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Table 7 Safety events from first dose of eculizumab in parent study

From: Outcomes in patients with atypical hemolytic uremic syndrome treated with eculizumab in a long-term observational study

Outcome Sex Age Category Description
Experienced meningococcal infection while on eculizumab treatment Female 20–29 CFH mutation
• Vaccinated with Mencevax® (ACYW135), not on prophylactic antibiotics
• Meningococcal infection serogroup B identified
• Received antibiotics for treatment of infection, which resolved after 9 days, and continued on eculizumab
Female 20–29 CFH mutation, renal transplant
• Vaccinated with Mencevax® (ACYW135), not on prophylactic antibiotics
• Meningococcal infection serogroup W135 identified
• Received antibiotics for treatment of infection, which resolved after 17 days, and continued on eculizumab
Male 20–29 • No identified complement abnormality at diagnosis; renal transplant
• Vaccinated with Menveo® (ACYW135), prophylactic antibiotics
• Meningococcal infection serogroup B identified
• Received antibiotics for treatment of infection, which resolved after 10 days, and continued on eculizumab
Male 13–19 C3 mutation, renal transplant
• Vaccinated with Menactra®, prophylactic antibiotics
• Clinical presentation was consistent with possible meningococcal infection (sore throat, knee pain and swelling, skin lesions), but all blood cultures were negative
• Received antibiotics for treatment of infection, which resolved after 6 days, and continued on eculizumab
Deatha Male 30–39 C3 mutation, renal transplant, hemorrhagic gastric ulcer s/p gastrotomy
• Had discontinued eculizumab approximately 6 months prior to death
Cause of death: Severe intensive care complications and multiorgan dysfunction secondary to gastrointestinal hemorrhage, lithiasic cholecystitis, and sepsis
Male < 5 • No complement abnormality identified at diagnosis;
renal failure, respiratory distress, hepatitis, and seizure disorder
• Patientb experienced abdominal pain, series of infections and bacterial infection after 10 months on eculizumab at a reduced dose; had seizures attributed to metabolic encephalopathy
Cause of death: Hypoxia due to diffuse alveolar hemorrhage
Female < 5 • No complement abnormality identified at diagnosis; renal and cardiac failure, pulmonary hypertension, cardiomyopathy
• Was on dialysis at diagnosis and was treated with eculizumab for 2 months but discontinued due to “lack of efficacy”
• Patient experienced a TMA manifestation with multiorgan failure
Cause of death: Respiratory failure led to cardiac arrest and anoxic brain injury after being off treatment for 7 months
  1. aHUS Atypical hemolytic uremic syndrome, CFH Complement factor H, TMA Thrombotic microangiopathy
  2. aNo death was considered related to eculizumab
  3. bPatient also described in Additional file 1: Table S2