The Federal Accounting Standards Advisory Board: A View of Its Role One Year Later

1992 ◽  
Vol 12 (4) ◽  
pp. 87-101
Author(s):  
Robert Bramlett ◽  
Frank Rexford
Keyword(s):  
Accounting Standards ◽  
Advisory Board ◽  
One Year

scholarly journals ICPC 14: what is missing?

2017 ◽  
Vol 28 (75) ◽  
pp. 478-485
Author(s):  
Ariovaldo dos Santos ◽  
Paola R. Londero
Keyword(s):  
Accounting Standards ◽  
Present Value ◽  
Reliable Representation ◽  
Net Equity ◽  
One Year

ABSTRACT The purpose of this study is to raise questions about Technical Interpretation 14 (ICPC 14) from the Accounting Standards Committee with regards to the statutory characteristics of Brazilian cooperative societies. We do not aim to provide definitive solutions by exhausting all conceptual analyses and accounting alternatives involving the reclassification of member shares, or “quotas”, from net equity to liabilities, but rather to present some considerations with regards to points that are not explicit in ICPC 14. Applying the concept of adjustment to present value (APV) is the main point of this study, which was not taken into account when ICPC 14 was elaborated. Analysis of the statutes of cooperatives indicates, as a common characteristic, the obligation to always pay the redemption of members’ quotas in a period of more than one year, and this leads us to conclude that for a reliable representation of the phenomenon it is necessary to recognize the APV of this reclassified liability.

scholarly journals Final Results of a Dual-Institution Phase I Clinical Trial of Targeted Marrow Irradiation (TMI) Intensification of Reduced-Intensity Fludarabine/Busulfan (Flu/Bu) Conditioning for Allogeneic Hematopoietic Cell Transplantation for Medically Frail Patients with High-Risk Hematological Malignancies

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 29-30
Author(s):  
Naveed Ali ◽  
Ana Carolina Pires de Rezende ◽  
Folashade Otegbeye ◽  
Mariana Nassif Kerbauy ◽  
Brenda W. Cooper ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Research Funding ◽  
Hematological Malignancies ◽  
Hematopoietic Cell Transplantation ◽  
Advisory Board ◽  
Matched Sibling ◽  
Grade 3 ◽  
One Year ◽  
Reduced Intensity

Background Reduced-intensity conditioning (RIC) regimens provide insufficient disease control in patients with high-risk hematological malignancies who are ineligible for myeloablative hematopoietic cell transplantation (HCT) due to advanced age or comorbidities. RIC fludarabine/busulfan (Flu/Bu) is generally well tolerated, but is associated with high relapse rates. We hypothesized that intensification of RIC Flu/Bu with targeted marrow irradiation (TMI) would be feasible and improve outcomes in such patients. Methods This dose escalation phase I clinical trial incorporated 3+3 design with expansion. The primary endpoint was to estimate safety and feasibility of TMI combined with Flu/Bu. Secondary endpoints included transplant-related mortality (TRM), disease free survival (DFS) and overall survival (OS). Eligible patients were ≥ 18 years diagnosed with high-risk hematological malignancies who were not candidates for myeloablative HCT. The conditioning regimen consisted of TMI (dose levels: 3 Gy, 4.5 Gy and 6 Gy) delivered at 1.5 Gy/fraction in twice daily fractions on days -10 through -7, fludarabine (30 mg/m2) on days -6 through -2 and busulfan (AUC 4800 µM*minute) on days -5 and -4. Radiation was targeted to bone marrow and spleen using intensity modulated radiation therapy (IMRT) technique while minimizing injury to organs at risk. GVHD prophylaxis included tacrolimus and methotrexate for matched sibling and unrelated donors (UD), and tacrolimus, mycophenolate mofetil and post-cyclophosphamide for haploidentical donors. Antithymocyte globulin (ATG) was added for recipients of UD transplants. Dose limiting toxicity (DLT) was defined as engraftment failure, grade ≥ 4 mucositis and grade ≥ 3 other non-hematological adverse events (AEs) from day -10 to day +32. Results A total of 26 patients (median age 64 years [range, 25-76]; 61% females) were enrolled in two transplant centers (Table 1). Diagnoses included AML (n=15), MDS (n=5), T-PLL (n=2), CLL (n=1), DLBCL (n=1), multiple myeloma (n=1) and myeloproliferative disorder (n=1). Sixteen (61%) patients had intermediate/high HCT-comorbidity index and high/very high disease risk index (DRI). At the time of HCT, 19 (73%) patients had active or residual disease. Donors were UD (n=18), matched sibling (n=5) and haploidentical (n=3). All patients engrafted neutrophils (median, 16 days [range, 10-29]). Most frequent AEs were mucositis (65%), gastrointestinal toxicity (62%), hepatotoxicity (hyperbilirubinemia and/or increased transaminase levels) (65%) and fatigue (69%). Twenty-four grade ≥ 3 AEs occurred in 13 patients; 2 patients experienced reversible DLT (mucositis and hepatotoxicity) at 6 Gy TMI dose level. Additional escalation was halted and 6 Gy cohort was expanded. Only 1 patient experienced reversible hepatotoxicity in the expansion cohort. Grade II-IV and III-IV acute GVHD rates at day +100 were 57% (95% CI, 39%-84%) and 22% (95% CI, 9%-53%), respectively. The 1-year cumulative incidence of chronic GVHD was 42% (95% CI, 24%-74%). The 1-year cumulative incidence of TRM and relapse was 8% (95% CI, 2%-32%) and 26% (95% CI, 13%-52%), respectively (Figure 1A). The overall TRM for 3 Gy, 4.5 Gy and 6 Gy cohorts was 25%, 12.5% and 12%, respectively. With a median follow up of 12.7 months (range, 1.1-36.8), 1-year DFS was 55% (95% CI, 34%-76%) and OS was 65% (95% CI, 46%-85%) (Figure 1B). One-year DFS was equivalent for patients transplanted in CR or with active disease (54% [95% CI, 14%-93%] vs 55% [95% CI, 29%-80%]; p=0.83) (Figure 1C). While no difference in DFS was observed between the 4.5 Gy and 6 Gy cohorts, the 3 Gy cohort was associated with inferior DFS (p=0.004) (Figure 1D). One-year DFS and OS for 6 Gy cohort was 58% (95% CI, 30%-87%) and 82% (95% CI, 59%-100%), respectively. Conclusion Intensification of RIC Flu/Bu with TMI is feasible, with low incidence of TRM in medically frail patients. Reversible mucositis and hepatotoxicity prevented dose escalation beyond 6 Gy. DFS and OS at 6 Gy are promising and deserve further investigation. Disclosures Malek: Janssen: Other: Advisory board, Speakers Bureau; Medpacto: Research Funding; Sanofi: Other: Advisory board; Clegene: Other: Advisory board , Speakers Bureau; Amgen: Honoraria; Takeda: Other: Advisory board , Speakers Bureau; Bluespark: Research Funding; Cumberland: Research Funding. de Lima:Pfizer: Other: Personal fees, advisory board, Research Funding; Celgene: Research Funding; Kadmon: Other: Personal Fees, Advisory board; Incyte: Other: Personal Fees, advisory board; BMS: Other: Personal Fees, advisory board. Caimi:Amgen: Other: Advisory Board; Bayer: Other: Advisory Board; Verastem: Other: Advisory Board; Kite pharmaceuticals: Other: Advisory Board; ADC therapeutics: Other: Advisory Board, Research Funding; Celgene: Speakers Bureau.

scholarly journals Treatment of Newly Diagnosed Moderate or Severe Chronic Graft-Versus-Host Disease with Prednisone and Everolimus (PredEver first): A Prospective Multicenter Phase IIa Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4523-4523
Author(s):  
Francis Ayuketang Ayuk ◽  
Eva Maria Wagner ◽  
Daniel Wolff ◽  
Stephanie von Harsdorf ◽  
Christian Koenecke ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Treatment Success ◽  
Underlying Disease ◽  
Advisory Board ◽  
Secondary Treatment ◽  
Newly Diagnosed ◽  
Graft Versus Host ◽  
Time To Treatment Failure ◽  
One Year

Background Chronic graft-versus-host disease (cGVHD) is the major cause of treatment related morbidity and mortality after allogeneic stem cell transplantation (allo-HSCT). Recently Paul Martin et al. reported that treatment success at 1 year (defined as a patient being in partial (PR) or complete remission (CR) of cGVHD, in ongoing remission of underlying disease and not requiring any secondary treatment for cGVHD) was the only endpoint associated with clinical benefit. Strikingly this robust endpoint was only achieved in less than 20% of patients undergoing primary treatment for cGVHD. Therefore, although most patients show initial response to first-line therapy, long-term clinically meaningful treatment success remains rare. Methods: We conducted a prospective multicentre phase II trial in 6 transplant centres across Germany (ClinicalTrials.gov Identifier: NCT01862965). Patients aged 18 years or older with newly diagnosed moderate or severe cGVHD were included. All patients received prednisone (1mg/kg BW) and everolimus (target level 3-8 ug/l). Study treatment was scheduled for 12 months followed by a one-year follow-up period. Primary endpoint was treatment success at 6 months defined as patient being alive, achieving PR or CR of cGVHD, having no relapse of underlying disease and requiring no secondary treatment for cGVHD. Secondary endpoints included time to treatment failure, overall survival at one and 2 years, time to response, incidence of PR /CR at 6 months, incidence of relapse, thrombotic microangiopathy, pneumonitis and osteonecrosis. Results: A total of 38 patients were included between March 2013 and February 2018 in the study. Four patients were excluded from the efficacy analysis because of screening failure. Of the 34 patients, 61% had moderate and 39% severe cGVHD. Of these 19 (56%) patients showed treatment success at 6 months with 22% and 52% of the patients in a CR and PR respectively. Overall 30 patients (88%) had a CR or PR as best response, nearly all responses (29/30) occurring within the first 6 weeks of treatment (figure 1). Median time to treatment failure was 24.7 weeks. The cumulative incidence of treatment failure at one year was 63%, resulting in a treatment success incidence of 37% (figure 2). Relapse of underlying disease was diagnosed in 2 (5.9%) patients. Other predefined side effects (thrombotic microangiopathy, pneumonitis and osteonecrosis) were not observed in any patient. Conclusion: This, to the best of our knowledge, is the first prospective study analysing the endpoint treatment success as defined by Paul Martin et al. Our results indicate that addition of everolimus to prednisolone is well tolerated and may help improve long-term outcome of patients with cGVHD. Acknowledgements: This study was supported by a research grant from Novartis to Nicolaus Kröger and Francis Ayuk Disclosures Ayuk: Novartis: Honoraria, Other: Advisory Board, Research Funding. Wagner:MEDAC: Other: Travel support; Novartis: Other: Advisory board; Pfizer: Other: Advisory board; MSD: Other: Advisory board. Wolff:Neovi: Honoraria; Novartis: Honoraria; Takeda: Honoraria; Mallinckrodt: Honoraria. von Harsdorf:Novartis: Other: none. Koenecke:Novartis: Other: none. Sayer:Novartis: Other: none. Kroeger:Novartis: Honoraria, Other: Advisory Board, Travel Costs, Research Funding. OffLabel Disclosure: Everolimus used for Treatment of chronic GVHD

scholarly journals Post-Transplant High Dose Cyclophosphamide and Bortezomib As Graft-Versus-Host Disease Prophylaxis Following Allogeneic Hematopoietic Stem Cell Transplantation

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3892-3892
Author(s):  
Benedetto Bruno ◽  
Frank Cirrone ◽  
Kelli Cole ◽  
Kelsey Stocker ◽  
Maher Abdul-Hay ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cell Transplantation ◽  
Graft Versus Host Disease ◽  
Cumulative Incidence ◽  
Chronic Gvhd ◽  
Advisory Board ◽  
High Dose ◽  
Graft Versus Host ◽  
One Year ◽  
Grade Iii

Abstract Introduction. Prevention of graft-versus-host disease (GvHD) following allogeneic hematopoietic cell transplantation (AHCT) remains a major challenge. The combination of methotrexate (MTX) and a calcineurin inhibitor has been the standard regimen for prophylaxis in patients receiving matched sibling donor (MSD) or matched unrelated donor (MUD) transplants for the past few decades. However, over 50% of patients undergoing AHCT still develop acute or chronic GvHD or even both, causing high rates of morbidity and mortality. Moreover, calcineurin inhibitors also have untoward toxic side effects. High dose post-transplant cyclophosphamide (PTCy), initially introduced for GvHD prevention in the setting of haploidentical transplantation, has now been studied in MSD and MUD transplants. We adopted a novel approach to prevent GvHD using a short course of PTCy and bortezomib. We hypothesized that such combination is safe and effective and omits the need for calcineurin or m-TOR inhibitors. Study Design. We report the outcomes of a prospective cohort of patients who received PTCy and bortezomib for GvHD prevention following MSD or MUD transplants. Twenty-eight patients were treated in a phase I-II trial and their clinical outcomes were previously reported (al-Homsi AS et al, BBMT 2019). Most of the remaining patients were treated on an extension trial. GvHD prevention consisted of PTCy 50 mg/kg IV on day +3 and +4, and bortezomib 1.3mg/m 2 IV 6 hours after transplant and again 72 hours after. Patients receiving MUD transplants also received rabbit ATG (thymoglobulin®) 5mg/kg total IV fractionated on day -4 to -2. All patients received peripheral blood grafts and standard supportive care as per Institutional policy. G-CSF was administered routinely until neutrophil engraftment. Results. Fifty-eight patients are included in this analysis. Median age was 60 (range 22-78) years. Fifty-three percent of patients were male. Underlying malignancies consisted of myeloid and lymphoid malignancies in 79.3% and 20.6%, respectively. Acute myeloid leukemia (50%) and myelodysplastic syndromes (24.1%) were the most common diseases. At transplant, disease risk index was low, intermediate, high and very high in 19.0%, 48.3%, 31.0% and 1.7% of patients, respectively. Median Pretransplant Assessment of Mortality Score (PAM) was 16.7 (5.4-29.4). Grafts were from MSD in 24.1% or MUD in 75.9% of patients. Recipient (R)/Donor (D) CMV status at transplant was as follows: R+/D+: 43%; R+/D-: 21%; R-/D+: 14% and R-/D-: 22%. Conditioning regimens consisted of reduced intensity fludarabine and busulfan in all but 2 patients who were conditioned with myeloablative fludarabine and busulfan. Overall, the regimen was remarkably well tolerated. Median times to neutrophil and platelet engraftment were 16 (13-28) and 26 (15-57) days respectively. No patient experienced primary graft failure. CMV and EBV reactivation rates were 46.6% and 24%. Cumulative incidences of grade II-IV and grade III-IV acute GVHD were 35% (95% CI: 22%-47%) and 15% (95% CI: 7%-25%) at day +120, respectively. Cumulative incidence of chronic GvHD was 14% at 1 year . Overall, 34% of patients required immunosuppression with systemic steroids after day +4 either for grade III-IV acute or chronic GvHD. Disease relapse rate was 26%. One-year cumulative incidence of transplant-related mortality was 14% (95% CI: 6%-25%). Median overall survival was 30.7 (95% CI: 15.7-not yet reached) months. One-year overall survival was 72% (95% CI: 57%-82%). One-year composite GvHD (acute and chronic) free and relapse free survival (GRFS) was 41.6% (95% CI: 28.9%-54%). Conclusion. PTCy and bortezomib combination for GvHD prophylaxis following MSD and MUD transplants is well tolerated and effective. It offers an alternative regimen to calcineurin and m-TOR inhibitor-containing regimens and may be preferred in certain settings including patients with limited resources, poor medication compliance, and with impaired renal function. A comparison of this cohort to a matched control group of patients receiving methotrexate and cyclosporine for GvHD prevention is ongoing. Disclosures Abdul-Hay: Amgen: Membership on an entity's Board of Directors or advisory committees; Servier: Other: Advisory Board, Speakers Bureau; Jazz: Other: Advisory Board, Speakers Bureau; Abbvie: Consultancy; Takeda: Speakers Bureau. Al-Homsi: Celyad: Other: Advisory Board; Daichii Sanyko: Consultancy. OffLabel Disclosure: Cyclophosphamide and Bortezomib are used for GvHD prevention

scholarly journals The Applicability of International Standards for Long-Term Leases through the Iraqi Government Accounting System

2019 ◽  
Vol 54 (6) ◽  
Author(s):  
Sattar Gaber Khallawy ◽  
Hagar Khadim Mohsen
Keyword(s):  
Accounting Standards ◽  
International Standards ◽  
International Accounting ◽  
Accounting System ◽  
International Accounting Standards ◽  
Government Accounting ◽  
Needed Information ◽  
The Government ◽  
One Year

The research highlights the long-term leases according to the international accounting standards in public sector within the economic units that apply the government accounting system. The long-term lease is a lease that has a framework of terms and conditions ratified between two persons; or it is a group of agreements which the two parties of the contract (lessor and lessee) are committed by. The lease is usually valid for over one year. The international accounting standards name several treatments in the lessor registry in order to get suitable measurement and disclosure of the users’ needed information and the statement of financial position of the economic unit. Measurements are one of the most important operations that facilitate accessing to reliable data; disclosure is the most significant operator in validity and accuracy of information about the building that is provided to the users.

scholarly journals IPTEKS PERLAKUAN AKUNTANSI TERHADAP PENGUKURAN ASET TETAP PADA KANTOR LURAH KLEAK

2018 ◽  
Vol 2 (02) ◽  
Author(s):  
Reinhard Valen Ipu ◽  
Sherly Pinatik
Keyword(s):  
Accounting Standards ◽  
Financial Accounting ◽  
Tangible Assets ◽  
Fixed Assets ◽  
Useful Life ◽  
Operational Activities ◽  
One Year ◽  
The Village ◽  
Office Equipment

Fixed assets are tangible assets owned by the company or agency in question not for sale, but to assist the operational activities of an agency and have a useful life of more than one year. The kleak village office has several supporting factors in conducting operational activities, one of which in the form of office equipment. This study aims to determine wherher the village office has measured fixed assets based on applicable financial accounting standards. Based on the data that the author obtained it can seen that the village office has not measured fixed assets in accordance with PSAK No. 16.Keywords : Measurement of fixed assets, PSAK No. 16

scholarly journals Is Capitalization of Operating Lease Way to Increase of Comparability of Financial Statements Prepared in Accordance with IFRS and US GAAP?

2015 ◽  
Vol 63 (2) ◽  
pp. 507-514
Author(s):  
Hana Bohušová
Keyword(s):  
Financial Analysis ◽  
Negative Impact ◽  
Stock Exchange ◽  
Accounting Standards ◽  
Financial Statements ◽  
Common Effort ◽  
One Year ◽  
Lease Contracts ◽  
The Impact ◽  
Us Gaap

The paper is concerned with an evaluation of possibilities of companies using operating lease and prepared financial statements under IFRS or US GAAP comparison. The data of non-financial companies listed on the Prague Stock Exchange and reporting information on operating lease in accordance with IAS 17 are used. The study presents the impact of operating lease capitalization on companies’ financial statements and financial analysis ratios. The results show a negative impact of operating lease capitalization on financial analysis ratios. The study was motivated by a common effort of the International Accounting Standards Board (IASB) and the Financial Accounting Standards Board (FASB) to develop the common standard for Lease reporting. In 2013, a joint exposure dra of standard (ED2013/6) Leases was published. Under the new standard, it is required to capitalize all lease agreements over one year. The distinction between operating leases and finance leases should not exist anymore. The study was carried out to demonstrate the potential impact resulting from the proposed adoption of the new accounting standard concerning mandatory capitalization of all lease contracts.

Feasibility and Outcome of Sequential Therapy in the Setting of HLA-Haploidentical Transplantation Utilizing Reduced-Intensity Conditioning, T-Cell-Replete Grafts and Post-Transplantation High-Dose Cyclophosphamide in the Treatment of High-Risk AML and MDS

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4318-4318
Author(s):  
Dusan Prevalsek ◽  
Susanne Fritsch ◽  
Max Hubmann ◽  
Nicole Engel ◽  
Anna-Katharina Zoellner ◽  
...  
Keyword(s):  
High Risk ◽  
Chronic Gvhd ◽  
Sequential Therapy ◽  
Advisory Board ◽  
High Dose ◽  
Reduced Intensity Conditioning ◽  
Post Transplantation ◽  
Hematopoietic Stem ◽  
One Year ◽  
Severe Grade

Abstract Hematopoietic stem cell transplantation is a potent curative treatment option for patients suffering from high-risk AML and MDS. However, not in all of our patients a suitable HLA-matched donor could be identified in time. To evaluate the feasibility and outcome of T-cell-replete (TCR) HLA-haploidentical hematopoietic stem cell transplantation (haplo-HSCT) utilizing post-transplantation high-dose cyclophosphamide (PTCY) in the context of sequential therapy in patients with high-risk, relapsed/refractory and progressive AML and MDS, we retrospectively analyzed the course of 64 patients (AML n=61, MDS n=3; median age: 50 years; male n=30) transplanted between 2009 and 2015 at our center. Disease was advanced in 55 patients including 24 patients with relapse after a first allogeneic transplantation. 54 patients presented with active disease at time of haplo-HSCT. Donors (median age: 38 years; male n=30) were fully HLA-haplotype mismatched (5/10 HLA-loci) in 48 cases (77%). All patients received sequential therapy prior to haplo-HSCT combining cytoreductive chemotherapy (clofarabine n=34; FLAMSA n=25; FLAG-Ida n=2; others n=3) and reduced-intensity conditioning (RIC) which was started after three days of rest thereafter. Conditioning was drug-based in 42 patients receiving fludarabine, cyclophosphamide (CY) and melphalan (110 mg/m2) while it was TBI-based in the others (n=22) consisting of fludarabine and CY plus either 4 (n=20) or 2 Gy TBI (n=2). Post-grafting immunosuppression was high-dose CY given on day + 3 and +4, tacrolimus and mycophenolate mofetil (both started on day +5) in all patients. Unstimulated bone marrow was the graft source in 37 patients. One graft rejection was observed after conditioning with 2 Gy TBI. Neutrophil/platelet engraftment was achieved in 49/58 evaluable patients at a median of 16 (range: 14-27) and 20 (range: 13-74) days, respectively. Acute GvHD grade II-IV occurred in 19 patients (30 %) while it was severe (grade III-IV) in only 3 (5 %). Chronic GvHD was most frequently mild (n=9) to moderate (n=8); one severe chronic GvHD occurred. Severe (grade III-IV) mucositis, hemorrhagic cystitis and hand-foot syndrome/rash were observed in 10, 5 and 2 patients, respectively; no patient developed VOD. Kidney failure requiring hemodialysis occurred in 7 patients. CMV reactivation was observed in 28 of 47 patients at risk (59 %) and EBV in 3, while only one patient developed CMV disease (pneumonia) and no patient developed PTLD. Probable or proven (n=2) invasive aspergillosis was diagnosed in 10 patients. One-year non-relapse mortality was 27.5 % (95% CI 17-41). After a median follow up of 21 months (range: 3-64), estimated one-year overall survival (OS) was 55 % (95 % CI 41-66), and one-year disease-free survival (DFS) was 43 % (95 % CI 26-51). At two-years after sequential haplo-HSCT OS and DFS were both 39 % (95 % CI 26-51). In summary, sequential therapy in the setting of RIC-TCR haplo-HSCT using PTCY is well tolerated with low rates of GvHD and acceptable NRM in patients with high-risk AML and MDS, while providing an effective anti-leukemic activity in advanced disease. Results are comparable to data of a historical cohort of patients with high-risk AML and MDS undergoing sequential therapy using the FLAMSA-RIC protocol in a HLA-matched setting, as reported by our group previously. Thus, we suggest that donor availability can be expanded in patients with high-risk and advanced AML/MDS who lack a conventional donor or need promptly access to a donor due to aggressive disease. Disclosures Hausmann: Sanofi-Aventis: Other: advisory board. Tischer:Sanofi-Aventis: Other: advisory board. Off Label Use: clofarabine in adults; efficacy is shown in myeloid blasts;.

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