paresis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk