subject incidence pharm.

[MashaTs]

Чем subject incidence от incidence отличается?
In the Primary Advanced Cancer Safety Analysis Set, the subject incidence of adverse events potentially associated with acute phase reactions during the first 3 days of the study was higher in ххх group than in the ууу group. This imbalance was observed across all 3 studies, although the incidence of acute phase reactions within the first 3 days of the study was higher in Study 111111111.
Заранее спасибо!

[silly.wizard]

(дилетантизм он) более точно ... указывает с кем это случилось
subjectы - обследуемые (?)
(дилетантизм офф)

[Dimpassy]

вероятно, выраженная в пациенто-годах и %, но нужно уточнить

[Игорь_2006]

По-моему, так:

subject incidence of adverse events potentially associated with - доля пациентов с нежелательными реакциями, потенциально связанными с ...
the incidence of acute phase reactions within the first 3 days - частота реакций острой фазы в течение первых 3 дней (поскольку у одного пациента за три дня может быть не один приступ/реакция острой фазы, то эти параметры не совпадают)
Если в разных исследованиях отслеживали эти разные показатели, то между данными возникают противоречия (imbalance was observed across all 3 studies)

[MashaTs]

Выражено в %.
Побольше кусок:
In the Primary Advanced Cancer Safety Analysis Set, the overall incidence of positively adjudicated ONJ was 1.8% in the хххх group and 1.3% in the уууу group. Within each study and the integrated analysis, the subject incidence of ONJ events was not significantly different between treatment groups.
In the Primary Advanced Cancer Safety Analysis Set, the subject incidence of adverse events in the infections and infestations system organ class was similar between the хххх and уууууу treatment groups. The most common adverse events of infection (≥ 5% incidence in either treatment group) were urinary tract infection (7.7% ххх, 9.2% уууу), nasopharyngitis (5.2%, 5.7%), and pneumonia (5.2%, 4.6%). The incidence of infection adverse events was 46.4% in the ххх group and 48.8% in the уууу group in Study ссссс, 40.8% and 39.7%, respectively, in Study аааа, and 42.6% and 39.7%, respectively, in Study ббббб. The subject incidence of adverse events in the infection and infestations system organ class considered related to investigational product by the investigator was 2.2% in the хххх group and 2.4% in the ууууу group.
The subject incidence of serious adverse events in the infections and infestations system organ class was 11.6% in the ххххх group and 10.9% in the ууууу group.
Большое спасибо!
Игорь, к пишу Ваш вариант. Спасибо!