Anonymous
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Anonymous
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Holy shit moron, read the study. I can only hope you are spreading your ignorant BS to your doctors so they can have a good laugh at your expense. Hospitalization was a separate and also highly significant endpoint. It is one thing not to know, it is another to pretend you are some kind of expert when you clearly know nothing. I can't be bothered to read the rest of your tripe to plumb it for more falsehoods but I am sure they are there.
Anyone can read your Mexican study with less than 10% US patients. That must be a new record for PAH bribery. See below-note that a patients 6MWD distance could actually decrease on MACI treatment by 14% and it was not considered an event.
That is really something. No wonder this pig got approved.
Outcome Measures
The composite primary end point was the time from the initiation of treatment to the first event related to pulmonary arterial hypertension (worsening of pulmonary arterial hypertension, initiation of treatment with intravenous or subcutaneous prostanoids, lung transplantation, or atrial septostomy) or death from any cause up to the end of treatment. Worsening of pulmonary arterial hypertension was defined by the occurrence of all three of the following: a decrease in the 6-minute walk distance of at least 15% from baseline, confirmed by a second 6-minute walk test performed on a different day within 2 weeks; worsening of symptoms of pulmonary arterial hypertension; and the need for additional treatment for pulmonary arterial hypertension. Worsening of symptoms of pulmonary arterial hypertension included at least one of the following: a change from baseline to a higher WHO functional class (or no change in patients who were in WHO functional class IV at baseline) and the appearance or worsening of signs of right heart failure that did not respond to oral diuretic therapy. An independent clinical event committee adjudicated, in a blinded fashion, all events related to pulmonary arterial hypertension and all deaths that were reported up to the end of treatment, including whether death was due to pulmonary arterial hypertension.
Prespecified secondary end points included the change from baseline to month 6 in the 6-minute walk distance, the percentage of patients with an improvement in WHO functional class at month 6, death due to pulmonary arterial hypertension or hospitalization for pulmonary arterial hypertension up to the end of treatment, and death from any cause up to the end of treatment and up to the end of the study. Safety end points included adverse events and laboratory abnormalities.