Stat & med gen.

[antiquebrushedoak]

Уважаемые форумчане!
Прошу вас проконсультировать меня по нижеизложенным вопросам. Спасибо.
1. This pooling of the groups was done to power the calculations.
In the adult phase 2 studies, when the results over the course of the studies were analyzed (114 subjects), the C-peptide of the groups treated with 1 mg XXX was significantly preserved as compared with the pooled placebo groups in all measured parameters: basal C-peptide, maximally stimulated C-peptide and area under the curve (AUC).
Это объединение данных групп проводилось для увеличения статистической мощности расчетов?
2.priming
инициирование?
The specific aim of this study is to evaluate the safety and treatment effect of long-term treatment with XXX at the same dose and at a similar dosing regimen administered in the original study: eight doses of 1 mg XXX at three month intervals.The administration given 1 month after baseline in the XXX study is not included in the dosing regimen of the extension study since it is only given to ensure the effective priming of treatment.
3. powered for significance
Since the extension study cannot be formally powered for significance, there is no definition of primary and secondary endpoints.
иметь адекватную статистическую мощность?
4. staging
включение в продленную фазу исследования?
The goal of the extension study is to evaluate the eligibility of patients who completed study XXX as soon as possible, and if they are willing, to proceed with staging them into the XXX study.
The rationale for trying to stage the patients as soon as possible is that they received their last injection 1 month before completing the initial XXX study, and any delay in staging will delay the next administration of XXX.
Once the eligibility of the subject is confirmed, the subject can be staged and the Baseline-Ext visit should occur prior to the expiry of the 2-months Screening-Ext period.
5.subject month
пациенто-месяц?
Number hypoglycemic events and rate of hypoglycemia events per subject month, change from baseline.
6.pooled sites
A mixed model for repeated measurements will be applied for analyzing the changes from baseline at any time, including the fixed effect time and adjusted for baseline C-peptide and for pooled sites (countries) as dummy variable.
7.missing at random approach
подход «случайный характер отсутствующих (пропущенных) данных» ?
For the analysis of the safety and efficacy variables the missing at random (MAR) approach will be used.
8 re-mapped
For subjects who withdraw early from the study, safety data recorded at the end of the study will be re-mapped to the visit at which they withdrew.

[glomurka]

7.missing at random approach
видимо, это hot-deck imputation
http://urls.by/9ef
http://www.rivita.ru/spssmacros.shtml

[Alex_Krotevich]

8 Цензурированы?

[vvs12]

8 смысл там не в пропорциональной коррекции? (prorated)