Study: NCT00760435

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Notes: Fever
Frequency: 11 affected / 98 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Coronary artery abnormality
Serious: yes
Organ System: Cardiac disorders
Notes: CAA that warranted prolonged hospitalization
Frequency: 6 affected / 98 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Coronary artery abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 98 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Vomiting/nausea/abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 98 at risk

Adverse event: Worsening of WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 98 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Notes: Fever
Frequency: 11 affected / 97 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Coronary artery abnormality
Serious: yes
Organ System: Cardiac disorders
Notes: CAA that warranted prolonged hospitalization
Frequency: 2 affected / 98 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Haemophagocytic lymphohistiocytosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: IVIG Infusion Reaction
Serious: no
Organ System: Immune system disorders
Notes: Hypotension or chills during IVIG infusion
Frequency: 13 affected / 98 at risk

Adverse event: Coronary artery abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 98 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Vomiting/nausea/abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 98 at risk

Adverse event: Worsening of WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 98 at risk