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Seberechts, Frank. ""Liewer op 'n meshoop". De Zuid-Afrikaanse Kompagnie en de Dietse uitwijking na de Tweede Wereldoorlog." WT. Tijdschrift over de geschiedenis van de Vlaamse beweging 70, no. 4 (December 7, 2011): 375–83. http://dx.doi.org/10.21825/wt.v70i4.12294.
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In het ADVN bevinden zich twee documenten die werden opgesteld en verspreid door de “Zuid-Afrikaanse Kompagnie” (ZAK). Deze organisatie trachtte in de eerste jaren na de Tweede Wereldoorlog Vlamingen te overhalen naar Zuid-Afrika te emigreren. Het was de bedoeling dat zij daar zouden meewerken aan de regeneratie van het Dietse volk. Met hun initiatief sluiten de auteurs aan bij een bredere stroom van tegelijkertijd imperialistische en volksnationalistische denkbeelden die de uitbreiding van het territorium zien als een noodzaak voor de versterking of de regeneratie van het eigen volk of ras. Vermoedelijk komen de documenten uit kringen van voormalige leden van de dissidente Vlaams-nationalistische jeugdbeweging.________“Rather on a dung heap”. The South-African Company and the Diets’ (Greater Netherlands) emigration after the Second World War. The ADVN holds two documents that were written and distributed by the “South African Company” (ZAK). In the first years after the Second World War, this organisation attempted to persuade Flemish people to emigrate to South Africa. It was the intention that they would cooperate in the regeneration of the Diets nation. With this initiative, the authors followed in the larger wake of imperialistic and extreme nationalist ideas, which consider the expansion of the territory as a necessity for the reinforcement or regeneration of their own people or race. It is likely that the documents originated from the groups of former members of the dissident Flemish nationalist youth movement.
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Coertzer, J., and M. J. Nolte. "Die Zebra-battery - ’n Suid-Afrikaanse aanspraakmaker in die elektriesevoertuigbedryf." Suid-Afrikaanse Tydskrif vir Natuurwetenskap en Tegnologie 15, no. 2 (July 10, 1996): 53–57. http://dx.doi.org/10.4102/satnt.v15i2.633.
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The Zebra battery is one of the most promising power sources for electric vehicles which might be on sale before the year 2000. It is a South African development which started at the CSIR and is at present jointly managed by the Anglo American Corporation of S.A. and the German company A.E.G. The chemical reaction converts common salt and nickel to nickel chloride and sodium during the charging phase.
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Firer, C., and G. Meth. "Voluntary information disclosure in company annual reports." South African Journal of Business Management 16, no. 4 (December 31, 1985): 151–56. http://dx.doi.org/10.4102/sajbm.v16i4.1089.
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The objective of this study was to measure the level of voluntary disclosure of information by listed South African manufacturing companies. A disclosure index designed to measure such disclosure was constructed. In general a fairly low level of disclosure of non-statutory items was observed in the companies studied. Disclosure tended to improve slightly during the five years 1979-1983. Limited correlation was found between the level of disclosure and firm size.Die doel van hierdie studie was om die vlak van vrywillige openbaarmaking van inligting deur Suid-Afrikaanse vervaardigingsmaatskappye wat op die effektebeurs verskyn, te meet. 'n Indeks om mate van vrywillige openbaarmaking in maatskappyjaarverslae te meet is saamgestel. Oor die algemeen is 'n taamlike lae vlak van openbaarmaking van nie-wetlike items waargeneem in die maatskappye wat bestudeer is. Openbaarmaking het gedurende die vyf jaar 1979-1983 effens verbeter. Beperkte korrelasie is tussen die vlak van openbaarmaking en maatskappygrootte waargeneem.
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Baskin, Monica L., Ivan Herbey, Ronnie Williams, Jamy D. Ard, Nataliya Ivankova, and Angela Odoms-Young. "Caregiver perceptions of the food marketing environment of African-American 3–11-year-olds: a qualitative study." Public Health Nutrition 16, no. 12 (July 5, 2013): 2231–39. http://dx.doi.org/10.1017/s1368980013001766.
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AbstractObjectiveTo assess caregivers’ perceptions of the extent to which the food marketing environment influences food consumption among African-American children (aged 3–11 years) in order to generate potential strategies to make the marketing environment more favourable to healthier eating.DesignIndividual semi-structured interviews with caregivers were conducted by trained community leaders to ascertain their awareness of and perceptions about food marketing environments contributing to African-American children's food consumption.SettingSix predominantly African-American communities in metro Birmingham, Alabama, USA with high proportions of school-age children and lower-income residents.SubjectsCaregivers (n 25) were predominantly female (93 %) and either parents/guardians (64 %) or grandparents (28 %) of African-American children aged 3–11 years. Caregiver mean age was 43 years and 46 % had lived in their current residence for over 10 years.ResultsCaregivers reported all aspects of the food marketing matrix as supporting unhealthy eating among African-American youth. Child preference for foods higher in fat and sugar, lower pricing of less healthy foods, limited access to healthier food retailers and targeted advertisements were particularly influential on the food selection, acquisition and consumption of children. Company loyalty, corporate sponsorship of local events and conflicts over parental v. food company responsibility contributed to less consensus about the overall impact (positive or negative) of food companies in African-American communities.ConclusionsWhile caregivers perceived aspects of their food marketing environments as primarily contributing to unhealthy eating among African-American children, framing the demand for changes in the food marketing environments of African-American youth may be particularly challenging.
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Inusa, Baba, Raffaella Colombatti, David C. Rees, Matthew M. Heeney, Carolyn C. Hoppe, Bernhards Ogutu, Hoda M. Hassab, et al. "Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study." Blood 128, no. 22 (December 2, 2016): 3653. http://dx.doi.org/10.1182/blood.v128.22.3653.3653.
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Abstract Background: Sickle cell anemia (SCA) is characterized by significant phenotypic variability. DOVE1 was a Phase 3, double-blind, randomized, parallel-group, placebo-controlled, multinational study that investigated the efficacy and safety of prasugrel, a P2Y12 adenosine diphosphate receptor antagonist, for reduction of vaso-occlusive crises (VOCs), a composite of painful crisis or acute chest syndrome, in 2- to <18-year-olds with SCA (age cohorts: 2 to <6 years, 6 to <12 years, and 12 to <18 years) (NCT01794000). Methods: DOVE was conducted at 51 sites in 13 countries across 4 continents. A total of 341 subjects were randomized (prasugrel, n=171; placebo, n=170) and SCA genotypes (homozygous hemoglobin S; hemoglobin Sβ0 thalassemia) were included. Eligibility required ≥2 VOCs in the prior year. Baseline clinical and laboratory characteristics and study endpoints were compared by region. Since no overall treatment effect was found, data provided reflect the combined 341 subjects (Americas, N=57; sub-Saharan Africa [SSA], N=148; North Africa/Middle East, N=110; Europe, N=26). Results: Per regional enrollment, the largest proportion of subjects were 6 to <12 years in SSA (48.6% [n=72]), 12 to <18 years in the Americas (45.6% [n=26]) and North Africa/Middle East (58.2% [n=64]), but more evenly divided among the 3 age groups in Europe (30.8-34.6% [n=8-9]). Self-reported racial groupings differed by region (p<0.001): 100% white in North Africa/Middle East; 100% black in SSA; 19.2% white, 76.9% black, and 3.8% multiple in Europe; and 1.8% white, 96.4% black, and 1.8% multiple in the Americas. Mean body mass index was <17 in SSA and Europe (15.3 and 16.6 kg/m2) but >18 in North Africa/Middle East and the Americas (18.3 and 18.1 kg/m2) (p<0.001). Mean blood pressures were lowest in SSA (systolic: 99.0 vs. 105.4-108.0 mmHg, p=0.004; diastolic: 58.3 vs. 60.4-62.9 mmHg, p=0.003). The proportion of subjects with history of acute chest syndrome prior to enrollment was lower in SSA (6.1%) than other regions (18.2-66.7%, p<0.001). Mean number of VOCs in the year prior to enrollment was higher in the Americas than other regions (5.8 vs. 3.2-3.4, p=0.041). Hydroxyurea (HU) use at baseline varied by region: 91.2% in the Americas, 72.7% in North Africa/Middle East, 42.3% in Europe, and 6.8% in SSA (p<0.001). For subjects not on HU at baseline (Table 1), mean hemoglobin at baseline was lowest in SSA (7.6 g/dL); reticulocyte count was lowest in the Americas (214.8 billion/L) and highest in Europe (327.8 billion/L) (p=0.004). For all geographic regions, the most frequent serious adverse events (SAEs) were classified as blood and lymphatic system disorders, with the highest percentage reported as painful crisis. The second most frequent SAEs in SSA, North Africa/Middle East, and Europe were various infections and infestations. The second most frequent in the Americas was respiratory, thoracic, and mediastinal disorders; all were reported as acute chest syndrome. The overall rate of VOCs (events per patient-year) was 3.2 in Europe, 3.0 in the Americas, 2.6 in SSA, and 2.0 in North Africa/Middle East. The percentage of patients hospitalized for VOCs was greatest in Europe (76.9%) compared to other regions (28.4-57.9%); however, mean hospital stay per VOC was similar across regions (5.3-6.2 days). The percentage of VOCs causing hospitalization was highest in Europe (67.7%), followed by North Africa/Middle East (48.7%), the Americas (46.5%), and SSA (26.4%). In SSA, the majority of VOCs were managed as outpatient hospital visits (67.9%), whereas other regions more frequently used inpatient hospital visits (33.2-55.2%). Regardless of region, almost all VOCs were treated with analgesics (overall: 99.5%) and approximately half were treated with intravenous (IV) fluids (overall: 54.4%). In contrast, the proportion of VOC-related transfusions was greater in North Africa/Middle East and Europe (18.6% and 18.8%) than in the Americas and SSA (10.0% and 6.4%). Conclusions: In the DOVE study, management of VOCs with analgesics and IV fluids was similar across regions. However, there were regional differences in VOC-related hospitalizations and transfusions that may reflect differences in culture, utilization of resources, disease severity, or a combination of factors. References: 1Heeney MM, et al. A multinational trial of prasugrel for sickle cell vaso-occlusive events. N Engl J Med. 2016;374:625-635. Disclosures Colombatti: Eli Lilly and Company: Research Funding. Heeney:Eli Lilly and Company: Research Funding; Sancilio and Company: Consultancy, Research Funding; Pfizer: Research Funding. Hoppe:Eli Lilly and Company: Consultancy. Ogutu:Eli Lilly and Company: Research Funding. Hassab:Eli Lilly and Company: Research Funding. Zhou:Eli Lilly and Company: Employment, Other: Minor Shareholder. Yao:Eli Lilly and Company: Employment. Brown:Eli Lilly and Company: Employment, Other: Minor Shareholder. Heath:Eli Lilly and Company: Employment. Jakubowski:Eli Lilly and Company: Employment, Other: Minor Shareholder. Abboud:Eli Lilly and Company: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees; MAST Therapeutics: Research Funding; Novartis: Honoraria.
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Zhuo, J., Q. Zhang, K. Knapp, Y. Wang, C. Gutierrez, D. He, L. Xie, S. Lama, and G. Craig. "OP0035 EXAMINATION OF INTERSTITIAL LUNG DISEASE IN PATIENTS WITH RHEUMATOID ARTHRITIS – PREVALENCE, TIME TO ONSET, AND CLINICAL CHARACTERISTICS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 24–25. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1189.
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Background:Interstitial lung disease (ILD) is a known extraarticular manifestation of rheumatoid arthritis (RA). Previous studies have shown variability in the prevalence of RA-ILD, as well as clinical characteristics and risk factors of RA-ILD.Objectives:To evaluate the prevalence and time to onset of ILD and compare the clinical characteristics between RA patients (pts) with or without ILD using a large US electronic medical record (EMR)-based dataset.Methods:Pts with an initial RA diagnosis (ICD-9-CM code: 714.0; ICD-10-CM codes: M05 & M06) during the study period (01JAN2009-20SEP2019) were included from the Discus Analytics JointMan database. The initial RA diagnosis date was defined as the index date. Pts with ILD were identified by ICD diagnosis codes or by provider indication in the JointMan record. Pts who developed ILD before RA were excluded from this analysis. The prevalence and time to onset of ILD were reported. Pt demographics, comorbidities, RA characteristics and disease activity scores were compared for 6 months prior to or on the index date (baseline period) for selected adult RA pts with available information.Results:Among 8,963 identified RA pts, 337 (3.8%) were diagnosed with ILD on or after RA diagnosis. The median time to ILD onset post-RA was 2.3 years, and 47% had ILD within 2 years after RA diagnosis. RA-ILD pts were significantly older than those without ILD (65.8 years vs. 59.1 years; p<0.001; Table 1). At baseline, a higher percentage of RA-ILD pts had history of chronic obstructive pulmonary disease, positive rheumatoid factor, rheumatoid nodules, erosive joint disease, positive anti-cyclic citrullinated peptide antibody, and joint swelling compared to RA-only pts (Table 2). The mean ESR and RA disease activity scores were also significantly higher for RA-ILD pts.Table 1.Patient DemographicsPatient demographicsRA-ONLY COhort(N = 5,612)RA-ild coHORT(N = 205)P-valueAge, Mean ± SD, years59.1 ± 14.265.8 ± 11.8<.001Male, N (%)1,375 (24.5%)72 (35.1%)0.001Race, N (%) White4,014 (71.5%)165 (80.5%)0.005 African American365 (6.5%)9 (4.4%)0.226 Other/Missing1,233 (22.0%)31 (15.1%)0.020Table 2.Baseline Clinical CharacteristicsClinical CharacteristicsRA-ONLY COhort(N = 3,846)RA-ild coHORT(N = 115)P-valueHistory of Chronic Obstructive Pulmonary Disease, N (%)102 (2.7%)8 (7.0%)0.006Hypertension, N (%)900 (23.4%)23 (20.0%)0.395Serious Infection, N (%)38 (1.0%)3 (2.6%)0.091Rheumatoid Factor Positive, N (%)1,388 (36.1%)69 (60.0%)<.001Joint Stiffness, N (%)1,092 (28.4%)39 (33.9%)0.197Rheumatoid Nodules, N (%)153 (4.0%)17 (14.8%)<.001Erosive Joint Disease, N (%)459 (11.9%)23 (20.0%)0.009Anti-CCP Antibody Positive, N (%)858 (22.3%)45 (39.1%)<.001Joint Swelling*, N (%)2,861 (58.0%)123 (68.0%)0.008Joint Tenderness*, N (%)3,728 (75.6%)138 (76.2%)0.851ESR**, Mean ± SD, mm/hr22.0 ± 22.630.1 ± 25.5<.001CRP**, Mean ± SD, mg/L22.5 ± 13.060.6 ± 25.00.086CDAI, Mean ± SD16.4 ± 12.318.9 ± 15.70.044DAS28-CRP, Mean ± SD2.6 ± 1.23.1 ± 1.4<.001DAS28-ESR, Mean ± SD3.3 ± 1.43.9 ± 1.5<.001SDAI, Mean ± SD20.2 ± 29.328.6 ± 40.20.048* A total of 4,929 non-ILD and 181 ILD patients had joint swelling and tenderness data.** Variables were calculated among patients who had available information.Conclusion:This large real-world RA population provides insight into the burden of ILD in RA pts. Pts with ILD had a higher proportion of comorbidities and RA-related conditions and higher RA activity. Further analysis is warranted to assess the risk factors of ILD and its prognosis.Disclosure of Interests:Joe Zhuo Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Qisu Zhang Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Keith Knapp Consultant of: In the last year, I was a paid consultant to Bristol Myers-Squibb Company., Employee of: I am a paid employee of Discus Analytics., Yuexi Wang Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Cynthia Gutierrez Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Ding He Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Lin Xie Consultant of: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company., Sonie Lama Shareholder of: I own shares of Bristol-Myers Squibb Company., Employee of: I am a paid employee of Bristol-Myers Squibb Company., Gary Craig Consultant of: I have served as a consultant to Bristol-Myers Squibb Company., Employee of: I am a paid employee of Arthritis Northwest and VP of Discus Analytics., Speakers bureau: I am a member of the speakers bureau for Bristol-Myers Squibb Company.
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Alamieyeseigha, Serafina. "Likelihood to Trust Sharing Knowledge in Multi-Cultural Consulting Companies." International Journal of Risk and Contingency Management 1, no. 2 (April 2012): 16–28. http://dx.doi.org/10.4018/ijrcm.2012040102.
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This study investigates the relationship of personality dimensions with the likelihood that professionals will trust, sharing their knowledge in a large multi-cultural consulting company. Trust was defined from the literature and used to measure likelihood to trust sharing knowledge. Personality was also grounded in the literature and used to measure the five-factor model of personality dimensions. A survey was given to professional workers at a financial-management consulting company in South Africa (n=125). Descriptive statistics, alpha reliability verification, correlation, ANOVA (Analysis of Variance), and Fisher post-hoc group comparisons were applied. A statistically significant model was developed which indicated three personality dimensions were positively related to the likelihood to trust sharing knowledge in the multi-cultural consulting company.
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Oluremi, Johnson R., Rafat Siddique, and Ekundayo P. Adeboje. "Stabilization Potential of Cement Kiln Dust Treated Lateritic Soil ." International Journal of Engineering Research in Africa 23 (April 2016): 52–63. http://dx.doi.org/10.4028/www.scientific.net/jera.23.52.
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A dark reddish-brown lateritic soil collected from existing borrow pit abandoned by Reynold Construction Company Ltd behind New WAZOBIA Market on Latitude 08008′N and Longitude 04014′E along Ogbomoso-Ilorin Express road, Ogbomoso, Oyo State. Nigeria was treated with cement kiln dust (CKD), a by-product of long wet kiln, obtained from West African Portland Cement Organisation (WAPCO), Ewekoro, Ogun State, Nigeria, under varying moulding water content.The results show gradual reduction in the plasticity index of the samples, decrease in the maximum dry densities (MDD) with corresponding increase in the optimum moisture contents (OMC) of the treated soil samples. The unconfined compressive strength (UCS) of the treated samples increases with both increase in the treatment content as well as compactive effort from British Standard (BS) to West African Standard (WAS) however, there was reduction in the UCS with varying moulding water content as the water content increases and decreases relative to optimum moisture content. The maximum UCS was obtained at optimum moisture content.Cement kiln dust though regarded as waste can therefore serve as potential material in the stabilization of the lateritic soil when compacted at moisture content within its OMC.
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D'Angelo, Heather, Guadalupe X. Ayala, Joel Gittelsohn, Melissa N. Laska, Lesley Schmidt Sindberg, Lucy Horton, Anna Y. Kharmats, and Kurt M. Ribisl. "An Analysis of Small Retailers' Relationships with Tobacco Companies in 4 US Cities." Tobacco Regulatory Science 6, no. 1 (January 1, 2020): 3–14. http://dx.doi.org/10.18001/trs.6.1.1.
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Objective: In this study, we examined small food store retailers' perspectives on tobacco company agreements specifying tobacco product display and promotion. Methods: We interviewed owners/managers of small food stores (N = 63) in lower-income neighborhoods in 4 US cities using open-and closed-ended questions between October 2013 and July 2014. We coded qualitative interview data and calculated descriptive statistics. Results: Most retailers had a formal contract with a tobacco company (87%). Retailers perceived that tobacco products generated low profits, but were important to attract customers. Nearly 95% with contracts reported receiving an incentive, including marketing materials (86.8%), displays (79%), and free/discounted products (50.9%). Contract requirements included placing branded displays and marketing materials in prime locations and setting cigarette prices. Retailers in urban, African-American neighborhoods felt pressure to maintain menthol cigarette contracts to stay in business. Conclusion: Contracts with tobacco companies were common among the small food stores in this study, and retailers felt they needed the contracts to keep prices competitive. Given the reliance of retailers on tobacco industry contracts, states and localities may need to adopt measures to counter their effects, especially the financial incentives that lead to lower cigarette prices and more prominent displays of promotions and marketing materials.
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Magder, L., D. Goldman, and M. A. Petri. "SAT0167 RACIAL DIFFERENCES IN THE IMPACT OF HYDROXYCHLOROQUINE ON IMMUNOLOGIC MARKERS IN SLE PATIENTS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1024–25. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5059.
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Background:In patients with Systemic Lupus Erythematosus (SLE), Hydroxychloroquine (HCQ) treatment has been associated with reduced disease activity, lower rates of certain forms of organ damage, and improved survival1.Objectives:To gain insight into the mechanisms involved, we examined the impact of HCQ treatment on immunologic biomarkers that have been associated with higher rates of organ damage. These include lupus anticoagulant, anti-dsDNA, low complement, and anticardiolipins (aCL).Methods:We analyzed retrospective data on more than 56,000 quarterly clinic visits from more than 1000 patients in a large American clinical cohort of SLE patients. Patients visits were classified as “on HCQ” if they reported taking HCQ at that visit and at the previous visit. Patient visits were classified as “off HCQ” if they reported not taking HCQ at that visit and at the previous visit. For each patient, visits on and off HCQ were compared with respect to the rates of biomarker positivity. These comparisons were summarized across patients using using conditional logistic regression controlling for age.Results:Table 1 shows the results of our analyses. While on HCQ, the odds of being positive was significantly reduced for each biomarker: Lupus Anticoagulant (OR= 0.65), antidsDNA (OR=0.82), Low Complement (OR=.71), aCL IgG (OR=0.26), and aCL IgM (OR=0.45). However, there was a substantial difference between Caucasian Americans (CAs)and African Americans (AAs) with respect to the impact of HCQ. Notably, HCQ was associated with a 62% reduction in the odds of lupus anticoagulant among CAs, but no association was observed among AAs. In addition, HCQ was associated with a 34% reduction in antidsDNA among AAs, but no significant reduction among CAs.Table.Impact of treatment with HCQ on the odds of being positive for immunologic markersClinical markerAll Patients(n=951)Caucasian Americans(n=462)African Americans(n=409)Odds Ratio(95% CI)P-valueOdds Ratio(95% CI)P-valueOdds Ratio(95% CI)P-valueConfirmed Lupus Anticoagulant0.65(0.50, 0.85)0.00190.381(0.24, 0.58)<0.00011.051(0.69, 1.60)0.82antidsDNA (% positive)0.82(0.73, 0.91)0.00050.901(0.76, 1.06)0.190.661(0.56, 0.79)<0.0001Low complement0.71(0.64, 0.79)<0.00010.71(0.61, 0.83)<0.00010.73(0.62 0.86)<0.0001aCL IGG (% pos)30.26(0.17, 0.39)<0.00010.161(0.09, 0.30)<0.00010.531(0.27, 1.05)0.069aCL IGM (% pos)30.45(0.29, 0.68)0.00020.171(0.09, 0.32)<0.00012.451(1.09, 5.55)0.0321P-value for difference between Caucasian and African Americans < 0.0001.Conclusion:HCQ use was associated with a substantial decline in the rates of positive immunologic biomarkers in SLE patients. The different impact of HCQ in different races suggests the existence of racial differences in SLE subtypes and may indicate the need for different treatment strategies.References:[1]Ponticelli C1, Moroni G; Hydroxychloroquine in systemic lupus erythematosus (SLE). Expert Opin Drug Saf. 2017 Mar;16(3):411-419.Acknowledgments:This work was supported by NIH RO1 AR069572,Disclosure of Interests:Laurence Magder: None declared, Daniel Goldman: None declared, Michelle A Petri Grant/research support from: GSK, Eli Lilly and Company, Consultant of: Eli Lilly and Company
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Tladinyane, Rebecca, and Marna Van der Merwe. "Age and race differences on career adaptability and employee engagement amongst employees in an insurance company." Journal of Governance and Regulation 4, no. 4 (2015): 720–26. http://dx.doi.org/10.22495/jgr_v4_i4_c6_p7.
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The objective of the study was to determine whether age and race groups differ significantly regarding career adaptability (measured by Career Adapt-Abilities Scale (CAAS) and employee engagement measured by Utrecht Work Engagement Scale (UWES). A quantitative survey was conducted with a convenience sample (N = 131) of employees in an insurance company within South Africa. Descriptive and inferential statistical analyses were performed to achieve the objective of the study. The results showed significant differences between age and race groups in relation to the constructs. Organisations need to recognise biographical differences with regards to career adaptability and employee engagement with reference to engagement interventions and the career counselling setting.
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Newbury, Colin. "Technology, Capital, and Consolidation: The Performance of De Beers Mining Company Limited, 1880–1889." Business History Review 61, no. 1 (1987): 1–42. http://dx.doi.org/10.2307/3115773.
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In this article, Dr. Newbury focuses on the technical and financial reasons for amalgamation at the Kimberley mines in South Africa, drawing on primary records to account for the rise of De Beers as the world's major diamond mining company in the 1880s. He finds that prior experience in local government and on the mining boards prepared company directors for competition in joint stock enterprise, while differences in production policies and performance influenced the pattern of mergers within and among the four Kimberley mines. De Beers's close relationship with diamond merchants and private banks in London, particularly N. M. Rothschild & Sons, was central to its position as a prime mover toward consolidation. Dr. Newbury views De Beers as a firm that relied for its success less on its renowned chairman, Cecil J. Rhodes, than on a combined managerial expertise that reflected the interests of both mining producers and merchant buyers.
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Gupta, Neeraj, Michael J. Hanley, R. Donald Harvey, Ashraf Z. Badros, Brea C. Lipe, Vishal Kukreti, Jesus G. Berdeja, et al. "Phase 1/1b Pharmacokinetic (PK) and Safety Study of the Investigational Oral Proteasome Inhibitor (PI) Ixazomib in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) with Severe Renal Impairment or End-Stage Renal Disease (ESRD) Requiring Hemodialysis." Blood 126, no. 23 (December 3, 2015): 4227. http://dx.doi.org/10.1182/blood.v126.23.4227.4227.
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Abstract Background Renal impairment (RI) is a major complication of MM. The oral PI ixazomib is currently under phase 3 investigation in MM. PK data from pts with mild or moderate RI (creatinine clearance [CrCl] ≥30 mL/min) suggest no ixazomib dose modification is needed in these pts (Gupta et al BJCP 2015). Hence, this study (NCT01830816) aimed to characterize the PK of ixazomib in pts with severe RI or ESRD requiring hemodialysis to provide posology recommendations in these pt populations. Methods Pts with RRMM or advanced malignant solid tumors were enrolled in the normal (N, CrCl ≥90 mL/min), severe (S, CrCl<30 mL/min) and ESRD requiring hemodialysis groups. CrCl was calculated using two blood samples according to the Cockcroft-Gault method. Pts received a single dose of ixazomib 3 mg. Blood samples were collected after the single dose, at multiple time points over 15 days, to characterize the plasma PK of ixazomib. For ESRD pts, pre- and post-dialyzer plasma samples were also collected hourly during the first 4-hour dialysis session 24−28 hrs after dosing. An additional pre-dose blood sample was collected for in vitro estimation of ixazomib plasma protein binding. After completion of PK sampling, pts could continue to receive ixazomib (at the higher dose of 4 mg if 3 mg was well tolerated) on days 1, 8, and 15 of 28-day cycles (part B of the study). Geometric mean ratios and 90% confidence intervals (CIs) of unbound PK parameters in the RI groups vs the normal group were calculated using an ANOVA model. Adverse events (AEs) were assessed using NCI CTCAE version 4.03. Results 41 pts were enrolled (20, 14, and 7 to the N, S, and ESRD groups); 61% female, and 66% Caucasian and 29% African American. Mean age was 61.7 years (range 40-82) and mean weight was 83.3 kg (range 46-147). 37 pts had RRMM, and 4 had advanced solid tumors (2 colon, 1 liver, 1 thyroid). 38 pts had reportable PK parameters (Cmax or AUC) and were PK-evaluable (18 N, 14 S, 6 ESRD) (Table). Following a 3 mg dose, ixazomib was rapidly absorbed in all 3 renal function groups, with a median Tmaxof 1.0 to 1.25 hours. Ixazomib was highly bound to plasma proteins with a similar mean fraction bound of approximately 99% in all 3 renal function groups. Unbound systemic exposures (AUC) of ixazomib were 38% higher in pts with severe RI or ESRD. PK profiles were similar in solid tumor and MM pts. Ixazomib concentrations were similar in pre- and post-dialyzer samples collected hourly from ESRD pts during the 4-hour hemodialysis. In the safety population (N=41), most pts (95%) experienced at least 1 AE; the most common were diarrhea (37%), nausea (32%), fatigue (29%), vomiting (29%), and anemia (20%). The incidence of these AEs was generally similar among renal function groups with the exception of anemia, which was more common in patients in the S and ESRD groups (5%, 36%, and 29% in the N, S, and ESRD groups, respectively). Although the incidences of the most common AEs were generally similar among renal function groups, the incidences of grade 3/4 AEs and serious AEs were greater in the S and ESRD groups versus the N group (79% and 43% vs 35%, and 43% and 57% vs 10%, respectively). In part B of the study, AEs resulting in dose reductions and discontinuations were more common in the S versus N groups (36% vs 25%, and 29% vs 10%, respectively); no pt had an AE leading to dose reduction or discontinuation in the ESRD groups. Relative ixazomib dose intensities were 93.8%, 79.6%, and 61.6% in the N, S, and ESRD groups. There were 3 on-study deaths (2 in the S group and one in the ESRD group). One MM pt in the S group died due to acute hypoxemic respiratory failure considered related to study treatment. Conclusions Compared with pts with normal renal function,unbound systemic exposures of ixazomib were 38% higher in pts with severe RI or ESRD requiring dialysis. Therefore, a reduced starting dose of 3 mg is recommended for pts with severe RI or ESRD requiring dialysis. Ixazomib is not dialyzable and can be administered without regards to the timing of dialysis. Table 1. Renal Function Group Geometric mean (%CV) PK Parameters Severe RI or ESRD vs Normal Least-squares Geometric Mean Ratio (90% CI) Unbound Cmax(ng/mL) Unbound AUC (ng.hr/mL) Unbound Cmax Unbound AUC Normal (n=18) 0.30 (66) 6.64 (61) N/A N/A Severe RI (n=14) 0.478 (86) 9.25 (55) 1.60 (0.99-2.58) 1.39 (0.88-2.20) ESRD (n=6) 0.213 (57) 8.93 (55) 0.71 (0.38-1.34) 1.34 (0.78-2.31) Severe RI/ ESRD (Combined) (n=20) 0.375 (98) 9.13 (54) 1.25 (0.79-1.98) 1.38 (0.93-2.04) Disclosures Gupta: Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Off Label Use: Investigational proteasome inhibitor ixazomib. Hanley:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Harvey:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Membership on an entity's Board of Directors or advisory committees, Research Funding. Kukreti:Lundbeck: Honoraria; Ortho: Honoraria; Janssen: Honoraria; Celgene: Honoraria; Amgen: Honoraria. Berdeja:Abbvie: Research Funding; Takeda: Research Funding; BMS: Research Funding; Array: Research Funding; Acetylon: Research Funding; Novartis: Research Funding; Janssen: Research Funding; Celgene: Research Funding; Onyx: Research Funding; Curis: Research Funding; MEI: Research Funding. Yang:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Hui:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Zhang:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Venkatakrishnan:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Chari:Novartis: Consultancy, Research Funding; Biotest: Other: Institutional Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Onyx: Consultancy, Research Funding; Array Biopharma: Consultancy, Other: Institutional Research Funding, Research Funding; Millennium/Takeda: Consultancy, Research Funding.
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Gupta, Neeraj, Michael J. Hanley, Karthik Venkatakrishnan, Raymond Perez, Robin E. Norris, John Nemunaitis, Huyuan Yang, Gerald Falchook, Richard Labotka, and Siqing Fu. "A Phase 1 Study to Assess Pharmacokinetics (PK) and Safety of Ixazomib, an Oral Proteasome Inhibitor, in Patients with Moderate or Severe Hepatic Impairment." Blood 126, no. 23 (December 3, 2015): 3032. http://dx.doi.org/10.1182/blood.v126.23.3032.3032.
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Abstract Background The investigational oral proteasome inhibitor ixazomib is under phase 3 clinical investigation in patients with multiple myeloma and amyloidosis. Metabolism is the major mechanism of ixazomib clearance; accordingly, hepatic impairment may increase ixazomib exposures. PK and safety data suggested no clinically relevant PK alterations in patients with mild hepatic impairment (Gupta et al BJCP 2015). This study (NCT01912222) was performed to characterize the PK of ixazomib in patients with moderate or severe hepatic impairment, as defined by the NCI Organ Dysfunction Working Group, to develop dosing recommendations for these specific patient populations. Methods Eligible adults had advanced malignancies for which no further effective therapy was available. Twelve PK-evaluable patients were planned to be enrolled to each of the normal (N), moderate (M) or severe (S) hepatic impairment groups. Patients received a single dose of ixazomib on day 1; those in the N, M, and S groups received ixazomib 4, 2.3, and 1.5 mg, respectively. Blood samples were collected at multiple time points for 15 days after dosing to characterize single dose PK (18 samples in total, 0.5-8 hr on day 1, days 2-8, days 11, 12, and 15). After completion of PK sampling, patients could continue on the study and receive ixazomib on days 1, 8, and 15 of 28-day cycles. Geometric mean ratios and 90% CIs of unbound dose-normalized (DN) PK parameters in the hepatic impairment vs normal groups were calculated using an ANOVA model. Treatment-emergent adverse events (TEAEs) were assessed using NCI CTCAE version 4.03. Results Forty-eight patients were enrolled (13, 15, and 20 patients to the N, M, and S groups, respectively); 32 were Caucasian, 10 African American, 2 Asian, and 4 other. Mean age was 56 years (range 24-83), mean weight 76 kg (range 43-127), and mean body surface area 1.9 m2 (range 1.4-2.5); 28 (58%) were male. The most common cancers were hepatocellular carcinoma (21%) and colorectal carcinoma, with or without liver metastases (10%). All patients in the S group had liver dysfunction due to primary or metastatic tumors. Forty-three patients had reportable PK parameters (Cmax or AUC) and were PK-evaluable (12 N, 13 M, 18 S). PK parameters are reported in the Table. Ixazomib was rapidly absorbed in all 3 hepatic function groups examined, with a median Tmaxof 0.95-1.5 hours. Ixazomib was highly bound to plasma proteins with a similar mean fraction bound (~99%) in all 3 groups. Only 1 (2%) patient continued on study for more than 3 cycles (endometrial carcinoma, 10 cycles). Discontinuations were due to progression (75% of discontinuations), TEAEs or death related to progression. The most common TEAEs were nausea (38%), fatigue (31%), peripheral edema (31%), vomiting (27%), dyspnea (23%), decreased appetite (21%), and hyperbilirubinemia (21%). Most patients (77%) had a grade ≥3 TEAE, including 15% with a grade ≥3 study drug-related TEAE (dehydration [6%], fatigue [4%], anemia [2%], and fall [2%]); no patient had a study drug-related grade 4 TEAE. There were 14 on-study deaths, all of which were considered related to disease progression. Conclusions Unbound systemic exposures of ixazomib were 27% higher in patients with moderate or severe hepatic impairment versus those in patients with normal hepatic function. A reduced starting ixazomib dose of 3 mg is recommended for patients with moderate or severe hepatic impairment. Table. Hepatic function group PK parameters Geometric mean (%CV) Hepatic impaired vs Normal Least-squares geometric mean ratio (90% CI) Unbound DN Cmax(ng/mL/mg) Unbound DN AUC (ng.hr/mL/mg) Unbound DN Cmax Unbound DN AUC Normal 0.127 (47) 2.41 (50) N/A N/A Moderate 0.162 (80) 3.19 (61) 1.27 (0.74-2.18) 1.32 (0.70-2.50) Severe 0.154 (84) 2.96 (63) 1.21 (0.74-2.01) 1.23 (0.66-2.29) Moderate/Severe (combined) 0.158 (81) 3.07 (61) 1.24 (0.79-1.95) 1.27 (0.75-2.16) Cmax, maximum plasma concentration; CV, coefficient of variation; AUC, area under the plasma concentration-time curve Disclosures Gupta: Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Off Label Use: Investigational proteasome inhibitor ixazomib. Hanley:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Venkatakrishnan:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Perez:Dompe: Research Funding; Eli Lilly: Research Funding; Incyte: Research Funding; Medimmune: Research Funding; Novartis: Research Funding; Pfizer: Research Funding; Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding; Immunogen: Research Funding; Bristol Meyers Squibb: Research Funding; Agensys: Research Funding; PRA: Consultancy; Tetralogics: Research Funding. Norris:Nektar Pharmaceuticals: Consultancy. Yang:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Falchook:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding. Labotka:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment.
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Yio, Jiang, Brian Wolf, Amber Yang, Ashrei Y. Bayewitz, and Yiqing Xu. "Analysis of correlations between driver mutations and biomarkers with response to immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC)." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): e21022-e21022. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e21022.
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e21022 Background: Next-generation sequencing (NGS) performs genomic profiling on tumor tissue and provides information on mutations on 300+ selected genes. While driver mutations have targeted therapy options, apt therapies for passenger mutations are not clearly defined. The level of PD-L1 expression and the total mutation burden (TMB) score for NSCLC have independent predictive values in response to check-point inhibition immunotherapy. Using NGS data, we aimed to evaluate the correlations of driver mutations and other biomarkers with immunotherapy response. Methods: We performed a retrospective analysis on the NGS results for NSCLC patients treated between November 2011 and February 2018. Patients were identified from the Foundation Medicine Company database and were linked to records at our cancer center. Patients’ demographics and treatment data were assessed. Results: 99 NSCLC patients (44 males and 55 females) were included with a median age of 65 (range 32-89). Races included Asian (n=42), Caucasian (n= 40), African American (n=8), and Hispanic (n=7). 49 patients possessed driver mutations, which were EGFR (n=22), ALK (n=5), RET (n=5), ROS (n=2), BRAF (n=5), MET amplification (n=5), BRCA 1 or 2 (n=4), and NTRK (n=2); 3 patients had both a driver and a non-driver mutation. In the entire cohort, 40 patients (58 total, 69%) had PD-L1 tumor proportion score (TPS) > 0% and 31 (53%) had TPS ≥10%. 30 patients (48 total, 63%) had TMB <10 and 18 (37%) had TMB ≥10. Patients with driver mutations had a lower probability of high TMB (p=0.007), but no difference in PD-L1 expression (p=0.61). PD-L1 TPS score had no correlation with TMB high or low scores (Table). In patients with driver mutations, other mutations were detected by NGS. In EGFR+ patients, the most common additional mutations were TP53 and CDKN2A/B. 23 patients received immunotherapy; the response rate in non-mutation carriers was 45.4% (5/11). Among the 7 patients with an EGFR mutation, 4 had PD-L1 TPS ≥30% and none had TMB ≥10; based on RECIST 1.1, stable disease (SD) was the best response in 2 patients. One patient with a BRAF mutation and another patient with an ALK mutation had partial responses (PR); both had TMB ≥ 10. Conclusions: NGS provides additional information in NSCLC patients with driver mutations. In patients with driver mutations, while PD-L1 expression may not be associated with response to immunotherapy, a high TMB level may be a predictive biomarker, which warrants further study.[Table: see text]
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Wong, Shekman, Cecile Marie Krejsa, Dana Lee, Anna Harris, Emilie Simard, Xiaohui Wang, Igor Rubets, et al. "Effect of Food on MDM2 Inhibitor KRT-232 Pharmacokinetics and Macrophage Inhibitory Cytokine-1 (MIC-1) Response in Healthy Volunteers." Blood 136, Supplement 1 (November 5, 2020): 7–8. http://dx.doi.org/10.1182/blood-2020-135985.
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Background: KRT-232 is a potent, selective, orally available, small-molecule drug that binds to mouse double minute 2 homolog (MDM2) and inhibits its interactions with tumor suppressor protein p53. KRT-232 is under development for treatment of myeloproliferative neoplasms, acute myeloid leukemia, and Merkel cell carcinoma. Increased serum MIC-1 (pg/mL) is a pharmacodynamic (PD) marker of p53-mediated activity in patients treated with KRT-232 (Allard,HemaSphere, 2020;4:S1, Abstract EP519). The aim of this study was to assess the safety and effect of a high-fat meal on KRT-232 pharmacokinetics (PK) and MIC-1 PD of a new tablet formulation in healthy volunteers. This is the first characterization of a MDM2-inhibitor-induced MIC-1 response in healthy volunteers. Methods: KRT-232-105 was a single-center, open-label, 60-mg single-dose, 3-treatment, 4-period, and 3-sequence study with a partial replicate crossover design. Volunteers (N=30) were randomized to three treatment groups: A: new tablet, fasted (reference, dosed twice in Periods 2-4); B: new tablet, 30 min after a high-fat, high-calorie meal (test 1, dosed once in periods 2-4); C: current tablet, fasted (test 2, period 1 only). Plasma KRT-232, its acyl glucuronide metabolite (M1) and serum MIC-1 concentrations were measured over 0-96 h. Urine from group C was collected over 0-48 h. Doses were one week apart. All volunteers had aH pyloribreath test and were genotyped for UGT1A1*28 polymorphisms. Results: Volunteers were 43% female, 7% African American and 77% Hispanic/Latino. Mean age was 38.1 y (range, 18-54), and mean body mass index was 26.9 kg/m2 (range, 21.4-30.9). No deaths, serious adverse events (SAEs), or discontinuations were reported. Twenty-one treatment-emergent AEs (TEAEs) were observed in 13 (43%) volunteers; constipation was the most frequent AE, followed by headache. All TEAEs were grade 1 (n=17) or grade 2 (n=4: 1 headache event [possibly study drug-related] and 3 events of headache, influenza-like illness, and pharyngitis). Mean (SD) concentration-time plots of KRT-232 and M1 were similar across the 3 groups (Figure 1a and b). A second peak was observed, consistent with enterohepatic recirculation. With a meal (test 1), KRT-232 geometric least-squares mean (GLSM) maximum concentration (Cmax) was similar (431 and 442 ng/mL (GLSM ratio [90% CI], 103% [87.4-121]) and KRT-232 GLSM area under the curve (AUC0-t) decreased from 2858 to 2325 ng∙h/mL (GLSM ratio [90% CI], 81.4 [76.2-86.9]). Median time of Cmax (Tmax) was 2 h fasted and 3 h fed. Geometric mean half life (t1/2) was unchanged (17.0 vs 17.1 h). Under fasting conditions, the current tablet (C, test 2) vs new tablet (A, reference), KRT-232 GLSM Cmax decreased from 431 to 337 ng/mL (GLSM ratio [90% CI], 78.4% [72.0-85.3]) and KRT-232 GLSM AUC0-t had a possible small decrease (2858 and 2455 ng∙h/mL, GLSM ratio [90% CI], 85.9 [80.5-91.7]). Median Tmax (~2 h) and geometric mean t1/2 (17 h) were unchanged. The fraction of the KRT-232 dose in urine as KRT-232 and M1 was negligible at 0.0201% and 0.0220% of dose, respectively. KRT-232 is a carboxylic acid with pH-dependent solubility that increases with increasing pH.H pyloriinfection, which can increase stomach pH, did not have any discernable impact on KRT-232 PK. KRT-232 and M1 exposure in heterozygous UGT1A1*28 poor metabolizers (6/7 TA repeats, N=16) was generally comparable to exposure in wild-type (WT) UGT1A1*28 (6/6 TA repeats, N=12) subjects. MIC-1 concentrations in serum were variable and followed the PK time course with a median Tmax lag of ~8-12 h. Group A: Mean Cmax 2115 pg/mL, C0 (Baseline) 170 pg/mL, AUC0-T 89267 pg*h/mL and mean t1/2 27 h. MIC-1 Cmax and AUC were generally comparable over 96 h across groups (Figure 1c).Figure 1dshows the statistically significant correlation between KRT-232 AUC0-t and MIC-1 AUC0-t. Conclusions: Based on generally comparable PK, KRT-232 can be administered with or without food, and no dose adjustment is warranted with a new tablet formulation. KRT-232 PK was not affected byH pylori, inferring that higher gastric pH did not alter absorption of KRT-232. KRT-232 exposure in UGT1A1*28 heterozygous poor metabolizers was generally comparable to WT UGT1A1*28 wild type healthy volunteers. The 60-mg KRT-232 dose elicited a reproducible and robust MIC-1 response that correlated with KRT-232 exposure, indicating MDM2-p53 target engagement. Disclosures Wong: Kartos Therapeutics:Current Employment;AbbVie Biotherapeutics:Ended employment in the past 24 months.Krejsa:Kartos Therapeutics:Current Employment;AstraZeneca:Current equity holder in publicly-traded company;Seattle Genetics:Current equity holder in publicly-traded company;Acerta Pharma:Current equity holder in private company.Lee:Kartos Therapeutics:Current Employment.Harris:Gilead Sciences:Current equity holder in publicly-traded company;Kartos Therapeutics:Current Employment, Current equity holder in private company;BeiGene:Ended employment in the past 24 months;Clovis:Current equity holder in publicly-traded company, Ended employment in the past 24 months.Simard:Certara:Current Employment;AltaScience:Ended employment in the past 24 months.Wang:Certara:Current Employment.Rubets:Certara:Current Employment.Allard:Certara:Consultancy, Ended employment in the past 24 months;CytomX Therapeutics:Ended employment in the past 24 months;Telios Pharma:Current Employment, Current equity holder in private company.Podoll:IV/PO, LLC:Consultancy.O'Reilly:Celerion:Current Employment.Slatter:Amgen:Divested equity in a private or publicly-traded company in the past 24 months;Kartos Therapeutics:Current Employment;AstraZeneca:Current equity holder in publicly-traded company. OffLabel Disclosure: Yes, KRT-232 is an investigational small molecule MDM2 inhibitor.
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Girnius, Saulius K., Habte A. Yimer, Stephen J. Noga, Sudhir Manda, Roger M. Lyons, Kimberly Bogard, Presley Whidden, et al. "In-Class Transition (iCT) from Parenteral Bortezomib to Oral Ixazomib Proteasome Inhibitor (PI) Therapy Increases the Feasibility of Long-Term PI Treatment and Benefit for Newly Diagnosed Multiple Myeloma (NDMM) Patients in an Outpatient Setting: Updated Real-World Results from the Community-Based United States (US) MM-6 Study." Blood 136, Supplement 1 (November 5, 2020): 2–4. http://dx.doi.org/10.1182/blood-2020-140482.
Full textAbstract:
Background Long-term PI-based treatment is associated with improved outcomes in MM. Nonetheless, prolonged therapy with parenteral PIs (e.g. bortezomib) can be challenging in the real world, with median duration of therapy (DOT) of 4-7 months. Barriers to this long-term approach may include the burden of repeated intravenous/subcutaneous administration, difficulty travelling to/accessing treatment centers (e.g. due to environmental factors, travel restrictions, social/family situations), patient preference for treatment outside of a hospital or clinic setting, comorbidities, and toxicity. The US MM-6 study (NCT03173092) is investigating in-class transition (iCT) from parenteral bortezomib-based induction to all-oral ixazomib-based therapy (ixazomib-lenalidomide-dexamethasone; IRd) in the diverse US community population with the aim of increasing PI-based treatment duration while maintaining quality of life and improving outcomes. We report updated efficacy and safety for the first 101 patients. Methods Transplant-ineligible/delayed-transplant (>24 months) NDMM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at US community sites (including Veterans Affairs hospitals) to receive IRd (ixazomib 4 mg, days 1, 8, 15; lenalidomide 25 mg, days 1-21; dexamethasone 40 mg, days 1, 8, 15, 22) for up to 39 x 28-day cycles or until progression/toxicity. The primary endpoint is progression-free survival (PFS); key secondary endpoints include rates of partial (PR), very good PR (VGPR), and complete response (CR), and DOT. Results As of June 1 2020, 101 patients had been treated at 21 sites. Median age was 73 years (range 48-90), with 46% aged ≥75 years; 16% and 10% were of African American and Hispanic ethnicity, respectively. Table 1 summarizes the key characteristics of these real-world patients. A total of 95% of patients had ≥1 comorbidity at the start of IRd therapy including renal and urinary disorders (38%), cardiac disorders (29%), peripheral neuropathy (PN; 14%), and diabetes mellitus (13%) (Table 2). With 53 (52%) patients remaining on therapy and enrollment ongoing, mean duration of PI therapy from the start of bortezomib-based induction was 12.4 months, and mean duration of IRd therapy after iCT was 9.2 months (Table 3). Patients have received up to 29.4 months (31 cycles) of IRd to date. The overall response rate (ORR) after bortezomib-based induction was 62% (7% CR, 32% ≥VGPR). After iCT to IRd, the ORR increased to 71%, with the CR and ≥VGPR rates increasing to 29% and 53%, respectively (Figure); of 33 patients with stable disease following bortezomib-based induction, 14 (42%) achieved CR (n=10) or VGPR (n=4) after iCT. With a median follow-up of 12 months and enrollment ongoing, 13 patients had progressed and two had died during PFS analysis. The 12-month PFS rate was 84% (95% CI, 73-91) from the start of bortezomib-based induction and 80% (95% CI, 69-88) from the start of IRd. During IRd treatment to date, 91% of patients have had treatment-emergent adverse events (TEAEs) (54% grade ≥3). Grade 3 TEAEs (≥5% of patients) were diarrhea (8%), pneumonia (7%), and syncope (5%). TEAEs led to study drug modification in 52% of patients and discontinuation in 7% of patients; 37% had serious TEAEs. Diarrhea, nausea, and vomiting occurred in 43%, 23%, and 14% of patients (8%, 2%, 2% grade 3), and led to dose modification in 11%, 5%, and 2%. PN (not elsewhere classified; high-level term) occurred in 32% of patients (2% grade 3) and led to dose modification in 9%. There were three on-study deaths (i.e. occurring <30 days after last dose). Conclusions US MM-6 patients reflect the heterogeneous real-world US MM population; the population for this study includes patients from the community who may not be eligible for traditional clinical trials. These updated data in mostly elderly, comorbid, NDMM patients treated in the community setting demonstrate the feasibility and tolerability of iCT to IRd after 3 cycles of bortezomib-based induction; approximately half of patients remain on treatment, and enrollment is ongoing. iCT to IRd resulted in improved responses, with increased rates of ≥VGPR, and prolonged DOT and may thereby improve outcomes for real-world patients. iCT to an all oral regimen could also prevent treatment interruptions for patients who are unable to or prefer not to travel in the context of travel restrictions or other factors. Disclosures Girnius: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Yimer:TG Therapeutics: Consultancy; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Sanofi: Speakers Bureau; Texas Oncology: Current Employment; BeiGene: Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding, Speakers Bureau; Janssen: Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding, Speakers Bureau; Takeda: Speakers Bureau; Celgene, a Bristol-Myers Squibb Company: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Karyopharm: Consultancy, Divested equity in a private or publicly-traded company in the past 24 months, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Epizyme: Consultancy, Divested equity in a private or publicly-traded company in the past 24 months. Noga:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Manda:AbbVie: Other: Investigator in AbbVie-sponsored clinical trials. Lyons:Texas Oncology/US Oncology: Current Employment; Novartis: Honoraria. Bogard:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Whidden:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Cherepanov:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Lu:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Aiello:Takeda: Honoraria; Travera: Honoraria; Celgene: Honoraria; Karyopharm: Honoraria. Richter:Celgene: Consultancy, Speakers Bureau; Adaptive Biotechnologies: Consultancy, Speakers Bureau; Janssen: Speakers Bureau; Sanofi: Consultancy; Karyopharm: Consultancy; Takeda: Consultancy; AstraZeneca: Consultancy; Secura Bio: Consultancy; Bristol Myers Squibb: Consultancy; X4 Pharmaceuticals: Consultancy; Oncopeptides: Consultancy; Antengene: Consultancy. Rifkin:McKesson: Current equity holder in publicly-traded company, Ended employment in the past 24 months, Other: Stock ownership; Takeda, Amgen, Celgene, BMS, Mylan, Coherus BioSciences, Fresenius: Consultancy; AbbVie: Other: Investigator in AbbVie sponsored clinical trials; Takeda, Amgen, BMS (Celgene): Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: Real-world evaluation of long-term proteasome inhibition with ixazomib in combination with lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma in non-transplant patients with stable disease after 3 cycles of a bortezomib-based induction.
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Slejko, Julia F., Dorothy Romanus, Daisuke Goto, Eberechukwu Onukwugha, Rahul Khairnar, Brian Seal, Candice Yong, and Jean Yared. "Patterns and Determinants of Cancer-Directed Drug Therapy in Medicare Beneficiaries with Multiple Myeloma." Blood 128, no. 22 (December 2, 2016): 5926. http://dx.doi.org/10.1182/blood.v128.22.5926.5926.
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Abstract Introduction: The introduction of novel therapies for multiple myeloma (MM) such as immunomodulatory drugs and proteasome inhibitors has led to considerable improvements in clinical outcomes, but the disease remains incurable. Both conventional and to a lesser extent novel therapies come with toxicity and treatment decisions need to be individualized based on factors such as age and comorbidities. Little is known about the frequency of drug therapy use in MM in real-world clinical practice. Objective: This study aimed to assess the prevalence of, and determinants associated with cancer-directed drug therapy among newly diagnosed symptomatic MM (NDMM) Medicare beneficiaries. Methods: This retrospective cohort study used Surveillance, Epidemiology, and End Results (SEER) registry and linked Medicare Claims (SEER-Medicare) data. We identified patients (>65 years) with an incident diagnosis of MM from 2007-2011 and associated claims from 2006-2012. Eligible patients had continuous enrollment in Medicare Parts A and B (12 months prior to) and in Part D (two months prior to) through six months post-diagnosis, or death (among patients who died within 6 months post diagnosis). Patients were required to have evidence of CRAB symptoms (hypercalcemia, renal insufficiency, anemia and bone disease) based on intravenous bisphosphonate utilization and ICD-9 diagnosis codes found in claims from six months pre- to one month post-MM diagnosis. Patients were followed until death; or censoring due to non-continuous Parts A, B and D enrollment after six months post diagnosis. We identified receipt of MM-directed therapies from Medicare claims during the follow up period using NDC and HCPCS codes for the following agents: bendamustine, bortezomib, cyclophosphamide, (liposomal) doxorubicin, interferon alfa-2b, etoposide, lenalidomide, melphalan, thalidomide, vincristine, and vorinostat, excluding dexamethasone monotherapy. The distribution of frontline therapies received within 90 days of diagnosis was characterized descriptively. Charlson Comorbidity Index (CCI) was derived based on claims within one year pre-diagnosis using a validated algorithm. Baseline characteristics among those who received any MM-directed treatment were compared to those who did not using t-tests and Chi-square tests for continuous and categorical variables, respectively. We also compared treatment rates in those diagnosed in an early (2007-2009) versus late period (2010-2011). Results: Of 3,391 patients with NDMM who met our inclusion criteria, 2,599 (76.6%) received MM-directed therapy during follow up. The median time until treatment initiation was 49 days (range: 0-2156). The treatment rate using a landmark analysis of patients who survived at least 6 months produced congruent results (77% treated patients). Those who initiated therapy were younger (mean age: 75.6 years) compared to untreated patients (mean age: 78.7 years, p<.001) and had a lower comorbidity burden based on the CCI (p<.001) (Table 1). Among those with CCI=0, 81.7% received treatment, while 79.0% of those with CCI=1 and 69.0% of those with CCI>1 received treatment (p<0.001). African American patients were less likely to receive therapy (68.6%) compared to Caucasians (77.7%) and those who were of another race/ethnicity (79.7%, p<0.001). The proportion of patients initiating treatment was highest in the West (78.8%) and Midwest (78.7%) versus the South (75.1%) and Northeast (72.6%) (p<0.001). Among patients receiving treatment, the following drug therapies were observed within three months of diagnosis: bortezomib (n=937 patients, 36.1%), lenalidomide (n=633,25.5%), melphalan (n=398, 15.9%), thalidomide (n=404, 15.5%) and cyclophosphomide (n=75, 2.8%). Of patients diagnosed in 2007-2009, 75.6% received MM-directed drug treatment compared to 78.0% of those diagnosed in 2010-2011 (p=0.12). Conclusion: Among NDMM patients, 23% did not receive MM-directed therapy. Treatment was associated with younger age and a lower comorbidity burden. Racial disparities, with a lower proportion of African American treated patients, and geographic variation in treatment rates were also observed. Future research is needed to assess the extent to which these determinants reflect patient preferences versus other factors, such as barriers to treatment access. Disclosures Slejko: PhRMA: Research Funding; Takeda: Research Funding; National Pharmaceutical Council: Research Funding. Romanus:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Goto:Novartis AG: Research Funding. Onukwugha:IMPAQ International: Honoraria; Bayer Healthcare: Research Funding; Takeda: Research Funding. Seal:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership. Yong:Takeda: Employment.
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Alvarez, Ofelia A., Sandra Echenique, Hector Rodriguez-Cortes, Thomas J. Harrington, E. Leila Jerome Clay, Vandy Black, Mary Murph, Christopher Wells, and Ifeyinwa (ify) Osunkwo. "Patient Perception on Health Care Delivery for Sickle Cell Disease and Opportunities for Quality Improvement." Blood 134, Supplement_1 (November 13, 2019): 5862. http://dx.doi.org/10.1182/blood-2019-123215.
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The Health Resources and Services (HRSA)-sponsored Sickle Cell Disease (SCD)Treatment Demonstration Regional Collaborative Program, EMBRACE SCD Florida has three aims: 1. To educate providers about SCD, 2. To assess patients' perception on health care and barriers encountered, and 3. To increase hydroxyurea (HU) treatment as disease-modifying therapy. We report the patients' perception on health care delivery as assessed by surveys of 65 patients at two SCD centers in South Florida. All participants signed the IRB-approved informed consent/assent and completed a 46-question survey. Surveys addressed patient demographics, HU use, pain experienced, facility utilization and confidence in SCD doctors and primary care providers (PCPs). Parents represented 62 % of the sample respondents. There were 37 female and 28 male patients, with a mean age of 14.8 years, median 12 years (range 1-45). Patients were self-identified as SS (N=42, 65%), SC (N=8), sickle-β+ thalassemia (N=5), sickle-β0 thalassemia (N=2), other (N=1), and 7 (11%) did not know their genotype. Most (55%) were African-Americans; 26% Haitians, 12% Black non-African-American or other, and 6% were White. Nine percent were Hispanic. Insurance coverage was identified as Medicaid (75%), Managed Care Organization (7%), Medicare (13%), and private insurance (5%). Of the 44 patients with SS and Sβ0, 84% (N=37) received medical advice to take HU from SCD provider. In addition, 12 patients (4 unknown type, 5 Sβ+ and 3 SC) were advised to take HU for a total of 49 or 75% of all patients surveyed. Seventy-eight percent (N=38) of those agreed to be treated, and 22% (N=11) declined HU. Eighty-four percent of those who agreed to be treated (N=32) reported taking HU as prescribed. Those patients who have received HU identified many barriers: lack of money to pay (N=5), nausea (N=5), hair loss (N=1), do not like the taste (N=8), do not like to take medications so they either do not take it frequently (N=7) or force themselves to take it (N=12), lack of effectiveness for their pain (N=10), and forgetting to take HU (N=18). Eighteen of 49 (37%) said they had no problems taking HU. We asked all patients about their pain experience. Of the 63 who responded, 30 (47.6%) said pain was managed well all the time, whereas the rest perceived difficulties in pain management: 20 (31.7%), 12 (19%), and one (1.6%) perceived their pain was managed well 75% of time, 50% of the time, and 25% or less of the time, respectively. The frequency of taking pain medications was variable among patients. The most common frequency of taking pain medications was several times a month (24 of 63 or 38%), but ranged from taking pain medication daily (N=9, 14%) to never or almost never (N=10, 16%). The emergency room (ER) was the first place they would go to when they get sick. One patient reported he prefers staying home. Patients reported a median of two ER visits (range 0-45) and two hospitalizations (range 0-30) in the previous 12 months. Almost all (92%) patients reported having a PCP. Sixty-seven percent visited the PCP 1-3 times per year, whereas 88% visited the SCD doctor 4-12 times per year. Whereas 68.3% patients trusted their PCP to manage their SCD, their level of trust with the SCD doctor was 95.2% (p <0.01). Similarly, 68% patients agreed that both the PCP and the SCD doctor should share responsibilities in their care. The table shows what participants considered most important for their PCP and their SCD doctor to know or learn about SCD. The most common single thing participants would change about the health care system was insurance/health care coverage (N=7), improved communication with providers (N=4), better care (N=2), or to have a cure for SCD (N=2). Six would not change anything. Eighty-four percent of patients did not know how to contact Sickle Cell Disease of America (SCDAA). Nine patients or parents (14%) felt discriminated against by health providers (N=3, doctors, nurses, pharmacy) and others (N=6, employers, classmates, others) as a result of their SCD. We identified five opportunities for quality improvement: 1. Improve pain control as 52.4% patients viewed their pain was sub-optimally managed, 2. Further examine and decrease barriers for HU treatment, 3. PCP education, as 31.7% of patients lacked trust in their competence, 4. Educate and encourage patient interaction with community-based organizations like SCDAA, and 5. Explore policy change in health care insurance coverage. Table Disclosures Alvarez: Forma Therapeutics: Consultancy; Novartis: Consultancy. Clay:Novartis: Speakers Bureau. Black:NHLBI: Research Funding; Micelle BioPharma: Research Funding; Pfizer: Research Funding; Sancilio and Company: Research Funding; Sanofi: Consultancy; Prolong Pharmaceuticals: Consultancy; Novartis: Research Funding; HRSA: Research Funding. Osunkwo:Novartis: Consultancy, Speakers Bureau; Pfizer: Consultancy; Terumo: Speakers Bureau; Micella Biopharma: Other: DSMB member.
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Charumbira, Ruramisai. "Nehanda and Gender Victimhood in the Central Mashonaland 1896–97 Rebellions: Revisiting the Evidence." History in Africa 35 (January 2008): 103–31. http://dx.doi.org/10.1353/hia.0.0011.
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In 1998 David N. Beach revisited the 1896-97 central MaShonaland rising in colonial Zimbabwe in an article titled “An Innocent Woman Unjustly Accused? Charwe, Medium of the Nehanda Mhondoro Spirit, and the 1896-97 Central Shona Rising in Zimbabwe.” Beach's main thesis was that, contrary to conventional wisdom that placed Nehanda-Charwe (and other leaders) at the center of those anti-European settler rebellions, Nehanda-Charwe might have been “an innocent woman unjustly accused.” For Beach, upstart Kaguvi-Gumboreshumba (a male spiritual leader) might have been the real hero, for he was to be found in all the sources and his tracks were better traceable than Nehanda-Charwe, who had a sporadic presence in the same sources.Since Beach's 1998 study, I have not come across any other original study that has extended or disputed his arguments; to that end, I consider this study a response to Beach's study and an invitation to revisit the historiography of early colonial Zimbabwe through feminist lenses. My main aim is to revisit two major issues Beach raised in his study, and to look at them through a feminist lens in order to understand whether Nehanda-Charwe was indeed an “innocent woman unjustly accused” or whether something else was at play. After giving a brief background to the rebellion in MaShonaland, I will look at the issue of the credibility of evidence given by Africans to colonial officials about those who were up in arms against the colonial authority, the British South Africa Company (BSAC), with a focus on women's testimonies.
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Ebert, David A., Leonard J. V. Compagno, and Paul D. Cowley. "Aspects of the reproductive biology of skates (Chondrichthyes: Rajiformes: Rajoidei) from southern Africa." ICES Journal of Marine Science 65, no. 1 (December 17, 2007): 81–102. http://dx.doi.org/10.1093/icesjms/fsm169.
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AbstractEbert, D. A., Compagno, L. J. V., and Cowley, P. D. 2008. Aspects of the reproductive biology of skates (Chondrichthyes: Rajiformes: Rajoidei) from southern Africa. – ICES Journal of Marine Science, 65: 81–102. New information is presented on the reproductive biology of 22 southern African skate species. Sex ratios for most species were relatively even. Sexual dimorphic differences in disc shape were evident in all species, but the total length (LT) to disc width (D) relationship was significantly different in only three species, and the LT to weight (W) relationship significant in just five species. Sexual dimorphism relative to maximum total length (LTmax) was absent in all but the two largest species. Males and females of the same species grow to a similar LTmax except those whose LTmax is >1.5 m LT. Size at first and 50% (LT50) sexual maturity was approximately the same for both sexes in all but the two largest species. First maturity occurred at >60% of LTmax for all species for which sufficient data were available, and most (n = 18) matured at >75% LTmax. The large size at maturity relative to LTmax suggests that growth slows or is partially suspended following sexual maturity. The egg cases of 15 species are described, and a key to their identification is presented. Egg cases in utero were observed throughout the year suggesting that most species reproduce year-round.
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Koffi, Yao Honoré, Sagbrou Chérubin Djro, and Urbain Wenmenga. "Lithostructural and Petrochemical Survey of Djarkadougou Gold Prospect (South West Burkina Faso / West Africa)." Earth Science Research 6, no. 1 (February 6, 2017): 155. http://dx.doi.org/10.5539/esr.v6n1p155.
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The Djarkadougou gold prospect is located on the Birimian greenstone belt of the Houndé exploration permit held by the company Orezone Inc. The permit is at 275 km far from the capital Ouagadougou south- western Burkina Faso, West Africa. This area is based on sheared and metamorphosed greenschist facies rocks. Metamorphism locally reaches to the amphibolite facies around intrusions. There are two major lithological units whose interface is marked by a NW-SE trending shear corridor: an unit of andesite-basaltic rocks of andesitic breccias in the East and volcaniclastic and sedimentary unit composed flows, tuffs and felsic to mafic breccia, interbedded volcano-sedimentary rocks. All this together is intruded by plutonic rocks, and various felsic to mafic dykes. These rocks have undergone ductile to brittle heterogeneous deformations and hydrothermal alteration sericite ±carbonate ±quartz±sulphide within deformation corridors. The rocks of the East and West domains affected by three phases of brittle-ductile deformation (D1, D2, and D3) and the meteoric alteration is systematic in superficial facies of Djarakadougou core drilling.Geochemical analysis shows a tholeiitic to calc-alkaline volcanic serie characteristic a bimodal volcanism. The spectra of normalized REE chondrites are generally flat and constant reminding those of N-MORB basalt. The chemical compositions of andesite and basalt are deferred on several discrimination diagrams especially Th / Yb - Nb / Yb and 2 Nb - Zr / 4 - Y show that andesites and basalts of the prospect are issued in geotectonic setting of volcanism preponderant arc.
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Noga, Stephen J., Robert M. Rifkin, Sudhir Manda, Ruemu Ejedafeta Birhiray, Roger M. Lyons, Presley Whidden, Robert L. Schlossman, Bingxia Wang, and Ralph V. Boccia. "Real-World (RW) Treatment Patterns and Patient-Related Factors Including Quality of Life (QoL), Medication Adherence, and Actigraphy in Community Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM) Transitioning from Bortezomib (btz) to Ixazomib: The US MM-6 Community-Based Study." Blood 134, Supplement_1 (November 13, 2019): 3168. http://dx.doi.org/10.1182/blood-2019-124784.
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Background US MM-6 is a US community-based study that investigates the transition from a parenteral (btz) to an oral (ixazomib) proteasome inhibitor (PI) in NDMM to increase PI-based treatment duration and adherence, maintain QoL, and improve outcomes. Here, we report on the novel, RW aspects of the study including the use of digital devices/wearables to evaluate QoL, medication adherence, and actigraphy (average steps and sleep time/ day) in a community oncology setting, for the first 55 enrolled pts. Methods NDMM pts who are transplant-ineligible or transplant-delayed >24 mos and have ≥stable disease after 3 cycles of btz-based induction are being enrolled at 23 community sites. Pts receive IRd (ixazomib 4 mg, d 1, 8, 15; lenalidomide 25 mg, d 1-21; dexamethasone 40 mg [20 mg for pts aged >75 yrs], d 1, 8, 15, 22; each 28-d cycle) for up to 26 x 28-d cycles or until progression/toxicity. The primary endpoint is progression-free survival. Novel secondary and exploratory endpoints are included to capture pts' experience in the RW community setting. Electronic pt-reported outcomes (ePROs) are used to assess medication adherence and QoL, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Core QoL Questionnaire (QLQ-C30), EORTC QoL Questionnaire-Multiple Myeloma Module (QLQ-MY20) for peripheral neuropathy (PN), and the Treatment Satisfaction Questionnaire for Medication (TSQM-9). Pts use wearable digital devices/smartphones to complete a monthly medication adherence survey and record actigraphy. Results At the data cutoff of April 1 2019, 55 pts had been enrolled at 16 sites in the US; 40 were still undergoing treatment. Females comprised 53% of pts, 13% were of Hispanic/Latino ethnicity, and 13% were black/African American. Pt/disease characteristics revealed a comorbid, difficult-to-treat RW population: median age was 72 yrs (35% 65-75 yrs; 42% ≥75 yrs); 40% had International Staging System stage III disease, and 42% had lytic bone disease. Most common comorbidities at study start were hypertension (51%), anemia (44%), fatigue (42%), renal and urinary disorders (36%), gastroesophageal reflux disease (31%), and cardiac disorders (27%). Prior to IRd treatment, the 3-cycle btz-based induction required adjusting in 11 (20%) pts: 38 (69%) pts started induction with btz-lenalidomide-dexamethasone (VRd) (1 had only 1 cycle documented, 1 de-escalated to Vd), 7 (13%) started on btz-cyclophosphomide-dexamethasone (VCd) (2 had only 1 cycle documented), 4 (7%) started on Vd (3 escalated to VRd), and 2 (4%) started on VCRd but de-escalated to VCd/VRd after 1 cycle; 3 (5%) pts received VR only (Figure). Average compliance with completing issued ePRO questionnaires during IRd treatment was 96%, and ≥87% in all cycles (61 pts; data cutoff July 8, 2019), revealing the feasibility of ePRO collection in community pts, most of whom were elderly. During IRd treatment, there was a trend toward improved treatment satisfaction and QoL, with no increase in PN symptoms (Figure). Mean change (95% CI) from baseline on EORTC QLQ-C30 score was 5.12 (-13.79-24.02) by cycle 5 (n=13), 15.47 (-16.45-47.39) by cycle 8 (n=7), and -4.18 (-21.29-12.94) by cycle 12 (n=5). Mean change (95% CI) from baseline on TSQM-9, subscale 'effectiveness', was 7.54 (-1.84-16.91) by cycle 5 (n=14), and 11.13 (-12.82-35.08) by cycle 12 (n=3), with similar patterns for subscales 'convenience' and 'global satisfaction' (Figure). Mean change from baseline on EORTC QLQ-MY20, PN component, was between 0.0-2.0 throughout all cycles. Patients recorded their monthly medication adherence for the previous 4 weeks; 81% of evaluable pts (n=32) in cycle 1, 81% in cycle 2 (n=27), 77% in cycle 3 (n=22), 96% in cycle 4 (n=24), and 94% in cycle 5 (n=18) (n<11 [20% of pts] beyond cycle 5) reported 'excellent'/'very good' adherence. Analysis of actigraphy data for 24 pts (2086 compliant days [≥12h of data]) (Figure) revealed normal levels of activity (Tudor-Locke 2011) and sleep durations (Coleman 2011). Updated actigraphy data will be presented. Conclusions Preliminary ePRO and actigraphy data from this RW community study suggest that long-term treatment with all-oral IRd has no impact on health-related QoL or on pts' lifestyle. High ePRO compliance indicates that RW studies using wearable electronic data collection devices are feasible in this mostly elderly, comorbid population, and may have a positive impact on medication adherence. Disclosures Noga: Takeda: Employment. Rifkin:Amgen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Birhiray:Alexion: Consultancy; Bayer: Honoraria; Helsin: Honoraria; Sanofi Oncology: Speakers Bureau; Puma: Consultancy, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Incyte: Research Funding, Speakers Bureau; Pharmacyclics: Consultancy, Speakers Bureau; Pfizer: Speakers Bureau; Amgen: Honoraria, Speakers Bureau; BMS: Speakers Bureau; Tessaro: Speakers Bureau; Exelexis: Speakers Bureau; Kite Pharma: Honoraria; Clovis Oncology: Speakers Bureau; Lilly: Speakers Bureau; AstraZeneca: Speakers Bureau; Celgene: Honoraria; Takeda: Research Funding, Speakers Bureau; Genomic Health: Speakers Bureau; Jansen Bioncology: Consultancy, Speakers Bureau; Seattle Genetics: Honoraria; Abbvie: Consultancy, Honoraria; Coheris: Honoraria. Lyons:Texas Oncology: Equity Ownership; Amgen: Consultancy; McKesson: Other: Leadership. Whidden:Takeda: Employment. Schlossman:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Wang:Millennium Pharmaceuticals, Inc., Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Boccia:Celgene: Speakers Bureau; Genentech: Speakers Bureau; Amgen: Speakers Bureau; AstraZeneca: Speakers Bureau; AMAG: Consultancy; DSI: Speakers Bureau.
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Fahey, Margaret C., Marion E. Hare, Gerald W. Talcott, Mehmet Kocak, Ann Hryshko-Mullen, Robert C. Klesges, and Rebecca A. Krukowski. "Characteristics Associated With Participation in a Behavioral Weight Loss Randomized Control Trial in the U.S. Military." Military Medicine 184, no. 3-4 (August 14, 2018): e120-e126. http://dx.doi.org/10.1093/milmed/usy199.
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Abstract Introduction Effective recruitment and subsequent enrollment of diverse populations is often a challenge in randomized controlled trials, especially those focused on weight loss. In the civilian literature, individuals identified as racial and ethnic minorities, men, and younger and older adults are poorly represented in weight loss interventions. There are limited weight loss trials within military populations, and to our knowledge, none reported participant characteristics associated with enrollment. There may be unique motives and barriers for active duty personnel for enrollment in weight management trials. Given substantial costs and consequences of overweight and obesity in the U.S. military, identifying predictors and limitations to diverse enrollment can inform future interventions within this population. The study aims to describe the recruitment, screening, and enrollment process of a military weight loss intervention. Demographic and lifestyle characteristics of military personnel lost between screening and randomization are compared to characteristics of personnel randomized in the study and characteristics of the Air Force in general. Materials and Methods The Fit Blue study, a randomized controlled behavioral weight loss trial for active duty personnel, was approved by the Institutional Review Board of the Wilford Hall Ambulatory Surgical Center in San Antonio, TX, USA and acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center. Logistic regressions compared participant demographics, anthropometric data, and health behaviors between personnel that attended a screening visit but were not randomized and those randomized. Multivariable models were constructed for the likelihood of being randomized using a liberal entry and stay criteria of 0.10 for the p-values in a stepwise variable selection algorithm. Descriptive statistics compared the randomized Fit Blue cohort demographics to those of the U.S. Air Force Results In univariate analyses, older age (p < 0.02), having a college degree or higher (p < 0.007) and higher military rank (p < 0.02) were associated with completing the randomization process. The randomized cohort reported a lower percentage of total daily kilocalories for fat compared to the non-randomized cohort (p = 0.033). The non-randomized cohort reported more total minutes and intensity of physical activity (p = 0.073). In the multivariate model, only those with a college degree or higher were 3.2 times more likely to go onto randomization. (OR = 3.2, 95% CI = 2.0, 5.6, p < 0.0001). The Fit Blue study included a higher representation of personnel who identified as African American (19.4% versus 15.0%) and Hispanic/Latino (22.7% versus 14.3%) compared with the U.S. Air Force in general; however, men were underrepresented (49.4% versus 80.0%). TABLE I.Comparisons of Demographic Characteristics of Randomized Fit Blue Cohort to Screened Non-Randomized CohortFit Blue Randomized Participants (N = 248)Non-Randomized Cohort (N = 111)All Screened Participants (N = 359)p-ValueSex N (%)0.73 Male122 (49.2)52 (46.8)174 (48.5) Female126 (50.8)59 (53.2)183 (51.5)Age Mean (±SD) years34 (±7.5)32 (±6.7)33 (±7.3)0.02Race N (%)0.89 African American49 (19.8)22 (19.8)71 (19.8) Caucasian163 (65.7)75 (67.6)238 (66.3) Other36 (14.5)14 (12.2)50 (13.9)Ethnicity N (%)0.59 Hispanic/Latino56 (22.6)28 (25.2)84 (23.4) Non-Hispanic/Latino192 (77.4)83 (74.8)275 (76.6)Education N (%)<0.0001 Less than college degree123 (49.6)82 (73.9)205 (57.1) College degree or greater125 (50.4)29 (26.1)154 (42.9)Marital status N (%)0.83 Single/never married40 (16.1)20 (18)60 (16.7) Married/living as married169 (68.1)72 (64.9)241 (67.1) Separated/divorced39 (15.7)19 (17.1)58 (16.2)Number of additional adults in household N (%)0.82 046 (18.5)22 (19.8)68 (18.9) 1162 (65.3)73 (65.8)235 (65.5) 231 (12.5)14 (12.6)45 (12.5) 3 or more9 (3.6)2 (1.8)11 (3.1)Number of children in household N (%)0.56 091 (36.7)37 (33.3)128 (35.7) 159 (23.8)23 (20.7)82 (22.8) 257 (23)26 (23.4)83 (23.1) 3 or more41 (16.5)25 (22.5)66 (18.4)Years in service mean (± SD)12 (±6.6)11 (±6.1)12 (±6.4)0.20Military gradeaN (%)0.02 E1–E434 (13.7)19 (17.1)53 (14.8) E5–E6105 (42.3)58 (52.3)163 (45.4) E7–E952 (21)21 (18.9)73 (20.3) O1–O317 (6.9)9 (8.1)26 (7.2) O4–O639 (15.7)4 (3.6)43 (12)Branch0.68 Army4 (1.6)1 (0.9)5 (1.4) Air Force234 (94.4)105 (94.6)339 (94.4) Navy8 (3.2)5 (4.5)13 (3.6) Marine Corp2 (0.8)0 (0.0)2 (0.6)BMI (m2/kg) N (%)30.6 (±2.7)30.4 (±2.9)30.6 (±2.8)BMI category N (%)0.76 Overweight115 (46.4)52 (48.1)167 (46.9) Obese133 (53.6)56 (51.9)189 (53.1)aMilitary ranking; Enlisted (E) categories: E1–E4 (enlisted), E5–E6 (non-commissioned officers), E7–E9 (senior non-commissioned officers) and two Officer categories (O): O1–O3 (Company Grade Officer) and O4–O6 (Field Grade Officer); standard deviation (SD).Table II.Comparisons of Anthropometric Characteristics of Randomized Fit Blue Cohort to Screened Non-Randomized CohortFit Blue Randomized Participants (N = 248)Non-Randomized Cohort (N = 111)All Screened Participants (N = 359)p-ValuePhysical activity Total physical activity2525 (±3218)2840 (±2541)2621 (±3028)0.027 (mean (±SD) minutes per week) Total sedentary physical activity5046 (±239)472 (±221)494 (±234)0.35 (mean (±SD) minutes per week) Vigorous physical activity34 (±145)54 (±152)40 (±147)0.036 (mean (±SD) minutes per week)Dietary intake Total sweetened beverages (kcal per day)165 (±206)152.9 (±166)160.8 (±194)0.80 Fruit and vegetable consumption (cups per day)3 (±1)3 (±1)3 (±1)0.52 Dietary fat (% total kcal)35 (±4)34 (±4)35 (±4)0.033 Conclusions Accounting for all influencing characteristics, higher educational status was the only independent predictor of randomization. Perhaps, highly educated personnel are more invested in a military career, and thus, more concerned with consequences of failing required fitness tests. Thus, it may be important for future weight loss interventions to focus recruitment on less-educated personnel. Results suggest that weight loss interventions within a military population offer a unique opportunity to recruit a higher prevalence of males and individuals who identify as racial or ethnic minorities which are populations commonly underrepresented in weight loss research.
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Law, Robin. "The Royal African Company of England's West African Correspondence, 1681-1699." History in Africa 20 (1993): 173–84. http://dx.doi.org/10.2307/3171971.
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This paper draws attention to an ambitious project in the publication of source material for the precolonial history of West Africa, which has recently been approved for inclusion in the Fontes Historiae Africanae series of the British Academy. In addition to self-promotion, however, I wish also to take the opportunity to air some of the problems of editorial strategy and choice which arise with regard to the editing and presentation of this material, in the hope of provoking some helpful feedback on these issues.The material to be published consists of correspondence of the Royal African Company of England relating to the West African coast in the late seventeenth century. The history of the Royal African Company (hereafter RAC) is in general terms well known, especially through the pioneering (and still not superseded) study by K.G. Davies (1957). The Company was chartered in 1672 with a legal monopoly of English trade with Africa. Its headquarters in West Africa was at Cape Coast (or, in the original form of the name, Cabo Corso) Castle on the Gold Coast, and it maintained forts or factories not only on the Gold Coast itself, but also at the Gambia, in Sierra Leone, and at Offra and Whydah on the Slave Coast. It lost its monopoly of the African trade in 1698, and thereafter went into decline, effectively ceasing to operate as a trading concern in the 1720s, although it continued to manage the English possessions on the coast of West Africa until it was replaced by a regulated company (i.e., one open to all traders), the Company of Merchants Trading to Africa, in 1750.
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Keirn, Tim. "Daniel Defoe and the Royal African Company." Historical Research 61, no. 145 (June 1, 1988): 243–47. http://dx.doi.org/10.1111/j.1468-2281.1988.tb01063.x.
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Girvin, Stephen D. "The antecedents of South African company law." Journal of Legal History 13, no. 1 (April 1992): 63–77. http://dx.doi.org/10.1080/01440369208531049.
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Pratz, Keith W., Courtney D. DiNardo, Dominik Selleslag, Junmin Li, Kazuhito Yamamoto, Marina Konopleva, Andrew McDonald, et al. "Cytopenia Management in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Venetoclax Plus Azacitidine in the VIALE-A Study." Blood 136, Supplement 1 (November 5, 2020): 51–53. http://dx.doi.org/10.1182/blood-2020-134832.
Full textAbstract:
Background: Patients with acute myeloid leukemia (AML) who are older or ineligible for intensive induction chemotherapy have limited treatment options and poor survival. In the VIALE-A study, venetoclax (Ven) + azacitidine (Aza) improved overall survival and response rates compared with placebo (Pbo) + Aza in older or unfit patients with newly diagnosed AML (DiNardo et al. N Engl J Med. 2020). Although cytopenia is common in AML, Ven+Aza was associated with hematologic adverse events in 83% of patients in the VIALE-A study (vs 69% in the Pbo+Aza arm). Here, the frequency and management of cytopenia are analyzed in patients achieving a best response of complete remission (CR) or CR with partial hematologic recovery (CRh) in the VIALE-A study. Methods: This double-blind, Pbo-controlled, multicenter Phase 3 study (NCT02993523) enrolled patients with newly diagnosed AML who were ineligible for intensive chemotherapy due to age ≥75 years or comorbidities. Patients were randomized 2:1 to receive 75 mg/m2 Aza (Days 1-7 of each 28-day cycle) plus either daily 400 mg Ven (Ven+Aza) or Pbo (Pbo+Aza). Disease response was assessed via bone marrow aspirate and biopsy at the end of Cycle 1 and at least every 3 cycles thereafter. After patients achieved blast clearance (bone marrow blasts <5%), various dosing modifications were implemented to manage cytopenia (Table 1). Cytopenia, defined here as Grade 4 neutropenia (absolute neutrophil count <500/μL) or Grade 4 thrombocytopenia (platelet count <25×103/μL) lasting ≥7 days, was assessed using laboratory data. Results: In total, 186 of 283 (66%) Ven+Aza-treated patients and 33 of 144 (23%) Pbo+Aza-treated patients achieved a best response of CR or CRh (CR/CRh). Of patients with a best response of CR/CRh in the Ven+Aza arm, 77% achieved blast clearance by the end of Cycle 1, 88% by the end of Cycle 2, 92% by the end of Cycle 3, and 98% by the end of Cycle 4. Of patients with a best response of CR/CRh in the Pbo+Aza arm, 33% achieved blast clearance by the end of Cycle 1, 55% by the end of Cycle 2, 76% by the end of Cycle 3, and 91% by the end of Cycle 4. After achieving blast clearance, 75% and 67% of patients in the Ven+Aza and Pbo+Aza arms, respectively, had a delay of the next cycle, with a median duration per cycle delay post-blast clearance (range) of 9.0 (1-39) and 5.5 (1-21) days. Among CR/CRh patients, more patients receiving Ven+Aza versus Pbo+Aza had post-remission cytopenia (87% vs 45%; Table 2). A similar percentage of CR/CRh patients in both arms (Ven+Aza, 26%; Pbo+Aza, 24%) had in-cycle dose interruptions (ie, days without Ven/Pbo exposure between a cycle's first and last Ven/Pbo dose), with a median duration (range) of 2.0 days (1-20) for Ven+Aza and 1.0 (1-13) for Pbo+Aza. A greater proportion of CR/CRh patients experienced post-remission cycle delays due to cytopenia in the Ven+Aza arm (77%) than in the Pbo+Aza arm (30%). Furthermore, a higher percentage of CR/CRh patients had post-remission cycles with a reduction in Ven/Pbo dosing days and/or cycle delays totaling ≥7 days due to cytopenia in the Ven+Aza arm (75%) than in the Pbo+Aza arm (27%). Among these patients, the median percentage of days without Ven/Pbo administration while in remission (out of the total number of days in remission) was 18% (range, 1-69) in the Ven+Aza arm and 13% (3-44) in the Pbo+Aza arm. Ultimately, 129 CR/CRh patients (69%) in the Ven+Aza arm and 10 (30%) in the Pbo+Aza arm received ≤21-day Ven/Pbo dosing post-remission, with a median time from remission to first ≤21-day cycle (range) of 92.0 days (1-480) for Ven+Aza and 74.0 days (6-405) for Pbo+Aza. Conclusion: In the VIALE-A study of older or unfit patients with newly diagnosed AML, the majority of responding patients in the Ven+Aza arm required dosing modifications to manage cytopenia, of which delays between cycles or within-cycle reductions of Ven dosing days were most common. Post-remission cytopenia and dosing modifications were more frequent with Ven+Aza versus Pbo+Aza treatment. The impact of cytopenia and dosing modifications on patient outcomes with Ven+Aza is currently being analyzed and will be reported at a future date. Disclosures Pratz: AbbVie: Other: Scientific Advisory Board, Research Funding; Boston BioMedical: Consultancy; Astellas: Other: Scientific Advisory Board, Research Funding; Jazz Pharmaceutical: Consultancy; Millennium: Research Funding; Daiichi Sankyo: Research Funding; Agios: Other: Scientific Advisory Board, Research Funding; Celgene: Other: Scientific Advisory Board. DiNardo:MedImmune: Honoraria; Agios: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Jazz: Honoraria; Takeda: Honoraria; AbbVie: Consultancy, Honoraria, Research Funding; Syros: Honoraria; Notable Labs: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Consultancy, Honoraria, Research Funding; ImmuneOnc: Honoraria; Novartis: Consultancy; Calithera: Research Funding. Selleslag:Amgen: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Astellas: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Speakers Bureau; Janssen Cilag: Consultancy, Honoraria, Speakers Bureau; AbbVie: Consultancy, Honoraria, Speakers Bureau; Belgian College: Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Speakers Bureau; MSD: Consultancy, Honoraria, Speakers Bureau; Incyte: Consultancy, Honoraria; Alexion: Consultancy, Honoraria; GSK: Consultancy, Honoraria; Teva: Consultancy, Honoraria, Speakers Bureau; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria, Speakers Bureau. Yamamoto:AbbVie: Consultancy, Honoraria, Research Funding; Astra-Zeneca: Consultancy, Research Funding; Zenyaku: Research Funding; Sumitomo Dainippon: Honoraria; Sanofi: Honoraria; Pfizer: Honoraria; Otsuka: Consultancy, Honoraria, Research Funding; Ono: Consultancy, Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Nippon Shinyaku: Honoraria, Research Funding; Mundipharma: Consultancy, Honoraria, Research Funding; MSD: Consultancy, Honoraria, Research Funding; Mochida: Honoraria; Meiji Seika Pharma: Consultancy, Honoraria; Kyowa Kirin: Honoraria; Janssen: Honoraria; Gilead Sciences: Research Funding; IQIVA/Incyte: Research Funding; HUYA: Consultancy; IQIVA/HUYA: Honoraria; Daiichi Sankyo: Consultancy; Eisai: Consultancy, Honoraria, Research Funding; Chugai: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Yakult: Research Funding; Stemline Therapeutics: Consultancy; Solasia Pharma: Research Funding; SymBio: Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria; Bayer: Research Funding; Aichi Cancer Center: Current Employment. Konopleva:AbbVie: Consultancy, Research Funding; Cellectis: Research Funding; Agios: Research Funding; Sanofi: Research Funding; Amgen: Consultancy; Reata Pharmaceutical Inc.;: Patents & Royalties: patents and royalties with patent US 7,795,305 B2 on CDDO-compounds and combination therapies, licensed to Reata Pharmaceutical; Ascentage: Research Funding; Eli Lilly: Research Funding; Stemline Therapeutics: Consultancy, Research Funding; Calithera: Research Funding; Forty-Seven: Consultancy, Research Funding; Ablynx: Research Funding; Rafael Pharmaceutical: Research Funding; F. Hoffmann La-Roche: Consultancy, Research Funding; Kisoji: Consultancy; AstraZeneca: Research Funding; Genentech: Consultancy, Research Funding. McDonald:venetoclax advisory board in South Africa (in CLL context): Consultancy; Alberts Cellular Therapy: Current Employment. Babu:Genentech, Inc./ F. Hoffmann-La Roche: Research Funding; Novartis: Research Funding; Janssen Oncology: Research Funding; Syndax: Research Funding; Nektar: Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Alexion Pharmaceuticals: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding, Speakers Bureau; Lilly: Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Bayer: Honoraria; AstraZeneca: Consultancy, Honoraria; AstraZeneca/MedImmune: Research Funding; Argenx: Consultancy, Research Funding; Boehringer Ingelheim: Consultancy; Merck: Research Funding; AbbVie: Research Funding; TG Therapeutics: Research Funding; Amgen: Research Funding; Lutheran Hospital: Other; Fort Wayne Medical Oncology & Hematology: Current Employment, Current equity holder in publicly-traded company; Sanofi: Research Funding. Stevens:Amgen, MorphoSys: Consultancy. Kantarjian:BioAscend: Honoraria; Delta Fly: Honoraria; Abbvie: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Ascentage: Research Funding; Janssen: Honoraria; Adaptive biotechnologies: Honoraria; Aptitute Health: Honoraria; Oxford Biomedical: Honoraria; Daiichi-Sankyo: Honoraria, Research Funding; BMS: Research Funding; Jazz: Research Funding; Immunogen: Research Funding; Novartis: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Sanofi: Research Funding; Actinium: Honoraria, Membership on an entity's Board of Directors or advisory committees. Traina:University of São Paulo at Ribeirão Preto Medical School: Current Employment; AbbVie: Other: Principal Investigator for Protocol Number M15-656 . Venditti:Jazz: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); AbbVie: Consultancy, Honoraria, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company); Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company); Amgen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Pfizer: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Novartis: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Mayer:AbbVie: Research Funding; Principia Biopharma: Research Funding. Montez:F. Hoffmann-La Roche: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment. Ramsingh:Roche: Current equity holder in publicly-traded company, Ended employment in the past 24 months; Genentech: Current Employment, Current equity holder in publicly-traded company. Jin:Genentech: Current Employment. Ainsworth:AbbVie: Current Employment, Current equity holder in publicly-traded company. Duan:AbbVie: Current Employment, Other: may hold stock or options. Svensson:AbbVie: Current Employment, Current equity holder in publicly-traded company. Werner:AbbVie: Current Employment, Current equity holder in publicly-traded company. Potluri:AbbVie: Current Employment, Other: may hold stock or stock options. Jonas:AbbVie: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Amgen: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; GlycoMimetics: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Celgene: Consultancy, Research Funding; Jazz: Consultancy, Research Funding; Takeda: Consultancy; Tolero: Consultancy; Treadwell: Consultancy; Forty Seven: Research Funding; Accelerated Medical Diagnostics: Research Funding; AROG: Research Funding; Daiichi Sankyo: Research Funding; F. Hoffmann-La Roche: Research Funding; Forma: Research Funding; Genentech/Roche: Research Funding; Hanmi: Research Funding; Incyte: Research Funding; LP Therapeutics: Research Funding; Pfizer: Research Funding; Pharmacyclics: Research Funding; Sigma Tau: Research Funding.
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Callaghan, Michael U., Claude Négrier, Ido Paz-Priel, Tiffany Chang, Sammy Chebon, Michaela Lehle, Johnny Mahlangu, et al. "Safety and Efficacy of Emicizumab in Persons with Hemophilia a with or without FVIII Inhibitors: Pooled Data from Four Phase III Studies (HAVEN 1-4)." Blood 136, Supplement 1 (November 5, 2020): 3–5. http://dx.doi.org/10.1182/blood-2020-137438.
Full textAbstract:
Introduction: Emicizumab-a subcutaneously administered, bispecific, humanized, monoclonal antibody-promotes effective hemostasis in people with hemophilia A (PwHA). The primary efficacy and safety of emicizumab were reported previously, but long-term data are limited. Here, data from a wide age-range of PwHA with/without factor (F)VIII inhibitors enrolled in the Phase III HAVEN 1 (NCT02622321), HAVEN 2 (NCT02795767), HAVEN 3 (NCT02847637), and HAVEN 4 (NCT03020160) studies are pooled to establish the durable efficacy and safety of emicizumab. Methods: The studies enrolled pediatric and adult PwHA with/without FVIII inhibitors. Participants received emicizumab prophylaxis 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks. All participants assigned to receive emicizumab (including those assigned to control arms who later switched) are included in this analysis. Participants and/or caregivers recorded outcomes of bleeding events via the Bleed and Medication Questionnaire (BMQ). Data from HAVEN 1-4 were pooled for an aggregate analysis of emicizumab efficacy and safety. Efficacy endpoints include calculated mean annualized bleed rates (ABRs; discrete, consecutive 24-week treatment intervals), model-based ABRs (calculated via negative binomial regression for full study period), percentage of participants with zero and 1-3 treated bleeds, and annualized cumulative dose of coagulation factor (ACD). Safety endpoints include incidence of adverse events (AEs) and AEs of special interest. Results: Overall, 400 PwHA in HAVEN 1, 2, 3 and 4 (n=113, 88, 151, and 48, respectively) are included in the efficacy analysis for a total of 970.3 patient years (cutoff: 15 May 2020). The safety population comprises 399 PwHA who received ≥1 dose of emicizumab (1 PwHA was randomized to receive emicizumab but did not start treatment). The median age at baseline was 28.5 (range 1-77) years. The majority of participants were White (66.8%) or Asian (18.8%); 52.3% had FVIII inhibitors. In the 24 weeks prior to study entry, 60.9% of participants had target joints. The median duration of efficacy period was 120.4 (interquartile range 89.0-164.4) weeks; 85.0% of participants had an efficacy period of ≥74 weeks; 11 participants (2.8%) discontinued study treatment. Across all 4 studies, 90.9-94.8% of the observation period was covered by completed BMQs. Across all studies, the model-based treated bleed ABR was 1.4 (95% confidence interval 1.1-1.7); treated bleed ABRs remained low throughout, and were seen to decrease with successive 24-week treatment intervals (Table 1). During Weeks 121-144 (n=170), 82.4% of participants had zero treated bleeds, and 15.3% of participants had 1-3 treated bleeds. During the same period, 91.8% and 90.0% had zero treated spontaneous/joint bleeds respectively (Figure 1). The proportion of participants with target joints reduced from 60.9% prior to study entry to 4.6% at Weeks 1-24, then <1.5% in all subsequent treatment intervals. ACD of FVIII (Table 2), activated prothrombin complex concentrate (aPCC) and activated recombinant FVII (rFVIIa, Table 3) generally decreased across each 24-week treatment interval. Emicizumab was well tolerated (Table 4), and no participants discontinued due to AEs beyond the five previously described (Oldenburg et al. N Engl J Med 2017; Young et al. Blood 2019; Mahlangu et al. N Engl J Med 2018; Pipe et al. Lancet Haem 2019). At data cut, 1 fatality, 3 thrombotic microangiopathies (TMAs), and 4 thromboembolic events (TEs) have been reported; all but 1 occurred in HAVEN 1. All TMAs and 2 of 4 TEs were associated with concomitant aPCC use. The percentage of participants with ≥1 drug-related AE in Weeks 1-24, 25-48 and 49-72 were 28.8%, 6.8%, and 3.0% respectively; over the same intervals, injection site reactions were observed in 23.3%, 4.8%, and 2.5% of participants. Conclusions: With nearly 3 years of follow-up, emicizumab maintained low bleed rates in PwHA of all ages, with/without FVIII inhibitors. ABRs continued to decrease and the proportion of participants with zero treated bleeds increased with each consecutive 24-week period; the trend was the same for the proportion of participants with zero joint bleeds and almost all target joints resolved. The ACDs of FVIII, aPCC, and rFVIIa decreased with successive treatment intervals. Emicizumab remains well tolerated over long-term follow-up, and no new safety concerns have been identified to date. Disclosures Callaghan: Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Biomarin: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Speakers Bureau; Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Research Funding; Grifols: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bioverativ: Membership on an entity's Board of Directors or advisory committees; Hema Biologics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Alnylum: Current equity holder in publicly-traded company; Spark: Honoraria, Membership on an entity's Board of Directors or advisory committees; Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Global Blood Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Speakers Bureau; Roche/Genentech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Site Investigator/sub-I Clinical Trial, Speakers Bureau; NovoNordisk: Other, Speakers Bureau; Sancillio: Other. Négrier:CSL Behring, Octapharma, Shire/Takeda, Sobi: Research Funding; CSL, F. Hoffmann-La Roche Ltd, Sobi: Other: Travel support; Bayer, Biomarin, CSL Behring, Freeline, LFB, Novo Nordisk, Octapharma, Pfizer, F. Hoffmann-La Roche Ltd, Sanofi, Shire/Takeda, Sobi, Spark: Consultancy. Paz-Priel:Genentech, Inc: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company, Other: All authors received editorial support for this abstract, provided by Scott Battle, PhD, of Health Interactions and funded by F. Hoffmann-La Roche.. Chang:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Chebon:F. Hoffmann-La Roche Ltd: Current Employment, Divested equity in a private or publicly-traded company in the past 24 months. Lehle:F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in private company. Mahlangu:CSL Behring, Catalyst Biosciences, Freeline Therapeutics, Novo Nordisk, F. Hoffmann-La Roche Ltd, Sanofi, Spark and Takeda: Consultancy; South Africa Medical Research Council, Wits Health Consortium, Colleges of Medicine of South Africa: Membership on an entity's Board of Directors or advisory committees; CSL Behring, Catalyst Biosciences, Novo Nordisk, F. Hoffmann-La Roche Ltd, Sanofi, Spark and Takeda: Speakers Bureau; BioMarin, CSL Behring, Freeline Therapeutics, Novo Nordisk, Novartis, Pfizer, Sanofi, F. Hoffmann-La Roche Ltd, uniQure: Research Funding. Young:Bayer, CSL Behring, Freeline, UniQure: Consultancy; Genentech/Roche, Grifols, and Takeda: Research Funding; BioMarin, Freeline, Genentech/Roche, Grifols, Kedrion, Novo Nordisk, Sanofi Genzyme, Spark, Takeda, and UniQure: Honoraria. Kruse-Jarres:Biomarin, Chugai Pharmaceutical Co., CSL Behring, CRISPR Therapeutics, Genentech, Inc.: Consultancy; CSL Behring, Genentech, Inc., Spark: Research Funding; Biomarin, Chugai Pharmaceutical Co., CSL Behring, CRISPR Therapeutics, Genentech, Inc.: Honoraria; F. Hoffmann-La Roche Ltd: Speakers Bureau. Mancuso:Bayer, CSL Behring, Novo Nordisk, Pfizer, F. Hoffmann-La Roche Ltd, Octapharma, Kedrion, Grifols, Sobi, PedNet Foundation: Consultancy; Bayer, CSL Behring, Novo Nordisk, F. Hoffmann-La Roche Ltd, Octapharma, Grifols, Sobi: Speakers Bureau; Bayer, CSL Behring, Novo Nordisk, Pfizer, F. Hoffmann-La Roche Ltd, Octapharma, Kedrion, Grifols, Catalyst, Kedrion, Sobi: Membership on an entity's Board of Directors or advisory committees; Center for Thrombosis and Hemorrhagic Diseases, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy: Current Employment. Niggli:F Hoffmann-La Roche Ltd: Current Employment. Kuebler:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Selak Bienz:F. Hoffmann-La Roche Ltd: Current Employment. Shima:Chugai Pharmaceutical Co., F. Hoffmann-La Roche Ltd, BioMarin, Bayer, Sanofi: Membership on an entity's Board of Directors or advisory committees; Chugai Pharmaceutical Co. , Sanofi, Bayer, Sysmex: Speakers Bureau; Patents related to anti-FIXa/FX bispecific antibodies: Patents & Royalties; Chugai Pharmaceutical Co.: Honoraria; Chugai Pharmaceutical Co. , F. Hoffmann-La Roche Ltd, Sanofi, CSL Behring, KM Biologics, Novo Nordisk, Shire/Takeda: Research Funding; Chugai Pharmaceutical Co.: Consultancy. Jimenez-Yuste:F. Hoffman-La Roche Ltd, Novo Nordisk, Takeda, Sobi, Pfizer, Grifols, Octapharma, CSL Behring, Bayer: Honoraria; F. Hoffman-La Roche Ltd, Novo Nordisk, Takeda, Sobi, Pfizer: Consultancy; Grifols, Novo Nordisk, Takeda, Sobi, Pfizer: Research Funding. Schmitt:F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company. Asikanius:Fimea: Current Employment; F Hoffman-La Roche Ltd: Ended employment in the past 24 months; F Hoffmann-La Roche Ltd: Divested equity in a private or publicly-traded company in the past 24 months. Levy:F Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company; Genentech, Inc.: Ended employment in the past 24 months; Spark Therapeutics: Current Employment; Baxalta US: Patents & Royalties: Royalties from ADAMTS13 patent . Pipe:Medical and Scientific Advisory Council to the National Hemophilia Foundation; Medical Advisory Board to World Federation of Hemophilia: Membership on an entity's Board of Directors or advisory committees; Apcintex, Bayer, BioMarin, Catalyst Biosciences, CSL Behring, HEMA Biologics, Freeline, Novo Nordisk, Pfizer, F. Hoffmann-La Roche Ltd/Genentech, Inc., Sangamo Therapeutics, Sanofi, Takeda, Spark Therapeutics, uniQure: Consultancy; Siemens: Research Funding. Oldenburg:Bayer, BioMarin, Biotest, Chugai Pharmaceuticals Co., CSL Behring, Grifols, Novo Nordisk, Octapharma, Pfizer, F. Hoffmann-La Roche, Ltd, Spark, Swedish Orphan Biovitrum and Takeda: Speakers Bureau; Bayer, BioMarin, Biotest, Chugai Pharmaceuticals Co., CSL Behring, Freeline, Grifols, Novo Nordisk, Octapharma, Pfizer, F. Hoffmann-La Roche. Ltd, Spark, Swedish Orphan Biovitrum and Takeda: Other; Bayer, BioMarin, Biotest, Chugai Pharmaceuticals Co., CSL Behring, Freeline, Grifols, Novo Nordisk, Octapharma, Pfizer, F. Hoffmann-La Roche, Ltd, Spark, Swedish Orphan Biovitrum and Takeda: Membership on an entity's Board of Directors or advisory committees; University Clinic Bonn: Current Employment; Bayer, Biotest, CSL Behring, Novo Nordisk, Octapharma, Pfizer and Takeda: Research Funding; Bayer, BioMarin, Biotest, Chugai Pharmaceuticals Co., CSL Behring, Freeline, Grifols, Novo Nordisk, Octapharma, Pfizer, F. Hoffmann-La Roche, Ltd, Spark, Swedish Orphan Biovitrum and Takeda: Honoraria.
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Barbieri, Diego Maria, Baowen Lou, Marco Passavanti, Cang Hui, Inge Hoff, Daniela Antunes Lessa, Gaurav Sikka, et al. "Impact of COVID-19 pandemic on mobility in ten countries and associated perceived risk for all transport modes." PLOS ONE 16, no. 2 (February 1, 2021): e0245886. http://dx.doi.org/10.1371/journal.pone.0245886.
Full textAbstract:
The restrictive measures implemented in response to the COVID-19 pandemic have triggered sudden massive changes to travel behaviors of people all around the world. This study examines the individual mobility patterns for all transport modes (walk, bicycle, motorcycle, car driven alone, car driven in company, bus, subway, tram, train, airplane) before and during the restrictions adopted in ten countries on six continents: Australia, Brazil, China, Ghana, India, Iran, Italy, Norway, South Africa and the United States. This cross-country study also aims at understanding the predictors of protective behaviors related to the transport sector and COVID-19. Findings hinge upon an online survey conducted in May 2020 (N = 9,394). The empirical results quantify tremendous disruptions for both commuting and non-commuting travels, highlighting substantial reductions in the frequency of all types of trips and use of all modes. In terms of potential virus spread, airplanes and buses are perceived to be the riskiest transport modes, while avoidance of public transport is consistently found across the countries. According to the Protection Motivation Theory, the study sheds new light on the fact that two indicators, namely income inequality, expressed as Gini index, and the reported number of deaths due to COVID-19 per 100,000 inhabitants, aggravate respondents’ perceptions. This research indicates that socio-economic inequality and morbidity are not only related to actual health risks, as well documented in the relevant literature, but also to the perceived risks. These findings document the global impact of the COVID-19 crisis as well as provide guidance for transportation practitioners in developing future strategies.
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Kloppers, Elbé, and Lynnette Fourie. "CSR communication in a South African agricultural company." Communicatio 40, no. 4 (October 2, 2014): 305–22. http://dx.doi.org/10.1080/02500167.2014.974638.
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Goings, Kenneth W., and Brian D. Page. "African Americans Versus the Memphis Street Railway Company." Journal of Urban History 30, no. 2 (January 2004): 131–51. http://dx.doi.org/10.1177/0096144203259545.
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Chen, Kegui, Behnam Khatabi, and Vincent N. Fondong. "The AC4 Protein of a Cassava Geminivirus Is Required for Virus Infection." Molecular Plant-Microbe Interactions® 32, no. 7 (July 2019): 865–75. http://dx.doi.org/10.1094/mpmi-12-18-0354-r.
Full textAbstract:
Geminiviruses (family Geminiviridae) are among the most devastating plant viruses worldwide, causing severe damage in crops of economic and subsistence importance. These viruses have very compact genomes and many of the encoded proteins are multifunctional. Here, we investigated the role of the East African cassava mosaic Cameroon virus (EACMCV) AC4 on virus infectivity in Nicotiana benthamiana. Results showed that plants inoculated with EACMCV containing a knockout mutation in an AC4 open reading frame displayed symptoms 2 to 3 days later than plants inoculated with wild-type virus, and these plants recovered from infection, whereas plants inoculated with the wild-type virus did not. Curiously, when an additional mutation was made in the knockout mutant, the resulting double mutant virus completely failed to cause any apparent symptoms. Interestingly, the role of AC4 on virus infectivity appeared to be dependent on an encoded N-myristoylation motif that mediates cell membrane binding. We previously showed that EACMCV containing the AC4T38I mutant produced virus progeny characterized by second-site mutations and reversion to wild-type virus. These results were confirmed in this study using additional mutations. Together, these results show involvement of EACMCV AC4 in virus infectivity; they also suggest a role for the combined action of mutation and selection, under prevailing environmental conditions, on begomovirus genetic variation and diversity.
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GONZALEZ, ANITA. "Maritime Migrations: Stewards of the African Grove." Theatre Research International 44, no. 1 (March 2019): 64–70. http://dx.doi.org/10.1017/s0307883318000962.
Full textAbstract:
This essay discusses how maritime migrations contribute to movements of ideas across transnational ethnic communities. It focuses on actors from the African Grove, a New York City-based African American theatre company. Actors in this company worked as stewards on transatlantic packet ships where the architecture of the ship supported intercultural exchanges.
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De Oliveira Silva, Mateus, Shirley Da Costa Lima, Myrella Katlhen Da Cunha de Araujo, Carlos Renato Guedes Ramos, Rafaelly Suzanye da Silva Santos, and Magnun Antonio Penariol da Silva. "ANÁLISE ENERGÉTICA DA PRODUÇÃO DE PALMA DE ÓLEO (Elaeis guineenses Jacq.) NO ESTADO DO PARÁ." ENERGIA NA AGRICULTURA 35, no. 2 (June 26, 2020): 295–307. http://dx.doi.org/10.17224/energagric.2020v35n2p295-307.
Full textAbstract:
ANÁLISE ENERGÉTICA DA PRODUÇÃO DE PALMA DE ÓLEO (Elaeis guineenses Jacq.) NO ESTADO DO PARÁ
MATEUS DE OLIVEIRA SILVA1, SHIRLEY DA COSTA LIMA2, MYRELLA KATLHEN DA CUNHA DE ARAUJO3, CARLOS RENATO GUEDES RAMOS4, RAFAELLY SUZANYE DA SILVA SANTOS5, MAGNUN ANTONIO PENARIOL DA SILVA6
1 Bacharel em Engenharia Agrícola, Universidade Federal Rural da Amazônia – UFRA, (PA 451, Km 03, Bairro Açaizal, 68680-000, Tomé-Açu, Pará, Brasil) e mateuseng.agricola@gmail.com.
2 Bacharel em Engenharia Agrícola, Universidade Federal Rural da Amazônia – UFRA, (PA 451, Km 03, Bairro Açaizal, 68680-000, Tomé-Açu, Pará, Brasil) e shirleylimatst@gmail.com.
3 Acadêmica do curso de Bacharelado em Engenharia Agrícola, Universidade Federal Rural da Amazônia – UFRA, (PA 451, Km 03, Bairro Açaizal, 68680-000, Tomé-Açu, Pará, Brasil) e myrellakaraujo@gmail.com.
4 Professor adjunto C da Universidade Federal Rural da Amazônia, Campus de Tomé-Açu/PA, (PA 451, Km 03, Bairro Açaizal, 68680-000, Tomé-Açu, Pará, Brasil) e carlosrgramos@outlook.com.
5 Professora adjunta C da Universidade Federal Rural da Amazônia, Campus de Tomé-Açu/PA, (PA 451, Km 03, Bairro Açaizal, 68680-000, Tomé-Açu, Pará, Brasil) e rafaellysuzanye@gmail.com.
6 Orientador. Professor adjunto C da Universidade Federal Rural da Amazônia, Campus de Tomé-Açu/PA, (PA 451, Km 03, Bairro Açaizal, 68680-000, Tomé-Açu, Pará, Brasil) e penariol@gmail.com.
RESUMO: A palma de óleo (Elaeis guineenses Jacq.) é uma espécie originária da costa africana com expressiva produção em todo mundo. As principais regiões produtoras no Brasil são norte e nordeste, com destaque aos estados do Pará, Bahia e Roraima. O objetivo foi realizar uma análise energética de produção de palma de óleo em três municípios do estado do Pará (Tomé-Açu, Moju e Tailândia), identificando o quantitativo de energia investida nas atividades de manejo cultural e a energia obtido através do beneficiamento e produção do biodiesel. Portanto, o estudo foi realizado em fazendas da empresa Belém Bioenergia Brasil localizadas nos municípios de Tomé-Açu, Moju e Tailândia. Os dados coletados foram sobre as operações de limpeza, adubação e colheita de toda área produtiva. Como resposta, a entrada cultural foi de 821739762,50 MJ, saída útil de 1106150299,00 MJ, energia cultural líquida de 284415536,30 MJ e eficiência cultural de 1,34. Também, o maior consumo de energia foi direcionado a aplicação de fertilizante nitrogenado (N) com gasto energético de 562789633,3 MJ. Com todas as entradas e saídas, a produção do dendê foi considerada uma atividade viável.
Palavras-chaves: biocombustível, dendê, balanço energético.
ENERGY ANALYSIS OF PALM OIL PRODUCTION (Elaeis guineenses Jacq.) IN THE STATE OF PARÁ
ABSTRACT: The oil palm (Elaeis guineenses Jacq.) is a species originally from African coast with significant production worldwide. The main producing regions in Brazil are north and northeast, with emphasis in the state of Pará, Bahia and Roraima. The aim of this study was to conduct an energy analysis of oil palm production in three municipalities in the state of Pará (Tomé-Açu, Moju and Tailândia), identifying the amount of energy invested in cultural management activities and the energy obtained through processing and production of biodiesel. Therefore, the study was carried out on farms owned by the company Belém Bioenergia Brasil located in the municipalities of Tomé-Açu, Moju and Tailândia. The data collected were about the cleaning, fertilizing and harvesting operations of the entire productive area. In response, cultural input was 821739762.50 MJ, useful output of 1106150299.00 MJ, net cultural energy of 284415536.30 MJ and cultural efficiency of 1.34. Also, the highest energy consumption was directed to the application of nitrogen fertilizer (N) with an energy expenditure of 562789633.3 MJ. With all inputs and outputs, oil palm production was considered a viable activity.
Keywords: biofuel, oil palm, energetic balance.
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Thomas, A., and D. Lindsay. "Organisational culture at a South African food service company." South African Journal of Business Management 34, no. 4 (December 31, 2003): 45–52. http://dx.doi.org/10.4102/sajbm.v34i4.691.
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The aim of the present exploratory study was to examine whether congruence exists between the organisational culture perceived to be evident at Compass, South Africa and the strategic objectives of the company. Information from the administration of the Harrison and Stokes (1992) instrument to measure existing and preferred organisational culture orientations was obtained from a sample of 86 employees representing two employee groupings at the company. The findings indicate that a difference in perception of the existing culture is evident between the CEO and the two employee groups and that there is a lack of alignment of the culture with the strategic objective of the company. The findings further suggest that there is consensus among the employee groups about the preferred culture that would appear to support the company strategy. Recommendations with regard to developing an organisational culture to support company strategic intent relate to the development of a learning organisation and the role of leadership in driving culture change.
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van Sittert, Lance. "‘Velddrift’: the making of a South African company town." Urban History 28, no. 2 (August 2001): 194–217. http://dx.doi.org/10.1017/s0963926801002036.
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Recent reviews of South African urban history have highlighted its neglect of rural urbanization and the role of the state and capital in urban development. Natural resource frontiers offer a uniquely unobstructed view of rural urbanization under the aegis of capital and the state. The process has been well documented for South Africa's mineral revolution, but other resource frontiers have been completely ignored. The latter developed in the long shadow cast by mining and the urban metropoles, with their centripetal pull on labour and the state, making the company town an archetypal urban form on the rural periphery.
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Mitchell, Matthew David. "Three English Cloth Towns and the Royal African Company." Journal of The Historical Society 13, no. 4 (November 25, 2013): 421–47. http://dx.doi.org/10.1111/jhis.12027.
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Erasmus, Henro, Surika Van Rooyen, and Merwe Oberholzer. "Unsystematic Risk In South African Privately-Owned Company Valuations." Journal of Applied Business Research (JABR) 28, no. 3 (April 30, 2012): 449. http://dx.doi.org/10.19030/jabr.v28i3.6961.
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The purpose of the study is to determine whether advisory firms valuing privately-owned companies in South Africa take unsystematic risk into account and, if they do, how objectively it is done. A literature search was reviewed and used as a foundation in a questionnaire to gather information from the big four audit, advisory and taxation firms (PricewaterhouseCoopers, KPMG, Deloitte & Touch and Ernst & Young). The study found that unsystematic risk is incorporated into privately-owned company valuations, but that the whole subject of valuations, especially privately-owned company valuations, does not entail entire objectivity. The study further concluded that it is possible to use unsystematic risk as a device to bring the final results of a valuation in line with the clients objective. Further research should be done by extending the population to include medium- and large advisory firms and comparing the approaches used by each group.
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Killian, Cornelius. "Making sense of the disclosure of latent defects in financial statements and company acquisition contracts." South African Journal of Economic and Management Sciences 13, no. 1 (May 4, 2011): 76–84. http://dx.doi.org/10.4102/sajems.v13i1.199.
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This paper analyses the statement made by the South African Appeal Court Judge Holmes in the Phame v Paizes (1973) case and, using economic and unique South African legal principles, it examines the true legal nature of a contract to regulate company acquisitions.1 Two solutions are offered for financial managers in South Africa: (1) the contract to regulate company acquisitions is a forward contract and (2) the difficulty in identifying latent defects should not be grounds for reducing the price paid for a company or enterprise in the South African legal system.
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Krasner, David, Lisa M. Anderson, Nadine George-Graves, John Rogers Harris, Barbara Lewis, Henry Miller, and Harvey Young. "African American Theatre." Theatre Survey 47, no. 2 (September 12, 2006): 191–97. http://dx.doi.org/10.1017/s0040557406000159.
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David Krasner: In surveying contemporary London theatre, New York Times critic Ben Brantley reported that the Tricycle Theatre hadinaugurated a season of African-American plays with the commandingly titled but obscure Walk Hard, Talk Loud, a play by Abram Hill from the early1940's. Abram who? The name meant nothing to me, but Abram Hill (1910–1986) was a founder and director of the American Negro Theater in New York (1940–1951) and a playwright, it seems, of considerable verve.3That Abram Hill and the American Negro Theatre—the most important black theatre company during the mid-twentieth century—has flown below the radar is indicative of how much work still needs to be accomplished.
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Vivian, Robert W. "A history of the South African Fire & Life Assurance Company: South Africa's first insurance company." South African Journal of Economic History 11, no. 1 (March 1996): 145–57. http://dx.doi.org/10.1080/10113439609511081.
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Sigauke, Joseph, Patrick Collins, Emanuel Mutambara, and Rosemary Sibanda. "The company secretary’s role in CG: private and public owned south African companies." Corporate Ownership and Control 13, no. 1 (2015): 401–13. http://dx.doi.org/10.22495/cocv13i1c3p8.
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This study investigates the role of the company secretary in ensuring and promoting proper Corporate Governance (CG) in public and private owned South African companies, so as to educate companies on their significance in reducing corporate scandals. The study followed a mixed research paradigm in which qualitative and quantitative methods of data collection were used. Fifty questionnaires were sent to company secretaries of different business sectors giving a response rate of 78% with four of the participants telephonically interviewed to gather qualitative data. The study confirmed that the company secretary still plays a significant role in promoting CG by giving support and advising the board and its directors on CG matters. The results further show that some company secretaries are involved in director selection, performance evaluation and implement induction, training and/or professional development to strengthen the company’s governance practices. Through the use of the Companies Act and the Kings report the company secretary ensures directors are kept abreast of relevant legislative and regulatory developments. It was observed that the company secretary ensures good information flow between the board, directors and stakeholders and keeps record of all conflicts of interest. Though the company secretary is appointed by the board they can whistle blow any misconduct under the protection of the Protected Disclosure Act, thus ensuring effectiveness of their role. Despite the fact that some of the company secretaries are facing challenges due to the ever evolving and increasing complexity of their roles, there has been evolution with regards to legislation, greater transparency, better governance and improved investor expectation. This study enriches company secretaries with knowledge of their expected role in CG.
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Munisi, Gibson, and Trond Randøy. "Corporate governance and company performance across Sub-Saharan African countries." Journal of Economics and Business 70 (November 2013): 92–110. http://dx.doi.org/10.1016/j.jeconbus.2013.08.003.
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Carlos, Ann M., Nathalie Moyen, and Jonathan Hill. "Royal African Company Share Prices during the South Sea Bubble." Explorations in Economic History 39, no. 1 (January 2002): 61–87. http://dx.doi.org/10.1006/exeh.2001.0776.
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Deysel, B., and J. Kruger. "The relationship between South African CEO compensation and company performance in the banking industry." Southern African Business Review 19, no. 1 (February 26, 2019): 137–69. http://dx.doi.org/10.25159/1998-8125/5837.
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This exploratory study is based on a statistical data analysis to determine whether a long-term correlation is present between South African CEO Compensation and company performance in the banking sector. The detailed analysis, using a seven-year time period, is performed at individual company level as well as at sector level and includes two measures of company performance, namely market performance (share price) and accounting performance (return on equity, EBITDA and HEPS). The study is based on the agency theory, which postulates that linking CEO compensation to company performance is a means of reducing agency monitoring costs. It takes into account the historical and current trends in CEO compensation, including King III and its “say-on-pay” provision. Six out of seven null hypotheses were accepted in the study, indicating a long-term correlation between CEO compensation and variables such as company performance, average employee salary, general market performance and inflation. No correlation was found with company size.
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Heilbrunn, John R. "African Studies Keyword: Oil." African Studies Review 64, no. 2 (June 2021): 458–83. http://dx.doi.org/10.1017/asr.2021.30.
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AbstractOil is a metonym for terms in books and articles in diverse disciplines in African studies. Some portray oil as a causal agent that thrusts formerly low-income countries into the highly competitive neoliberal global economy. Others present it according to the oil curse/blessing binary. As a curse, petroleum causes dysfunctional and costly behavior. But increased revenues from oil just as certainly result in concrete improvements demonstrating a resource blessing. Heilbrunn uses case materials to explore environmental degradation, oil theft, community-company relations, post-conflict reconstruction, local content in contracts, and corruption. These key concepts form a basis for the keyword/concept essay on oil in Africa.
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Ilyas, Dr Muhammad, and Dr Zainab Ameen. "Analytical Review of Noel James Coulson Book’s A History of Islamic Law." Journal of Islamic Civilization and Culture 3, no. 01 (July 17, 2020): 168–89. http://dx.doi.org/10.46896/jicc.v3i01.90.
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The Western Orientalism movement had resulted in the creation of a large academic asset of Islamic literature. The Orientalists had struggled in two ways; by introducing and editing old Islamic manuscripts, and by commenting on the various aspects of the Prophet’s (PBUH) life and his traditions. Moreover, some Orientalists had worked on the Islamic jurisprudence, too. As Coulson, have been discussed analytical studies of Islamic jurisprudence, in this regard his book, “ The History of Islamic Law”, is a sorely needed book; it will substantiate a highly impactful, direly beneficial and effective book; and above all, it is a remarkably well-constructed book.
Mr. Coulson’s compact volume is a clear, comprehensive, and authoritative treatment of the genesis and history of Islamic law in theory and practice, and of the central problem of legal reform now confronting Muslim society. Islamic law, the Sharia of medieval Islam, is for Muslims and the comprehensive catalogue of God’s commands and recommendations laid down for the guidance of man… In recent times, with the wholesome adoption by Muslim countries of western legal ideas and institutions, the Sharia has seemingly been all but forsaken and abandoned… Unless the idea of a law system based on religion is to be abandoned entirely… [Coulson] points out, the task for modern Muslims, like that of their medieval predecessors, is once more to ascertain and impose the central ethical criterion norms of Islam upon the functioning’s of their society. N. J. Coulson was a chair of oriental laws at the School of Oriental and African Studies, University of London. In this article the analytical and critical review is discussed.
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Muyengwa, Goodwell, Partson Dube, Kimbelry Battle, and Errol Masinga. "An Enterprise Development Initiative: Incubation In The South African Motor Body Repair Sector." Balkan Region Conference on Engineering and Business Education 1, no. 1 (August 15, 2014): 41–46. http://dx.doi.org/10.2478/cplbu-2014-0009.
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AbstractThe paper investigates motivations, challenges and success factors experienced by an incubator company and panel shop owners during transformation from a non-registered to a registered panel shop. Since 2006 the company has assisted six black owned panel shops in upgrading their businesses through an annual grant of R1.5 million per business. The objective is to develop and empower disadvantaged black owned motor body repairers. The study was conducted through multiple case studies and in-depth interviews with owners and staff of these panel shops including incubator company personnel. The study revealed that noticeable improvements were in better infrastructure, improved management skills, registration with the repair authority, access to work from the insurance industry and better turnover. Challenges faced were in building of trust among panel shop owners and support agencies seconded to their businesses by the incubator company during the incubation process.
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Pienaar, A. J., and M. Shotter. "A South African perspective on the existence of an interest tax shield." South African Journal of Economic and Management Sciences 3, no. 2 (June 30, 2000): 308–19. http://dx.doi.org/10.4102/sajems.v3i2.2613.
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This paper investigates whether the use of debt in the capital structure of a company is beneficial to its shareholders. It finds that, in the South African context, gearing has no effect on the value of a company. The use of debt can increase the value of a company in a country where capital profits and interest are taxed equally. This is the result of an interest tax shield, which is directly related to the tax deductibility of interest paid. However, when capital growth and dividends are exempt in the bands of investors, as is the case in South Africa, the interest tax shield does not exist, and there appears to be no benefit in increasing debt.