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Journal articles on the topic "United States. Bureau of Corporations"
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Parasuraman, Shreekant V., Ahmad B. Naim, Dilan C. Paranagama, Maureen Thyne, Sara Goldberger, John O. Mascarenhas, James Mangan, Salman Fazal, Carole B. Miller, and Ruben A. Mesa. "Financial Burden of Myeloproliferative Neoplasms on Patients: Results from the MPN Landmark Survey in the United States." Blood 126, no. 23 (December 3, 2015): 5561. http://dx.doi.org/10.1182/blood.v126.23.5561.5561.
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Abstract Background: Myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET) are chronic myeloproliferative neoplasms (MPNs). Patients across all 3 MPNs experience marked disease burden in terms of symptoms and negative effects on quality of life (QoL), productivity, and activities of daily living (ADL). To improve the lives and health of patients with MPNs, it is also important to have a current understanding of these burdens from a financial standpoint. This analysis of MPN Landmark survey data examined the financial burden of patients who reported that their MPN affected their employment (ie, reduced work hours, discontinued employment, or went on medical disability) or experienced no such effects on their employment. Methods: Patients diagnosed with MF, PV, or ET were recruited to participate in a real-world retrospective study (MPN Landmark survey) in the US (fielded May - July 2014). Only respondents who were diagnosed before 2013 and were 16 to 65 years of age at the time of diagnosis were eligible for this analysis. Participants were asked if their MPN had an impact in terms of reduced work hours, discontinued employment, medical disability, or no impact; the first 3 categories were not mutually exclusive. Participants provided information on their annual household income in 2013 before taxes by selecting from the following categories: ≤$15,000, $15,001-$25,000, $25,001-$35,000, $35,001-$50,000, $50,001-$75,000, $75,001-$100,000, and >$100,000. The mid value of each range was used to calculate mean income levels within each subgroup evaluated. Results: A total of 813 patients completed the web-based Landmark survey and 369 eligible patients were included in this analysis (MF, 85; PV, 172; ET, 112). Median age among patients with ET was slightly lower than among patients with MF and PV at time of MPN diagnosis (ET, 48 years; MF, 56 years; PV, 53 years). The majority of respondents were women (MF, 62%; PV, 52%; ET, 75%). Almost all patients (99%) had health insurance, primarily group commercial insurance through an employer (MF, 46%; PV, 53%; ET, 57%) and Medicare (MF, 40%; PV, 34%; ET, 24%). Most patients had at least some college education (ie, some college, 4-year degree, or postgraduate degree): MF, 86%; PV, 90%; ET, 88%. The mean 2013 household income of patients with MF, PV, and ET were similar to each other ($79,800, $80,200, and $80,400, respectively) and slightly higher than the total 2013 US mean household income of $75,839. A notable proportion of patients in each MPN group reported that their disease led to reduced work hours, discontinued employment, and medical disability: MF, 38%, 35%, and 33%, respectively; PV, 33%, 28%, and 15%; ET, 28%, 21%, and 4%. Patient demographics, such as age and health insurance status, were similar among patients who reported MPN-associated effects on employment and patients who did not within each MPN. In each MPN group, the mean percentage household income loss in patients with reduced work hours, discontinued employment, and medical disability were: MF, 16%, 18%, and 28%, respectively; PV, 15%, 24%, and 17%; and ET, 0%, 24%, and 37%, compared with patients who did not experience any effects of their MPN on employment (Figure 1). Discontinued employment and medical disability tended to have a greater impact compared with reduced work hours across MPNs. Conclusion: Patients withMPNs may experience a considerable negative impact on their employment status, which in turn may be associated with reduced annual household income. Therefore, across all MPNs, forestalling or reversing discrete aspects of the diseases that negatively impact individual productivity is an important factor in the management of these chronic neoplasms. Disclosures Parasuraman: Incyte Corporation: Employment, Equity Ownership. Naim:Incyte Corporation: Employment, Equity Ownership. Paranagama:Incyte Corporation: Employment, Equity Ownership. Thyne:Incyte Corporation: Speakers Bureau. Mascarenhas:Incyte Corporation: Research Funding; Novartis Pharmaceuticals Corporation: Research Funding; Promedior: Research Funding; Roche: Research Funding; CTI Biopharma: Research Funding; Kalobios: Research Funding. Mangan:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Fazal:Bristol Myers Squibb: Consultancy, Honoraria, Speakers Bureau; Ariad: Consultancy, Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau. Miller:Incyte Corporation: Honoraria, Research Funding. Mesa:Promedior: Research Funding; Gilead: Research Funding; Incyte Corporation: Research Funding; NS Pharma: Research Funding; CTI Biopharma: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; Genentech: Research Funding; Pfizer: Research Funding.
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Fazal, Salman, Carole B. Miller, John O. Mascarenhas, Maureen Thyne, Sara Goldberger, Dilan C. Paranagama, Shreekant V. Parasuraman, Ahmad B. Naim, James Mangan, and Ruben A. Mesa. "Phlebotomy Frequency and Quality of Life and Productivity in Patients with Polycythemia Vera: Results from the MPN Landmark Survey in the United States." Blood 126, no. 23 (December 3, 2015): 5184. http://dx.doi.org/10.1182/blood.v126.23.5184.5184.
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Abstract Background: Phlebotomy is a common and established treatment in patients diagnosed with polycythemia vera (PV) to reduce the risk of thromboembolic events, in both acute and chronic settings. However, phlebotomy may not alleviate all PV-related symptoms and its frequent application can cause moderate to profound iron deficiency, which may worsen PV-related symptoms. This analysis of MPN Landmark survey data examined patient-reported quality of life (QoL) and productivity outcomes in patients with PV based on phlebotomy treatment history. Methods: Patients who were diagnosed with a myeloproliferative neoplasm (MPN) were recruited to participate in the MPN Landmark survey in the US (fielded May - July 2014). This analysis describes responses from patients with PV on questions regarding PV-related symptom burden, QoL, and productivity. Patient responses were analyzed based on phlebotomy treatment history and included patients who were actively receiving phlebotomy within the last 3 months (≥1 per month, every other month, and every 3 months or longer), had discontinued phlebotomy, or were phlebotomy-naive. Descriptive statistical analyses were used to evaluate these outcomes based on phlebotomy frequency, as appropriate. Results: Overall, 813 patients completed the Landmark survey, and 274 out of the 380 patients with PV who completed the survey were evaluable for this analysis. Mean age ranged from 61.6-65.4 years among phlebotomy subgroups (Table 1). The average duration of PV was longest among patients with PV who had discontinued phlebotomy (12.0 years) compared with phlebotomy-naive patients (6.3 years) and patients actively treated with phlebotomy (5.9-8.9 years). The percentage of patients diagnosed within 1 year of the survey ranged from 4.1% to 11.5% among the patients who had been treated with phlebotomy and was 15.4% in the phlebotomy-naive subgroup. Most patients reported PV-related symptoms; symptom burden was similar in all phlebotomy subgroups. Fatigue was the most common symptom reported in all subgroups (range, 71.4%-80.8%). QoL measures were generally worse with higher phlebotomy frequency (Table 1). Similarly, more frequent phlebotomy procedures was found to be associated with reduced productivity: patients who received ≥1 phlebotomy per month had the highest mean number (in the preceding 30 days) of sick days (among patients employed), days spent in bed, and days with plans canceled. Of note, approximately one third of patients receiving more frequent phlebotomy procedures were also receiving concomitant hydroxyurea to manage their PV (≥1 per month, 38.5%; every other month, 36.4%). Conclusion: Patients with PV may experience disease-related symptoms and reductions in QoL and work productivity. Frequent phlebotomy procedures were associated with increasingly worsened QoL and decreased work productivity. Further research is needed to better understand the impact of phlebotomy on patient-reported outcomes in patients with PV. Disclosures Fazal: Bristol Myers Squibb: Consultancy, Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Ariad: Consultancy, Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau. Miller:Incyte Corporation: Honoraria, Research Funding. Mascarenhas:Promedior: Research Funding; Roche: Research Funding; CTI Biopharma: Research Funding; Kalobios: Research Funding; Novartis Pharmaceuticals Corporation: Research Funding; Incyte Corporation: Research Funding. Thyne:Incyte Corporation: Speakers Bureau. Paranagama:Incyte Corporation: Employment, Equity Ownership. Parasuraman:Incyte Corporation: Employment, Equity Ownership. Naim:Incyte Corporation: Employment, Equity Ownership. Mangan:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Mesa:Promedior: Research Funding; Genentech: Research Funding; Gilead: Research Funding; NS Pharma: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; CTI Biopharma: Research Funding; Pfizer: Research Funding; Incyte Corporation: Research Funding.
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Verstovsek, Srdan, Shreekant Parasuraman, Jingbo Yu, Anne Shah, Shambhavi Kumar, Ann Xi, and Claire Harrison. "Real-World Survival Among Patients with Intermediate- to High-Risk Myelofibrosis in the United States: Impact of Ruxolitinib Approval." Blood 136, Supplement 1 (November 5, 2020): 46–47. http://dx.doi.org/10.1182/blood-2020-140820.
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Background The myeloproliferative neoplasm myelofibrosis (MF) is associated with reduced overall survival (OS) compared with the general population (Hultcrantz M, et al. J Clin Oncol. 2012;30[24]:2995-3001; Price GL, et al. PLoS One. 2014;9[3]:e90299). The Janus kinase 1 and 2 inhibitor ruxolitinib (RUX) was approved by the US Food and Drug Administration in November 2011 for the treatment of adult patients with intermediate- or high-risk MF based on data from the phase 3 COMFORT trials, which showed significantly improved OS in patients who received RUX (Verstovsek S, et al. J Hematol Oncol. 2017;10:156). Understanding the clinical benefit of RUX in real-world practice requires an understanding of changes in patient outcomes for those exposed to RUX compared with those never exposed to RUX, both before and after approval. The aim of this analysis was to assess the OS of patients newly diagnosed with intermediate- to high-risk MF before RUX approval, and for those who were RUX-unexposed vs -exposed in the post-RUX approval time frame. Study Design and Methods All data from the Medicare Fee-for-Service claims database (Parts A/B/D) from January 2010 to December 2017 were used to identify patients who were ≥65 years old (intermediate-1 or higher risk MF due to age) with ≥1 inpatient claim or ≥2 outpatient claims with a documented MF diagnosis. The index date was the date of the first qualifying MF claim; ≥12 months of pre-index continuous medical and pharmacy enrollment was required. Patients with evidence of an MF diagnosis ≤12 months before the index date were excluded. Patients with a diagnosis of myelodysplastic syndrome, hematologic malignancies (leukemias, multiple myeloma, and lymphomas), or solid tumors either ≤12 months before, on, or any time after index were also excluded in a stepwise manner. The study sample was classified into 3 groups: patients diagnosed with MF pre-RUX approval (index year 2010-2011; no post-index exposure to RUX); those diagnosed with MF post-RUX approval and unexposed to RUX (index year 2012-2017); and those diagnosed with MF post-RUX approval and exposed to RUX (index year 2012-2017). One-year survival rate and risk of mortality were estimated using Kaplan-Meier and Cox proportional hazards regression analyses, adjusting for baseline demographic and clinical characteristics. OS was measured from the index date until death or end of follow-up. Patients without a death date were censored at disenrollment or the end of the study period, whichever occurred first. Results Among eligible patients with an MF diagnosis (N=1677), median age was 78 years, 39.8% were male, and 84.1% were white. The analysis included 278 patients diagnosed pre-RUX approval (all RUX-unexposed) and 1399 diagnosed post-RUX approval (RUX-unexposed, n=1127; RUX-exposed, n=272). Median follow-up for the pre- and post-RUX approval groups was 12.5 and 11.3 mo (RUX-unexposed, 10.2 mo; RUX-exposed, 14.0 mo), respectively. In the pre-RUX approval group, 119 (42.8%) patients had a valid death date compared with 436 (31.2%) in the post-RUX approval group (RUX unexposed, n=382 [33.9%]; RUX exposed, n=54 [19.9%]). The 1-year survival rate (95% CI) was 55.6% (49.4%-61.3%) for the pre-RUX approval group, 72.5% (69.5%-75.2%) for the post-RUX approval RUX-unexposed group, and 82.3% (76.7%-86.7%) for the post-RUX approval RUX-exposed group (Figure). The risk of mortality was lowest among RUX-exposed patients (adjusted hazard ratio [HR], 0.36; 95% CI, 0.26-0.50; P<0.0001 vs the pre-RUX approval group). Patients in the post-RUX approval group who had never been exposed to RUX also had a lower risk of mortality, although less pronounced than RUX-exposed patients, compared with the pre-RUX approval group (adjusted HR, 0.67; 95% CI, 0.56-0.80; P<0.0001). Conclusions In this real-world study of US patients diagnosed with intermediate- or high-risk MF, 1-year OS was improved in patients diagnosed after RUX approval compared with before RUX approval. Notably, in the post-RUX approval time frame, 1-year OS was greater for those who received RUX than for those who did not receive RUX. These findings complement the survival benefit results demonstrated in the COMFORT studies using real-world data. Disclosures Verstovsek: Gilead: Research Funding; NS Pharma: Research Funding; Genentech: Research Funding; Incyte Corporation: Consultancy, Research Funding; CTI Biopharma Corp: Research Funding; Celgene: Consultancy, Research Funding; Sierra Oncology: Consultancy, Research Funding; AstraZeneca: Research Funding; ItalPharma: Research Funding; Protagonist Therapeutics: Research Funding; PharmaEssentia: Research Funding; Blueprint Medicines Corp: Research Funding; Novartis: Consultancy, Research Funding; Roche: Research Funding; Promedior: Research Funding. Parasuraman:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Yu:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Shah:Avalere Health: Current Employment. Kumar:Avalere Health: Current Employment; Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation. Xi:Avalere Health: Current Employment; Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation. Harrison:Gilead Sciences: Honoraria, Speakers Bureau; CTI Biopharma Corp: Honoraria, Speakers Bureau; Shire: Honoraria, Speakers Bureau; Novartis: Honoraria, Research Funding, Speakers Bureau; Roche: Honoraria; Sierra Oncology: Honoraria; Celgene: Honoraria, Research Funding, Speakers Bureau; Janssen: Speakers Bureau; Incyte Corporation: Speakers Bureau; AOP Orphan Pharmaceuticals: Honoraria; Promedior: Honoraria.
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Mesa, Ruben A., Carole B. Miller, John O. Mascarenhas, Maureen Thyne, Sara Goldberger, Dilan C. Paranagama, Shreekant V. Parasuraman, Salman Fazal, Ahmad B. Naim, and James Mangan. "Hydroxyurea Treatment History and Quality of Life in Patients with Polycythemia Vera: Results from the MPN Landmark Survey in the United States." Blood 126, no. 23 (December 3, 2015): 4077. http://dx.doi.org/10.1182/blood.v126.23.4077.4077.
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Abstract Background: Patients with the myeloproliferative neoplasm (MPN) polycythemia vera (PV) require treatment to manage blood cell counts and reduce the risks of cardiovascular/thromboembolic events. Hydroxyurea (HU) is a common cytoreductive treatment; however, some patients discontinue HU treatment because of resistance, intolerance, or frequently a combination of both limitations. Patients may also continue to receive HU despite diminishing or nonexistent clinical benefit, sometimes in combination with persistent need for phlebotomy procedures. This analysis of MPN Landmark survey data examined patient-reported quality of life (QoL) outcomes in patients with PV who were naive to HU (HU-N), were continuing HU (HU-C), or had discontinued HU (HU-D). Methods: Patients with an MPN under active management in the US were eligible to complete an online survey (fielded May - July 2014). This is a report of responses given by patients with PV to questions about symptom burden, QoL, activities of daily living (ADL), and work/productivity. PV-related effects on patients feeling depressed/discouraged, patients feeling anxious/worried, or interference with ADLs were considered to be at high levels if the patient-reported score was ≥4 on a scale of 1 (not at all) to 5 (a great deal). Symptom severity was rated on a scale of 0 (absent) to 10 (worst imaginable). Results: The survey respondents included 380 patients with PV (HU-N, n=159; HU-C, n=181; HU-D, n=40). Mean age was 62.2 years, 65.1 years, and 64.2 years in the HU-N, HU-C, and HU-D groups, respectively. Mean duration of PV was 8.3 years, 10.3 years, and 13.9 years in the HU-N, HU-C, and HU-D groups, respectively. Patients who had not received HU were currently or previously treated with phlebotomy (87.4%), interferon (11.3%), or anagrelide (9.4%); 66.0% of HU-N patients were classified as high-risk based on information provided by the patients in the survey (ie, age 60 or older or history of thrombosis). Among HU-C and HU-D patients, treatment history included phlebotomy (89.5% and 100%, respectively), interferon (7.2% and 52.5%), or anagrelide (15.5% and 35.0%); 79.6% and 82.5%, respectively, were classified as high-risk. Ruxolitinib was not FDA-approved for PV at the time of this survey. Patients reported high levels of feeling anxious/worried and depressed/discouraged as a result of their PV across all subgroups: HU-N, 27.7% and 15.1%, respectively; HU-C, 22.7% and 15.5%; HU-D, 32.5% and 22.5%. Many patients also experienced a high level of PV-related interference with ADLs, which was more common in the HU-D group (30.0%) than the HU-N (11.3%) or HU-C (18.2%) groups. HU-D patients were more likely to have reported ever reducing their work hours (54.2% of the patients who responded) compared with the HU-N (33.3%) and HU-C groups (36.8%). Among all patients, HU-D patients reported a mean of 8.3 doctor visits in the past 12 months, compared with 5.6 in the HU-N group and 6.6 in the HU-C group. Most patients had experienced PV-related symptoms in the past 12 months (Table 1), particularly fatigue, itching, and day/night sweats; fatigue was ranked first as the symptom that patients would most like to resolve. Conclusion: Patients with PV in a large retrospective real-world survey across the US are found to experience burdensome PV-related symptoms and reduced QoL. The findings from this study also show that standard treatments do not address these aspects of PV in many patients, and patients who have discontinued HU may experience an even greater disease burden, possibly because of a lack of effective and/or safe alternative treatment options. Importantly, while 66.0% of the patients in the HU-N group were classified as high-risk, the majority of the high-risk patients in the HU-N group (81.0%) were not treated with cytoreductive agents, suggesting a potential knowledge deficit regarding recommendations for PV management. Collectively, these results illustrate the adverse impact of PV-related symptom burden on patient QoL and reinforce the importance of unmet control of PV-related symptoms in choosing PV therapy. Disclosures Mesa: Novartis Pharmaceuticals Corporation: Consultancy; NS Pharma: Research Funding; Pfizer: Research Funding; Genentech: Research Funding; CTI Biopharma: Research Funding; Incyte Corporation: Research Funding; Promedior: Research Funding; Gilead: Research Funding. Miller:Incyte Corporation: Honoraria, Research Funding. Mascarenhas:Promedior: Research Funding; Roche: Research Funding; CTI Biopharma: Research Funding; Incyte Corporation: Research Funding; Novartis Pharmaceuticals Corporation: Research Funding; Kalobios: Research Funding. Thyne:Incyte Corporation: Speakers Bureau. Paranagama:Incyte Corporation: Employment, Equity Ownership. Parasuraman:Incyte Corporation: Employment, Equity Ownership. Fazal:Bristol Myers Squibb: Consultancy, Honoraria, Speakers Bureau; Ariad: Consultancy, Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau. Naim:Incyte Corporation: Employment, Equity Ownership. Mangan:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees.
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Mesa, Ruben, Carole B. Miller, Maureen Thyne, James Mangan, Sara Goldberger, Salman Fazal, Xiaomei Ma, et al. "Impact of Myeloproliferative Neoplasms (MPNs) on Patients’ Overall Health and Productivity: Results from the MPN LANDMARK SURVEY in the United States." Blood 124, no. 21 (December 6, 2014): 3183. http://dx.doi.org/10.1182/blood.v124.21.3183.3183.
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Abstract Background: Myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET), are chronic MPNs associated with a broad array of symptoms that may negatively impact patients’ quality of life (QoL). To enhance patient care, it is important to have a current and clear understanding of how MPNs affect the overall health and daily lives of patients. The MPN LANDMARK SURVEY was developed to examine patients’ perceptions of these MPNs related to disease burden, QoL, productivity, and activities of daily living (ADLs). Methods: Eligible patients diagnosed with an MPN were recruited to participate in an online survey conducted from May–July 2014in the US. Patients were asked about the overall burden of disease and impact of symptoms on their QoL, productivity, and ADLs. Descriptive analyses were conducted to assess these outcomes and examined by calculated (not reported) prognostic risk score (MF - DIPSS: Passamonti, Blood 2010; PV: Tefferi, Leuk 2013; ET - IPSET: Passamonti, Blood 2012) and symptom severity quartiles, which were determined using the MPN Symptom Assessment Form (MPN-SAF) total symptom scores. Results: 813 patients (MF=207; PV=380; ET=226) responded to the survey. A majority of patients were female (MF, 54%; PV, 62%; ET, 72%), approximately half were aged 60–74 years (MF, 55%; PV, 51%; ET, 46%), and most were covered by health insurance (>98%). Nearly half (48%) were diagnosed within the last 5 years and average time to diagnosis from first symptoms was >2 years. A high proportion of patients had intermediate to high prognostic risk scores (MF, 94%; PV, 87%; ET, 44%). The majority of patients reported feeling anxious or worried about their MPN (MF, 91%; PV, 78%; ET, 74%). Among all groups, fatigue was the most severe symptom reported (mean MPN-SAF score=6.0–6.4 on a scale of 0–10). A subset of patients in each group described their symptoms as very severe (severity score ≥7 on a scale of 0–10; MF: fatigue [59%], problems with sexual desire [49%], inactivity [46%]; PV: inactivity [48%], fatigue [49%], problems with sexual desire [49%]; and ET: problems with sexual desire [49%], fatigue [50%], headaches [40%]). The majority of patients reported that MPN-related symptoms reduced their QoL (MF, 81%; PV, 66%; ET, 57%); this was reported in all risk groups but more frequently by patients with a high risk score vs a low risk score in MF and ET (MF, 89% vs 69%; PV, 63% vs 65%; ET, 71% vs 59%). A more substantial QoL impact was reported by patients in high vs low symptom quartiles (MF, 95% vs 51%; PV, 94% vs 33%; ET, 93% vs 15%). Similarly, MPNs also had a marked negative impact on reduced work hours, sick days, voluntary job termination, receipt of medical disability, early retirement, and ADLs (Table 1). For example, among patients employed, approximately one fourth reported missing ≥1 day of work (MF, 29%; PV, 19%; ET, 23%) in the last 30 days before the survey. Even patients with low prognostic risk scores often reported missing ≥1 day of work (MF, 33%; PV, 23%; ET, 22%) or cancelling ≥1 day of planned activities (MF, 46%; PV, 35%; ET, 34%). Patients in the high vs low symptom quartiles were more likely to call in sick to work (MF, 48% vs 0%; PV, 52% vs 4%; ET, 38% vs 0%) or cancel ≥1 day of planned activities (MF, 77% vs 5%; PV, 56% vs 7%; ET, 67% vs 3%). Conclusion: The findings from this large, first-of-its-kind survey demonstrate a marked burden of disease across all 3 MPNs that is not limited to symptoms but extends to QoL, productivity, and ADLs. Although high prognostic risk scores have long been associated with a significant burden of disease, in this study, patients with a low risk score also reported significant burden. The symptom burden reported is consistent with previous studies, thus validating the present dataset. MPN treatment considerations should include reducing the symptom burden and improving QoL and productivity to enhance the overall health and lives of MPN patients. Disclosures Mesa: Incyte Corporation: Research Funding; CTI: Research Funding; Gilead: Research Funding; Genentech: Research Funding; Eli Lilly: Research Funding; Promedior: Research Funding; NS Pharma: Research Funding; Sanofi: Research Funding; Celgene: Research Funding. Miller:Incyte Corporation: Honoraria, Research Funding. Thyne:Incyte Corporation: Speakers Bureau. Mangan:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees; Alexion Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Goldberger:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Fazal:Incyte Corporation: Consultancy, Research Funding, Speakers Bureau; Gilead: Research Funding, Speakers Bureau. Ma:Incyte Corporation: Consultancy. Wilson:Incyte Corporation: Honoraria. Dubinski:Incyte Corporation: Employment, Equity Ownership. Boyle:ICF International: Employment, Equity Ownership. Mascarenhas:Incyte Corporation: Consultancy, Research Funding; Novartis Pharmaceuticals Corporation: Research Funding.
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Shah, Nirmish, Ralph Boccia, Walter K. Kraft, Brandon M. Hardesty, Jincy Paulose, Dram Laine, Das Purkayastha, Savita Nandal, and Abdullah Kutlar. "A Multicenter Retrospective Noninterventional Follow-up Study in Patients with Sickle Cell Pain Crisis Who Previously Participated in the Sustain Trial in the United States Successor Study." Blood 132, Supplement 1 (November 29, 2018): 4910. http://dx.doi.org/10.1182/blood-2018-99-111332.
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Abstract INTRODUCTION SUSTAIN was a randomized, double-blind, placebo-controlled, phase 2, 52-week study that compared the effect of crizanlizumab, a P-selectin inhibitor, versus placebo on the frequency of sickle cell pain crises (SCPCs, or vaso-occlusive crises [VOCs] leading to a health care visit) in patients with any genotype of sickle cell disease (SCD). Crizanlizumab 5.0 mg/kg significantly reduced the annual frequency of VOCs versus placebo (1.6 vs 3.0, P=0.01) and increased the time to first on-treatment VOC (4.1 vs 1.4 months, P=0.001). The current study, SUCCESSOR (SUSTAIN Chart-review of Crizanlizumab to Evaluate Sickle-cell Study One-year Retrospective), reviewed medical records of patients who completed the SUSTAIN study at US sites to assess additional cases of significant pain crisis events, and to generate real-world data on treatment patterns and health care resource utilization upon completion of treatment with crizanlizumab. METHODS SUCCESSOR is a retrospective cohort study of adult patients (≥18 years old) who participated in the SUSTAIN study in the United States to evaluate outcomes related to SCD up to 52 weeks following their completion of the trial. SUCCESSOR included the per protocol population from SUSTAIN, which included the intent-to-treat patients who received at least 12 of the 14 planned study drug doses, completed a visit at least 14 days after the final dose of study drug, and had no major protocol violations that impacted the efficacy assessments. The overall study period for the retrospective study was from September 2015 to March 2017 and patient data were obtained from medical records. Crizanlizumab was not administered post-SUSTAIN. Patient consent was obtained prior to data collection if required by local and/or central research ethics review. RESULTS In this preliminary analysis, a total of 6 patient data sets were extracted. These patients had been randomized to the following treatment arms in the SUSTAIN study: 1 placebo, 1 crizanlizumab 2.5 mg/kg, and 4 crizanlizumab 5.0 mg/kg. The patient who had received placebo during SUSTAIN was a 27-year-old male with HbS/β0-thalassemia SCD. The patient who had received crizanlizumab 2.5 mg/kg was a 42-year-old female with HbSC SCD. The patients who had received crizanlizumab 5.0 mg/kg were: a 28-year-old male with HbSS SCD; a 32-year-old female with HbSS SCD; a 56-year-old female with HbSC SCD; and a 65-year-old female with HbSS SCD. All patients were Black or African-American. In the 52 weeks following completion of the SUSTAIN study, patients who had received placebo or crizanlizumab 2.5 mg/kg reported 4 and 5 VOC events, respectively, while crizanlizumab 5.0 mg/kg patients reported 0-2 VOC events (Table). Four patients (3 crizanlizumab 5.0 mg/kg, 1 placebo) reported hydroxyurea (HU) usage during and after SUSTAIN. One patient who had received crizanlizumab 5.0 mg/kg and did not report HU usage during SUSTAIN reported HU usage post-SUSTAIN. All patients reported opioid usage after SUSTAIN. Transfusions were not allowed during SUSTAIN; 2 patients, 1 who had received crizanlizumab 5.0 mg/kg and 1 who had received placebo, reported transfusions post-SUSTAIN. Five of the 6 patients reported utilizing health care resources (eg, clinic visits, emergency department visits, or hospitalizations) post-SUSTAIN. One patient who received crizanlizumab 5.0 mg/kg did not report utilizing any health care resources post-SUSTAIN and did not report any VOC events in the 52 weeks after SUSTAIN. CONCLUSIONS We report our initial results from a limited number of patients from SUCCESSOR and therefore summarized post-SUSTAIN outcomes without analysis. In 5 of the 6 patients, the annual frequency of VOC events remained the same or increased in the post-SUSTAIN period compared to that during the SUSTAIN study. Data collection is ongoing in additional eligible patients. Disclosures Shah: Novartis: Consultancy, Research Funding, Speakers Bureau. Boccia:Amgen: Honoraria, Research Funding, Speakers Bureau; Celgene: Research Funding, Speakers Bureau; BMS: Research Funding, Speakers Bureau. Hardesty:Biomarin: Research Funding; Bioverativ: Research Funding; Global Blood Therapeutics: Research Funding; Novo Nordisk: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Octapharma: Consultancy, Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Prometic: Research Funding; Sangamo: Research Funding; Shire: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Paulose:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Laine:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Purkayastha:Novartis Pharmaceuticals Corporation: Employment. Nandal:Novartis Pharmaceuticals Corporation: Employment. Kutlar:Sancilio: Other: DSMB Chair; Bluebird Bio: Other: DSMB Member; Novartis: Consultancy, Honoraria, Other: Personal fees, Research Funding.
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Hari, Parameswaran, Haris Ali, Yi-Bin Chen, Salman Fazal, Tara K. Gregory, Sarah M. Anand, Ahmad Naim, et al. "Safety Analysis of Patients Who Received Ruxolitinib for the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease in an Expanded Access Program." Blood 136, Supplement 1 (November 5, 2020): 39–40. http://dx.doi.org/10.1182/blood-2020-140541.
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Background Graft-versus-host disease (GVHD) is a serious, potentially fatal complication of allogeneic hematopoietic cell transplantation (HCT). Ruxolitinib (RUX), a Janus kinase (JAK) 1/JAK2 inhibitor, is in phase 3 development for patients (pts) with steroid-refractory chronic GVHD (SR cGVHD), and is approved for the treatment of steroid-refractory acute GVHD (SR aGVHD) in the United States. Outside of clinical trials, access to RUX is provided to pts with SR cGVHD through an expanded access program (EAP) sponsored by Incyte Corporation in the United States. The primary objective of this analysis was to report safety data from pts with SR cGVHD who received RUX in the Incyte-sponsored US EAP. Study Design and Methods Patients eligible to enroll in the open-label, multicenter US EAP from September 2017-May 2020 were ≥12 years of age, developed SR aGVHD or SR cGVHD after allogeneic HCT, and had an ECOG PS of 0-3. Pts with SR aGVHD and those with incomplete or missing data were excluded from the analysis. Based on clinical experience, the recommended starting dose of oral RUX for pts with cGVHD was 10 mg twice daily (BID). Doses could not be escalated above 10 mg BID, but dose reductions were permitted during treatment based on safety and laboratory assessments. The dose of RUX could be re-escalated if toxicity management thresholds were met or if pts experienced GVHD flares and had adequate hematologic parameters. Any GVHD treatments received before RUX initiation were recorded, and concurrent therapy with other cGVHD treatments was permitted. Serious adverse events (SAEs) were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03 from the time of consent until 30 days after end of treatment. Pt characteristics, prior treatments, and RUX dosing were summarized using descriptive statistics. Overall survival (OS) was assessed using Kaplan-Meier methodology. Results The analysis included 481 pts with SR cGVHD and complete data (data cutoff, 08 May 2020). Median (range) age was 60.0 (15-81) years; 51.8% of pts were male. At the time of RUX initiation, the organs involved included the skin (70.7%), eyes (59.3%), mouth (55.7%), joints (38.0%), lungs (34.9%), gastrointestinal tract (28.1%), liver (18.9%), and genitals (11.0%). Most pts (65.3%) received ≥2 prior treatments for GVHD, including systemic corticosteroids (54.9%), calcineurin inhibitors (25.6%), sirolimus (20.8%), mycophenolate mofetil (14.6%), ibrutinib (7.1%), and RUX (3.1%); 26.6% of pts received topical corticosteroids and 12.3% received other topical treatments. Most pts initially received RUX 5 mg BID (n=228 [47.4%]) or 10 mg BID (n=229 [47.6%]); 276 pts (57.4%) received RUX 10 mg BID as their last dose at the time of discontinuation or data cutoff. At data cutoff, 332 pts (69.0%) were still receiving RUX. Primary reasons for treatment discontinuations were death (7.1%), GVHD progression (5.4%), malignancy relapse (3.5%), and adverse events (2.5%). The median (range) duration of RUX treatment was 7.2 (0.03-33.0) months. SAEs, regardless of causality, were reported in 162 pts (33.7%). Median (range) time to first SAE from RUX initiation was 77.0 (1-693) days. The most common SAEs were sepsis (n=18 [3.7%]), pyrexia (n=9 [1.9%]), dyspnea (n=8 [1.7%]), respiratory failure (n=8 [1.7%]), acute kidney injury (n=7 [1.5%]), failure to thrive (n=7 [1.5%]), influenza (n=7 [1.5%]), diarrhea (n=6 [1.2%]), fall (n=6 [1.2%]), pulmonary embolism (n=6 [1.2%]), and upper respiratory tract infection (n=6 [1.2%]). One pt (0.2%) had a cytomegalovirus viremia SAE. There were few SAEs reported for cytopenias (febrile neutropenia, n=2 [0.4%]) or fungal infections (fungal pneumonia, n=1 [0.2%]); SAEs for neoplasms were reported for 8 pts (1.7%). There were no SAEs of thrombotic microangiopathy. Forty-six pts (9.6%) had fatal SAEs, most commonly attributed, at least in part, to infections (n=13 [28.3% of SAE-related fatalities]). Thirty-six pts (7.5%) had SAEs deemed related to RUX. The OS rates (95% CI) were 88% (84-91) at 1 year and 82% (74-88) at 2 years (Figure). Conclusions Patients with SR cGVHD in the RUX EAP program were heavily pretreated and primarily had organ involvement of the skin, eyes, and mouth. SAEs were reported in one-third of pts, including 7% of pts with RUX-related SAEs. Ten percent of pts had fatal SAEs, primarily due to infectious complications of cGVHD. No new or unexpected SAEs were reported. Figure 1 Disclosures Hari: Incyte Corporation: Consultancy; Takeda: Consultancy; BMS: Consultancy; Amgen: Consultancy; GSK: Consultancy; Janssen: Consultancy. Ali:Incyte Corporation: Consultancy. Chen:Takeda: Consultancy; Incyte Corporation: Consultancy; Equillium: Other: Data and Safety Monitoring Board Member; Actinium: Other: Data and Safety Monitoring Board Member; Magenta: Consultancy; Kiadis: Consultancy; AbbVie: Other: Data and Safety Monitoring Board Member. Fazal:Agios: Consultancy, Speakers Bureau; Jazz Pharma: Consultancy, Speakers Bureau; Jansen: Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Glaxosmith Kline: Consultancy, Speakers Bureau; Stemline: Consultancy, Speakers Bureau; Incyte Corporation: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Karyopham: Speakers Bureau; Gilead/Kite: Consultancy, Speakers Bureau; Celgene: Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau. Gregory:Bluebird: Research Funding; Celgene: Research Funding; BMS: Research Funding; CURIS: Research Funding; Celularity: Research Funding; Constellation: Research Funding; CRISP Therapeutics: Research Funding; Acetylon: Research Funding; AbbVie: Research Funding; Amgen: Research Funding; Incyte Corporation: Consultancy; Vivolux: Research Funding; Teva: Research Funding; Takeda: Research Funding; Sanofi: Research Funding; Poseida: Research Funding; Novartis: Research Funding; Kesios: Research Funding; Lilly: Research Funding; Janssen: Research Funding; Glenmark: Research Funding; Genentech: Research Funding; EMD Sorono: Research Funding. Anand:AltruBio: Research Funding; CSL Behring: Research Funding; Incyte Corporation: Research Funding; Equillium: Research Funding; Kadmon: Research Funding. Naim:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Paranagama:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Bhatt:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Blithe:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. DiPersio:Magenta Therapeutics: Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: Ruxolitinib is a JAK1/JAK2 inhibitor approved by the FDA for the treatment of adults with steroid-refractory acute GVHD. Ruxolitinib is in phase 3 testing for the treatment of steroid-refractory chronic GVHD but is currently not approved for this indication.
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Weinreb, Neal J., Deborah Barbouth, and Robert E. Lee. "Causes of Death in 184 Patients with Type 1 Gaucher Disease From the United States Who Were Never Treated with Enzyme Replacement Therapy." Blood 118, no. 21 (November 18, 2011): 3128. http://dx.doi.org/10.1182/blood.v118.21.3128.3128.
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Abstract Abstract 3128 Type 1 Gaucher disease (GD1) is caused by deficient lysosomal glucocerebrosidase activity with resultant accumulation of glucosylceramide predominantly within hepatic, splenic, pulmonary and bone marrow macrophages. Intravenous recombinant glucocerebrosidase (ERT) is generally safe and effective in decreasing morbidity due to the heterogeneous manifestations of GD1: hematological cytopenias, hepatosplenomegaly, bone pain, osteonecrosis, osteopenia and fractures. There are other complications whose responsiveness to conventional treatment is yet undetermined: atypical Parkinsonism and an increased risk for cancer (CA), particularly plasma cell and other hematological and lymphoid malignancies and hepatocellular carcinoma. Because of the widespread use of ERT during the past 20 years and attrition of older medical records, a phenotypically representative control group of untreated symptomatic patients for study of these late outcome events is hard to find. From 1961–97, one of us (REL) collected information on 395 US patients with GD1. We determined through public records that 217 died from 1950–2010 of whom 184 never received ERT. Here, we report confirmed causes of death (COD) for the untreated GD1 patients compared to COD reported for this time period in an age comparable overall US population. Methods: After IRB approval, COD recorded in death certificates were accessed via the National Death Index for available years 1979–2008. COD prior to 1979 were determined based on autopsy or physician communication with REL and, where possible, by death certificates obtained from State Bureaus of Vital Records. Information on COD (1950–2008) for the general US population is from US National Vital Statistics Reports. The analysis included descriptive statistics, calculation of proportional mortality ratios (PMR), and 2-tailed Fisher exact test calculations based on absolute death numbers in the GD1 and general populations. Results: COD is unknown for 9 patients who died before 1979. 111 pts were male (60.3%); 124 (67.4%) were Ashkenazi Jewish. Median age at death was 66y (2–97y). Median age at GD1 diagnosis (N=102): 39y (1–83y). Spleen status: Splenectomy 94 (51.1%); Intact 56 (30.4%); Unknown 34 (18.5%). Median age at splenectomy: 36y (1.3–78y). Symptomatic bone disease was present in 74 (40.2%), absent in 7 (3.8%) and undocumented for 103 (60.0%). COD for which the PMR was significantly increased (P<0.01): malignant neoplasms (PMR 1.57), suicide/drug overdose (PMR 3.86), chronic liver disease (PMR 4.76) and septicemia (PMR 9.22). Other COD that were disproportionately high included CNS and gastrointestinal bleeding, post-splenectomy complications, pulmonary hypertension (PHT), and Parkinsonism. Heart disease/atherosclerosis was the only COD for which PMR was very significantly decreased (0.33). PMR for cerebrovascular disease was 0.48 (P=0.027). For 57 pts with a CA COD, PMRs for myeloma (9.66), kidney CA (4.63), liver CA (4.36), NHL (4.13), and all leukemia (3.19) were significantly elevated (P<0.01). Conversely, the PMR for lung CA was 0.32 (P=0.002). There was 1 death from breast CA and none from gynecological CA. PMR for colorectal, pancreatic and prostate CA were not divergent from expected. Compared to the control population, the age distribution of deaths was identical for heart disease, septicemia, and suicide. Age at death was not younger than expected in pts with myeloma but there was a tendency for death at a younger age for GD pts with NHL, chronic liver disease and Parkinsonism. COD significantly more prevalent in surgically asplenic pts included chronic liver disease, septicemia, GI bleeding, PHT and post-splenectomy complications. Spleen status was statistically irrelevant to CA deaths including myeloma except for hepatocellular CA (splenectomy) and CLL (intact spleen). Conclusions: With earlier diagnosis, improved risk assessment and phase-out of splenectomy, COD that we encountered (chronic liver disease, GI bleeding, septicemia, PHT, suicide and drug dependency) should be increasingly rare with timely institution of appropriate treatment. Our study population of untreated pts (estimated at 5% of all US GD1 deaths from 1950–2008 but a substantially greater percentage of GD1 deaths over age 60y), should serve as a valuable control for future studies of the effect of GD1 treatment on mortality due to malignancy or other later course events. Disclosures: Weinreb: Genzyme Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Shire HGT: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Actelion Corporation: Speakers Bureau.
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Stein, Brady L., Ahmad Naim, Michael R. Grunwald, Alison R. Moliterno, Stephen T. Oh, Dilan Paranagama, Joseph A. Cordaro, et al. "Examining the Clinical Features and Underlying Cardiovascular Risk Among Patients with Polycythemia Vera in the REVEAL Study." Blood 128, no. 22 (December 2, 2016): 1934. http://dx.doi.org/10.1182/blood.v128.22.1934.1934.
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Abstract Background:Patients with polycythemia vera (PV) often present with a broad range of clinical characteristics that may contribute to increased risks of cardiovascular (CV) morbidity and mortality, including thrombotic events (TE). Limited contemporary real-world data have been reported about the clinical burden of PV and treatment patterns in the United States. The ongoing REVEAL study collects data on disease burden, clinical management, patient-reported outcomes, and healthcare resource utilization for patients with PV in the United States. This analysis reports clinical characteristics, including underlying CV risk factors, for patients enrolled in the REVEAL study as of April 28, 2016. Methods: REVEAL is a multicenter, nonrandomized, prospective, observational study enrolling patients ≥18 years of age with a PV diagnosis who are actively managed in an academic or community setting. For this analysis, data regarding PV disease and diagnosis, clinical characteristics, and treatment patterns were collected at enrollment during usual-care visits and were based on physician assessment, electronic medical records, and local laboratory values. Ten-year CV risk factors selected for this analysis were adapted from the Framingham Heart Study for CV diseases. Results: At data cutoff, 2307 patients were available for this analysis. Mean (SD) age was 66.3 (12.2) years, 54.4% were male, 89.9% were white, 62.7% had at least some college education, and 51.1% were retired. Approximately 6% of patients had a family history of PV, primarily in parents (35.1%) and siblings (33.8%). A history of second malignancies was reported for 344 patients (14.9%). The majority of patients (84.6%) were diagnosed with PV based on an abnormal blood test alone or in combination with a bone marrow test. Among patients who were diagnosed with a mutational test (n=1078), 95.2% were diagnosed via an abnormal JAK2V617F test result. Abnormal hemoglobin (57.3%), hematocrit (55.4%), or both (47.5%) were among the most common blood values assessed for PV diagnosis. At diagnosis, 58.5% of patients were classified with high-risk PV (age ≥60 years or history of a TE); this percentage increased to 77.3% at REVEAL enrollment. The average (SD) disease duration from diagnosis to enrollment was 5.8 (6.1) years. At enrollment, 91.5% of patients were under active management for PV (phlebotomy ± aspirin, 34.0%; hydroxyurea ± aspirin, 27.0%; and phlebotomy + hydroxyurea ± aspirin, 23.2%). Underlying CV risk factors that were either diagnosed or treated in 86.0% of enrolled patients included hypertension (66.5%), history of smoking (46.2%), current smoking at enrollment (10.9%), obesity (34.2%), hyperlipidemia (27.4%), and diabetes (14.8%). At enrollment, 431 (18.7%) patients reported having ≥1 TE, including 181 patients who had a TE between PV diagnosis and enrollment. Venous and arterial TEs were reported in 11.1% and 8.6% of patients, respectively. Most commonly reported venous TEs were deep vein thrombosis (5.9%) and pulmonary embolism (2.5%); most common arterial TEs were cerebrovascular arterial thrombosis including transient ischemic attack (5.1%) and acute myocardial infarction (1.7%). Increased rates of TEs were observed among patients with hyperlipidemia (23.6%) and hypertension (21.0%; Table 1), compared with patients who did not have any risk factors (10.5%). Conclusion: A large proportion of patients in the REVEAL study had 1 or more underlying CV risks, including age, hypertension, smoking, obesity, hyperlipidemia, and diabetes, which may contribute to the risk of thrombosis. Longitudinal data from REVEAL will provide a better understanding of how these factors affect CV outcomes over time. Disclosures Stein: Incyte Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding. Naim:Incyte Corporation: Employment, Equity Ownership. Grunwald:Janssen: Research Funding; Forma Therapeutics: Research Funding; Medtronic: Equity Ownership; Alexion: Membership on an entity's Board of Directors or advisory committees; Ariad: Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding; Incyte Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Oh:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Research Funding; CTI: Research Funding. Paranagama:Incyte Corporation: Employment, Equity Ownership. Cordaro:Incyte Corporation: Employment, Equity Ownership. Sun:Incyte Corporation: Employment, Equity Ownership. Parasuraman:Incyte Corporation: Employment, Equity Ownership. Boccia:Celgene: Consultancy, Honoraria, Speakers Bureau; Amgen/Onyx: Consultancy, Honoraria, Speakers Bureau; Gilead: Speakers Bureau; Genentech: Consultancy, Honoraria, Speakers Bureau; Eisai: Consultancy, Honoraria, Speakers Bureau. Mesa:Ariad: Consultancy; CTI: Research Funding; Gilead: Research Funding; Galena: Consultancy; Novartis: Consultancy; Promedior: Research Funding; Celgene: Research Funding; Incyte Corporation: Research Funding.
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Guru Murthy, Guru Subramanian, Binod Dhakal, Vijaya R. Bhatt, Paulette Mehta, Patrick C. Foy, Laura C. Michaelis, Karen B. Carlson, and Ehab Atallah. "Incidence and Overall Survival of Therapy Related Myeloid Neoplasm in United States." Blood 128, no. 22 (December 2, 2016): 3992. http://dx.doi.org/10.1182/blood.v128.22.3992.3992.
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Abstract Background: Therapy related myeloid neoplasm (t-MN) such as acute myeloid leukemia and myelodysplasia are emerging challenges in the current era when newer therapies are improving patient survival in many malignancies. Although clinical trials have reported the outcomes of t-MN, the real world data on its incidence and overall survival (OS) at population level remains sparse. Methods: Using Surveillance Epidemiology and End Results (SEER-18) database, we identified patients aged ≥ 10 years with pathologically confirmed t-MN (ICD-0-3 code 9920) diagnosed between the years 2000-2013 and actively followed. Incidence rate per 100000 population and incidence rate ratio (IRR) were calculated to describe the relative differences in disease incidence between the subgroups. Race was divided as Whites, Blacks, American Indians and Asian/pacific islanders. Three year OS was calculated by Kaplan-Meier method and compared by log rank test. Determinants of OS were analyzed with Cox proportional hazard regression method. Statistical analyses were done with significance level of p < 0.05. Results: A total of 941 patients with t-MN who met the study criteria were identified. Median age of the cohort was 63 years (10-85 years). Majority of the patients had age ≥60 years (58.2%), females (55.2%) and White race (86.4%). Overall incidence of t-MN was 0.09 cases/100000 population and showed significant variations with age, race and the period of diagnosis (Table 1). The disease incidence increased significantly after the age 40 (IRR ranging from 4.23 to 15.68, p < 0.01) and after the year 2005 (IRR ranging from 2.97 to 10.42, p < 0.01). Compared to White race, Blacks (IRR 0.65, p < 0.01) and Asian/pacific islanders (IRR 0.55, p < 0.01) had a significantly lower disease incidence. The 3-year OS significantly declined with increasing age (41.8% in age group 10-39, 27.3% in age group 41-59, 11.9% in age group 61-79 and 8.0% in age ≥ 80, p < 0.01). However, 3-year OS did not significantly vary by gender (19.3% in females vs. 20.7% in males, p = 0.92) or race (Whites 19.9%, Blacks 10.6%, American Indians 26.7%, Asian/pacific islander 30.7%, p = 0.43). There was an improvement in the 3-year OS over period (year 2000-2004- 13.4% vs. year 2005-2009 -17.1% vs. year 2010-2013 - 20.6%, p < 0.01). On multivariate analysis, increasing age was associated with significantly higher risk of mortality (age 40-59 - HR 1.46, CI 1.07 - 2.00, p = 0.01; age 60-79 - HR 2.32, CI 1.72 - 3.14, p < 0.01; age ≥80 - HR 3.81, CI 2.63 - 5.50, p < 0.01). Compared to the period 2000-2004, a significantly lower risk for mortality was seen in the period 2010-2013 (HR 0.55, CI 0.42-0.74, p < 0.01). Conclusions: The incidence of t-MN has significantly increased in the last decade and varies with factors such as age and race. Although OS has improved in the period 2010-2013, outcomes of this disorder continue to remain poor at the population level. Further research to identify the disease risk factors and development novel therapies is required to improve the outcomes. Disclosures Michaelis: Pfizer: Equity Ownership; Cellgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte Corporation: Consultancy, Honoraria. Atallah:Pfizer: Other: Grant review; Takeda: Research Funding; Novartis: Consultancy; BMS: Consultancy; CTI biopharma: Consultancy; Incyte: Consultancy; Ariad: Honoraria.
Dissertations / Theses on the topic "United States. Bureau of Corporations"
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Thomson, Belinda. "A cost effective grassland management strategy to reduce the number of bird strikes at the Brisbane airport." Queensland University of Technology, 2007. http://eprints.qut.edu.au/16576/.
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In an era of acute concern about airline safety, bird strikes are still one of the major hazards to aviation worldwide. The severity of the problem is such that it is mandatory in all developed countries to include bird management as part of airport safety management programs. In Australia, there are approximately 500 bird aircraft strikes per year (Bailey 2000). Brisbane airport has a relatively high occurrence of strikes, with an average of 77 recorded every year (2002-2004). Given the severity of the problem, a variety of techniques have been employed by airports to reduce bird strikes. Scare devices, repellents, continuous patrols for bird hazing, use of raptors to clear airspace of birds and depredation are used by many airports. Even given the diversity of control methods available, it is accepted that habitat management is the most effective long term way to control birds in and around the airport space. Experimental studies have shown that habitat manipulation and active scaring measures (shooting, scaring etc), can reduce bird numbers to an acceptable level. The current study investigated bird populations in six major vegetation habitat types identified within the operational and surrounding areas of Brisbane airport. In order to determine areas where greater bird control and management should be focused, bird abundance, distribution, and activity were recorded and habitats that pose the greatest bird strike risk to aircraft were identified. Secondly, species with high hazard potential were identified and ranked according to their hazard potential to aircraft. This study also investigated the effectiveness of different vegetation management options to reduce bird species abundance within operational areas of Brisbane airport. Four different management options were compared. Each management option was assessed for grass structural complexity and potential food resources available to hazardous bird species. Analysis of recorded data showed that of the habitats compared within the Brisbane airport boundaries, grasslands surrounding runways, taxiways and aprons possess the greatest richness and abundance of bird species that pose the greatest potential hazard to aircraft. Ibis and the Australian kestrel were identified as the bird species that pose the greatest risk to aircraft at Brisbane airport, and both were found in greatest numbers within the managed grasslands surrounding operational areas at the airport. An improved reporting process that allows correct identification of all individual bird species involved in bird strikes will not only increase the accuracy of risk assessments, but will also allow implementation of more effective control strategies at Brisbane airport. Compared with current grassland management practice, a vegetation management option of maintaining grass height at 30-50cm reduced total bird utilisation by 89% while utilisation of grassland by potentially hazardous birds was also reduced by 85%. Maintaining grass height within the 30-50cm range also resulted in a 45% reduction in the number of manipulations required per year (11 to 6), when compared with current management practices, and a 64% reduction in annual maintenance cost per hectare. When extrapolated to the entire maintained grass area at Brisbane airport, this resulted in a saving of over $60 000 annually. Optimisation of potential hazard reduction will rely on future studies that investigate the effect of particular vegetation species that could replace the existing mix of grasses used at Brisbane airport and an understanding of the relative importance of vegetation structure and food supply in determining utilisation by potentially hazardous bird species.
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Tanimura, Joseph Kiyoshi. "Taxes, financial distress and capital structure in the United States and Japan." Thesis, Connect to this title online; UW restricted, 2001. http://hdl.handle.net/1773/8745.
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Cho, Wonsang. "Human resource management policy in Japanese manufacturing firms in the United States /." view abstract or download file of text, 2000. http://wwwlib.umi.com/cr/uoregon/fullcit?p9978251.
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Thesis (Ph. D.)--University of Oregon, 2000.Typescript. Includes vita and abstract. Includes bibliographical references (leaves 142-153). Also available for download via the World Wide Web; free to University of Oregon users. Address: http://wwwlib.umi.com/cr/uoregon/fullcit?p9978251.
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Thalmann, Vanessa. "Prison labour for private corporations : the impact of human rights." Thesis, McGill University, 2004. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=82672.
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In the past two decades, the prison population has increased considerably in many industrialized countries. In the United States, for example, the prison population has more than quadrupled since 1980. As a response to the considerable incarceration costs, the number of private prisons and the number of prisoners working for private corporations have increased significantly. Proponents of private sector involvement in prison industries argue that inmate labour can reduce the incarceration costs and contribute to rehabilitation of prisoners.The question of private sector involvement in prison facilities raises significant concerns as regards to international labour standards. Opponents of private sector involvement argue that private hiring of prison labour can involve exploitation. They also argue that the authority for punishment is a core governmental function that cannot be delegated to the private sector. Furthermore, in most cases, labour and social security laws are not applied to inmates. Therefore, prison labour can constitute unfair competition with free labour or even go as far as to replace free labour.
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Ito, Kinko. "Organizational adaptation of Japanese companies in the United States /." The Ohio State University, 1987. http://rave.ohiolink.edu/etdc/view?acc_num=osu1487332636473682.
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Wang, Qi. "Disclosure of internal control weaknesses and the capital market valuation of earnings surprise after the Sarbanes-Oxley Act of 2002." Click to view the E-thesis via HKUTO, 2008. http://sunzi.lib.hku.hk/hkuto/record/B41290550.
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Roubi, Raafat Ramadan. "The Association Between the Establishment of Audit Committees Composed of Outside Directors and a Change in the Objectivity of the Management Results-Reporting Function: an Empirical Investigation Into Income Smoothing Patterns." Thesis, North Texas State University, 1985. https://digital.library.unt.edu/ark:/67531/metadc331852/.
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The purpose of this research was to empirically examine the effect of the establishment of outside audit committees on the objectivity of the management results-reporting practices of those companies that established such committees in response to the New York Stock Exchange mandate effective June 30, 1978. Management income smoothing behavior is taken as a measurable surrogate for the objectivity of the management results-reporting practices. This research involved the testing of one research problem. The research question asks, "Will the establishment of outside audit committees by companies that had no such committees prior to the New York Stock Exchange mandate effective June 30, 1978, be associated with a decrease in the degree of smoothing in the net income series for the period after that date relative to the degree of smoothing prior to that date?" The answer to this question required the selection of an experimental and a control group. Each group was composed of fifty New York Stock Exchange listed firms.
Linear and semi-log regression models were used to measure each firm's degree of income smoothing (defined as reducing the variability of a net income series about its trend line). The change in mean square errors of the experimental and control groups was compared using the chisquare and median tests. Neither the chi-square or the median test found a statistically significant increase in the objectivity of the management results-reporting function for the firms that established outside audit committees in response to the NYSE mandate effective June 30, 1978.
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Gose, Michael A. "Corporate Inversions: Realigning Tax Incentives to Keep Corporations in the United States." Scholarship @ Claremont, 2015. http://scholarship.claremont.edu/cmc_theses/1033.
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ABSTRACT
This thesis analyzes the corporate income tax, more specifically related to foreign sourced income, and proposes a solution to reduce the desirability of tax inversions and restore the competitiveness of United States’ corporations. The paper introduces the topic and discusses why corporate taxation has returned to the forefront of political discussion. It then addresses early 2000s regulation passed in response to increased inversion activity of the late ‘90s and how that regulation failed to achieve its intended purpose. Then, the current laws will be introduced with a focus on corporate actions to circumvent these laws in order to reduce tax liabilities. Then, I will propose a solution that emphasizes altering the incentives of corporations as opposed to creating rules to prevent corporate actions.
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Mori, Naoko. "Role of public relations in management: Japanese corporations in the United States." Thesis, Boston University, 1988. https://hdl.handle.net/2144/38082.
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Thesis (M.S.)--Boston UniversityPLEASE NOTE: Boston University Libraries did not receive an Authorization To Manage form for this thesis or dissertation. It is therefore not openly accessible, though it may be available by request. If you are the author or principal advisor of this work and would like to request open access for it, please contact us at open-help@bu.edu. Thank you.
This study explores how Japanese corporations operating in the U.S. accommodate their management systems to an American work environment, and examines the role of public relations activities in the management systems. Nine interviews were conducted with American and Japanese executives at five Japanese corporations in Massachusetts and Connecticut. The major research questions were: What are the management policies and how is the management structured at each company? What kind of communication method is used for employee and community relations programs? How do the differences between American and Japanese cultures, such as languages and work values, affect the corporations? How do public relations activities support management objectives? All the executives concluded that cultural differences between the U.S. and Japan do not become communication barriers once people from both nations gain mutual understanding. Due to differences in the nature of employees and communities in which they operate, the types of management systems and the communication methods adopted by the five companies vary. Public relations can help management monitor these environmental differences and establish its goals according to the environment. To implement these goals, organizations need active managers who are willing to understand the cultural differences of their organizations and to get involved with employee and community activities. In this way, the managers can facilitate two-way communication among the organizations and between the organizations and the communities.
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Strohm, Christiane Watrin Christoph. "United States and European Union auditor independence regulation implications for regulators and auditing practice /." Wiesbaden : Deutscher Universitäts-Verlag, 2006. http://site.ebrary.com/id/10231815.
Full textBooks on the topic "United States. Bureau of Corporations"
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Division, United States General Accounting Office Accounting and Information Management. Financial audit: Schedule of Loans Receivable serviced by the Bureau of the Public Debt. Washington, D.C. (P.O. Box 37050, Washington, D.C. 20013): The Office, 1998.
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United States. General Accounting Office. Accounting and Information Management Division. Financial audit: Schedule of Loans Receivable serviced by the Bureau of the Public Debt. Washington, D.C. (P.O. Box 37050, Washington, D.C. 20013): The Office, 1998.
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Shea, Stanton, Karpan, and Youngblood nominations: Hearing before the Committee on Energy and Natural Resources, United States Senate, One HUndred Fifth Congress, first session ... July 17, 1997. Washington: U.S. G.P.O., 1997.
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United States. Congress. Senate. Committee on Appropriations. Subcommittee on the Dept. of the Interior and Related Agencies. Proposed Aerojet General Corp./Bureau of Land Management land exchange in Nevada: Hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundredth Congress, first session : special hearing. Washington: U.S. G.P.O., 1988.
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Appropriations, United States Congress Senate Committee on. Proposed Aerojet General Corp./Bureau of Land Management land exchange in Nevada: Hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundredth Congress, first session : special hearing. Washington: U.S. G.P.O., 1988.
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Area, United States Bureau of Land Management White River Resource. Wolf Ridge Corporation mine plan for a nahcolite solution mine: Record of decision. Meeker, Colo: The Resource Area, 1987.
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Oversight of the antitrust enforcement agencies: Hearing before the Subcommittee on Intellectual Property, Competition, and the Internet of the Committee on the Judiciary, House of Representatives, One Hundred Twelfth Congress, first session, December 7, 2011. Washington: U.S. G.P.O., 2012.
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Office, General Accounting. [Financial audit--Resolution Trust Corporation's 1991 management letter]. Washington, D.C: The Office, 1992.
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Office, General Accounting. [Management letter]: [Pension Benefit Guaranty Corporation's accounting procedures]. Washington, D.C: The Office, 1994.
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United States. Congress. House. Committee on Foreign Affairs. Subcommittee on International Economic Policy and Trade. Oversight of the private sector activities of the Overseas Private Investment Corporation and the Agency for International Development's Bureau for Private Enterprise: Hearing before Subcommittee on International Economic Policy and Trade of the Committee on Foreign Affairs, House of Representatives, Ninety-ninth Congress, second session, September 10, 1986. Washington: U.S. G.P.O., 1988.
Find full textBook chapters on the topic "United States. Bureau of Corporations"
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Collins, Julie H., and Douglas A. Shackelford. "Corporate Domicile and Average Effective Tax Rates: The Cases of Canada, Japan, the United Kingdom, and the United States." In The Taxation of Multinational Corporations, 51–79. Dordrecht: Springer Netherlands, 1996. http://dx.doi.org/10.1007/978-94-009-1818-4_4.
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MacAvoy, Paul W., George S. McIsaac, William Niskanen, and Louis De Alessi. "The Performance and Management of United States Federal Government Corporations." In Privatization and State-Owned Enterprises, 77–142. Dordrecht: Springer Netherlands, 1989. http://dx.doi.org/10.1007/978-94-011-7429-9_3.
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Kerrigan, Heather. "Census Bureau Releases Annual Report on Poverty in the United States : September 12, 2018." In Historic Documents of 2018, 512–30. 2455 Teller Road, Thousand Oaks California 91320: CQ Press, 2019. http://dx.doi.org/10.4135/9781544352572.n41.
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Wood, Chris, Andy Viksne, Jon Ake, and David Copeland. "Current Status of Strong-Motion Monitoring and Notification at the United States Bureau of Reclamation." In Strong Motion Instrumentation for Civil Engineering Structures, 331–41. Dordrecht: Springer Netherlands, 2001. http://dx.doi.org/10.1007/978-94-010-0696-5_23.
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Sullivan, Mercer L. "Housing as an Anchor for Community Building: Community Development Corporations in the United States." In Rebuilding Community, 64–82. London: Palgrave Macmillan UK, 2001. http://dx.doi.org/10.1057/9781403919878_4.
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Kerrigan, Heather. "Census Bureau Releases Annual Report on Poverty in the United States : September 10 and October 7, 2019." In Historic Documents of 2019, 457–75. 2455 Teller Road, Thousand Oaks California 91320: CQ Press, 2020. http://dx.doi.org/10.4135/9781544384641.n38.
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Jasso-Aguilar, Rebeca, Howard Waitzkin, and Angela Landwehr. "Multinational Corporations and Health Care in the United States and Latin America: Strategies, Actions and Effects." In Commercialization of Health Care, 38–50. London: Palgrave Macmillan UK, 2005. http://dx.doi.org/10.1057/9780230523616_3.
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Lewandowski, Jill, Elizabeth Burkhard, Kimberly Skrupky, and Deborah Epperson. "United States Bureau of Ocean Energy Management, Regulation and Enforcement: Filling Data Gaps to Better Understand the Effects of Anthropogenic Noise on Marine Life." In Advances in Experimental Medicine and Biology, 567–70. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4419-7311-5_128.
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Celeste, Edoardo, and Federico Fabbrini. "Competing Jurisdictions: Data Privacy Across the Borders." In Palgrave Studies in Digital Business & Enabling Technologies, 43–58. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-54660-1_3.
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Abstract Borderless cloud computing technologies are exacerbating tensions between European and other existing regulatory models for data privacy. On the one hand, in the European Union (EU), a series of data localisation initiatives are emerging with the objective of preserving Europe’s digital sovereignty, guaranteeing the respect of EU fundamental rights and preventing foreign law enforcement and intelligence agencies from accessing personal data. On the other hand, foreign countries are unilaterally adopting legislation requiring national corporations to disclose data stored in Europe, in this way bypassing jurisdictional boundaries grounded on physical data location. The chapter investigates this twofold dynamic by focusing particularly on the current friction between the EU data protection approach and the data privacy model of the United States (US) in the field of cloud computing.
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"Water Corporations." In United States Water Law, 107–11. CRC Press, 2008. http://dx.doi.org/10.1201/9781420086423.ch15.
Full textConference papers on the topic "United States. Bureau of Corporations"
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Klumpp, Cassie C. "United States Bureau of Reclamation's Contribution in K-12 Education." In World Water and Environmental Resources Congress 2003. Reston, VA: American Society of Civil Engineers, 2003. http://dx.doi.org/10.1061/40685(2003)202.
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Sipior, Janice, and Burke Ward. "A Framework for Information Security Management Based on Guiding Standards: A United States Perspective." In InSITE 2008: Informing Science + IT Education Conference. Informing Science Institute, 2008. http://dx.doi.org/10.28945/3188.
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Despite government oversight, consumers continue to be concerned about the security of personal information used by corporations. Consumer concerns give rise to the necessity for corporations to manage information security. Navigating the multitude of existing security standards, including dedicated standards for information security and frameworks for controlling the implementation of information technology, presents a challenge to organizations. In response, we propose our ISM framework which considers global, national, organizational, and employee standards to guide ISM. We contend that a strategic approach to ISM will enable a focus on managing information as a key resource in global competition. This framework is intended to promote a cohesive approach which considers a process view of information within the context of the entire organizational operational environment. This framework can be used by international, national, and regional corporations to formulate, implement, enforce, and audit information security policies and practices.
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Fonseka, W. R. A., D. G. M. Nadeesha, P. M. C. Thakshila, N. A. Jeewandara, D. M. Wijesinghe, R. V. De S. Sahabandu, and P. P. G. D. Asanka. "Use of data warehousing to analyze customer complaint data of Consumer Financial Protection Bureau of United States of America." In 2016 IEEE International Conference on Information and Automation for Sustainability (ICIAfS). IEEE, 2016. http://dx.doi.org/10.1109/iciafs.2016.7946520.
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Viselli, Anthony, Nathan Faessler, and Matthew Filippelli. "Analysis of Wind Speed Shear and Turbulence LiDAR Measurements to Support Offshore Wind in the Northeast United States." In ASME 2018 1st International Offshore Wind Technical Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/iowtc2018-1003.
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This paper presents wind speed measurements collected at 40m to 200m above sea-level to support the New England Aqua Ventus I 12 MW Floating Offshore Wind Farm to be located 17km offshore the Northeast United States. The high-altitude wind speed data are unique and represent some of the first measurements made offshore in this part of the country which is actively being developed for offshore wind. Multiple LiDAR measurements were made using a DeepCLiDAR floating buoy and LiDARs located on land on a nearby island. The LiDARs compared favorably thereby confirming the LiDAR buoy measurements. Wind speed shear profiles are presented. The measurements are compared against industry standard mesoscale model outputs and offshore design codes including the American Bureau of Shipping, American Petroleum Institute, and DNV-GL guides. Significant variation in the vertical wind speed profile occurs throughout the year. This variation is not currently addressed in offshore wind design standards which typically recommend the use of only a few values for wind shear in operational and extreme conditions. The mean wind shears recorded were also higher than industry recommended values. Additionally, turbulence measurements made from the LiDAR, although not widely accepted in the scientific community, are presented and compared against industry guidelines.
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Dwyer, Mark G., Anthony M. Viselli, Habib J. Dagher, and Andrew J. Goupee. "Experimental Verification of ABS Concrete Design Methodology Applied to the Design of the First Commercial Scale Floating Offshore Wind Turbine in the United States." In ASME 2017 36th International Conference on Ocean, Offshore and Arctic Engineering. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/omae2017-62461.
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The abundance of consistent high strength winds off the world’s coastlines and the close proximity to dense population centers has led to development of innovative marine structures to support wind turbines to capture this energy resource. Off the US coast, 60% of the offshore wind lies in deep water (greater than 60m) where the development of Floating Offshore Wind Turbine (FOWT) hull technology will likely be required in lieu of fixed bottom technology such as jacket structures. The United States National Renewable Energy Laboratory (NREL) and the offshore wind community commonly refer to 60m as the transition point between fixed bottom structures and floating structures due to economic reasons. Floating wind turbines deployed in the harsh offshore marine environment require the use of materials that are cost-effective, corrosion resistant, require little maintenance and are highly durable. This has led the University of Maine to develop a concrete hull technology called VolturnUS for full-scale 6MW FOWTs. In this work, experimental testing was conducted to verify the performance of the concrete under operational, serviceability, and extreme loading conditions as required by the American Bureau of Shipping Guide for Building and Classing Floating Offshore Wind Turbines. The testing included structural testing sub-components of the hull and served as experimental verification of American Bureau of Shipping (ABS) concrete design methodology which is currently approved and being used to design the first commercial scale FOWTs in the United States. Two 6MW wind turbines supported on VolturnUS concrete hulls will be used for the New England Aqua Ventus I project. The project is planned to be deployed and connected to the grid by 2019 in the Northeast U.S. and is funded by the US Department of Energy.
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Merchant, John, and Sylnovie Merchant. "Information Technology and the Work/Cultural Orientations of Americans, Mexicans and Germans." In InSITE 2007: Informing Science + IT Education Conference. Informing Science Institute, 2007. http://dx.doi.org/10.28945/3118.
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From a business perspective, the political and economic effectiveness of the United States in the global market-place will depend on individual abilities to communicate with people from other cultures. Most multinational corporations have one individual from one culture managing employees from other cultures. This has led to conflict, law-suits, and reduced productivity. To date, US business people sent overseas have not fared well compared to their counterparts from Europe and Asia, primarily because of cultural conflicts. The future success of American business, therefore, is its ability to interact with other cultures and to understand the orientations of these individuals.
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White, Nancy J., Sigitas Mitkus, and Renata Cibulskienė. "Classification of a defect as breach of contract or tort: a comparative study of the U.S. and the Republic of Lithuania." In Contemporary Issues in Business, Management and Economics Engineering. Vilnius Gediminas Technical University, 2019. http://dx.doi.org/10.3846/cibmee.2019.067.
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Purpose – this paper compares the approach of United States’ law and Lithuanian law in classifying a construction defect as a breach of contract or tort. Research methodology – the paper uses case studies to analyze. Unites States’ law approach divides damages into damages for breach of contract and tort damages. According to Lithuanian law, civil liability is assigned to contractual and non-contractual (tort) liability depending on the nature of the unlawful actions. Findings – the cases demonstrate that a defect usually is considered a breach of contract. Different types of damages are recoverable: compensatory damages according to United States’ law and direct and indirect damages are recoverable according to Lithuanian law. Research limitations – both contractual and non-contractual liability are analyzed. In addition, defects to construction by an act of fraud are covered. More research is needed on how the law affects the extension of the warranty period or the statute of limitations. Originality/Value – the paper provides a new interpretation of classification a construction defect as a breach of contract or tort and offers new insights comparing the different approach of law. Practical implications – the paper will be instructive to developers, contractors, management corporations
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Chao, Lawrence P., Kurt A. Beiter, and Kosuke Ishii. "Design Process Error-Proofing: International Industry Survey and Research Roadmap." In ASME 2001 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers, 2001. http://dx.doi.org/10.1115/detc2001/dfm-21196.
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Abstract This paper presents the results of a survey on the use of error management methods during the design process at several leading corporations in the United States and Japan. The survey reveals that although many companies are aware of the benefits of structured design processes, and although most have implemented systematic design practices to some level, many companies are still reliant on reactive tools (such as design reviews and checklists) to manage design-related errors. This paper discusses the survey methodology, the results of the survey, and the authors’ proposed work to address the existing lack of a systematic approach to design process error-proofing.
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Nieves-Zárate, Margarita. "Ten Years After the Deepwater Horizon Accident: Regulatory Reforms and the Implementation of Safety and Environmental Management Systems in the United States." In SPE/IADC International Drilling Conference and Exhibition. SPE, 2021. http://dx.doi.org/10.2118/204056-ms.
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Abstract The Deepwater Horizon accident is one of the major environmental disasters in the history of the United States. This accident occurred in 2010, when the Deepwater Horizon mobile offshore drilling unit exploded, while the rig's crew was conducting the drilling work of the exploratory well Macondo deep under the waters of the Gulf of Mexico. Environmental damages included more than four million barrels of oil spilled into the Gulf of Mexico, and economic losses total tens of billions of dollars. The accident brought into question the effectiveness of the regulatory regime for preventing accidents, and protecting the marine environment from oil and gas operations, and prompted regulatory reforms. Ten years after the Deepwater Horizon accident, this article analyzes the implementation of Safety and Environmental Management Systems (SEMS) as one of the main regulatory reforms introduced in the United States after the accident. The analysis uses the theory of regulation which takes into account both state and non-state actors involved in regulation, and therefore, the shift from regulation to governance. The study includes regulations issued after the Deepwater Horizon accident, particularly, SEMS rules I and II, and reports conducted by the National Academy of Sciences, the National Commission on the BP Oil Spill, the Center for Offshore Safety, the Chemical Safety and Hazard Investigation Board, and the Bureau of Safety and Environmental Enforcement (BSEE). The article reveals that though offshore oil and gas operators in the U.S. federal waters have adopted SEMS, as a mechanism of self-regulation, there is not clarity on how SEMS have been implemented in practice towards achieving its goal of reducing risks. The BSEE, as the public regulator has the task of providing a complete analysis on the results of the three audits to SEMS conducted by the operators and third parties from 2013 to 2019. This article argues that the assessment of SEMS audits should be complemented with leading and lagging indicators in the industry in order to identify how SEMS have influenced safety behavior beyond regulatory compliance. BSEE has the challenge of providing this assessment and making transparency a cornerstone of SEMS regulations. In this way, the lessons of the DHW accident may be internalized by all actors in the offshore oil and gas industry.
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Jones, Richard H., and David A. Keough. "Water Use and Wastewater Flow Reduction in the Citrus Processing Industry." In ASME 1994 Citrus Engineering Conference. American Society of Mechanical Engineers, 1994. http://dx.doi.org/10.1115/cec1994-4005.
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The Citrus Processing Industry is faced with increased pressures from a number of different sources to reduce water consumption and wastewater discharges. The Florida Water Management Districts are moving toward more restrictive limits on consumptive use permits. The United States Environmental Protection Agency (EPA) and the Florida Department of Environmental Protection (DEP) are moving toward zero discharge limits for industry wastewater discharges to surface waters, wherever possible. The cost of water consumption and wastewater treatment and disposal are increasing, therefore, there is a significant cost incentive for industry to reduce water consumption and wastewater discharge. A logical and economical approach to addressing this issue is by reduction of: • In-plant water use • Wastewater volume • Wastewater concentrations Implementation of a water use and waste reduction program establishes a pro-active environmental image for the corporations and industry as a whole. Paper published with permission.
Reports on the topic "United States. Bureau of Corporations"
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Cummins, Jason. Taxation and the Sources of Growth: Estimates from United States Multinational Corporations. Cambridge, MA: National Bureau of Economic Research, April 1998. http://dx.doi.org/10.3386/w6533.
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Noble, C., and J. Solberg. Nonlinear Seismic Analysis of Morrow Point Dam: A Study for the United States Bureau of Reclamation. Office of Scientific and Technical Information (OSTI), February 2004. http://dx.doi.org/10.2172/15013970.
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Heston, Roxanne. Mapping U.S. Multinationals’ Global AI R&D Activity. Center for Security and Emerging Technology, December 2020. http://dx.doi.org/10.51593/20190008.
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Many factors influence where U.S. tech multinational corporations decide to conduct their global artificial intelligence research and development (R&D). Company AI labs are spread all over the world, especially in North America, Europe and Asia. But in contrast to AI labs, most company AI staff remain concentrated in the United States. Roxanne Heston and Remco Zwetsloot explain where these companies conduct AI R&D, why they select particular locations, and how they establish their presence there. The report is accompanied by a new open-source dataset of more than 60 AI R&D labs run by these companies worldwide.
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The directory of United States coal & technology export resources. Profiles of domestic US corporations, associations and public entities, nationwide, which offer products or services suitable for export, relating to coal and its utilization. Office of Scientific and Technical Information (OSTI), January 1994. http://dx.doi.org/10.2172/10126352.
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