Study: NCT00397215

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and 51 post vaccination.
Frequency: 1 affected / 165 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 164 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 164 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 164 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 164 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 164 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 130 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 130 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 130 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 2 affected / 130 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 122 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Month 12 and Month 24.
Frequency: 1 affected / 122 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 69 affected / 164 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 10 affected / 164 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 19 affected / 164 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 19 affected / 164 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 164 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 164 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 27 affected / 164 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 164 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 164 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 16 affected / 164 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and 51 post vaccination.
Frequency: 1 affected / 61 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 58 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 58 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 58 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 45 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 45 at risk

Adverse event: Arterial insufficiency
Serious: yes
Organ System: Vascular disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 45 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 45 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 45 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 45 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 45 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Month 12 and Month 24.
Frequency: 1 affected / 45 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 61 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 8 affected / 61 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Day 0 and 51 post vaccination.
Frequency: 1 affected / 159 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 158 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 158 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 158 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 158 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Day 52 and 180 post vaccination.
Frequency: 1 affected / 158 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 125 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 125 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 125 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 125 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 117 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 117 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 117 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 117 at risk

Adverse event: Peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 117 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported between Month 12 and Month 24.
Frequency: 1 affected / 117 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported between Month 12 and Month 24.
Frequency: 1 affected / 117 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 75 affected / 159 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 15 affected / 159 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 30 affected / 159 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 159 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 159 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 39 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 34 affected / 159 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 159 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 159 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 19 affected / 159 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 0 and 51 post vaccination.
Frequency: 1 affected / 52 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 42 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported between Day 181 and Month 12 post vaccination.
Frequency: 1 affected / 42 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 36 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported between Month 12 and Month 24 post vaccination.
Frequency: 1 affected / 36 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk