Type/Severity | Criteria |
---|---|
Laboratory values changea |
The occurrence of a change in ≥ 2 laboratory valuesb: • Platelet count decrease ≥ 25%c and < LLN • Increase in SCr ≥ 25%c and > ULN • Increase in LDH ≥ 25%c and > ULN |
Clinical signs and symptoms of TMAd |
Clinical signs and symptoms considered definitely related to aHUS, including: • Thrombosis • Seizure • Reduction in renal function • Proteinuria (new or worsec and > 1+ or > 30 mg/dL) • Hematuria (new or worsec and > 50 RBCs/HPF) • Increased hemolytic anemia • Biopsy-proven TMA • Other (eg, extrarenal TMA manifestations, including confusion, cardiovascular abnormalities, pericarditis, gastrointestinal symptoms/diarrhea) |
Interventiond | The patient required PE/PI, dialysis, blood transfusions, or renal transplant due to a TMA manifestation |