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Journal Articles

2017-2018 Hematology Drug Approvals at the Food and Drug Administration (FDA): Communication of Patient-Reported Outcomes (PRO) Information in FDA Clinical Reviews and Prescribing Information (PI)

Janice Kim, PharmD, MSc, Bindu Kanapuru, MD, Jessica K Roydhouse, PhD MPH, Ann T. Farrell, MD, Najat Bouchkouj, MD, Hussein Ezzeldin, PhD, Paul Kluetz, MD

Blood (2019) 134 (Supplement_1): 3450.

https://doi.org/10.1182/blood-2019-125798

Published: 2019

Journal Articles

Safety and Efficacy of Fibrinogen Concentrate in Congenital Fibrinogen Deficiency: A Post-Marketing Observational Study

Bruce A. Schwartz, PhD, Flora Peyvandi, MD PhD, Cristina Solomon, Sigurd Knaub, Balazs Toth

Blood (2019) 134 (Supplement_1): 4971.

https://doi.org/10.1182/blood-2019-129891

Published: 2019

Journal Articles

Post-Marketing Use Outcomes of an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, Axicabtagene Ciloleucel (Axi-Cel), for the Treatment of Large B Cell Lymphoma (LBCL) in the United States (US)

Marcelo C. Pasquini, MDMS, Frederick L. Locke, MD, Alex F. Herrera, MD, Tanya Siddiqi, MD, Armin Ghobadi, MD, Krishna V Komanduri, MD, Zhen-Huan Hu, MPH, Hua Dong, PhD, Peiman Hematti, MD, Sarah Nikiforow, MD PhD, Patricia Steinert, PhD, Anna Purdum, PharmD,MS, Mary M. Horowitz, Michelle Hooper, Jun Kawashima, MD, Caron A. Jacobson, MD

Blood (2019) 134 (Supplement_1): 764.

https://doi.org/10.1182/blood-2019-124750

Published: 2019

Journal Articles

Comorbidities Are Frequent in Older Patients with De Novo Acute Lymphoblastic Leukemia (ALL) and Correlate with Induction Mortality: Analysis of More Than 1200 Patients from GMALL Data Bases

Blood (2018) 132 (Supplement 1): 660.

https://doi.org/10.1182/blood-2018-99-111954

Published: 2018

Journal Articles

United States Post-Marketing Safety (PMS) Study of rpFVIII in Patients with Acquired Hemophilia A: Preliminary Data

R. Crea, DVM, MSc, Jui-Fu Huang, Naghmana Bajwa, Alessandro Gringeri, MD PhD

Blood (2017) 130 (Supplement 1): 3686.

https://doi.org/10.1182/blood.V130.Suppl_1.3686.3686

Published: 2017

Journal Articles

Endpoints of Clinical Trials for Marketing Authorization of Drugs for Hematologic Malignancy in Japan, the US and the EU

Sumimasa Nagai, MD, PhD

Blood (2014) 124 (21): 2603.

https://doi.org/10.1182/blood.V124.21.2603.2603

Published: 2014

Journal Articles

Analysis of 3 Year Post Marketing Surveillance of Eculizumab in Japan

Blood (2014) 124 (21): 4870.

https://doi.org/10.1182/blood.V124.21.4870.4870

Published: 2014

Journal Articles

Post-Marketing Safety Experience with Edoxaban in Japan for Thromboprophylaxis Following Major Orthopedic Surgery

Yasufumi Kuroda, PhD, Hitoshi Hotoda, PhD, Yasuhiro Nishikawa, MD, Akinori Nishiwaki, PhD

Blood (2012) 120 (21): 4697.

https://doi.org/10.1182/blood.V120.21.4697.4697

Published: 2012

Journal Articles

A Novel Approach to Capturing Post-Marketing Safety Information On Recombinant Factor VIIa (rFVIIa) in Acquired Hemophilia: Final Data From the Acquired Hemophilia Surveillance (AHS) Project

Steven R. Lentz, MD, PhD, Anand Tandra, MD, Robert Z. Gut, MD, PhD, David L. Cooper, MD, MBA

Blood (2012) 120 (21): 3371.

https://doi.org/10.1182/blood.V120.21.3371.3371

Published: 2012

Journal Articles

Evaluation of the Safety, Efficacy of Recombinant Factor IX (nonacog alfa) in Japanese Patients with Hemophilia B- Interim Result of Post Marketing Surveillance Study -

Takashi Suzuki, MD, PhD, Katsuyuki Fukutake, MD, PhD, Kagehiro Amano, MD, PhD, Hideji Hanabusa, MD, Masashi Taki, MD, PhD, Tadashi Matsushita, MD, PhD, Midori Shima, MD, PhD, Michio Sakai, MD, PhD, Masahiro Iizuka, Yoshiyuki Shibasaki

Blood (2012) 120 (21): 3378.

https://doi.org/10.1182/blood.V120.21.3378.3378

Published: 2012

Journal Articles

The Utilization of NET Promoter System As a Blood Supply Management Strategy

Gustavo De Carvalho Duarte, MD, Erich V de Paula, MD, PhD, Francisco J P Aranha, MD, PhD, Gislaine Borba Oliveira, MD, Afonso Celso Vigorito, MD, PhD, Carmino Antonio De Souza, MD, PhD, José Francisco Marques, PhD

Blood (2012) 120 (21): 4378.

https://doi.org/10.1182/blood.V120.21.4378.4378

Published: 2012

Journal Articles

Efficacy of Gemtuzumab Ozogamicin (GO) Monotherapy on Relapsed/Refractory Acute Promyelocytic Leukemia (APL)

Blood (2011) 118 (21): 1532.

https://doi.org/10.1182/blood.V118.21.1532.1532

Published: 2011

Journal Articles

POST Marketing Observational Study of Children (6 years or older) Treated with Deferasirox (Exjade ICL 670)-One Year analysis

Nagina Parmar, PhD, Manroop Singh, BSc, Isaac Odame, MD, Melanie Kirby, MD

Blood (2011) 118 (21): 5295.

https://doi.org/10.1182/blood.V118.21.5295.5295

Published: 2011

Journal Articles

The Acquired Hemophilia Surveillance (AHS) Project: A Novel Mechanism of Capturing Post-Marketing Safety Information on rFVIIa (NovoSeven ® RT) In Acquired Hemophilia.

Steven R. Lentz, MD, PhD, Anand Tandra, MD, Tracy J. Peters, David L. Cooper, MD, MBA

Blood (2010) 116 (21): 3674.

https://doi.org/10.1182/blood.V116.21.3674.3674

Published: 2010

Journal Articles

The substrate is down: is the IV out?

Jeff Szer

Blood (2010) 116 (6): 860–861.

https://doi.org/10.1182/blood-2010-05-285163

Published: 2010

Journal Articles

Duplicate Submissions to the American Society of Hematology (ASH) and American Society of Clinical Oncology (ASCO) Meetings.

Radhakrishnan Ramchandren, MD, Charles A. Schiffer, MD

Blood (2009) 114 (22): 4532.

https://doi.org/10.1182/blood.V114.22.4532.4532

Published: 2009

Journal Articles

Photochemical Pathogen Inactivation Treatment of Human Plasma (amotosalen + UVA) Has No Major Impact on the Protein expression pattern Assessed by a 2-DIGE Proteomic Assay.

Jean-Pierre Cazenave, MD, PhD, Philippe Ohlmann, Hervé Isola, Christian Gachet, MD

Blood (2008) 112 (11): 1994.

https://doi.org/10.1182/blood.V112.11.1994.1994

Published: 2008

Journal Articles

Interim Analysis of a Post Marketing All Cases Surveillance Study of Mylotarg in Japan.

Noriko Usui, MD, Jin Takeuchi, MD, Hisashi Sakamaki, MD, Ryuzo Ohno, MD, Michio Suzukawa, MD, Eliot Obi-Tabot, MD, Jay M. Feingold, MD, PhD

Blood (2007) 110 (11): 4376.

https://doi.org/10.1182/blood.V110.11.4376.4376

Published: 2007

Journal Articles

Waiting for Godot: Thirty-Six Month Follow-Up on Accelerated FDA Approval of Drugs To Treat Hematologic Malignancies.

Veena Shankaran, MD, June McKoy, MD, MPH, JD, Ben Djulbegovic, MD, PhD, Allison Lyons, BA, Ken Carson, MD, Cara Tigue, BA, Neal Dandade, BA, Martin Tallman, MD, Oliver Sartor, MD, Charles Bennett, MD, PhD, MPP

Blood (2007) 110 (11): 3340.

https://doi.org/10.1182/blood.V110.11.3340.3340

Published: 2007

Journal Articles

Hematology-Related Direct-to-Consumer Advertising: A Content Analysis and Verification of Claims from Print Media.

Gregory A. Abel, MD, MPH, Marie-Adele Sorel, BA, Ellis J. Neufeld, MD, PhD, Jane C. Weeks, MD, MSc

Blood (2006) 108 (11): 3346.

https://doi.org/10.1182/blood.V108.11.3346.3346

Published: 2006

NARROW

2017-2018 Hematology Drug Approvals at the Food and Drug Administration (FDA): Communication of Patient-Reported Outcomes (PRO) Information in FDA Clinical Reviews and Prescribing Information (PI)

Safety and Efficacy of Fibrinogen Concentrate in Congenital Fibrinogen Deficiency: A Post-Marketing Observational Study

Post-Marketing Use Outcomes of an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, Axicabtagene Ciloleucel (Axi-Cel), for the Treatment of Large B Cell Lymphoma (LBCL) in the United States (US)

Comorbidities Are Frequent in Older Patients with De Novo Acute Lymphoblastic Leukemia (ALL) and Correlate with Induction Mortality: Analysis of More Than 1200 Patients from GMALL Data Bases

United States Post-Marketing Safety (PMS) Study of rpFVIII in Patients with Acquired Hemophilia A: Preliminary Data

Endpoints of Clinical Trials for Marketing Authorization of Drugs for Hematologic Malignancy in Japan, the US and the EU

Analysis of 3 Year Post Marketing Surveillance of Eculizumab in Japan

Post-Marketing Safety Experience with Edoxaban in Japan for Thromboprophylaxis Following Major Orthopedic Surgery

A Novel Approach to Capturing Post-Marketing Safety Information On Recombinant Factor VIIa (rFVIIa) in Acquired Hemophilia: Final Data From the Acquired Hemophilia Surveillance (AHS) Project

Evaluation of the Safety, Efficacy of Recombinant Factor IX (nonacog alfa) in Japanese Patients with Hemophilia B- Interim Result of Post Marketing Surveillance Study -

The Utilization of NET Promoter System As a Blood Supply Management Strategy

Efficacy of Gemtuzumab Ozogamicin (GO) Monotherapy on Relapsed/Refractory Acute Promyelocytic Leukemia (APL)

POST Marketing Observational Study of Children (6 years or older) Treated with Deferasirox (Exjade ICL 670)-One Year analysis

The Acquired Hemophilia Surveillance (AHS) Project: A Novel Mechanism of Capturing Post-Marketing Safety Information on rFVIIa (NovoSeven ® RT) In Acquired Hemophilia.

The substrate is down: is the IV out?

Duplicate Submissions to the American Society of Hematology (ASH) and American Society of Clinical Oncology (ASCO) Meetings.

Photochemical Pathogen Inactivation Treatment of Human Plasma (amotosalen + UVA) Has No Major Impact on the Protein expression pattern Assessed by a 2-DIGE Proteomic Assay.

Interim Analysis of a Post Marketing All Cases Surveillance Study of Mylotarg in Japan.

Waiting for Godot: Thirty-Six Month Follow-Up on Accelerated FDA Approval of Drugs To Treat Hematologic Malignancies.

Hematology-Related Direct-to-Consumer Advertising: A Content Analysis and Verification of Claims from Print Media.

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