One issue, says Martin, is that
the cardiac events reported in the trial were not assessed by outsiders, as is common.
Not exact matches
The analytic review of the FDA MAUDE database identified five adverse
event reports that noted death and another 23
reports of cases necessitating urgent
cardiac surgery.
Only 35 percent
reported an ECG in the previous year and 46 percent said they had an ECG in the previous five years, reducing the possibility that the low number of
cardiac events stemmed from at - risk runners being screened out before the race.
Only two serious
cardiac events were
reported during the time period and none were fatal or life threatening.
All
reported cases of SCA were based on emergency medical service
reports containing detailed information regarding cause of the
cardiac arrest
event.