scholarly journals Donor Safety in Haemapheresis: Development of an Internet-Based Registry for Comprehensive Assessment of Adverse Events from Healthy Donors

2016 ◽  
Vol 44 (3) ◽  
pp. 188-200 ◽  
Author(s):  
Hans-Gert Heuft ◽  
Eike Fischer ◽  
Tina Weingand ◽  
Thomas Burkhardt ◽  
Gerda Leitner ◽  
...  
Keyword(s):  
Adverse Events ◽  
Comprehensive Assessment ◽  
Donor Safety ◽  
Healthy Donors

Axl blockade in vitro and in patients with high-risk MDS by the small molecule inhibitor BGB324.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 7059-7059 ◽  
Author(s):  
Sonja Loges ◽  
Isabel Ben Batalla ◽  
Michael Heuser ◽  
Nikolas Berenbrok ◽  
Thomas Schroeder ◽  
...  
Keyword(s):  
Bone Marrow ◽  
High Risk ◽  
Adverse Events ◽  
Small Molecule ◽  
Small Molecule Inhibitor ◽  
Loading Dose ◽  
Bone Marrow Stroma ◽  
Healthy Donors ◽  
Molecule Inhibitor ◽  
Marrow Stroma

7059 Background: The interplay with bone marrow stroma plays an important role in the pathobiology of MDS. Gas6 is secreted by mesenchymal bone marrow stroma cells and promotes survival and therapy resistance of AML cells expressing the Axl receptor. We hypothesized that inhibiting Axl by the small molecule inhibitor BGB324 might hold therapeutic potential in MDS. Methods: We investigated the inhibitory effect of BGB324 on primary bone marrow mononucleated cells (BMMNC) and mesenchymal stroma cells (MSC) from MDS patients in comparison to healthy donors. In the ongoing first-in-patient Phase 1a/b trial BGBC003 A standard 3 + 3 dose escalation study was performed to identify the maximum tolerated dose of BGB324 in patients with previously treated high risk MDS or AML. BGB324 was administered as an oral loading dose on days one and two followed by a reduced daily maintenance. Three dose levels were explored 400/100mg, 600/200mg and 900/300mg. Results: We found that BGB324 inhibited BMMNC from low- and high-risk MDS patients with an IC50 of 2.1 µM and 3.8 µM, respectively (n = 5). In comparison, BMNNC from healthy donors were resistant to BGB324 (IC50 9.4 µM, p < 0.05, n = 10). Axl expression was present in MSC isolated from the BM of MDS patients and BGB324 inhibited the proliferation of MSC from low- and high-risk MDS patients (IC50 2.5 µM and 2.7 µM, respectively; n = 7/5).To date, 3 patients with MDS were treated with 400 mg loading dose and 100 mg maintenance dose of BGB324. Therapy has been well-tolerated and the MTD has not yet been reached. The majority of adverse events reported have been Grade 1 and 2. The most common related adverse events are diarrhea and fatigue. One patient with MDS was treated for 80 weeks and experienced a PR. Evidence of target inhibition was demonstrated by almost complete inhibition of Axl phosphorylation accompanied by reduction in phosphoErk and phosphoAkt signalling at day 21 of treatment. Conclusions: BGB324 is well-tolerated and might represent a promising novel treatment approach in MDS. Safety and efficacy of BGB324 will be explored further in clinical trials. Clinical trial information: NCT02488408.

Delayed adverse events in male plateletpheresis donors: Initial insights on donor safety

2019 ◽  
Vol 35 (1) ◽  
pp. 18-24
Author(s):  
Abhaykumar M. Gupta ◽  
Meenu Bajpai
Keyword(s):  
Adverse Events ◽  
Donor Safety

scholarly journals Comprehensive Assessment of Serious Adverse Events Following Immunization by Health Care Providers

2013 ◽  
Vol 162 (6) ◽  
pp. 1276-1281.e1 ◽  
Author(s):  
S. Elizabeth Williams ◽  
Kathryn M. Edwards ◽  
Roger P. Baxter ◽  
Philip S. LaRussa ◽  
Neal A. Halsey ◽  
...  
Keyword(s):  
Health Care ◽  
Adverse Events ◽  
Health Care Providers ◽  
Comprehensive Assessment ◽  
Care Providers ◽  
Serious Adverse Events

Prophylactic platelet transfusions from healthy apheresis platelet donors undergoing treatment with thrombopoietin

Blood ◽  
2001 ◽  
Vol 98 (5) ◽  
pp. 1346-1351 ◽  
Author(s):  
Lawrence T. Goodnough ◽  
David J. Kuter ◽  
Jeffrey McCullough ◽  
Sherrill J. Slichter ◽  
John DiPersio ◽  
...  
Keyword(s):  
Platelet Count ◽  
Adverse Events ◽  
Growth And Development ◽  
Platelet Transfusion ◽  
Intensive Chemotherapy ◽  
Platelet Concentrates ◽  
Platelet Counts ◽  
Development Factor ◽  
Healthy Donors ◽  
Platelet Transfusions

Many patients receiving dose-intensive chemotherapy acquire thrombocytopenia and need platelet transfusions. A study was conducted to determine whether platelets harvested from healthy donors treated with thrombopoietin could provide larger increases in platelet counts and thereby delay time to next platelet transfusion compared to routinely available platelets given to thrombocytopenic patients. Community platelet donors received either 1 or 3 μg/kg pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) or placebo and then donated platelets 10 to 15 days later. One hundred sixty-six of these platelet concentrates were then transfused to 120 patients with platelets counts 25 × 109/L or lower. Pretransfusion platelet counts (11 × 109/L) were similar for recipients of placebo-derived and PEG-rHuMGDF–derived platelets. Early after transfusion, the median platelet count increment was higher in patients receiving PEG-rHuMGDF–derived platelets: 19 (range, −12-66) × 109/L, 41 (range, 5-133) × 109/L, and 82 (range, −4-188) × 109/L for placebo-, 1-μg/kg–, and 3-μ/kg–derived platelets, respectively. This difference was maintained 18 to 24 hours after transfusion. Transfusion-free intervals were 1.72, 2.64, and 3.80 days for the recipients of the placebo-, 1-μg/kg–, and 3-μ/kg–derived platelets, respectively. The rate of transfusion-related adverse events was not different in recipients of placebo-derived and PEG-rHuMGDF–derived platelets. Therefore, when transfused into patients with thrombocytopenia, platelets collected from healthy donors undergoing thrombopoietin therapy were safe and resulted in significantly greater platelet count increments and longer transfusion-free intervals than platelets obtained from donors treated with placebo.

Postvaccination Adverse Events

2010 ◽  
Vol 44 (12) ◽  
pp. 16
Author(s):  
STEPHEN I. PELTON
Keyword(s):  
Adverse Events
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