patient-year

patient-year

A patient experience of 1 year's duration, e.g., on a waiting list, in a treatment program, under observation, or suffering an illness. One patient-year is equal to, for example, the experience of two patients for 6 months, or 12 patients for 1 month each.
References in periodicals archive ?
To date, more than 2,450 patient-years of inclisiran safety data have been accumulated in the ORION programme, a seven-fold (or 2,120 patient-year) increase over the total patient exposure from the ORION Phase 1 and Phase 2 trials.
These results, included in the submission, were well under the requirement specified by the FDA guidance of no more than 1 acute serious bacterial infection per patient-year.
In the insulin glargine arm, the rate of severe hypoglycemia was 0.01 episodes per patient-year of exposure versus 0.003 episodes per patient-year for standard care.
The mean number of nights with detected hypoglycemia was 21 (4-42) per patient-year, or 6% of all nights.
Comparison of the estimates by individual guideline shows that the practices resulting in the largest patient-year gains were increasing patient albumin above 40 g/L and reducing facility catheter use to below 10%.
To date, more than 1,899 patient-years of safety data have been accumulated in the ORION Phase III program, a five-fold (or 1,560 patient-year) increase over the total patient exposure from the ORION Phase I and Phase II trials.
The rate of recurrent VTE was 1.3% per patient-year (95% confidence interval [CI], 0.0% - 4.7%) in the warfarin-treated group and 27.4% per patient-year (95% CI, 12.9% - 39.4%) in the placebo group.
After a median follow-up of 3.6 years, there were 13 local recurrences, for an ipsilateral recurrence rate of 2.4% per patient-year, or a 5-year rate of 12%.
Becattini reported that a VTE recurrence occurred in 28 patients in the aspirin group (6.6% per patient-year) and in 43 patients in the placebo group (11.0% per patient-year).
This analysis concluded that the risk of serious infections was 0.015 cases per patient-year of exposure to adalimumab, 0.014 per patient-year for various dosages of etanercept, and 0.018 per patient-year for infliximab.
On the basis of existing treatment data from these HSCT-TMA patients and a further 20 cumulative patient-years of data from other patients treated with nomacopan, Akari is working with the FDA Model Informed Drug Development Program to optimize the pediatric dosing with nomacopan for the planned pivotal HSCT-TMA trial.

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