Study: NCT00288704

Adverse event: Meningitis pneumococcal
Serious: yes
Organ System: Infections and infestations
Notes: This SAE resulted in subject's death. The investigator reported that this was not drug-related. Interleukin-1 blockade may interfere with immune response to infections. Life-threatening infections have been reported in patients taking rilonacept.
Frequency: 1 affected / 104 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Treatment Emergent Serious Adverse Events are reported for all phases of the study.
Frequency: 1 affected / 104 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 104 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Notes: Sciatica was the only serious adverse event during the first 24 weeks of the study. It occurred during the single-blind period between Parts A and B when all subjects received rilonacept.
Frequency: 1 affected / 104 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 104 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 104 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Arteriosclerosis of the coronary artery
Serious: yes
Organ System: Cardiac disorders
Notes: The arteriosclerosis of the coronary artery resulted in the subject's death. The investigator reported that this was deemed not to be drug-related but related to the patient's underlying history of CHD.
Frequency: 1 affected / 104 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Included erythema, pruritis, swelling, bruising, inflammation, mass, or pain at the injection site. All injection site reactions in part a were mild or moderate in severity.
Frequency: 11 affected / 23 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Included erythema, pruritis, swelling, bruising, inflammation, mass, or pain at the injection site. All injection site reactions in part a were mild or moderate in severity.
Frequency: 3 affected / 24 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Abdominal pain, upper abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk