Deep-vein thrombosis in patients with multiple myeloma receiving first-line thalidomide-dexamethasone therapy

Blood ◽  
2002 ◽  
Vol 100 (6) ◽  
pp. 2272-2272 ◽  
Author(s):  
Michele Cavo ◽  
Elena Zamagni ◽  
Claudia Cellini ◽  
Patrizia Tosi ◽  
Delia Cangini ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Deep Vein Thrombosis ◽  
First Line ◽  
Vein Thrombosis ◽  
Dexamethasone Therapy ◽  
Deep Vein

Thalidomide Plus Dexamethasone for Untreated Newly Diagnosed Multiple Myeloma Patients and Deep Vein Thrombosis.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5093-5093 ◽  
Author(s):  
Victor H. Jiménez ◽  
Virginia J. Domínguez ◽  
Eduardo E. Reynoso
Keyword(s):  
Multiple Myeloma ◽  
Deep Vein Thrombosis ◽  
Oral Dose ◽  
Newly Diagnosed ◽  
First Line ◽  
Factor V Leiden Mutation ◽  
Vein Thrombosis ◽  
First Line Therapy ◽  
Line Therapy ◽  
Deep Vein

Abstract Background The combination of thalidomide/dexamethasone (TD) induces remission in approximately 70% of previously untreated patients with low or intermediate tumor mass. TD appeared superior to previous programs because of the high response rate and reasonable survival and its low frequency of serious complications. The aim of our study was to assess the efficacy of thalidomide plus dexamethasone as first line therapy and the incidence of deep vein thrombosis. Material and methods Patients with newly diagnosed and symptomatic MM (untreated patients) were evaluated. We enrolled all patients who fulfilled entire criteria for multiple myeloma between January 1998 and December 2005. Patients were divided into 2 groups: thalidomide plus dexamethasone (TD) and VAD group. The present study is a prospective, descriptive, longitudinal and observational one. Thalidomide was prescribed in an oral dose of 100 mg qhs and increased by 50 mg every 7 days to a maximum dose of 300 mg, depending on side effects. Dexamethasone was given in an oral dose of 20 mg/m2 each morning after breakfast on days 1–4, 9–12 and 17–20, followed by 10 days without therapy prior to the next cycle. Treatment with the combination was continued for at least 6 months or until the earliest occurance of maximum plateau of myeloma protein reduction, autologous transplant-supported intensification or other treatments. VAD was given as an Out-patient regimen including: vincristine (0.4mg/day, continuous IV), doxorubicin (9mg/m2/day, continuous IV) and dexamethasone (40 mg/day PO) with a median of 6 courses. Citrate plasma was used to investigate coagulation and anticoagulation parameters. Results Sixty newly diagnosed multiple myeloma patients were included in the study, 35 (58%) male and 25 (42%) female, aged 45–85 (mean 63). Underlying diagnosis was IgG MM in 44 (73.3%), IgA in 12 (20%) and light chain disease in 4 (6.7%). Clinical characteristics were similar for both groups. According to Durie Salmon criteria patients were grouped into: IA (n6, 10%), IB (n3, 5%), IIA (n12, 20%), IIB (n6, 10%), IIIA (n19, 31.6%) and IIIB (n14, 23.4%). The frequency of response (CR, NCR/VGPR and PR) in the group of thalidomide and dexamethasone was 73% being higher than VAD (53%)p0.005. CR was observed in 5 patients treated with thalidomide/dexamethasone (16%). Thrombosis complications DVT was observed in 7 patients. DVT occurred in 4 patients treated with TD and 3 with VAD. From the last 40 patients, 5 presented APC-R and 3 of them developed DVT. A significant shorter time to DVT was observed in patients exposed to VAD chemotherapy (first 2 cycles p 0.007). Patients developing APC-R were tested for Factor V Leiden mutation resulting negative. After patients developed any response criteria were retested for acquired activated protein C resistance, all of them went back to normal. Finally we conclude TD is an effective, less toxic therapy in comparison with VAD as first line therapy and in order to reduce incidence of DVT effective prophylactic anticoagulation should be implemented in all controlled trials, at least during the first few cycles of treatment.

Thalidomide-Induced Leukopenia in Japanese Patients with Refractory Multiple Myeloma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5089-5089
Author(s):  
Hirokazu Murakami ◽  
Hiroshi Handa ◽  
Masahiro Abe ◽  
Shinsuke Iida ◽  
Akihiro Ishii ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Platelet Count ◽  
Deep Vein Thrombosis ◽  
Adverse Events ◽  
Low Dose ◽  
The United States ◽  
Refractory Multiple Myeloma ◽  
Vein Thrombosis ◽  
Dexamethasone Therapy ◽  
Deep Vein

Abstract Background: Thalidomide is effective for treating refractory multiple myeloma; however, it induces many adverse events, including peripheral neuropathy, deep vein thrombosis, constipation, and neuropsychological symptoms. Hematological adverse events have rarely been reported in the United States and Europe. Some Japanese cases have been reported to reveal leucopenia during thalidomide therapy. We report here severe leucopenia, which has been observed in the JMSG phase II study “Low-dose thalidomide plus low-dose dexamethasone therapy for refractory myeloma”, and analyze the factors related to leucopenia. Patients and Methods: Patients with refractory myeloma were eligible. Thalidomide at 100 mg/day was administered on Days 1–7 and increased to 200 mg/day without severe adverse events, and continued until disease progression. Dexamethasone at 4 mg/day was administered on Days 1–28, decreased to 1 mg/day, and maintained at 1 mg/day. The response was assessed by the finding of a decline in paraprotein in serum or urine on two occasions at least 4 weeks apart. Results: Sixty-six patients (male/female ratio: 0.7; median age, 64.5 years; range, 40–74 years) were enrolled in the study. The myeloma subtypes were 48 IgG, 6 IgA, 1 IgD, and 11 light chain only. Forty-nine patients were refractory for conventional chemotherapy and 17 patients had relapsed disease after autologous stem cell transplantation. Responses were observed in 30 patients (4 near complete response, 9 partial response, and 17 minimal response) (45.5%). Median progression-free and overall survivals were 6.2 months and 23.3 months. The incidence rates of grade 2 or higher events were: peripheral neuropathy, 7.5%; hyperglycemia, 1.5%; skin rash, 4.5%; constipation, 4.5%; and deep vein thrombosis, 4.8%. Grade 1–2 incidence of leukopenia was 41% and of thrombocytopenia was 27%; Grade 3 or higher leucopenia was observed in 12%. One patient died from sepsis caused by severe leucopenia. Thalidomide-induced leucopenia was closely related to pre-treatment white blood cell count (p<0.02) and platelet count (p<0.001). Thrombocytopenia was related to pre-treatment platelet count (p<0.01). In addition, the incidence of leucopenia was significantly higher in patients with a pretreatment platelet count <100×109/L (p<0.001). There was no relationship between hematological adverse events and disease period. Conclusion: Low-dose thalidomide plus low-dose dexamethasone therapy was as effective as low-dose thalidomide plus high-dose dexamethasone therapy in patients with refractory multiple myeloma. The incidence of adverse events including deep vein thrombosis and hyperglycemia was lower than the data reported in the United States and Europe. However, leukopenia is one of the most serious adverse events in Japanese patients, especially in patients with low pretreatment white blood cell and platelet counts.

Rapid Control of Previously Untreated Multiple Myeloma with Bortezomib-Lenalidomide-Dexamethasone (BLD).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3611-3611 ◽  
Author(s):  
Michael Wang ◽  
Kay Delasalle ◽  
Sergio Giralt ◽  
Raymond Alexanian
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Deep Vein Thrombosis ◽  
Intensive Therapy ◽  
Primary Treatment ◽  
Short Exposure ◽  
Newly Diagnosed ◽  
Vein Thrombosis ◽  
Grade 3 ◽  
Deep Vein

Abstract Introduction: Both bortezomib (B) and lenalidomide (L) are effective against relapsed/refractory and newly-diagnosed multiple myeloma (MM). The 3-drug combination of bortezomib-thalidomide-dexamethasone had induced remission in 87% of patients with untreated myeloma, significantly higher than the frequency of 66% observed with thalidomide dexamethasone. Patients and Method: We conducted a retrospective review of a pilot study in 17 previously-untreated patients with MM who were treated with bortezomib-lenalidomide dexamethasone between 4/06–4/07. Median age was 60 (35–71), median B2M was 3.7 mg/L (1.8–11.7) and median Hgb was 11 g/dl (6–14.7). Serum creatinine was greater than 2 mg/dl in one patient (6%). Bortezomib was given at 1.3 mg/m2 intravenously on days 1,4, 8 and 11; lenalidomide was at 25 mg orally daily for 21 days; and dexamethasone was at 20 mg/m2 daily orally for 4 days beginning on days 1, 9 and 17. Each cycle was 28 days. After the first cycle, a second cycle was given to 10 patients so that the median cycles of therapy was 2. As prophylaxis for deep vein thrombosis, all patients received warfarin with a targeted INR range between 2–3. All patients received daily orally vancyclovir to prevent herpes zoster. Results: Applying the Blade criteria of response (PR: greater than 50% reduction of serum myeloma protein and/or greater than 90% reduction of Bence Jones protein), remission of disease was observed in 14/17 patients (82%), including 2 patients (12%) with CR based on negative immunofixations and 12 patients (70%) with PR. All but one patient achieved remission after 1 cycle of treatment. Three patients were resistant to bortezomib-lenalidomide-dexamethasone after 2 cycles. One patient had deep vein thrombosis with pulmonary emboli. One patient had short-term grade 3 neuropathy. One patient had grade 3 thrombocytopenia and one patient had nonneutropenic pneumonia. Median nadir neutrophil count was 3000/ul (range 1400–5400/ul), and median nadir platelet count was 174 k/ul (range 38–270 k/ul). After a median 3.6 months (range 3.3–5.5), intensive therapy supported by autologous blood stem cells was given to 11 patients. Three of the 11 patients in PR after induction with bortezomib-lenalidomide-dexamethasone were converted to CR with intensification. Consequently, the CR rate after intensification 29%. Intensification is planned for the 3 patients with primary resistant MM. Discussion: Overall response and CR rates were similar to those observed previously among similar patients treated with bortezomib-thalidomide-dexamethasone. All reported primary treatment programs based on bortezomib-dexamethasone have induced high response rates of 82–92%, regardless of whether melphalan, lenalidomide, or thalidomide were included. Conclusions: One or two cycles of bortezomib-lenalidomide-dexamethasone were associated with rapid onset of response in patients with newly-diagnosed multiple myeloma. Toxicity was infrequent due to short exposure to bortezomib-lenalidomide-dexamethasone. There was early access to intensive therapy supported by autologous stem cells. Reduced exposure to drugs given as primary treatment should help preserve disease sensitivity to later treatment upon relapse.

Elevated Levels of Circulating Nucleosomes Are Not Associated with Venous Thrombosis or Neutrophil Activation in Patients with Multiple Myeloma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 274-274
Author(s):  
Mandy N. Lauw ◽  
Frank W.G. Leebeek ◽  
Moniek P.M. de Maat ◽  
Gerard J. van Mierlo ◽  
Saskia Middeldorp ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Deep Vein Thrombosis ◽  
Human Neutrophil ◽  
Research Funding ◽  
Neutrophil Activation ◽  
Extracellular Dna ◽  
Human Neutrophil Elastase ◽  
Newly Diagnosed ◽  
Vein Thrombosis ◽  
Deep Vein

Abstract Background: Patients with multiple myeloma (MM) are at a 9-fold increased risk of venous thromboembolism (VTE). Mechanisms underlying the increased VTE risk in MM have not yet been clarified. Recently, extracellular DNA, e.g. nucleosomes, has been shown to play a central role in coagulation activation and propagation in vivo and in animal models. Increased nucleosome levels were demonstrated in patients with VTE, supporting their role in VTE development. The prothrombotic activity of nucleosomes may be of importance in systemic inflammatory states, in which activated immune cells can release nucleosomes, such as neutrophils by forming neutrophil extracellular traps (NETs). However, during inflammation and upon chemotherapy, parenchymal cells and tumor cells, respectively, can also release extracellular DNA in the form of nucleosomes, which could promote coagulation. As MM is regarded as a systemic inflammatory disease, we hypothesized to find elevated levels of nucleosomes in MM patients, with an association between the highest levels of nucleosomes and development of VTE. Therefore, we assessed levels of nucleosomes and neutrophil activation, and their association with VTE, in a cohort of patients with newly diagnosed MM. Methods: We assessed levels of circulating nucleosomes and systemic neutrophil activation, by presence of elastase-α1-antitrypsin (EA) complexes, in 131 patients with newly diagnosed MM using plasma samples. Interleukin (IL)-6 and IL-8 levels were also assessed to estimate the inflammatory state. We used a case-cohort design to investigate the association between nucleosomes, neutrophil activation and VTE, by calculating odds ratios (ORs) with corresponding 95% confidence intervals (CIs) using nucleosomes and EA complexes as categorical variables, based on the 80th percentile for MM patients without VTE, with ≤80th percentile being the reference category. To compare levels of nucleosomes and neutrophil activation complexes in MM patients with patients with other malignancies, a comparison was made with a cohort of cases with objectified deep-vein thrombosis (DVT) of the leg and screened controls without DVT, stratified by malignancy status. Results: 19 of 131 MM patients (14.5%) developed VTE during MM treatment. Levels of nucleosomes (median 39.5 U/mL; interquartile range [IQR] 7.9-156.8, vs. median 25.6 U/mL; IQR 10.9-76.4; p=0.61) and neutrophil activation, as evidenced by presence of EA complexes (median 30.1 U/mL; IQR 22.6-39.3, vs. median 31.6 U/mL; IQR 24.3-46.0; p=0.45), did not differ between MM patients with and without VTE. No association was found between high levels (>80th percentile of non-VTE MM patients) of nucleosomes or neutrophil activation, and VTE (OR 0.5; 95% CI 0.2-1.6, and OR 2.1; 95% CI 0.5-9.7, respectively) in MM patients. IL-6 and IL-8 levels were low in all MM patients, irrespective of VTE. Nucleosome levels were similarly high in MM patients compared with DVT patients with other malignancies, and significantly higher compared with DVT patient without malignancies, and with DVT controls, irrespective of malignancy status (Fig. 1A). In contrast, levels of neutrophil activation were significantly lower in MM patients in all comparisons (Fig. 1B). Conclusions: Elevated levels of nucleosomes were found in MM patients, but without correlating high levels of neutrophil activation. Nucleosome levels in MM patients with and without VTE were similar, and there was no association between high levels of circulating nucleosomes or neutrophil activation, and VTE in MM patients. Our results suggest that elevated levels of nucleosomes in MM patients are independent of neutrophil activation or inflammatory status, but rather a marker of plasma cell injury or death. This could also explain absence of a clear association with VTE. Future studies are necessary to confirm the source and the clinical relevance of high levels of nucleosomes in MM patients. Figure 1 Levels of nucleosomes and neutrophil activation (by presence of human neutrophil elastase-α1-antitrypsin (EA) complexes) in patients with multiple myeloma (MM), compared with cases with deep vein thrombosis (DVT) of the leg with other malignancies or without malignancies, and DVT controls with other malignancies or without malignancies Median levels of circulating nucleosomes (1A), and median levels of EA complexes (1B). Bars represent median with interquartile ranges (IQR). Figure 1. Levels of nucleosomes and neutrophil activation (by presence of human neutrophil elastase-α1-antitrypsin (EA) complexes) in patients with multiple myeloma (MM), compared with cases with deep vein thrombosis (DVT) of the leg with other malignancies or without malignancies, and DVT controls with other malignancies or without malignancies. / Median levels of circulating nucleosomes (1A), and median levels of EA complexes (1B). Bars represent median with interquartile ranges (IQR). Disclosures Leebeek: Baxter: Research Funding; UniQure: Consultancy; Netherlands Hemophilia Foundation: Research Funding; CSL Behring: Research Funding.

scholarly journals Deep vein thrombosis in patient with pulmonary tuberculosis: a rare and interesting causative link?

2019 ◽  
Vol 6 (2) ◽  
pp. 542
Author(s):  
Rohin Saini ◽  
Arvind Mishra ◽  
Kamlesh Kumar Gupta ◽  
Monika Kallani
Keyword(s):  
Deep Vein Thrombosis ◽  
Pulmonary Tuberculosis ◽  
Complete Recovery ◽  
Iliac Vein ◽  
Acute Onset ◽  
First Line ◽  
Vein Thrombosis ◽  
Thrombogenic Potential ◽  
Deep Vein ◽  
Causative Link

Pulmonary tuberculosis is a devastating disease affecting millions of people in developing countries such as India. Many complications of this disease are known, however only few of its hematological complications have been reported. Discovery of its unknown thrombogenic potential is one such disturbing new entity. Tuberculosis can induce a hypercoagulable state and can lead to thromboembolic complications and deep vein thrombosis. Here we report an interesting and rare case of 20-year-old male, newly diagnosed case of Pulmonary Tuberculosis presenting with complaints of acute onset right lower limb swelling and pain. He was diagnosed with thrombosis of external iliac vein. All possible causes for a provoked deep vein thrombosis were evaluated for and ruled out. The patient was started with first line anti tubercular treatment-rifampicin, isoniazid, pyrizinamide, ethambutol along with anti-thrombotics injection enoxaparin and warfarin and followed up for 6 months. He made complete recovery of both his pulmonary and limb disease.

Stratification of Venous Thromboembolism Risk in Ovarian Cancer Patients During Chemotherapy

2009 ◽  
Vol 19 (1) ◽  
pp. 79-83 ◽  
Author(s):  
Liliana Mereu ◽  
Saverio Tateo ◽  
Catherine Klersy ◽  
Eva Martinotti Gabellotti ◽  
Franco Polatti
Keyword(s):  
Ovarian Cancer ◽  
Deep Vein Thrombosis ◽  
Prognostic Factors ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
First Line ◽  
Susceptible Population ◽  
Vein Thrombosis ◽  
Multivariable Regression ◽  
Deep Vein

Background:The prevalence of venous thromboembolism (VTE) in ovarian cancer during first-line chemotherapy (CHT) ranges between 6.4% and 10.6%. Identification of the susceptible population is crucial for effective thromboprophylaxis.Methods:We performed a retrospective study of all our patients with epithelial ovarian cancer who underwent ambulatory first-line CHT between 1990 and 2004. Data were collected regarding age, body mass index (BMI), previous deep vein thrombosis, pulmonary embolism (PE), menopause status, FIGO stage, grade, histology, type of surgery, residual disease, and CHT. Univariable and multivariable regression analyses were performed to assess independent prognostic factors for VTE/PE to calculate a prognostic index (PI).Results:Of 203 patients, 16 (7.8%) had symptomatic VTE: 15 deep vein thrombosis and 1 PE. Multivariable regression analysis found that age (P = 0.01), BMI (P = 0.01), and stage (P = 0.05) were independent prognostic factors for VTE. Age, BMI, and stage were used to calculate the PI: 0.285 × age + 0.555 × BMI + 1.110 × stage. The PI was dichotomized according to its median cutoff (5.8) to define a low (3.8% at 6 months) and a high (11.3%) VTE incidence group.Conclusions:Age, BMI, and stage permit to identify ovarian cancer patients with a high risk in developing symptomatic VTE during CHT.

Thalidomide and Deep Vein Thrombosis in Multiple Myeloma: Risk Factors and Effect on Survival

2003 ◽  
Vol 4 (1) ◽  
pp. 32-35 ◽  
Author(s):  
Maurizio Zangari ◽  
Bart Barlogie ◽  
Raymond Thertulien ◽  
Joth Jacobson ◽  
Paul Eddleman ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multiple Myeloma ◽  
Deep Vein Thrombosis ◽  
Vein Thrombosis ◽  
Deep Vein

The Incidence of Deep Vein Thrombosis Is Lower in Japanese Patients with Multiple Myeloma Treated with Thalidomide and Corticosteroids or Chemotherapy

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5215-5215
Author(s):  
Naoko Takei ◽  
Masahiro Kami ◽  
Masaharu Tsubokura ◽  
Yuji Miura ◽  
Takehiro Issiki ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Deep Vein Thrombosis ◽  
Combination Treatment ◽  
Medical Center ◽  
Japanese Patients ◽  
Chemotherapeutic Agents ◽  
Ultra Sound ◽  
Newly Diagnosed ◽  
Vein Thrombosis ◽  
Deep Vein

Abstract Background: Deep vein thrombosis (DVT) is an important complication of thalidomide therapy especially when it is combined with corticosteroids or chemotherapy. Japanese patients with multiple myeloma (MM) are currently prescribed thromboprophylaxis after ASCO guideline, although there are limited data for asian population. We examined the incidence of DVT in Japanese patients with MM. Methods: We reviewed the records of 145 patients receiving thalidomide for newly diagnosed or relapsed/refractory MM at Kameda Medical Center and Tsukuba Memorial Hospital during the 10-year period 1998–2008. Patients were considered to have developed DVT if they presented with suggestive symptoms of leg swelling and had a Doppler ultra-sound study confirming acute thrombosis. Results: 95 of the 145 patients received thalidomide in combination with a corticosteroid or other chemotherapeutic agents. 70 of 95 patients were prescribed thromboprophylaxis; of these, 53 patients received warfarin, 17 patients received aspirin during combination treatment. 38 of 70 patients were newly diagnosed. Only 1 of 70 patients (1.4%) developed DVT. None of the patients who were not received any prophylaxis developed DVT during combination treatment. Conclusion: The incidence of deep vein thrombosis is lower in Japanese patients with MM treated with thalidomide and corticosteroids or chemotherapy than previous report from western countries.

Cancer associated thrombosis in patients taking direct oral anticoagulants (DOACs): Retrospective review of a single institutional series.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14080-e14080
Author(s):  
Sophia Angelov ◽  
Andrew Peter Dean
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Retrospective Review ◽  
Pulmonary Embolus ◽  
Oral Anticoagulants ◽  
First Line ◽  
Vein Thrombosis ◽  
Therapeutic Doses ◽  
Deep Vein ◽  
Limb Deep Vein Thrombosis

e14080 Background: Venous thromboembolism (VTE) is a common and often serious complication for patients with malignancy. Even though low molecular weight heparin (LMWH) is recommended as first line therapy for initial and long term anticoagulation, patient choice may demand oral anticoagulants. This retrospective review illustrates the repeated observation of recurrent thromboembolic disease in patients taking the new class of oral anticoagulant, DOAC. Methods: The pharmacy database at our institution was searched to identify oncology patients who had received a prescription for a DOAC (rivaroxaban or apixiban). Sixtyfive patients were identified and case records were then examined for evidence of venous thromboembolism. Results: Five seperate episodes of recurrent venous thromboembolism were identified in four patients in our cohort., one patient having two seperate episodes of pulmonary embolus. All were on recommended therapeutic doses of DOAC at the time of thromboembolic event. Two patients experienced proven pulmonary embolus on CT pulmonary angiography (1 twice), one lower limb deep vein thrombosis and one upper limb deep vein thrombosis. Conclusions: This retrosepctive review reinforces the clinical guidelines stated by the Cochrane review and ASCO that LMWH should always be first line for the initial and continuation treatment of a VTE. The guidelines did not focus on the suboptimal anticoagulation aspect of the newer oral anticoagulants but more on the safety issues. Research has been mainly focused on comparing LMWH with unfractionated heparin (UFH) or oral warfarin. Comparisons between DOAC versus Warfarin as an oral form of therapy have also been made. In the available published literature, there is a paucity of research comparing DOACs to LMWH. We have identified four patients out of sixtyfive treated with therapeutic doses of DOAC who developed subsequent thromboembolism. This is additional supportive evidence that newer oral anticoagulant agents may not be efficacious in malignancy driven VTE and that LMWH should remain the standard of care. Patients specifically requesting DOAC for cancer associated VTE should be made aware of this data.

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