Jun 10, 2016 20:14
7 yrs ago
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English term
major adverse events и minor adverse events ... в данном контексте
English to Russian
Medical
Medical: Instruments
Клинические исследования
Клиническое исследование. Речь идет об Устройстве для эмболизации PED (Pipeline Embolization Device).
Как здесь перевести major adverse events и minor adverse events? Вот именно в данном контексте. Что смущает? И major adverse events и minor adverse events = was ischemic stroke! Значимые и незначимые НЯ? Т.е. получается ишемический инсульт может быть незначимым? Тяжелые и нетяжелые, серьезные и несерьезные? Как правильно? Я уже думаю, может основные нежелательные явления и второстепенные, но что-то не нравится. Помогите пожалуйста.
Conclusions: The IntrePED registry confirmed that the PED is safe when used for the treatment of IAs in routine clinical practice. The rate of major adverse events after PED placement (neurological morbidity rate) was 7.4%. A total of 63 major adverse events occurred in 59 subjects. The most common major adverse event of interest was ischemic stroke, which occurred in 4.7% of subjects. Major adverse events largely occurred during the immediate postoperative time interval (0-30 days post procedure). No major adverse events were reported beyond 13 months. In addition to the major events described, there were a total of 27 minor events reported in 25 subjects. The most common minor adverse event was ischemic stroke, which occurred in 15 (1.9%) subjects. The neurological mortality rate was 3.8% (30/793). There were three additional deaths reported due to non-neurological reasons. The neurological morbidity and mortality rate was 8.4%. Overall, data from this registry have established that the PED is safe for the treatment of IAs in routine clinical practice.
Благодарю заранее.
Как здесь перевести major adverse events и minor adverse events? Вот именно в данном контексте. Что смущает? И major adverse events и minor adverse events = was ischemic stroke! Значимые и незначимые НЯ? Т.е. получается ишемический инсульт может быть незначимым? Тяжелые и нетяжелые, серьезные и несерьезные? Как правильно? Я уже думаю, может основные нежелательные явления и второстепенные, но что-то не нравится. Помогите пожалуйста.
Conclusions: The IntrePED registry confirmed that the PED is safe when used for the treatment of IAs in routine clinical practice. The rate of major adverse events after PED placement (neurological morbidity rate) was 7.4%. A total of 63 major adverse events occurred in 59 subjects. The most common major adverse event of interest was ischemic stroke, which occurred in 4.7% of subjects. Major adverse events largely occurred during the immediate postoperative time interval (0-30 days post procedure). No major adverse events were reported beyond 13 months. In addition to the major events described, there were a total of 27 minor events reported in 25 subjects. The most common minor adverse event was ischemic stroke, which occurred in 15 (1.9%) subjects. The neurological mortality rate was 3.8% (30/793). There were three additional deaths reported due to non-neurological reasons. The neurological morbidity and mortality rate was 8.4%. Overall, data from this registry have established that the PED is safe for the treatment of IAs in routine clinical practice.
Благодарю заранее.
Proposed translations
(Russian)
| 4 +2 | существенные / незначительные нежелательные явления |
Natalie
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Proposed translations
+2
40 mins
Selected
существенные / незначительные нежелательные явления
Вот описание, содержащее определения именно для вашего контекста:
Because this was a retrospective study, procedural details and periprocedural patient management varied across centers. All centers used a common study protocol that specified the data to be collected, study end points, events of interest, and statistical analyses. The Steering Committee defined neurologic “clinical safety events of interest” a priori, including spontaneous rupture of the target aneurysm causing subarachnoid hemorrhage or cavernous carotid fistula, intraparenchymal hemorrhage (IPH) (both ipsilateral and contralateral), ischemic stroke, parent artery stenosis, and permanent cranial neuropathy. Site investigators identified events of interest according to the study protocol through retrospective review of the patient's record. All events of interest were reviewed in detail by an Adverse Events Review Committee, comprising of 3 members of the Steering Committee, including the overall study principal investigator. The committee determined the category of event and whether the event was major or minor. A “major” adverse event was defined as an ongoing clinical deficit at 7 days following the event. “Minor” adverse events were defined as events that resolved within 7 days with no clinical sequelae. All major adverse events are included in the neurologic morbidity and mortality rates. Long-term neurologic morbidity and mortality rates included morbidity and mortality due to adverse events occurring any time in the postoperative period (<30 days and ≥30 days).
http://www.ajnr.org/content/36/1/108.full
Как видно из определений, при оценке учитывались степень тяжести, время наступления, продолжительность и последствия НЯ.
Because this was a retrospective study, procedural details and periprocedural patient management varied across centers. All centers used a common study protocol that specified the data to be collected, study end points, events of interest, and statistical analyses. The Steering Committee defined neurologic “clinical safety events of interest” a priori, including spontaneous rupture of the target aneurysm causing subarachnoid hemorrhage or cavernous carotid fistula, intraparenchymal hemorrhage (IPH) (both ipsilateral and contralateral), ischemic stroke, parent artery stenosis, and permanent cranial neuropathy. Site investigators identified events of interest according to the study protocol through retrospective review of the patient's record. All events of interest were reviewed in detail by an Adverse Events Review Committee, comprising of 3 members of the Steering Committee, including the overall study principal investigator. The committee determined the category of event and whether the event was major or minor. A “major” adverse event was defined as an ongoing clinical deficit at 7 days following the event. “Minor” adverse events were defined as events that resolved within 7 days with no clinical sequelae. All major adverse events are included in the neurologic morbidity and mortality rates. Long-term neurologic morbidity and mortality rates included morbidity and mortality due to adverse events occurring any time in the postoperative period (<30 days and ≥30 days).
http://www.ajnr.org/content/36/1/108.full
Как видно из определений, при оценке учитывались степень тяжести, время наступления, продолжительность и последствия НЯ.
Peer comment(s):
| agree |
Evgeni Kushch
: да, в таком духе; можно и другие синонимы рассматривать, наверное
16 hrs
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Спасибо!
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| agree |
Margarita Vidkovskaia
22 hrs
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Спасибо!
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4 KudoZ points awarded for this answer.
Comment: "Большое Спасибо :)"
Discussion
У вас в тексте речь не только об инсульте, просто он оказался самым частым и в группе major, и в группе minor. Так что, по-моему, уже это указывает, что все же речь о степени тяжести/клинической значимости, значительности.