Study: NCT00053495

Adverse event: Pregnancy Not Otherwise Specified
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 51 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 51 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 51 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 51 at risk

Adverse event: Vomiting Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 51 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 43 affected / 51 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 27 affected / 51 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 51 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 18 affected / 51 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 14 affected / 51 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 7 affected / 51 at risk

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 51 at risk

Adverse event: Headache Not Otherwise Specified
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 51 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Rash Not Otherwise Specified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: Pregnancy Not Otherwise Specified
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 101 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 59 affected / 101 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 101 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 101 at risk

Adverse event: Vomiting Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 89 affected / 101 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 65 affected / 101 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 59 affected / 101 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 101 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 27 affected / 101 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 26 affected / 101 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 14 affected / 101 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 101 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 101 at risk

Adverse event: Headache Not Otherwise Specified
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 101 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 101 at risk

Adverse event: Rash Not Otherwise Specified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 101 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 61 affected / 101 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 101 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 101 at risk

Adverse event: Vomiting Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 101 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 82 affected / 101 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 64 affected / 101 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 58 affected / 101 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 55 affected / 101 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 29 affected / 101 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 24 affected / 101 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 19 affected / 101 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 101 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 101 at risk

Adverse event: Headache Not Otherwise Specified
Serious: no
Organ System: Nervous system disorders
Frequency: 49 affected / 101 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: Rash Not Otherwise Specified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 101 at risk

Adverse event: Pregnancy Not Otherwise Specified
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 51 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 51 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 51 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 51 at risk

Adverse event: Vomiting Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 51 affected / 51 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 37 affected / 51 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 35 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 51 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 18 affected / 51 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 13 affected / 51 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 51 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 51 at risk

Adverse event: Headache Not Otherwise Specified
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 51 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Rash Not Otherwise Specified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 51 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 44 affected / 49 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 49 at risk

Adverse event: Diarrhea Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: Vomiting Not Otherwise Specified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 49 affected / 49 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 37 affected / 49 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 35 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 49 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 23 affected / 49 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 19 affected / 49 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 14 affected / 49 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 49 at risk

Adverse event: Headache Not Otherwise Specified
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 49 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Rash Not Otherwise Specified
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 49 at risk