Páginas 48, 49 y 50. Los casos son de gente con patologías previas: obesos, gente con infartos previos y afecciones coronarias y hay hasta 1 acohólico. Estoy flipando en colores.
Magnifica compra la de ayer quien se subiera al carro.
The proportion of participants with events retrieved using the SMQ Cardiomyopathy (broad and narrow) was comparable between the NVX-CoV2373 (0.5%) and placebo (0.4%) arms. In general, the proportion of participants reporting each type of event was comparable across treatment groups. However, terms specific for events of cardiomyopathy or cardiac failure were reported by nine participants in the NVX arm (0.05%) compared to two participants in the placebo arm (0.02%). The time to onset was within ~2 weeks for 5 events (56%) in the NVX arm and within 2 weeks for 1 event (50%) in the placebo arm. Both events in the placebo arm and 6 of 9 events in the NVX arm were serious, and none of the events were considered related. All participants in the NVX arm with events of cardiomyopathy or cardiac failure had a history of previous cardiac disease, obesity, or other co-morbidities, with the exception of one participant with a non-serious event of stress cardiomyopathy who had no medical history reported. The proportion of participants with events retrieved using the SMQ Cardiac failure (broad and narrow), was slightly higher in the NVX arm (0.2%) compared to the placebo arm (0.1%). However, terms specific for events of cardiac failure were reported by 8 participants in the NVX arm (0.04%) compared to 2 participants in the placebo arm (0.02%). The onset of the event reported in the placebo arm was 8 days post-Dose 2 of placebo. Of the 8 cases in the NVX arm, 6 occurred in participants with a history of congestive heart failure, 6 had time to onset within 21 days of the most recent NVX-CoV2373 dose, 6 were serious, and none were considered related. All participants had co-morbidities, including obesity. The proportion of participants with events retrieved using the SMQ Cardiac arrythmia (broad and narrow) was comparable between the NVX-CoV2373 (0.3%) and placebo (0.3%) arms. Events of atrial fibrillation heart rate increased were reported by a slightly higher proportion of participants in the NVX arm compared to the placebo arm, although the differences were small and most events of atrial fibrillation were >2 weeks following vaccination and most events of heart rate increased were the day of or shortly following vaccination, which may reflect reactogenicity. In the post-crossover period through September 27, 2021, a total of 53/21,714 (0.2%) participants who received NVX-CoV2373 either in the pre-or post-crossover period experienced adverse events in the SOC Cardiac disorders. Of the 61 events, 40 (66%) were serious, including 3 fatal events (1 event each of cardiac arrest and myocardial infarction, and 1 event of alcoholic cardiomyopathy). The time to onset of the fatal events from the most recent NVXCoV2373 dose was 8 days for an event of cardiac arrest and >80 days for the remaining events. Three events (myocarditis, pericarditis, and bradycardia) were considered related by the investigator. Although the arm that crossed over to receive placebo is not a true comparator, given the previous exposure to NVX-CoV2373, imbalances during the post-crossover period that may reflect short-term risk interval windows were assessed. A total of 6/6,416 (0.1%) participants who crossed over to receive NVX-CoV2373 experienced events consistent with myocardial infarction compared to 7/15,298 (0.05%) participants who crossed over to receive placebo. Events in the arm that crossed over to NVX-CoV2373 had time to onset of <30 days (n=3), 31-60 days (n=1), and >90 days (n=2), compared to events in the arm that crossed over to receive placebo, which had time to onset of <30 days (n=4), 31-60 days (n=2), and >90 days (n=1), relative to the most recent placebo dose. The time to onset is comparably distributed across the treatment arms, suggesting that there is no increase in events occurring in the risk window immediately following vaccination; however, varying lengths of follow up post-crossover may limit a full assessment of temporal clustering. A review of cases retrieved using the SMQs Ischemic heart disease, Cardiac failure, Cardiac arrhythmias, and Cardiomyopathy did not reveal additional imbalances between participants who crossed over to receive NVX-CoV2373 or placebo. Additional data provided at FDA’s request in a dataset with a cutoff date of February 17, 2022, was used to assess additionally accrued AEs of cardiac events in the post-crossover period. An imbalance in the proportion of participants was observed for the terms of acute myocardial infarction (n=6/6,146, 0.09% in participants crossed over to NVX-CoV-2373 and n=4/15,298, 0.03% in participants crossed over to placebo) and coronary artery disease (n=5/6,146, 0.08% in participants crossed over to NVX-CoV-2373 and n=1/15,298, 0.01% in participants crossed over to placebo). In aggregate, terms associated with myocardial infarction were reported by 18/6,146 (0.3%) participants who crossed over to receive NVX-CoV2373 compared to 19/15,298 (0.1%) of participants who crossed over to receive placebo. The time to onset was comparably distributed among the treatment arms, as described above. The February 17, 2022, updated data reflected a cumulative total of 48 participants who received NVX-CoV2373 in the pre- or post-crossover period (n=26,106) and reported events consistent with the medical concept of myocardial infarction (n=37), myocarditis (n=3), pericarditis (n=1), and cardiac arrest (n=7). To assess for potential long-term cardiac events, events consistent with the medical concept of cardiomyopathy and cardiac failure were analyzed. A total of 22 participants reported 27 AEs, none of which were considered related, without temporal clustering noted. With the exception of stress cardiomyopathy, all participants with these events had risk factors for cardiac disease (e.g., obesity, pre-existing heart disease). In summary, numerical imbalances were noted between the treatment arms with respect to events of cardiac failure and cardiomyopathy, including some events in close temporal proximity to vaccination. Cardiac events, including fatal events of cardiac arrest and myocardial infarction, were reported with close temporal relationship to NVX-CoV2373; however, the proportions of participants with fatal, serious, and ischemic cardiac events were generally balanced across the treatment arms for the blinded pre-crossover period, with comparable times to onset. As discussed in the Deaths section below, there was little to no information available on many of the cardiac deaths, precluding a full assessment of causality. Although it is possible that some cardiac events, including fatal events, were severe manifestations of undiagnosed myocarditis (see below), there is comparability across treatment arms in aggregate analyses of the type, severity, and temporality of cardiac events. Additionally, attribution of causality in many of the cardiac events is confounded by the presence of pre-existing conditions and risk factors.
