adverse event of special interest

Association between PD-L1 inhibitor, tumor site and adverse events of potential immune etiology within the US FDA adverse event reporting system

Immunotherapy ◽

10.2217/imt-2021-0068 ◽

2021 ◽

Author(s):

Omar Abdel-Rahman

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Special Interest ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Multivariable Logistic Regression Analysis ◽

Tumor Type ◽

Related Factors ◽

Event Reporting

Objective: To analyze tumor- and treatment-related factors that might impact the development of certain adverse events (AEs) of potential immune etiology among patients receiving PD-(L)1 inhibitors. Methods: The FDA Adverse Event Reporting System (FAERS) was accessed, and AE reports related to the use of PD-L1 inhibitors were reviewed. Associations between treatment, tumor type and occurrence of AEs of special interest were analyzed through multivariable logistic regression analysis. Results: A total of 80,304 AE reports were included in the current analysis. Diagnosis with lung cancer was associated with a higher probability of pneumonitis; diagnosis with melanoma was associated with a higher probability of hepatitis, hypophysitis/hypopituitarism and uveitis; and diagnosis with genitourinary cancers was associated with a higher probability of nephritis, adrenal insufficiency and myocarditis. Conclusion: Within this cohort limited to AEs reported to the FAERS, there is an association between different AEs of special interest, agent(s) used and tumor(s) treated.

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Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry

Rheumatology ◽

10.1093/rheumatology/kez577 ◽

2019 ◽

Vol 59 (9) ◽

pp. 2287-2298 ◽

Cited By ~ 2

Author(s):

Ariane Klein ◽

Jens Klotsche ◽

Boris Hügle ◽

Kirsten Minden ◽

Anton Hospach ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Special Interest ◽

Poisson Model ◽

Incidence Rates ◽

Serious Adverse Events ◽

Mixed Effect ◽

Long Term Treatment ◽

Systemic Onset

Abstract Objective Using data from the German Biologics JIA Registry (BIKER), long-term safety of biologics for systemic-onset JIA with regard to adverse events of special interest was assessed. Methods Safety assessments were based on adverse event reports after first dose through 90 days after last dose. Rates of adverse event, serious adverse event and 25 predefined adverse events of special interest were analysed. Incidence rates were compared for each biologic against all other biologics combined applying a mixed-effect Poisson model. Results Of 260 systemic-onset JIA patients in this analysis, 151 patients received etanercept, 109 tocilizumab, 71 anakinra and 51 canakinumab. Patients with etanercept had higher clinical Juvenile Arthritis Disease Activity Score 10 scores, active joint counts and steroid use at therapy start. Serious adverse events were reported with higher frequency in patients receiving canakinumab [20/100 patient years (PY)] and tocilizumab (21/100 PY). Cytopenia and hepatic events occurred with a higher frequency with tocilizumab and canakinumab. Medically important infections were seen more often in patients with IL-6 or IL-1 inhibition. Macrophage activation syndrome occurred in all cohorts with a higher frequency in patients with canakinumab (3.2/100 PY) and tocilizumab (2.5/100 PY) vs anakinra (0.83/100 PY) and etanercept (0.5/100 PY). After adjustment only an elevated risk for infections in anakinra-treated patients remained significant. Three definite malignancies were reported in patients ever exposed to biologics. Two deaths occurred in patients treated with etanercept. Conclusion Surveillance of pharmacotherapy as provided by BIKER is an import approach especially for patients on long-term treatment. Overall, tolerance was acceptable. Differences between several biologics were noted and should be considered in daily patient care.

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Arthritis as an adverse event of special interest post COVID-19 vaccine implementation

Aging Pathobiology and Therapeutics ◽

10.31491/apt.2021.03.050 ◽

2021 ◽

Vol 3 (1) ◽

pp. 10-11

Author(s):

Shyh Poh Teo ◽

Keyword(s):

Adverse Event ◽

Special Interest

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Crystalloid Inclusions in Hepatocyte Mitochondria and Their Similarity to Cytoplasmic Crystalloids

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100051001 ◽

1974 ◽

Vol 32 ◽

pp. 198-199

Author(s):

Odell T. Minick ◽

Hidejiro Yokoo

Keyword(s):

Liver Disease ◽

Alcoholic Liver Disease ◽

Special Interest ◽

Structural Variations ◽

Mitochondrial Alterations ◽

The Matrix ◽

Crystalloid Inclusions ◽

Liver Biopsies

Mitochondrial alterations were studied in 25 liver biopsies from patients with alcoholic liver disease. Of special interest were the morphologic resemblance of certain fine structural variations in mitochondria and crystalloid inclusions. Four types of alterations within mitochondria were found that seemed to relate to cytoplasmic crystalloids.Type 1 alteration consisted of localized groups of cristae, usually oriented in the long direction of the organelle (Fig. 1A). In this plane they appeared serrated at the periphery with blind endings in the matrix. Other sections revealed a system of equally-spaced diagonal lines lengthwise in the mitochondrion with cristae protruding from both ends (Fig. 1B). Profiles of this inclusion were not unlike tangential cuts of a crystalloid structure frequently seen in enlarged mitochondria described below.

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Proceedings of the joint symposium of the Section on Educational Research/Development and Curriculum, and the Special Interest Group of Academic Deans: faculty development: essence of vitality

Journal of Dental Education ◽

10.1002/j.0022-0337.1991.55.10.tb02578.x ◽

1991 ◽

Vol 55 (10) ◽

pp. 655-655

Author(s):

ME Parker

Keyword(s):

Faculty Development ◽

Educational Research ◽

Interest Group ◽

Special Interest ◽

Academic Deans ◽

Special Interest Group ◽

Research Development ◽

Joint Symposium

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Grammatical Morpheme Intervention Issues for Students Who Use AAC

Perspectives on Augmentative and Alternative Communication ◽

10.1044/aac17.2.62 ◽

2008 ◽

Vol 17 (2) ◽

pp. 62-68 ◽

Cited By ~ 4

Author(s):

Cathy Binger

Keyword(s):

Special Interest ◽

Augmentative And Alternative Communication ◽

Intervention Program ◽

Annual Conference ◽

Alternative Communication ◽

Research Results ◽

School Aged Children ◽

Grammar Acquisition ◽

Device Use

Abstract Many children who use AAC experience difficulties with acquiring grammar. At the 9th Annual Conference of ASHA's Special Interest Division 12, Augmentative and Alternative Communication, Binger presented recent research results from an intervention program designed to facilitate the bound morpheme acquisition of three school-aged children who used augmentative and alternative communication (AAC). Results indicated that the children quickly began to use the bound morphemes that were taught; however, the morphemes were not maintained until a contrastive approach to intervention was introduced. After the research results were presented, the conference participants discussed a wide variety of issues relating to grammar acquisition for children who use AAC. Some of the main topics of discussion included the following: provision of supports for grammar comprehension and expression, intervention techniques to support grammatical morpheme acquisition, and issues relating to AAC device use when teaching grammatical morpheme use.

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