Estimation of Multiple Response Rates in Phase II Clinical Trials with Missing Observations.

Posted by rob on February 26, 2010 under Uncategorized | Comments are off for this article

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Estimation of Multiple Response Rates in Phase II Clinical Trials with Missing Observations.

J Biopharm Stat. 2009 Sep;19(5):791-802

Authors: Chang M

Responses are often correlated in clinical trials. A patient who is not evaluable for a response may still provide some information to the response through his or her status on other responses. Under the assumption of missing at random, we propose the utilization of a self-consistent estimator. We show that the proposed estimators are more efficient than the conventional estimators by asymptotic relative efficiency and simulation study. An example from a Phase II clinical trial on children with chronic myelogenous leukemia is provided.

PMID: 20183444 [PubMed - in process]

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Cord blood stem cell transplantation in a patient with disseminated mucormycosis and acute myelogenous leukemia.

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Cord blood stem cell transplantation in a patient with disseminated mucormycosis and acute myelogenous leukemia.

Transpl Infect Dis. 2010 Feb 17;

Authors: Aoki T, Kamezaki K, Miyamoto T, Nagafuji K, Mori Y, Yamauchi T, Takenaka K, Iwasaki H, Harada N, Shimono N, Teshima T, Akashi K

T. Aoki, K. Kamezaki, T. Miyamoto, K. Nagafuji, Y. Mori, T. Yamauchi, K. Takenaka, H. Iwasaki, N. Harada, N. Shimono, T. Teshima, K. Akashi. Cord blood stem cell transplantation in a patient with disseminated mucormycosis and acute myelogenous leukemia. Transpl Infect Dis 2010. All rights reserved.

PMID: 20180927 [PubMed - as supplied by publisher]

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[A patient with acute Philadelphia-chromosome-positive mixed phenotype leukemia developing ecthyma gangrenosum while undergoing combined imatinib mesylate chemotherapy]

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[A patient with acute Philadelphia-chromosome-positive mixed phenotype leukemia developing ecthyma gangrenosum while undergoing combined imatinib mesylate chemotherapy]

Kansenshogaku Zasshi. 2009 Nov;83(6):669-72

Authors: Suzuki K, Sekine T

A 67-year-old woman with acute Philadelphia-chromosome-positive mixed phenotype leukemia developed bilateral periorbital ecthyma gangrenousum (EG) subsequent to periorbital edema while undergoing combined imatinib mesylate (imatinib) chemotherapy. Although initial periorbital edema was considered an imatinib side effect, the lesion deteriorated rapidly with high fever in the neutropenic phase, and the woman died of septic shock. Cultures from blood and exudative fluid grew Pseudomonas aeruginosa, after which EG was diagnosed. EG is a well-recognized emergent cutaneous infection most commonly associated with Pseudomonas aeruginosa bactremia. Because some patients present with EG a few days prior to developing life-threatening septicemia, it is important that EG be diagnosed correctly. Imatinib side effects such as edema are usually tolerable, and imatinib is widely used to treat Philadelphia-chromosome-positive leukemia, particularly in those with acute lymphoblastic leukemia, and neutropenic patients undergoing imatinib therapy are expected to increase in number. Delay in initiating appropriate therapy is correlated with poor outcome, so drug side effects and EG must be carefully differentiated when skin edema with surrounding erythema is noted in neutropenic patients undergoing imatinib therapy.

PMID: 20034323 [PubMed - indexed for MEDLINE]

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Gelatinous transformation of the bone marrow as a late morphological change in imatinib mesylate treated chronic myeloid leukaemia.

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Gelatinous transformation of the bone marrow as a late morphological change in imatinib mesylate treated chronic myeloid leukaemia.

Pathology. 2010 Jan;42(1):84-5

Authors: Hong FS, Mitchell CA, Zantomio D

PMID: 20025487 [PubMed - indexed for MEDLINE]

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Successful completion of pregnancy in a patient with chronic myeloid leukemia without active intervention: a case report and review of the literature.

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Successful completion of pregnancy in a patient with chronic myeloid leukemia without active intervention: a case report and review of the literature.

Clin Lymphoma Myeloma. 2009 Aug;9(4):324-7

Authors: Cole S, Kantarjian H, Ault P, Cortés JE

The management of patients with chronic myeloid leukemia (CML) during pregnancy is a matter of continued debate. We present a 21-year-old woman in whom CML was diagnosed during early pregnancy. Because the patient was asymptomatic and desired to carry the pregnancy to term while minimizing fetal exposure to medication, she was observed with no therapy for the duration of her pregnancy. The white blood cell count showed a slow downward trend throughout her pregnancy. She delivered a healthy baby and breast fed for a time before initiating therapy for CML. We reviewed the published case reports of women who had a pregnancy occur in the setting of treatment with imatinib. Given the adverse effects of fetal exposure to imatinib as treatment for the mother with CML, close observation might be an option for selected patients who are diagnosed with CML while pregnant and who have minimal clinical manifestations of CML.

PMID: 19717385 [PubMed - indexed for MEDLINE]

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