SAE
1
8.3
- noun
- Specialized
- In clinical trials, researchers must carefully monitor any serious adverse events, or SAEs, that may affect participant safety.
- serious adverse SAEs
- SAEs and AEs
- related SAEs
Examples
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Further, the combination was associated with an excess of SAEs, some not previously reported, including infections, bleeding, gastrointestinal and musculoskeletal disturbances, and new-onset and worsening diabetes.
Academic text (2014) -
The four SAEs in which the relation to trial participation was uncertain occurred in the control group.
Academic text (2018) -
These SAEs were identified in Pfizer Inc.
Academic text (2014) -
None of the remaining 28 SAEs (19 women) were related to trial participation.
Academic text (2018) -
The greater number of SAEs overall recorded in the intervention group was probably due to greater contact with DVA advocates.
Academic text (2018) -
For three women (four events) in the intervention group, it was unclear from the information available whether the SAEs were related to trial participation.
Academic text (2018) -
However, AEs, SAEs, and discontinuations were higher in patients receiving background biologic therapy.
Academic text (2007) -
The systematic review and meta-analysis by Avni and colleagues concludes that IV iron does not increase SAEs overall or mortality, with fairly tight confidence intervals around risk estimates.
Academic text (2015) -
The rates of AEs and SAEs were similar in the subgroup receiving abatacept plus non-biologic background therapy and the subgroup receiving placebo plus non-biologic background therapy.
Academic text (2007) -
Therefore, the findings of Bangalore and colleagues are consistent with the findings of other large-scale RCTs: Atorvastatin vs placebo for renal-related serious adverse events (SAEs).
Academic text (2014)
How Serious
Surface Forms
Etymology
SAE is made from the first letters of serious, adverse, and event, so it names a 'serious bad event' that happens during medical care. That's why an SAE means a severe harmful problem in a trial that must be reported.