Words similar to saes
Example sentences for: saes
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Additional secondary outcomes included (1) safety outcomes (serious adverse events [SAEs] and patient withdrawal based on criteria defined above), (2) retention of ART-mediated immune reconstitution, and (3) detection of viral resistance.
Secondary Outcomes SAEs and patient discontinuation
However, four non-study-related SAEs occurred: two patients from the continuous therapy/single interruption arm were hospitalized, one for a cholecystectomy and one for acute rectal bleeding, during the 40-wk ART period; a patient from the repeated interruptions arm died of liver cancer during week 26 of the open-ended interruption after previously reaching a viral load greater than 5,000 copies/ml yet electing to stay off ART; and a patient from the repeated interruptions arm developed a transient ileitis.
Based on secondary outcome measures, the incidence of adverse events (SAEs, therapy failure, and patient discontinuation) or clinical disease progression (as indicated by CD4 count on therapy or opportunistic infections) was not observed to be different between arms.
No patient discontinuation in either group was due to study-defined changes in CD4 cell count (reviewed further below) or due to study-associated SAEs (disease progression or acute retroviral syndrome).