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2018 - 2020
Adverse Event Circumstances and the Case of Drug Interactions

Soldatos, Jackson.

Healthcare (Basel). 2019 Mar 19;7(1). pii: E45. doi: 10.3390/healthcare7010045.

Adverse events are a common and for the most part unavoidable consequence of therapeutic intervention. Nevertheless, available tomes of such data now provide us with an invaluable opportunity to study the relationship between human phenotype and drug-induced protein perturbations within a patient system...

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Precision Oncology - The Quest for Evidence

Soldatos TG, Kaduthanam S, Jackson DB.

2019 Sep 5;9(3). pii: E43. doi: 10.3390/jpm9030043.

The molecular characterization of patient tumors provides a rational and highly promising approach for guiding oncologists in treatment decision-making. Notwithstanding, genomic medicine still remains in its infancy, with innovators and early adopters continuing to carry a significant portion of the clinical and financial risk...

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Target‐Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

Peter Schotland, Rebecca Racz, David Jackson, Robert Levin, David G. Strauss and Keith Burkhart

24 October 2018

Clinical trials can fail to detect rare adverse events (AEs). We assessed the ability of pharmacological target adverse‐event (TAE) profiles to predict AEs on US Food and Drug Administration (FDA) drug labels at least 4 years after approval...

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Association Between Serotonin Syndrome and Second-Generation Antipsychotics via Pharmacological Target-Adverse Event Analysis

Racz, Soldatos, Jackson, Burkhart.

Clin Transl Sci (2018) 00, 1–8; doi:10.1111/cts.12543

Case reports suggest an association between second-generation antipsychotics (SGAs) and serotonin syndrome (SS). The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) was analyzed to generate hypotheses about how SGAs may interact with pharmacological targets associated with SS...

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In Silico Profiling of Clinical Phenotypes for Human Targets Using Adverse Event Data

Soldatos, Taglang, Jackson

High Throughput. 2018 Nov 23;7(4). pii: E37. doi: 10.3390/ht7040037

We present a novel approach for the molecular transformation and analysis of patient clinical phenotypes. Building on the fact that drugs perturb the function of targets/genes, we integrated data from 8.2 million clinical reports detailing drug-induced side effects with the molecular world of drug-target information...

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Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data


Diagnostics (Basel). 2018 Oct 31;8(4). pii: E76. doi: 10.3390/diagnostics8040076

Recent studies suggest that combining nivolumab with ipilimumab is a more effective treatment for melanoma patients, compared to using ipilimumab or nivolumab alone. However, treatment with these immunotherapeutic agents is frequently associated with increased risk of toxicity, and (auto-) immune-related adverse events...

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