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 Alexgrus

link 3.04.2017 14:22 
Subject: SOCs excepting clin.trial.
The frequency of overall AEs (adverse events) were essentially balanced across SOCs excepting. Treatment-related AE (as assessed by investigator): the slight excess in treatment related AE seen in the reslizumab 3 mg/kg group (12%) vs. placebo (8%) was generally related to accrual of single AEs (incidence < 1%) across multiple SOCs without apparent pattern. Serious AE for reslizumab all occurred in the 3 mg/kg dose; none related. Same patient: 1 each - pneumonia; road accident/rib fracture; asthma exacerbation - not related; 1 sinusitis - not related; 2 asthma exacerbation - not related. Discontinuation AEs for reslizumab included asthma (4), myalgia (1) and pneumonia (1). Conclusion: No specific safety concerns. The topline safety results for 3081 are consistent with the known safety profile for reslizumab.

Что здесь означает словосочетание SOCs excepting и вообще абревиатура SOCs?

 Анна Ф

link 3.04.2017 14:23 
System Organ Class

 Alexgrus

link 3.04.2017 14:27 
А как здесь вяжется excepting? Как тут можно перевести SOCs excepting.

 Mumma

link 3.04.2017 18:50 
В вашем тексте встречаются standard-of-care therapies, в частности, в виде сокращения SoC Tx. Может, SOCs это тоже standard-of-care therapies?

Substantial placebo effects are not unexpected given that patients were allowed to continue SoC Tx and likely become more compliant during the study.

In subjects with elevated blood eosinophils, 4 monthly doses of reslizumab were well tolerated and associated with improvements in pulmonary function and patient-reported asthma control on top of standard-of-care therapies.
http://www.google.com/patents/WO2016040007A1?cl=en

 Petrelnik

link 3.04.2017 19:28 
Да не, это точно system organ classes, потому что дальше речь о нежелательных явлениях. Я бы сказала, что возможно после excepting просто что-то пропущено.
", за исключением ... чего-то."

 Alex_Krotevich

link 9.04.2017 7:22 
Поддержу "что-то пропущено" Частота развития АЕ сбалансирована между органами и системами за исключением (трансфузионных реакций, к примеру)

 

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