Study: NCT00290147

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Severe; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Mild; Probable
Frequency: 10 affected / 10 at risk

Adverse event: Echymosis right arm following trauma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Right arm pain following trauma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Not related
Frequency: 2 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Moderate; Unlikely related
Frequency: 2 affected / 10 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild; Unlikely related
Frequency: 2 affected / 10 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Chest pain following trauma
Serious: no
Organ System: General disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Jaw pain following trauma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Investigations
Notes: Severe; Unlikely related
Frequency: 3 affected / 10 at risk

Adverse event: Low blood sugar
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 7 affected / 10 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Investigations
Notes: Moderate; Unlikely related
Frequency: 2 affected / 10 at risk

Adverse event: Decreased bicarbonate level
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 2 affected / 10 at risk

Adverse event: Increased diastolic BP
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Burn left hand following trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Increased systolic BP
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Urine - Trace protein
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Elevated eosinophilis
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 1 affected / 10 at risk

Adverse event: Decreased HgB
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild; Unlikely related
Frequency: 2 affected / 10 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 10 at risk

Adverse event: Right shoulder discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 10 at risk

Adverse event: Elevated CK
Serious: no
Organ System: Investigations
Notes: Severe; Unlikely related
Frequency: 1 affected / 10 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Moderate; Probable
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Flu illness
Serious: no
Organ System: General disorders
Notes: Moderate; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Moderate; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Right lower wisdom tooth pain / impaction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Intermittent left arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate; Unlikely related
Frequency: 1 affected / 10 at risk

Adverse event: Intermittent left arm weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate; Unlikely related
Frequency: 1 affected / 10 at risk

Adverse event: Black out (syncope) episode
Serious: no
Organ System: Nervous system disorders
Notes: Moderate; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Herpes zoster (shingles)
Serious: no
Organ System: Infections and infestations
Notes: Moderate; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Elevated calcium
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Probable
Frequency: 1 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild; Probable
Frequency: 1 affected / 10 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Notes: Mild; Probable
Frequency: 1 affected / 10 at risk

Adverse event: Alcohol withdrawal
Serious: yes
Organ System: Psychiatric disorders
Notes: Not related
Frequency: 1 affected / 12 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Mild; Probable
Frequency: 12 affected / 12 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Moderate; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Investigations
Notes: Severe; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Investigations
Notes: Moderate; Unlikely related
Frequency: 5 affected / 12 at risk

Adverse event: Increased diastolic BP
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Increased systolic BP
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 3 affected / 12 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Moderate; Probable
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Moderate; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Probable
Frequency: 3 affected / 12 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Notes: Mild; Probable
Frequency: 8 affected / 12 at risk

Adverse event: Elevated systolic BP
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 4 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Severe; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Moderate; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Right shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Moderate; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Unlikely related
Frequency: 3 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild; Unlikely related
Frequency: 7 affected / 12 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Mild; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Flu-like syndrome (fever, chills)
Serious: no
Organ System: General disorders
Notes: Moderate; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Probable
Frequency: 12 affected / 12 at risk

Adverse event: Increased respiratory rate
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 3 affected / 12 at risk

Adverse event: Ageusia
Serious: no
Organ System: Nervous system disorders
Notes: Mild; Probable
Frequency: 1 affected / 12 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild; Suspected
Frequency: 3 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Suspected
Frequency: 2 affected / 12 at risk

Adverse event: Papule (skin lesion) at vaccination site
Serious: no
Organ System: General disorders
Notes: Mild; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Burn on left ankle
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Moderate; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild; Not related
Frequency: 3 affected / 12 at risk

Adverse event: Trace proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 4 affected / 12 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: Mild; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Mild; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Weird dreams (nightmares)
Serious: no
Organ System: Psychiatric disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Moderate; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Mild; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Left forearm injury and pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Decreased WBC - 3.3
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Elevated systolic BP (142)
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Decreased lymphocytes (818)
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Low lymphocyte count
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Right knee pain (increased)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Investigations
Notes: Moderate; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Low hemoglobin
Serious: no
Organ System: Investigations
Notes: Mild; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Mild anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Mild; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Decreased absolute lymphocytes
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated creatine kinase
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Indegestion
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated DBP (93)
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Suspected
Frequency: 5 affected / 12 at risk

Adverse event: Elevated diastolic blood pressure
Serious: no
Organ System: Investigations
Notes: Moderate; Not related
Frequency: 2 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 3 affected / 12 at risk

Adverse event: Low bicarbonate
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 2 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Elevated diastolic BP
Serious: no
Organ System: Investigations
Notes: Severe; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated systolic BP
Serious: no
Organ System: Investigations
Notes: Moderate; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Moderate; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild; Suspected
Frequency: 3 affected / 12 at risk

Adverse event: Decreased CO2
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Right thigh pain (s/p fall)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Mild; Suspected
Frequency: 1 affected / 12 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Trace protein on uA
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated BUN
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Increased CPK
Serious: no
Organ System: Investigations
Notes: Moderate; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Increased HR (109)
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Increased diastolic BP
Serious: no
Organ System: Investigations
Notes: Moderate; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Trace proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Increased respiratory rate - 22
Serious: no
Organ System: Investigations
Notes: Moderate; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: Mild; Unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Decreased blood glucose
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Investigations
Notes: Mild; Not related
Frequency: 1 affected / 12 at risk