Study: NCT00271570

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Persistent fever plus rising CRP treated with IV methylprednisilone; aneurysms of RCA and LAD (z-max: RCA, 7.2; LAD, 8.1)
Frequency: 1 affected / 12 at risk

Adverse event: Persistent Fever
Serious: yes
Organ System: General disorders
Notes: Persistent fever treated with IV methylprednisilone, oral steroids, and methotrexate; dilated coronary arteries (z-max: RCA, 4.6; LAD, 3.3), dilatation resolved
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acute gastroentiritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Secondary to rotavirus
Frequency: 1 affected / 12 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Ankle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Coronary artery aneurysm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Notes: I/VI systolic ejection murmur
Frequency: 1 affected / 12 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 12 at risk

Adverse event: IV infiltrate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Irregular heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Lip laceration from accidental trauma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Lung infiltrate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Peeling of fingers and toes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 12 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Temperature of 99.5 F
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Cerebellar ataxia
Serious: yes
Organ System: Nervous system disorders
Notes: Acute cerebellar ataxia attributed to KD (resolved); giant aneurysms (\> 8 mm) treated with warfarin (z-max: RCA, 15.8; LAD, 7.44)
Frequency: 1 affected / 12 at risk

Adverse event: Enlarging aneurysms
Serious: yes
Organ System: Cardiac disorders
Notes: Enlarging aneurysms (z-max: RCA, 7.5; LAD, 4.9); readmitted for repeat infliximab and IVIG infusion; aneurysms resolved
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Drug-related rash with eosinophilia and systemic symptoms, attributed to azithromycin administered before study entry (reported to the FDA), requiring hospitalization for supportive care; normal coronary arteries
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Coronary artery aneurysm
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 12 at risk

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

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Notes: I/VI systolic ejection murmur
Frequency: 1 affected / 12 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 12 at risk

Adverse event: High pitched crying
Serious: no
Organ System: General disorders
Notes: Sometimes raspy voice
Frequency: 1 affected / 12 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: IV infiltrate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Interval increase in size of coronary artery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Peeling of fingers and toes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Peeling of hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Notes: Trivial size
Frequency: 1 affected / 12 at risk

Adverse event: Phimosis with swelling of foreskin
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Steven's Johnson Syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk