4 ms·
> In the small study, those who received the higher doses had flulike symptoms for a few hours. Two patients had serious adverse events that the study’s indepen
by gnicholas 3y ago
> In the small study, those who received the higher doses had flulike symptoms for a few hours. Two patients had serious adverse events that the study’s independent data safety and monitoring board deemed a result of their underlying severe heart disease. The board advised the researchers not to stop the study.
One had a fatal cardiac arrest five weeks after receiving the infusion. An autopsy showed that several of his coronary arteries were blocked.
The other patient had a heart attack the day after the infusion. It turned out that he had been having chest pain before receiving the infusion but had not reported it. If the investigators had known, he would not have received the treatment.
So 2 patients had SAEs, 1 died the next day, and 1 died five weeks later. I get that the profile of people admitted to the study was probably on the more sickly side, and obviously there will be larger studies before this is rolled out to the public. But given these outcomes, I won't be anywhere near first in line for this treatment.
I wonder how they even calculated the benefit for these people — did they exclude the guy who died five weeks later? Is the "10 participants" before or after removing the people who died?