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Trial Population purchase cialis online Figure 1. Figure 1 purchase cialis online. Screening, Randomization, Treatment, and Analysis. In the original phase 3 portion of the trial, Regeneron requested purchase cialis online that 2, 1, and 5 patients in the placebo, REGEN-COV 2400-mg, and REGEN-COV 8000-mg groups, respectively, withdraw from the trial because these patients underwent randomization in error. In the amended phase 3 portion of the trial, Regeneron requested that 2, 4, and 2 patients in the placebo, REGEN-COV 1200-mg, and REGEN-COV 2400-mg groups, respectively, withdraw from the trial because these patients underwent randomization in error.

The modified full analysis set included all patients who were confirmed by means of quantitative reverse-transcriptase–polymerase-chain-reaction testing at a central laboratory to be positive for severe acute respiratory syndrome erectile dysfunction 2 at baseline and who had at least one risk factor for severe erectile dysfunction disease 2019 (erectile dysfunction treatment).Patients were enrolled between purchase cialis online September 24, 2020, and January 17, 2021. Initially, in the original phase 3 portion of the trial, 3088 patients, with or without risk factors for severe erectile dysfunction treatment, were randomly assigned to receive a single intravenous dose of REGEN-COV (8000 mg or 2400 mg) or placebo. In the amended phase 3 portion of the trial, an additional 2519 patients with at least one risk factor for severe erectile dysfunction treatment were randomly assigned to purchase cialis online receive a single dose of REGEN-COV (2400 mg or 1200 mg) or placebo (Figure 1). The median follow-up was 45 days, and 96.6% of the patients had more than 28 days of follow-up. Table 1 purchase cialis online.

Table 1. Baseline Demographic and Clinical Characteristics purchase cialis online of Patients in the Modified Full Analysis Set. The primary efficacy population included patients with at least one risk factor for severe erectile dysfunction treatment and a test for erectile dysfunction confirmed at a central laboratory to be positive at baseline (modified full analysis set) (Figure 1). Among the 4057 patients in the modified full analysis set, demographic and baseline medical characteristics were balanced between the purchase cialis online REGEN-COV and placebo groups (Table 1, and Table S2). In the overall modified full analysis set, the median age was 50 years (interquartile range, 38 to 59), 14% were at least 65 years of age, 49% were men, and 35% were Hispanic.

The most common risk factors were obesity (in 58%), age of 50 years or older (52%), and cardiovascular disease (36%) purchase cialis online. A total of 3% of the patients were immunocompromised (Table S3). The median viral load on nasopharyngeal RT-PCR was purchase cialis online 6.98 log10 copies per milliliter (range, 5.45 to 7.85), and the majority of patients (69%) were erectile dysfunction serum antibody–negative at baseline. The high median viral load and the lack of an endogenous immune response at baseline suggested that enrolled patients were in the early phase of . At randomization, the purchase cialis online patients reported that they had had erectile dysfunction treatment symptoms for a median of 3 days (interquartile range, 2 to 5).

The nasopharyngeal viral load, serum antibody–negative status, and median duration of erectile dysfunction treatment symptoms at randomization were similar across the trial groups. The demographic and baseline medical characteristics of the patients in the purchase cialis online REGEN-COV (8000 mg) modified full analysis set and the concurrent placebo group are shown in Table S4. Natural History of erectile dysfunction treatment in Outpatients Among the patients who received placebo, there was an association between the baseline viral load and erectile dysfunction treatment–related hospitalization or death from any cause. A total of 55 of 876 patients (6.3%) with a high baseline viral load (>106 copies per milliliter) were hospitalized or died, as compared with 6 of 457 patients (1.3%) with a lower viral purchase cialis online load (≤106 copies per milliliter) (Table S5). Patients in the placebo group who were serum antibody–negative purchase cialis online at baseline had higher median viral loads at baseline than those who were serum antibody–positive (7.45 log10 copies per milliliter and 4.96 log10 copies per milliliter, respectively).

It also took longer for the viral levels in patients in the placebo group who were serum antibody–negative at baseline to fall below the lower limit of quantification (Fig. S2). Despite these population-level observations, the baseline serum antibody status of patients who received placebo was not predictive of subsequent erectile dysfunction treatment–related hospitalization or death from any cause, because the incidences of these outcomes were similar among patients who were serum antibody–negative and those who were serum antibody–positive (49 of 930 patients [5.3%] and 12 of 297 patients [4.0%], respectively). The finding that serum antibody–positive status did not have a predictive value with respect to the reduction in the incidences of hospitalization or death suggests that some patients had an ineffective immune response. For example, patients in the placebo group who were serum antibody–positive but still had disease progression leading to hospitalization or death had high viral loads at baseline and day 7, similar to those in the placebo group who were serum antibody–negative and were hospitalized or died (Table S6).

Efficacy Primary End Point Table 2. Table 2. Hierarchical End Points. Figure 2. Figure 2.

Clinical Efficacy. Panel A shows the percentage of patients who were hospitalized or died from any cause in the amended phase 3 portion of the trial. Panel B shows the percentage of patients who were hospitalized or died from any cause in the original and amended phase 3 portions of the trial combined. Panel C shows the time to resolution of symptoms in the amended phase 3 portion of the trial. The lower and upper confidence limits are shown.erectile dysfunction treatment–related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%.

95% confidence interval [CI], 51.7 to 82.9. P<0.001). These outcomes occurred in 7 of 736 patients in the REGEN-COV 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomization concurrently (3.2%) (relative risk reduction, 70.4%. 95% CI, 31.6 to 87.1. P=0.002) (Table 2, Figure 2A and 2B, and Table S7).

Five deaths occurred during the efficacy assessment period, including one in the REGEN-COV 2400-mg group, one in the REGEN-COV 1200-mg group, and three in the placebo group. Similar decreases in erectile dysfunction treatment–related hospitalization or death from any cause were observed across subgroups, including in patients who were serum antibody–positive at baseline (Table 2, and Fig. S3). REGEN-COV was also associated with decreases in hospitalization for any cause or death from any cause (Table S8). Key Secondary End Points The between-group difference in the percentage of patients with erectile dysfunction treatment–related hospitalization or death from any cause was observed starting approximately 1 to 3 days after the patients received REGEN-COV or placebo (Figure 2A and 2B).

After these first 1 to 3 days, 5 of 1351 patients in the REGEN-COV 2400-mg group (0.4%), 5 of 735 patients in the REGEN-COV 1200-mg group (0.7%), 46 of 1340 patients in the placebo group who underwent randomization concurrently with the REGEN-COV 2400-mg group (3.4%), and 18 of 748 patients in the placebo group who underwent randomization concurrently with the REGEN-COV 1200-mg group (2.4%) had erectile dysfunction treatment–related hospitalization or died (Table 2 and Fig. S4). The median time to resolution of erectile dysfunction treatment symptoms was 4 days shorter in both REGEN-COV dose groups than in the placebo groups (10 days vs. 14 days, respectively. P<0.001 each for 2400 mg and 1200 mg) (Table 2 and Figure 2C).

The more rapid resolution of erectile dysfunction treatment symptoms with either dose of REGEN-COV was evident by day 3. Both REGEN-COV doses were associated with similar improvements in resolution of symptoms across subgroups (Fig. S5). Other Secondary End Points and Additional Analyses The incidence of erectile dysfunction treatment–related hospitalization was lower among patients who received REGEN-COV than among those who received placebo (Table S9). Among patients who were hospitalized due to erectile dysfunction treatment, those in the REGEN-COV groups had shorter hospital stays and a lower incidence of admission to an intensive care unit (ICU) than those in the placebo groups (Table S10).

erectile dysfunction treatment–related hospitalization, emergency department visits, or death from any cause through day 29 occurred in fewer patients in the REGEN-COV groups than in the placebo groups (Table S11), and fewer patients in the REGEN-COV groups had worsening erectile dysfunction treatment leading to any medically attended visit (hospitalization, an emergency department visit, a visit to an urgent care clinic or physician’s office, or a telemedicine visit) or death from any cause (Table S9). The clinical efficacy of REGEN-COV at a dose of 8000 mg is shown in Tables S12 and S13. Fewer symptomatic patients without risk factors for severe erectile dysfunction treatment had at least one erectile dysfunction treatment–related hospitalization or death from any cause in the REGEN-COV groups than in the placebo groups, although there were few hospitalizations or deaths overall (Table S14). In patients without risk factors, the time to resolution of symptoms was 2 or 3 days shorter in patients who received REGEN-COV than in those who received placebo. Collectively, these data indicate a potential benefit of REGEN-COV, regardless of the presence or absence of baseline risk factors for severe erectile dysfunction treatment.

All REGEN-COV dose levels led to similar and more rapid declines in the viral load than placebo. The least-squares mean difference between 1200 mg, 2400 mg, and 8000 mg of REGEN-COV and placebo in the viral load from baseline through day 7 was −0.71 log10 copies per milliliter (95% CI, −0.90 to −0.53), −0.86 log10 copies per milliliter (95% CI, −1.00 to −0.72), and −0.87 log10 copies per milliliter (95% CI, −1.07 to −0.67), respectively (Figs. S6 through S8). Safety Table 3. Table 3.

Serious Adverse Events and Adverse Events of Special Interest in the Safety Population. More patients had serious adverse events in the placebo group (4.0%) than in the three REGEN-COV groups (1.1 to 1.7%) (Table 3). More patients had adverse events that resulted in death in the placebo group (5 of 1843 patients [0.3%]) than in the REGEN-COV groups. 1 of 827 patients (0.1%) in the 1200-mg group, 1 of 1849 patients (<0.1%) in the 2400-mg group, and none of the 1012 patients in the 8000-mg group (Table 3 and Table S15). Most adverse events were consistent with complications of erectile dysfunction treatment (Table S16), and the majority were not considered by the investigators to be related to the trial drug.

Few patients had infusion-related reactions of grade 2 or higher (no patients in the placebo group. 2 patients in the 1200-mg group, 1 patient in the 2400-mg group, and 3 patients in the 8000-mg group) or hypersensitivity reactions (1 patient in the placebo group and 1 patient in the 2400-mg group) (Table 3). A similar safety profile was observed among the REGEN-COV doses, with no discernable imbalance in safety events. Pharmacokinetics The mean concentrations of casirivimab and imdevimab in serum increased in a dose-proportional manner and were consistent with linear pharmacokinetics for the single intravenous doses (Table S17). At the end of the infusion, the mean (±SD) concentrations of casirivimab and imdevimab in serum were 185±74.5 mg per liter and 192±78.9 mg per liter, respectively, with the REGEN-COV 1200-mg dose and 321±106 mg per liter and 321±112 mg per liter, respectively, with the REGEN-COV 2400-mg dose.

At day 29, the mean concentrations of casirivimab and imdevimab in serum were 46.4±22.5 mg per liter and 38.3±19.6 mg per liter, respectively, with the REGEN-COV 1200-mg dose and 73.2±27.2 mg per liter and 60.0±22.9 mg per liter, respectively, with the REGEN-COV 2400-mg dose. The mean estimated half-life was 28.8 days for casirivimab and 25.5 days for imdevimab.Study Population Our study population included health care personnel who had been tested for erectile dysfunction. Participants were enrolled from December 28, 2020 (2 weeks after the introduction of a erectile dysfunction treatment), through May 19, 2021, at 33 sites across 25 U.S. States, representing more than 500,000 health care personnel (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). The majority (68%) of the participating facilities were acute care hospitals (with or without affiliated outpatient and urgent care clinics), and 32% were long-term care facilities.

erectile dysfunction treatments were introduced at the participating facilities in December 2020, and the treatment coverage among health care personnel at these facilities reached 55 to 98% for the receipt of at least one dose of treatment and 51 to 94% for the receipt of two treatment doses during the study period. The study protocol was reviewed by the Centers for Disease Control and Prevention and the institutional review board at each participating medical center and was conducted in accordance with federal laws and institutional policies. The authors vouch for the accuracy and completeness of the data reported and for the fidelity of the study to the protocol. Study Design We conducted a test-negative case–control study involving health care personnel, a group that comprised all paid and unpaid health care personnel with the potential for direct exposure to patients or the potential for indirect exposure to infectious materials at the workplace.13 Testing for erectile dysfunction was based on occupational health practices at each facility and was leveraged to identify cases and controls for this study. Case participants were defined as health care personnel who had at least one erectile dysfunction treatment–like symptom and a positive result for erectile dysfunction on polymerase-chain-reaction (PCR) testing, other nucleic acid amplification testing, or antigen-based testing.14 The index test date (date that the specimen was obtained) for cases was the first erectile dysfunction–positive test for the episode of erectile dysfunction treatment–like illness for which case participants were enrolled.

The illness was defined as symptomatic if the participant had at least one of the following symptoms present within 14 days before or after the index test date. Fever (a body temperature documented at ≥38°C or subjective fever), chills, cough (dry or productive), shortness of breath, chest pain or tightness, fatigue or malaise, sore throat, headache, runny nose, congestion, muscle aches, nausea or vomiting, diarrhea, abdominal pain, altered sense of smell or taste, loss of appetite, or red or bruised toes or feet. Persons who tested negative on PCR or other laboratory-based nucleic acid amplification testing, regardless of symptoms, were eligible for inclusion as controls. Control participants were matched to case participants according to site of enrollment and week of test date. Within any given week and study site, any participants who tested positive for erectile dysfunction (cases) and those who tested negative (controls) and agreed to complete a survey or to be interviewed were matched, with a target ratio of three controls per case.

Persons with previous , defined as a positive erectile dysfunction test (on PCR or antigen testing) that had occurred more than 60 days before the index test date, were excluded. Information on the participants’ demographic characteristics, symptoms of erectile dysfunction treatment–like illness, underlying conditions and risk factors associated with severe erectile dysfunction treatment,15 and medical care received was collected by means of interviews or participant-completed surveys. The interviews and surveys also included information on potential confounders related to workplace and community behaviors. Medical records were reviewed in order to collect information about the erectile dysfunction test, including the date, test type, and result, and about the medical care sought during the erectile dysfunction treatment–like illness. Information on erectile dysfunction treatment vaccination dates and products received was obtained from occupational health clinics, treatment cards, state registries, or medical records.

Vaccination Status Vaccination status of the participants was determined at the time of their erectile dysfunction test date. Participants were considered to be unvaccinated if they had not received any dose of erectile dysfunction treatment as of the test date. We defined the interval from days 0 through 13 after receipt of the first dose as the time before effectiveness from a single dose is expected. We further stratified this interval to evaluate for a potential early effect of the first dose by measuring treatment effectiveness at 0 to 9 days and at 10 to 13 days after receipt of the first dose, on the basis of the cutoff when treatment effectiveness after the first dose was measured both in this study and in clinical trials.1,7 The effectiveness of a single treatment dose was measured from 14 days after receipt of the first dose through 6 days after receipt of the second dose (partially vaccinated). We conducted a sensitivity analysis to evaluate the effectiveness of a single treatment dose before receipt of the second dose to exclude potential early effects after receipt of the second dose.

In an additional sensitivity analysis that evaluated the potential influence of treatment-related reactions leading to the testing of health care personnel, we excluded participants who had been tested within 0 to 2 days after receipt of the second dose. The effectiveness of two doses of treatment was measured at 7 days or more after receipt of the second dose (complete vaccination), which was consistent with the Pfizer–BioNTech clinical trial.7 In a sensitivity analysis, we also evaluated the effectiveness of two doses of treatment at 14 days or more after receipt of the second dose, which was consistent with the Moderna trial.8 Statistical Analysis We used conditional logistic regression to estimate treatment effectiveness as 1 minus the matched odds ratio (×100%) for partial vaccination or complete vaccination as compared with no vaccination. We evaluated the influence of age, race and ethnic group, presence of underlying medical conditions or risk factors for severe erectile dysfunction treatment, and other factors related to community and workplace behaviors, such as the use of personal protective equipment and receipt of influenza treatment during the current respiratory season, as potential confounders for treatment effectiveness by including each variable with vaccination status in the model and then retaining variables that resulted in a change of more than 10% in the model estimate for vaccination status. In the final model, we adjusted for age, race and ethnic group, presence of at least one underlying condition or risk factor for severe erectile dysfunction treatment, and close contact with patients with erectile dysfunction treatment in the workplace or with persons with erectile dysfunction treatment outside the workplace. We evaluated treatment effectiveness according to treatment product and in subgroups defined according to participants’ age (<50 years or ≥50 years), race and ethnic group, presence of underlying conditions, health care job categories, and clinical case definitions that were consistent with those used in the clinical trials.

We examined the adjusted treatment effectiveness according to 2-week intervals of follow-up after receipt of the second dose (as compared with unvaccinated participants) to assess for waning of treatment effect. All the statistical analyses were conducted with the use of SAS software, version 9.4 (SAS Institute).Study Population Figure 1. Figure 1. Study Population. The participants in the study included persons who were 60 years of age or older and who had been fully vaccinated before March 1, 2021, had available data regarding sex, had no documented positive result on polymerase-chain-reaction assay for erectile dysfunction before July 30, 2021, and had not returned from travel abroad in August 2021.

The number of confirmed s in each population is shown in parentheses.Our analysis was based on medical data from the Ministry of Health database that were extracted on September 2, 2021. At that time, a total of 1,186,779 Israeli residents who were 60 years of age or older had been fully vaccinated (i.e., received two doses of BNT162b2) at least 5 months earlier (i.e., before March 1, 2021) and were alive on July 30, 2021. We excluded from the analysis participants who had missing data regarding sex. Were abroad in August 2021. Had received a diagnosis of PCR-positive erectile dysfunction treatment before July 30, 2021.

Had received a booster dose before July 30, 2021. Or had been fully vaccinated before January 16, 2021. A total of 1,137,804 participants met the inclusion criteria for the analysis (Figure 1). The data included vaccination dates (first, second, and third doses). Information regarding PCR testing (sampling dates and results).

The date of any erectile dysfunction treatment hospitalization (if relevant). Demographic variables, such as age, sex, and demographic group (general Jewish, Arab, or ua-Orthodox Jewish population), as determined by the participant’s statistical area of residence (similar to a census block)8. And clinical status (mild or severe disease). Severe disease was defined as a resting respiratory rate of more than 30 breaths per minute, an oxygen saturation of less than 94% while breathing ambient air, or a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of less than 300.9 Study Design Our study period started at the beginning of the booster vaccination campaign on July 30, 2021. The end dates were chosen as August 31, 2021, for confirmed and August 26, 2021, for severe illness.

The selection of dates was designed to minimize the effects of missing outcome data owing to delays in the reporting of test results and to the development of severe illness. The protection gained by the booster shot was not expected to reach its maximal capacity immediately after vaccination but rather to build up during the subsequent week.10,11 At the same time, during the first days after vaccination, substantial behavioral changes in the booster-vaccinated population are possible (Fig. S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). One such potential change is increased avoidance of exposure to excess risk until the booster dose becomes effective. Another potential change is a reduced incidence of testing for erectile dysfunction treatment around the time of receipt of the booster (Fig.

S2). Thus, it is preferable to assess the effect of the booster only after a sufficient period has passed since its administration. We considered 12 days as the interval between the administration of a booster dose and its likely effect on the observed number of confirmed s. The choice of the interval of at least 12 days after booster vaccination as the cutoff was scientifically justified from an immunologic perspective, since studies have shown that after the booster dose, neutralization levels increase only after several days.6 In addition, when confirmed (i.e., positivity on PCR assay) is used as an outcome, a delay occurs between the date of and the date of PCR testing. For symptomatic cases, it is likely that occurs on average 5 to 6 days before testing, similar to the incubation period for erectile dysfunction treatment.12,13 Thus, our chosen interval of 12 days included 7 days until an effective buildup of antibodies after vaccination plus 5 days of delay in the detection of .

To estimate the reduction in the rates of confirmed and severe disease among booster recipients, we analyzed data on the rate of confirmed and on the rate of severe illness among fully vaccinated participants who had received the booster dose (booster group) and those who had received only two treatment doses (nonbooster group). The membership in these groups was dynamic, since participants who were initially included in the nonbooster group left it after receipt of the booster dose and subsequently were included in the booster group 12 days later, provided that they did not have confirmed during the interim period (Fig. S3). In each group, we calculated the rate of both confirmed and severe illness per person-days at risk. In the booster group, we considered that days at risk started 12 days after receipt of the third dose and ended either at the time of the occurrence of a study outcome or at the end of the study period.

In the nonbooster group, days at risk started 12 days after the beginning of the study period (August 10, 2021) and ended at time of the occurrence of a study outcome, at the end of the study period, or at the time of receipt of a booster dose. The time of onset of severe erectile dysfunction treatment was considered to be the date of the confirmed . In order to minimize the problem of censoring, the rate of severe illness was calculated on the basis of cases that had been confirmed on or before August 26, 2021. This schedule was adopted to allow for a week of follow-up (until the date when we extracted the data) for determining whether severe illness had developed. The study protocol is available at NEJM.org.

Oversight The study was approved by the institutional review board of the Sheba Medical Center. All the authors contributed to the writing and critical review of the manuscript, approved the final version, and made the decision to submit the manuscript for publication. The Israeli Ministry of Health and Pfizer have a data-sharing agreement, but only the final results of this study were shared. Statistical Analysis We performed Poisson regression to estimate the rate of a specific outcome, using the function for fitting generalized linear models (glm) in R statistical software.14 These analyses were adjusted for the following covariates. Age (60 to 69 years, 70 to 79 years, and ≥80 years), sex, demographic group (general Jewish, Arab, or ua-Orthodox Jewish population),8 and the date of the second treatment dose (in half-month intervals).

We included the date of the second dose as a covariate to account for the waning effect of the earlier vaccination and for the likely early administration of treatment in high-risk groups.2 Since the overall rate of both confirmed and severe illness increased exponentially during the study period, days at the beginning of the study period had lower exposure risk than days at the end. To account for growing exposure risk, we included the calendar date as an additional covariate. After accounting for these covariates, we used the study group (booster or nonbooster) as a factor in the regression model and estimated its effect on rate. We estimated the rate ratio comparing the nonbooster group with the booster group, a measure that is similar to relative risk. For reporting uncertainty around our estimate, we took the exponent of the 95% confidence interval for the regression coefficient without adjustment for multiplicity.

We also used the results of the model to calculate the average between-group difference in the rates of confirmed and severe illness.15 In a secondary analysis, we compared rates before and after the booster dose became effective. Specifically, we repeated the Poisson regression analysis described above but compared the rate of confirmed between 4 and 6 days after the booster dose with the rate at least 12 days after the booster dose. Our hypothesis was that the booster dose was not yet effective during the former period.10 This analysis compares different periods after booster vaccination among persons who received the booster dose and may reduce selection bias. However, booster recipients might have undergone less frequent PCR testing and behaved more cautiously with regard to cialis exposure soon after receiving the booster dose (Fig. S2).

Thus, we hypothesize that the rate ratio could be underestimated in this analysis. To further examine the reduction in the rate of confirmed as a function of the interval since receipt of the booster, we fitted a Poisson regression that includes days 1 to 32 after the booster dose as separate factors in the model. The period before receipt of the booster dose was used as the reference category. This analysis was similar to the Poisson modeling described above and produced rates for different days after the booster vaccination. To test for different possible biases, we performed several sensitivity analyses.

First, we analyzed the data using alternative statistical methods relying on matching and weighting. These analyses are described in detail in the Methods section in the Supplementary Appendix. Second, we tested the effect of a specific study period by splitting the data into different study periods and performing the same analysis on each. Third, we performed the same analyses using data only from the general Jewish population, since the participants in that cohort dominated the booster-vaccinated population.Trial Population Figure 1. Figure 1.

Screening, Randomization, and Analyses. Of the 34,301 persons initially screened, 184 were screened twice and counted twice. A total of 34,117 unique participants were screened for the trial. 181 persons failed screening twice and were counted twice, and 1661 unique participants failed screening, which does not include 4 persons who were screened and did not undergo randomization but are not included in the number of failed screenings. Of the total 32,451 participants who underwent randomization, 1 participant was enrolled at two separate sites under two subject identification numbers, underwent randomization at both sites, and received both doses of assigned treatment or placebo.

This participant is included once in the all-participants analysis population but is excluded from all other analysis populations. Three participants underwent randomization twice in error. The safety analysis population for each group reflects treatment actually received. The number of participants in each group who received the second dose are those included as of data cutoff. Participants could be excluded from the fully vaccinated analysis population for more than one reason, including for not receiving two doses, and may therefore be counted for exclusion twice.

Group assignment was unblinded for 7635 participants (35.3%) in the AZD1222 group and 4157 participants (38.4%) in the placebo group after the second dose. erectile dysfunction treatment denotes erectile dysfunction disease 2019, RT-PCR reverse transcriptase–polymerase chain reaction, and erectile dysfunction severe acute respiratory syndrome erectile dysfunction 2.Table 1. Table 1. Demographic and Clinical Characteristics of the Safety Population at Baseline. Between August 28, 2020, and January 15, 2021, a total of 34,117 unique participants were screened, 32,451 of whom met eligibility criteria and underwent randomization to receive the AZD1222 treatment (21,635 participants) or placebo (10,816 participants) (Figure 1).

The majority of participants were men (55.6%) and had at least one coexisting condition (59.2%). The mean (±SD) age was 50.2±15.9 years (Table 1). Overall, 79.0% of the participants were White, 8.3% were Black, 4.4% were Asian, 4.0% were American Indian or Alaska Native, 2.4% were of multiple races or ethnic groups, 0.3% were Native Hawaiian or other Pacific Islander, and the remainder were of unknown or unreported race or ethnic group. Across both groups, 22.3% of participants were Hispanic or Latinx. Baseline demographic and clinical characteristics were balanced between the trial groups in both the safety analysis population (Table 1) and the fully vaccinated analysis population (Table S1 in the Supplementary Appendix).

A total of 347 participants (1.6%) in the AZD1222 group and 169 (1.6%) in the placebo group were living with well-controlled human immunodeficiency cialis . Safety The incidence of adverse events is shown in Table S2. A total of 11,972 participants (37.0%) — 8771 (40.6%) in the AZD1222 group and 3201 (29.7%) in the placebo group — reported 23,538 adverse events. The most common adverse events, occurring in at least 5% of participants within 28 days after any dose in either group, were general pain (8.2% in the AZD1222 group and 2.3% in the placebo group), headache (6.2% and 4.6%, respectively), injection-site pain (6.8% and 2.0%), and fatigue (5.1% and 3.5%). A similar percentage of participants in each group had a serious adverse event within 28 days after any dose.

119 serious adverse events occurred among 101 participants (0.5%) in the AZD1222 group and 59 events among 53 participants (0.5%) in the placebo group. During the entire trial period, a total of 7 adverse events leading to death occurred in 7 participants in the AZD1222 group, and 9 adverse events leading to 7 deaths occurred in the placebo group. These deaths are described in Table S2. No deaths were considered by investigators to be related to the treatment or placebo. No deaths related to erectile dysfunction treatment occurred in the AZD1222 group, and two deaths related to erectile dysfunction treatment occurred in the placebo group.

Medically attended adverse events and adverse events of special interest within 28 days after a dose also occurred in similar proportions in the two groups (Table S2). The incidences of individual adverse events related to the treatment or placebo during the entire trial period are shown in Tables S3 through S5. The incidence of potential immune-mediated conditions was similar in the two groups (1.8% in the AZD1222 group and 3.4% in the placebo group), as were the incidences of adverse events of special interest. Neurologic (0.5% in the AZD1222 group and 0.4% in the placebo group), vascular (0.1% in the AZD1222 group and <0.1% in the placebo group), and hematologic (<0.1% in both groups). Specifically, the incidences of deep-vein thrombosis (<0.1% in both groups), pulmonary embolism (<0.1% in both groups), thrombocytopenia (<0.1% in the AZD1222 group and none in the placebo group), and immune thrombocytopenia (none in the AZD1222 group and <0.1% in the placebo group) were low and similar in the groups.

There were no cases in either group of thrombosis with thrombocytopenia, cerebral venous sinus thrombosis, or venous thrombosis in unusual locations. Reactogenicity Figure 2. Figure 2. Local and Systemic Solicited Adverse Events after First and Second Dose, by Age Group. Erythema and induration were classified by size as mild (2.5 to 5 cm), moderate (5.1 to 6 cm), or moderate-to-severe (>6 cm).

Fevers were graded by temperature as none (≤37.8°C), mild (37.9 to 38.4°C), moderate (38.5 to 38.9°C), severe (39.0 to 40.0°C), or life threatening (≥40.1°C). The most common solicited adverse events that occurred in at least 5% of participants within 7 days after any dose in either group were tenderness (68.4% in the AZD1222 group and 19.0% in the placebo group) and pain (58.3% and 15.7%), both local adverse events. The most common systemic adverse events were headache (50.2% in the AZD1222 group and 35.5% in the placebo group), fatigue (49.7% and 31.2%), muscle pain (41.9% and 19.5%), malaise (35.0% and 17.0%), chills (28.2% and 9.5%), nausea (15.3% and 12.1%), and temperature higher than 37.8°C (7.0% and 0.6%). The All Ages group included 1013 participants for dose 1, placebo. 968 for dose 2, placebo.

2037 for dose 1, AZD1222. And 1962 for dose 2, AZD1222. The age 18 to 64 group included 663 participants for dose 1, placebo. 629 for dose 2, placebo. 1339 for dose 1, AZD1222.

And 1288 for dose 2, AZD1222. The age 65 and older group included 350 participants for dose 1, placebo. 339 for dose 2, placebo. 698 for dose 1, AZD1222. And 674 for dose 2, AZD1222.In the substudy population, more participants in the AZD1222 group than in the placebo group had local solicited adverse events (74.1% in the AZD1222 group vs.

24.4% in the placebo group) and systemic solicited adverse events (71.6% vs. 53.0%) (Figure 2). The majority of solicited adverse events (92.6%) across both groups were mild or moderate in intensity. Events occurred less frequently after the second dose than after the first dose in both age groups, a difference that was more marked in participants 18 to 64 years of age. The majority of local and systemic solicited adverse events resolved within 1 to 2 days after onset.

Efficacy Figure 3. Figure 3. Estimated treatment Efficacy ≥15 Days after the Second Dose (Fully Vaccinated Analysis Population). Values shown for no. Of events/total no.

Are the number of events that occurred among the participants within each group and do not account for censoring due to unblinding of group assignment or loss to follow-up. The primary efficacy end point is the first case of erectile dysfunction RT-PCR–positive symptomatic illness occurring 15 days or more after the second dose of AZD1222 or placebo among participants with negative serostatus at baseline. treatment efficacy is shown with 95% confidence intervals (CIs), except for treatment efficacy values for the primary efficacy end point according to erectile dysfunction baseline serostatus, the secondary end point of severe or critical symptomatic erectile dysfunction treatment, and the exploratory end point of erectile dysfunction treatment–related intensive care unit (ICU) admissions, which are based on a one-sided 97.5% CI calculated with the exact Poisson model, owing to nonconvergence of the Poisson regression with robust variance. Race and ethnic group were reported by the participant. Other denotes participants who provided a race or ethnic group identification other than White, Black, or American Indian or Alaska Native.

Key secondary end points were incidence of symptomatic illness (at 15 days or more after the second dose of AZD1222 or placebo) regardless of evidence of previous erectile dysfunction at baseline, severe or critical symptomatic erectile dysfunction treatment (at 15 days or more after the second dose of AZD1222 or placebo), erectile dysfunction treatment–related emergency department visits, symptomatic erectile dysfunction treatment as defined by Centers for Disease Control and Prevention (CDC) criteria, and first response (change from negative serostatus for erectile dysfunction nucleocapsid antibodies at baseline to positive serostatus after receiving AZD1222 or placebo). P values are reported for the primary and key secondary outcomes. Analyses followed prespecified plan to adjust for multiple comparisons. I bars indicate confidence intervals. Arrows indicate truncated values, with actual values shown in the accompanying column.

The dashed vertical line represents the upper limit (i.e., 100% treatment efficacy). And the solid vertical line represents the nominally statistically significant criterion of a lower confidence interval greater than 30% applicable to the primary end point and is shown for reference. NA denotes not available, and NE could not be estimated.Figure 4. Figure 4. Time to First erectile dysfunction RT-PCR–Positive Symptomatic Illness Occurring 15 Days or More after the Second Dose (Fully Vaccinated Analysis Population).

The time to the first event was relative to the time of the actual second dose administration, calculated as (date of erectile dysfunction–positive test) – (date of second dose of AZD1222 or placebo + 14 days) + 1. For participants whose data were censored, the censoring time was from the date of the second dose of AZD1222 or placebo + 14 days to the last time observed before data cutoff (March 5, 2021). The cumulative incidence of erectile dysfunction treatment was estimated with the Kaplan–Meier method. treatment efficacy, estimated on the basis of the supportive analysis of the time to primary efficacy end point with the use of the Cox proportional-hazards model, with the randomization and age groups at the time of informed consent as covariates, was 73.9% (95% CI, 65.3 to 80.5). Tick marks indicate censored data.Once adjudication of all events that occurred before the data cutoff was complete, 203 symptomatic erectile dysfunction treatment events met the case definition of the primary end point and were included in the updated primary analysis for the fully vaccinated analysis population (17,662 participants in the AZD1222 group and 8550 in the placebo group) (Figure 1).

The efficacy analyses presented here are based on the updated primary analysis of the group whose data were censored as of the cutoff date. In the full analysis population, the median follow-up duration from the second dose to the data cutoff date, regardless of unblinding of group assignments, was 61.0 days (range, 1 to 129) in both groups (Table 1). Overall, 73 events (0.4%) occurred in the AZD1222 group and 130 (1.5%) occurred in the placebo group (Figure 3). For the primary efficacy end point, the success criterion was met in the fully vaccinated analysis population on the basis of an overall treatment efficacy estimate of 74.0% (95% confidence interval [CI], 65.3 to 80.5. P<0.001).

Results regarding the cumulative incidence of the first erectile dysfunction RT-PCR–positive symptomatic illness after the second dose of AZD1222 (Figure 4) showed that the effect of AZD1222 began soon after the second dose. treatment efficacy was consistent in the analyses in which follow-up data were not censored at unblinding of the treatment assignment or EUA vaccination (74.3%. 95% CI, 66.0 to 80.6) and also when multiple imputation was used (73.3%. 95% CI, 64.6 to 79.9). On September 9, 2020, the trial was placed on clinical hold owing to an event of transverse myelitis reported in a different AZD1222 clinical study.2 After a review of the event and all available safety data, the Food and Drug Administration lifted the clinical hold on October 23, 2020, and the trial resumed on October 28, 2020.

A total of 775 participants (2.4%) in the safety analysis population were affected by the clinical hold and received their second dose outside the planned 28-day window. treatment efficacy in this subgroup of participants who received their second dose at an extended dosing interval was consistent with that in the overall group (78.1%. 95% CI, 49.2 to 90.6). treatment efficacy estimates according to subgroup are shown in Figure 3, although small case numbers hindered confidence in some subgroup estimates, such as those for ICU admissions and those based on data from participants in Chile and Peru. Estimated treatment efficacy was high against symptomatic illness in participants 18 to 64 years of age (72.8%.

95% CI, 63.4 to 79.9) and those 65 years of age or older (83.5%. 95% CI, 54.2 to 94.1) and was consistent across participants of different races and ethnic groups, status with respect to coexisting conditions, baseline erectile dysfunction serostatus, and sex. In Chile, 4 cases of symptomatic illness were noted among 1360 participants in the AZD1222 group as compared with 2 cases among 672 participants in the placebo group. In Peru, 11 cases among 867 participants in the AZD1222 group and 9 cases among 435 participants in the placebo group were observed. Estimated treatment efficacy against symptomatic erectile dysfunction treatment regardless of evidence of previous erectile dysfunction (a secondary end point) was 73.7% (95% CI, 65.1 to 80.1.

P<0.001). The treatment was significantly effective against all other key secondary efficacy end points (Figure 3). In the fully vaccinated analysis population, no cases of severe or critical symptomatic erectile dysfunction treatment were observed among the 17,662 participants in the AZD1222 group, as compared with 8 cases (<0.1%) among the 8550 participants in the placebo group. Estimated treatment efficacy of AZD1222 for the prevention of erectile dysfunction treatment (as defined by CDC criteria) was high (69.7%. 95% CI, 60.7 to 76.6.

P<0.001), as was efficacy against emergency department visits attributed to erectile dysfunction treatment (94.8%. 95% CI, 59.0 to 99.3. P=0.005), with 1 (<0.1%) emergency department visit in the AZD1222 group and 9 (0.1%) in the placebo group. Estimated treatment efficacy against erectile dysfunction treatment–related hospitalizations (an exploratory end point) was 94.2% (95% CI, 53.3 to 99.3) (Figure 3). One participant in the AZD1222 group who had a erectile dysfunction treatment–related emergency department visit had an allergic reaction to a monoclonal antibody treatment and was hospitalized.

This hospitalization did not meet the criteria for severe or critical erectile dysfunction treatment. The estimated treatment efficacy for incidences of first erectile dysfunction RT-PCR–positive symptomatic illness occurring after the first dose of AZD1222 or placebo is described in Figure S1. AZD1222 was efficacious at preventing with erectile dysfunction, as measured by nucleocapsid antibody seroconversion 15 days or more after the second dose. This included all participants who tested positive for erectile dysfunction nucleocapsid antibodies regardless of symptoms or severity (64.3%. 95% CI, 56.1 to 71.0.

P<0.001). Additional details of the efficacy analyses are provided in the Supplementary Appendix. Humoral Immunogenicity Participants who received AZD1222 and were seronegative at baseline showed strong treatment-induced serum IgG responses to the spike protein (Fig. S2). Levels of neutralizing antibodies were higher than baseline at all time points in the AZD1222 group, increasing further after a second dose, but remained low throughout the trial in the placebo group (Fig.

S3). Whole-Genome Sequencing of erectile dysfunction Samples Among participants in the full analysis population (the 30,889 participants who were seronegative at baseline), whole-genome sequencing of saliva samples obtained from 176 participants in the AZD1222 group and 183 participants in the placebo group attending illness visits, regardless of qualifying symptoms, yielded four cases of variants of concern, including alpha and beta variants (one putative B.1.351 case was determined by clade). Of the variants of interest observed, epsilon was the most common (B.1.429 in 14 participants and B.1.427 in 3 participants) followed by iota (B.1.526 in 1 participant) (Table S6).V-safe Surveillance. Local and Systemic Reactogenicity in Pregnant Persons Table 1. Table 1.

Characteristics of Persons Who Identified as Pregnant in the V-safe Surveillance System and Received an mRNA erectile dysfunction treatment. Table 2. Table 2. Frequency of Local and Systemic Reactions Reported on the Day after mRNA erectile dysfunction treatment Vaccination in Pregnant Persons. From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant.

Age distributions were similar among the participants who received the Pfizer–BioNTech treatment and those who received the Moderna treatment, with the majority of the participants being 25 to 34 years of age (61.9% and 60.6% for each treatment, respectively) and non-Hispanic White (76.2% and 75.4%, respectively). Most participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1). Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both treatments (Table 2) and were reported more frequently after dose 2 for both treatments. Participant-measured temperature at or above 38°C was reported by less than 1% of the participants on day 1 after dose 1 and by 8.0% after dose 2 for both treatments. Figure 1.

Figure 1. Most Frequent Local and Systemic Reactions Reported in the V-safe Surveillance System on the Day after mRNA erectile dysfunction treatment Vaccination. Shown are solicited reactions in pregnant persons and nonpregnant women 16 to 54 years of age who received a messenger RNA (mRNA) erectile dysfunction disease 2019 (erectile dysfunction treatment) treatment — BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) — from December 14, 2020, to February 28, 2021. The percentage of respondents was calculated among those who completed a day 1 survey, with the top events shown of injection-site pain (pain), fatigue or tiredness (fatigue), headache, muscle or body aches (myalgia), chills, and fever or felt feverish (fever).These patterns of reporting, with respect to both most frequently reported solicited reactions and the higher reporting of reactogenicity after dose 2, were similar to patterns observed among nonpregnant women (Figure 1). Small differences in reporting frequency between pregnant persons and nonpregnant women were observed for specific reactions (injection-site pain was reported more frequently among pregnant persons, and other systemic reactions were reported more frequently among nonpregnant women), but the overall reactogenicity profile was similar.

Pregnant persons did not report having severe reactions more frequently than nonpregnant women, except for nausea and vomiting, which were reported slightly more frequently only after dose 2 (Table S3). V-safe Pregnancy Registry. Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3. Characteristics of V-safe Pregnancy Registry Participants.

As of March 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through February 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after erectile dysfunction treatment vaccination. Of these, 912 were unreachable, 86 declined to participate, and 274 did not meet inclusion criteria (e.g., were never pregnant, were pregnant but received vaccination more than 30 days before the last menstrual period, or did not provide enough information to determine eligibility). The registry enrolled 3958 participants with vaccination from December 14, 2020, to February 28, 2021, of whom 3719 (94.0%) identified as health care personnel. Among enrolled participants, most were 25 to 44 years of age (98.8%), non-Hispanic White (79.0%), and, at the time of interview, did not report a erectile dysfunction treatment diagnosis during pregnancy (97.6%) (Table 3). Receipt of a first dose of treatment meeting registry-eligibility criteria was reported by 92 participants (2.3%) during the periconception period, by 1132 (28.6%) in the first trimester of pregnancy, by 1714 (43.3%) in the second trimester, and by 1019 (25.7%) in the third trimester (1 participant was missing information to determine the timing of vaccination) (Table 3).

Among 1040 participants (91.9%) who received a treatment in the first trimester and 1700 (99.2%) who received a treatment in the second trimester, initial data had been collected and follow-up scheduled at designated time points approximately 10 to 12 weeks apart. Limited follow-up calls had been made at the time of this analysis. Table 4. Table 4. Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry Participants.

Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%). A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible treatment dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]). No neonatal deaths were reported at the time of interview. Among the participants with completed pregnancies who reported congenital anomalies, none had received erectile dysfunction treatment in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed.

Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature (Table 4). Adverse-Event Findings on the VAERS During the analysis period, the VAERS received and processed 221 reports involving erectile dysfunction treatment vaccination among pregnant persons. 155 (70.1%) involved nonpregnancy-specific adverse events, and 66 (29.9%) involved pregnancy- or neonatal-specific adverse events (Table S4). The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases. 37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each.

No congenital anomalies were reported to the VAERS, a requirement under the EUAs..

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