The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field.

2005 ◽  
pp. 157-167 ◽  
Author(s):  
Bankole A Johnson ◽  
Nassima Ait-Daoud ◽  
John D Roache
Keyword(s):  
Adverse Events ◽  
Clinical Studies

scholarly journals Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Danling Gu ◽  
Hanning Tang ◽  
Jiazhu Wu ◽  
Jianyong Li ◽  
Yi Miao
Keyword(s):  
Adverse Events ◽  
Tyrosine Kinase ◽  
B Cell ◽  
Clinical Studies ◽  
Acquired Resistance ◽  
B Cell Malignancies ◽  
Bcr Signaling ◽  
Bruton Tyrosine Kinase ◽  
Covalent Inhibitors ◽  
Btk Inhibitors

AbstractB cell receptor (BCR) signaling is involved in the pathogenesis of B cell malignancies. Activation of BCR signaling promotes the survival and proliferation of malignant B cells. Bruton tyrosine kinase (BTK) is a key component of BCR signaling, establishing BTK as an important therapeutic target. Several covalent BTK inhibitors have shown remarkable efficacy in the treatment of B cell malignancies, especially chronic lymphocytic leukemia. However, acquired resistance to covalent BTK inhibitors is not rare in B cell malignancies. A major mechanism for the acquired resistance is the emergence of BTK cysteine 481 (C481)  mutations, which disrupt the binding of covalent BTK inhibitors. Additionally, adverse events due to the off-target inhibition of kinases other than BTK by covalent inhibitors are common. Alternative therapeutic options are needed if acquired resistance or intolerable adverse events occur. Non-covalent BTK inhibitors do not bind to C481, therefore providing a potentially effective option to patients with B cell malignancies, including those who have developed resistance to covalent BTK inhibitors. Preliminary clinical studies have suggested that non-covalent BTK inhibitors are effective and well-tolerated. In this review, we discussed the rationale for the use of non-covalent BTK inhibitors and the preclinical and clinical studies of non-covalent BTK inhibitors in B cell malignancies.

P3-014: DEEP LEARNING IN AUTOMATED CLASSIFICATION OF ADVERSE EVENTS IN CLINICAL STUDIES OF ALZHEIMER'S DISEASE

2006 ◽  
Vol 14 (7S_Part_19) ◽  
pp. P1067-P1068
Author(s):  
Pradeep Anand Ravindranath ◽  
Rema Raman ◽  
Tiffany W. Chow ◽  
Michael S. Rafii ◽  
Paul S. Aisen ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Deep Learning ◽  
Adverse Events ◽  
Clinical Studies ◽  
Automated Classification

Resorbable polymer implants in unilateral transforaminal lumbar interbody fusion

2002 ◽  
Vol 97 (4) ◽  
pp. 464-467 ◽  
Author(s):  
Thomas G. Lowe ◽  
Jeffrey D. Coe
Keyword(s):  
Adverse Events ◽  
Biodegradable Polymers ◽  
Clinical Studies ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Degenerative Disease ◽  
Lumbar Interbody Fusion ◽  
Content Type ◽  
Fine Print

Object. Sixty patients underwent instrumentation-assisted posterior transforaminal lumbar interbody fusion (TLIF) with resorbable polymer cages and autograft bone for degenerative disease. This article discusses the technique of TLIF and its early outcomes. Methods. Although the follow-up period is short and results are preliminary, no adverse events or complications were attributed to the resorbable polymer. Conclusions. Further multicenter clinical studies are underway with a minimum 2-year follow-up period chosen as an endpoint to provide insight as to the future of biodegradable polymers as spinal interbody devices.

scholarly journals Psychiatric and behavioral adverse events in randomized clinical studies of the noncompetitive AMPA receptor antagonist perampanel

Epilepsia ◽  
2015 ◽  
Vol 56 (8) ◽  
pp. 1252-1263 ◽  
Author(s):  
Alan B. Ettinger ◽  
Antonia LoPresti ◽  
Haichen Yang ◽  
Betsy Williams ◽  
Sharon Zhou ◽  
...  
Keyword(s):  
Adverse Events ◽  
Receptor Antagonist ◽  
Ampa Receptor ◽  
Clinical Studies ◽  
Ampa Receptor Antagonist

scholarly journals Real-Life Experience of Nivolumab in Heavily Pretreated Relapsed and Refractory Classical Hodgkin Lymphoma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3008-3008 ◽  
Author(s):  
Ohad Benjamini ◽  
David Lavie ◽  
Eldad J Dann ◽  
Chava Perry ◽  
Ory Rouvio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Hodgkin Lymphoma ◽  
Clinical Studies ◽  
Life Experience ◽  
Real Life ◽  
Brentuximab Vedotin ◽  
Efficacy And Safety ◽  
Classical Hodgkin Lymphoma ◽  
Post Transplantation ◽  
Heavily Pretreated

Abstract Background: The fully human IgG4 anti-PD-1 monoclonal antibody, nivolumab, has shown to be highly efficacious in relapsed and refractory (RR) classical Hodgkin lymphoma (cHL). Initial results of a single-arm nivolumab monotherapy in heavily pretreated young adults with RR cHL, previously treated with autologous hematopoetic stem cell transplantation (autoSCT) and brentuximab vedotin are promising. However, demonstrating similar results in real-life experience in patients not on Pharma clinical studies are of major clinical importance. Aim: The aim of the current study was to evaluate the efficacy and safety of nivolumab in previously heavily pretreated patients with RR cHL not on Pharma clinical studies. Methods: The records of patients with RR cHL who were treated with nivolumab in seven medical centers were reviewed. The regimen consisted of nivolumab 3 mg/kg once every 2 weeks until disease progression or unacceptable toxicity. Results: Between May 2015 and April 2016, 30 patients with RR cHL received nivolumab monotherapy. The median age was 35 years (range: 21 to 88). Patients were extremely heavily pretreated with median of 6 prior therapies (range: 3 to 11); 73% of them received ≥ 5 lines of therapy. Specifically, 29/30 (97%) received ABVD, 7/30 (23%) escBEACOPP, 20/30 (67%) gemcitabine based regimens, 30/30 (100%) brentuximab vedotin, 8/30 (27%) bendamustine, 3/30 (10%) lenalidomide, 28/30 (93%) other combinations of chemotherapy and 22/30 (73%) radiotherapy. Twenty patients (67%) previously underwent autoHSCT and 4/30 (13%) allogeneic transplantation (alloSCT), two before and two after receiving nivolumab. Median number of nivolumab doses received was 8 (range 1 to 29). Twenty three patients (77%) are still on treatment. Seven patients (23%) discontinued therapy due to disease progression 3/30 (10%), adverse events 2/30 (7%) and referral to alloSCT 2/30 (7%). Overall response rate among 25 evaluable patients was 76%, complete response (CR) - 7/25 (28%), partial response - 12/25 (48%), stable disease - 3/25 (12%) and only 3/25 (12%) progressed, one of them with cHL type of Richter's transformation. Two patients underwent alloSCT in remission following nivolumab treatment. One patient was transplanted from a matched sibling donor and the second patient from a T replete haploidentical donor with post transplantation cyclophosphamide as anti-graft versus host disease prophylaxis. Both patients are in CR, ten and three months post transplantation, respectively. The median overall survival (OS) and progression free survival (PFS) for the cohort were not reached (Figure 1). At 24 weeks the PFS was 74%. Adverse events reported in 9/30 patients (30%) were usually mild. Severe nivolumab related adverse events in 3/30 (10%) included immune related pneumonitis, myelitis and uveitis. No treatment related death occurred. Conclusions: The check point inhibitor nivolumab is a novel therapy for RR cHL patients, previously with unmet need following relapse or refractory to autoHSCT and brentuximab vedotin. Our real life experience confirms and highlights the efficacy and safety of nivolumab in very heavily pretreated young and elderly patients with cHL eligible as well as ineligible for autologous HSCT. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

TD-P-016: DEEP LEARNING IN AUTOMATED CLASSIFICATION OF ADVERSE EVENTS IN CLINICAL STUDIES OF ALZHEIMER'S DISEASE

2006 ◽  
Vol 14 (7S_Part_3) ◽  
pp. P193-P193
Author(s):  
Pradeep Anand Ravindranath ◽  
Rema Raman ◽  
Tiffany W. Chow ◽  
Michael S. Rafii ◽  
Paul S. Aisen ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Deep Learning ◽  
Adverse Events ◽  
Clinical Studies ◽  
Automated Classification

[P4-007]: MACHINE LEARNING IN AUTOMATED CLASSIFICATION OF ADVERSE EVENTS IN CLINICAL STUDIES OF ALZHEIMER's DISEASE

2017 ◽  
Vol 13 (7S_Part_26) ◽  
pp. P1256-P1256 ◽  
Author(s):  
Pradeep Anand Ravindranath ◽  
Stefania Bruschi ◽  
Karin Ernstrom ◽  
Rema Raman ◽  
Tiffany Chow ◽  
...  
Keyword(s):  
Machine Learning ◽  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Clinical Studies ◽  
Automated Classification

scholarly journals United States Pharmacopeia (USP) Safety Review of Gamma-Aminobutyric Acid (GABA)

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2742
Author(s):  
Hellen A. Oketch-Rabah ◽  
Emily F. Madden ◽  
Amy L. Roe ◽  
Joseph M. Betz
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Dietary Supplement ◽  
Clinical Studies ◽  
Case Reports ◽  
Endocrine System ◽  
Chronic Administration ◽  
Fermented Milk ◽  
Gamma Aminobutyric Acid ◽  
Serious Adverse Events

Gamma-amino butyric acid (GABA) is marketed in the U.S. as a dietary supplement. USP conducted a comprehensive safety evaluation of GABA by assessing clinical studies, adverse event information, and toxicology data. Clinical studies investigated the effect of pure GABA as a dietary supplement or as a natural constituent of fermented milk or soy matrices. Data showed no serious adverse events associated with GABA at intakes up to 18 g/d for 4 days and in longer studies at intakes of 120 mg/d for 12 weeks. Some studies showed that GABA was associated with a transient and moderate drop in blood pressure (<10% change). No studies were available on effects of GABA during pregnancy and lactation, and no case reports or spontaneous adverse events associated with GABA were found. Chronic administration of GABA to rats and dogs at doses up to 1 g/kg/day showed no signs of toxicity. Because some studies showed that GABA was associated with decreases in blood pressure, it is conceivable that concurrent use of GABA with anti-hypertensive medications could increase risk of hypotension. Caution is advised for pregnant and lactating women since GABA can affect neurotransmitters and the endocrine system, i.e., increases in growth hormone and prolactin levels.

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