Study: NCT00211887

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 499 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 499 at risk

Adverse event: Hepato-biliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 499 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 499 at risk

Adverse event: Musculoskeletal, connective tissue and bone disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 499 at risk

Adverse event: Neoplasms benign and malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 499 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 499 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 15 affected / 499 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 499 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 499 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 499 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 499 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 499 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 499 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 499 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 81 affected / 499 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 64 affected / 499 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 499 at risk

Adverse event: Allergies (Environmental or Seasonal)
Serious: no
Organ System: Immune system disorders
Frequency: 29 affected / 499 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Immune system disorders
Frequency: 44 affected / 499 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 197 affected / 499 at risk

Adverse event: Cough
Serious: no
Organ System: Immune system disorders
Frequency: 21 affected / 499 at risk

Adverse event: Flu/Flu Like Symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 98 affected / 499 at risk

Adverse event: GI Virus
Serious: no
Organ System: Immune system disorders
Frequency: 33 affected / 499 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 139 affected / 499 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 79 affected / 499 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 499 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: General disorders
Frequency: 99 affected / 499 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: General disorders
Frequency: 64 affected / 499 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 46 affected / 499 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 499 at risk

Adverse event: Joint Pain/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 499 at risk

Adverse event: Cognitive Difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 499 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 499 at risk

Adverse event: Extremity Pain/Soreness/Stiffness
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 499 at risk

Adverse event: Extremity Weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 499 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 499 at risk

Adverse event: Paresthesias
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 499 at risk

Adverse event: Unspecified Neuropathic Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 103 affected / 499 at risk

Adverse event: Anxiety/Panic Attacks
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 499 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 88 affected / 499 at risk

Adverse event: Urinary/Bladder Issues
Serious: no
Organ System: Renal and urinary disorders
Frequency: 44 affected / 499 at risk

Adverse event: Dental Abcess/Extraction/Procedure
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 499 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 499 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 250 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 250 at risk

Adverse event: Hepato-biliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 250 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 250 at risk

Adverse event: Musculoskeletal, connective tissue and bone disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Neoplasms benign and malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 250 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 250 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 250 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 250 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 250 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 250 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 250 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 250 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 250 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 250 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 250 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 15 affected / 250 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 250 at risk

Adverse event: Allergies (Environmental or Seasonal)
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 250 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 250 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 102 affected / 250 at risk

Adverse event: Cough
Serious: no
Organ System: Immune system disorders
Frequency: 17 affected / 250 at risk

Adverse event: Flu/Flu Like Symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 51 affected / 250 at risk

Adverse event: GI Virus
Serious: no
Organ System: Immune system disorders
Frequency: 21 affected / 250 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 69 affected / 250 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 32 affected / 250 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: General disorders
Frequency: 53 affected / 250 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: General disorders
Frequency: 37 affected / 250 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 250 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 250 at risk

Adverse event: Joint Pain/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 250 at risk

Adverse event: Cognitive Difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 250 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 250 at risk

Adverse event: Extremity Pain/Soreness/Stiffness
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 250 at risk

Adverse event: Extremity Weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 250 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 250 at risk

Adverse event: Paresthesias
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 250 at risk

Adverse event: Unspecified Neuropathic Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 58 affected / 250 at risk

Adverse event: Anxiety/Panic Attacks
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 250 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 250 at risk

Adverse event: Urinary/Bladder Issues
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 250 at risk

Adverse event: Dental Abcess/Extraction/Procedure
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 250 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 250 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 259 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 259 at risk

Adverse event: Hepato-biliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 259 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Musculoskeletal, connective tissue and bone disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 259 at risk

Adverse event: Neoplasms benign and malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 259 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 259 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 259 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 259 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 259 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 259 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 259 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 259 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 42 affected / 259 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 26 affected / 259 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 259 at risk

Adverse event: Allergies (Environmental or Seasonal)
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 259 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Immune system disorders
Frequency: 22 affected / 259 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 98 affected / 259 at risk

Adverse event: Cough
Serious: no
Organ System: Immune system disorders
Frequency: 12 affected / 259 at risk

Adverse event: Flu/Flu Like Symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 44 affected / 259 at risk

Adverse event: GI Virus
Serious: no
Organ System: Immune system disorders
Frequency: 30 affected / 259 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 75 affected / 259 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 46 affected / 259 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 259 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: General disorders
Frequency: 51 affected / 259 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: General disorders
Frequency: 37 affected / 259 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 259 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 259 at risk

Adverse event: Joint Pain/Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 259 at risk

Adverse event: Cognitive Difficulties
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 259 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 259 at risk

Adverse event: Extremity Pain/Soreness/Stiffness
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 259 at risk

Adverse event: Extremity Weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 259 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 259 at risk

Adverse event: Paresthesias
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 259 at risk

Adverse event: Unspecified Neuropathic Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 259 at risk

Adverse event: Anxiety/Panic Attacks
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 259 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 43 affected / 259 at risk

Adverse event: Urinary/Bladder Issues
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 259 at risk

Adverse event: Dental Abcess/Extraction/Procedure
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 259 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 259 at risk