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389 results on '"RAFANIELLO, Concetta"'

3. Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.

Author

Cutroneo, Paola Maria, Sartori, Daniele, Tuccori, Marco, Crisafulli, Salvatore, Battini, Vera, Carnovale, Carla, Rafaniello, Concetta, Capuano, Annalisa, Poluzzi, Elisabetta, Moretti, Ugo, and Raschi, Emanuel

Subjects
DRUG side effects, SIGNAL detection, JUDGMENT (Psychology), DATABASES, MEDICAL personnel
Abstract

Spontaneous reporting systems remain pivotal for post-marketing surveillance and disproportionality analysis (DA) represents a recognized approach for early signal detection. Although DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient, their role remain irreplaceable for rapid detection of rare and unpredictable adverse drug reactions with strong drug-attributable component (e.g., designated medical events), especially when developed by a multidisciplinary team and combined with a careful case-by-case analysis (individual inspection of reports for causality assessment or to uncover reporting patterns and clinical features). In the recent past, a remarkable increase in publications of pharmacovigilance studies using DAs was observed, albeit the quality was debated: several publications contained "spin", namely, misinterpretation of results to infer causality, calculate incidence, or provide risk stratification, which may ultimately result in unjustified alarm. The development of dedicated Guidelines by the international READUS-PV project (https://readus-statement.org/) will allow reproducible and transparent publication of accurate DAs, thus supporting their real transferability and exploitation by regulators and clinicians. This review offered a perspective on methodological aspects (and understanding) of DAs, their rationale, design, reporting, and interpretation. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Can Pharmacovigilance Data Represent a Potential Tool for Early Detection of the Antibiotic Resistance Phenomenon?

Author

Cagnotta, Cecilia, Zinzi, Alessia, Gargano, Francesca, Liguori, Valerio, Campitiello, Maria Rosaria, Perrella, Alessandro, Capuano, Annalisa, Rafaniello, Concetta, and Trama, Ugo

Subjects
KLEBSIELLA infections, DRUG resistance in bacteria, DRUG resistance, MEDICATION safety, DATABASES
Abstract

Background: Antibiotic resistance represents a growing concern. A new strategy developed to treat severe infections is represented by ceftazidime/avibactam (CZA/AVI). Despite the promising activities against more pathogens, continuous monitoring is required to identify potential antibiotic resistance in clinical practice settings. Therefore, real-world data from pharmacovigilance databases can help to better define the safety profile. Methods: We analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on ICSRs with at least one adverse event (AE) potentially suggestive of drug resistance (DR) and drug ineffectiveness (DI). Results: A total of 654 ICSRs related to CZA/AVI were retrieved from EudraVigilance, of which N = 378 (57.8%) were related to male and N = 230 (35.1%) to adult patients. A total of 80.2% of all AEs were serious but with a positive outcome. Overall, we found N = 129 (19.7%) cases of potential DR or DI after CZA/AVI administration. The majority of CZA/AVI-induced DR or DI occurred in adult male patients. The most frequently reported AEs were "drug ineffective" and "pathogen resistance". Lastly, CZA/AVI was mostly used for the treatment of "Klebsiella infection" and "Pneumonia". Conclusions: The present study showed how pharmacovigilance could play a key role in generating evidence about the safety profile of CZA/AVI. Further studies are warranted. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Antipsychotics and Cardiac Side Effects

Author

Mascolo, Annamaria, Scavone, Cristina, Rafaniello, Concetta, Capuano, A., Coppini, Raffaele, Section editor, Govoni, Stefano, editor, Politi, Pierluigi, editor, and Vanoli, Emilio, editor

Published
2020
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10. Pregnancy Recommendations Solely Based on Preclinical Evidence Should Be Integrated with Real-World Evidence: A Disproportionality Analysis of Certolizumab and Other TNF-Alpha Inhibitors Used in Pregnant Patients with Psoriasis.

Author

Gaio, Mario, Vastarella, Maria Giovanna, Sullo, Maria Giuseppa, Scavone, Cristina, Riccardi, Consiglia, Campitiello, Maria Rosaria, Sportiello, Liberata, and Rafaniello, Concetta

Subjects
PREGNANT women, PREGNANCY outcomes, FETAL distress, CESAREAN section, GESTATIONAL diabetes, PLACENTA praevia, MISCARRIAGE
Abstract

Treatment for pregnant women with psoriasis is limited by the lack of information typically related to clinical trials. While anti-tumor necrosis factor (TNF) drugs offer therapeutic benefits, their safety during pregnancy is a concern. Notably, certolizumab is comparatively safer than adalimumab, etanercept, infliximab, and golimumab according to the current recommendations. Thus, this study aimed to conduct a pharmacovigilance comparative analysis of maternal and neonatal outcomes associated with certolizumab versus other anti-TNF drugs by using data from EudraVigilance. A descriptive analysis was performed of Individual Case Safety Reports (ICSRs) associated with an anti-TNF drug and related to the pregnant patients with psoriasis from 2009 and 2023, focusing our analysis on the specific pregnancy outcomes and fetal/neonatal disorders. The most common pregnancy-related adverse event was spontaneous abortion, predominantly related to adalimumab and certolizumab. Certolizumab was also reported in cases of caesarean section, gestational diabetes, abortion, fetal death, fetal distress syndrome, pre-eclampsia, and premature separation of placenta. Generally, the findings from our study depicted a safety profile that overlapped for each anti-TNF drug, both in maternal/neonatal outcomes and other adverse events, suggesting no substantial differences between treatments. We advocate for further investigations before making concrete recommendations. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Sodium-glucose cotransporter–2 (SGLT2) inhibitors and the reporting of falls and fractures: an european pharmacovigilance analysis

Author

Mascolo, Annamaria, primary, Rafaniello, Concetta, additional, di Mauro, Gabriella, additional, Ruggiero, Donatella, additional, Campitiello, Maria Rosaria, additional, Donniacuo, Maria, additional, Berrino, Pasquale Maria, additional, Rossi, Francesco, additional, Paolisso, Giuseppe, additional, and Capuano, Annalisa, additional

Published
2023
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14. Multisystem Inflammatory Syndrome in Children Following COVID-19 Vaccination: A Sex-Stratified Analysis of the VAERS Database Using Brighton Collaboration Criteria

Author

Liguori, Valerio, primary, Zinzi, Alessia, additional, Gaio, Mario, additional, Riccardi, Consiglia, additional, Di Costanzo, Luigi, additional, Gargano, Francesca, additional, Carpentieri, Claudia, additional, D’Elia, Maria, additional, Bernardi, Francesca Futura, additional, Trama, Ugo, additional, Capuano, Annalisa, additional, and Rafaniello, Concetta, additional

Published
2023
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17. COVID-19 and atrial fibrillation: Intercepting lines

Author

Donniacuo, Maria, De Angelis, Antonella, Rafaniello, Concetta, Cianflone, Eleonora, Paolisso, Pasquale, Torella, Daniele, Sibilio, Gerolamo, Paolisso, Giuseppe, Castaldo, Giuseppe, Urbanek, Konrad, Rossi, Francesco, Berrino, Liberato, Cappetta, Donato, Donniacuo, Maria, De Angelis, Antonella, Rafaniello, Concetta, Cianflone, Eleonora, Paolisso, Pasquale, Torella, Daniele, Sibilio, Gerolamo, Paolisso, Giuseppe, Castaldo, Giuseppe, Urbanek, Konrad, Rossi, Francesco, Berrino, Liberato, and Cappetta, Donato

Subjects
atrial remodeling, inflammation, COVID-19, atrial fibrillation, Cardiology and Cardiovascular Medicine, COVID-19 drug
Abstract

Almost 20% of COVID-19 patients have a history of atrial fibrillation (AF), but also a new-onset AF represents a frequent complication in COVID-19. Clinical evidence demonstrates that COVID-19, by promoting the evolution of a prothrombotic state, increases the susceptibility to arrhythmic events during the infective stages and presumably during post-recovery. AF itself is the most frequent form of arrhythmia and is associated with substantial morbidity and mortality. One of the molecular factors involved in COVID-19-related AF episodes is the angiotensin-converting enzyme (ACE) 2 availability. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses ACE2 to enter and infect multiple cells. Atrial ACE2 internalization after binding to SARS-CoV-2 results in a raise of angiotensin (Ang) II, and in a suppression of cardioprotective Ang(1–7) formation, and thereby promoting cardiac hypertrophy, fibrosis and oxidative stress. Furthermore, several pharmacological agents used in COVID-19 patients may have a higher risk of inducing electrophysiological changes and cardiac dysfunction. Azithromycin, lopinavir/ritonavir, ibrutinib, and remdesivir, used in the treatment of COVID-19, may predispose to an increased risk of cardiac arrhythmia. In this review, putative mechanisms involved in COVID-19-related AF episodes and the cardiovascular safety profile of drugs used for the treatment of COVID-19 are summarized.

Published
2023

21. Capillary leak syndrome following COVID-19 vaccination: Data from the European pharmacovigilance database Eudravigilance

Author

Ruggiero, Rosanna, Balzano, Nunzia, Di Napoli, Raffaella, Mascolo, Annamaria, Berrino, Pasquale Maria, Rafaniello, Concetta, Sportiello, Liberata, Rossi, Francesco, Capuano, Annalisa, Ruggiero, Rosanna, Balzano, Nunzia, Di Napoli, Raffaella, Mascolo, Annamaria, Berrino, Pasquale Maria, Rafaniello, Concetta, Sportiello, Liberata, Rossi, Francesco, and Capuano, Annalisa

Subjects
AEFI, safety, Adult, COVID-19 Vaccines, Ad26COVS1, SARS-CoV-2, Vaccination, Immunology, hypercytokinemia, COVID-19, Eudravigilance, Pharmacovigilance, Cross-Sectional Studies, plausibility, Adverse Drug Reaction Reporting Systems, Cytokines, Humans, Immunology and Allergy, Female, RNA, Messenger, COVID-19 vaccine, BNT162 Vaccine, Capillary Leak Syndrome, 2019-nCoV Vaccine mRNA-1273
Abstract

Capillary leak syndrome (CLS) emerged as new adverse event after immunization (AEFI) associated to COVID-19 vaccination. CLS is a rare condition characterized by increased capillary permeability, resulting in hypoalbuminemia, hypotension, and edema mainly in the upper and lower limbs. Our pharmacovigilance study aims to evaluate the CLS onset following receipt of COVID-19 mRNA vaccines (mRNA-1273 and BNT162b2) compared to viral vector vaccines (Ad26.COV2-S and ChAdOx1-SARS-COV-2). We carried a cross-sectional study using all Individual Case Safety Reports (ICSRs) reporting a COVID-19 vaccine as suspected drug and CLS as AEFI, which were collected in the pharmacovigilance database EudraVigilance from January 1st, 2021, to January 14th, 2022. We applied the Reporting Odds Ratio (ROR) 95% CI for the disproportionality analysis. During our study period, CLS was described as AEFI in 84 out of 1,357,962 ICRs reporting a vaccine COVID-19 as suspected drug and collected in the EV database. Overall, the ICSR reported by CLS were mainly related to the viral vector COVID-19(ChAdOx1-SARS-COV-2 = 36; Ad26.COV2-S = 9). The mRNA COVID-19 vaccines were reported in 39 ICSRs (BNT162b2 =33; mRNA-1273 =6). Majority of ICSRs were reported by healthcare professionals (71.4%). Majority of the patients were adult (58.3%) and the female gender accounted in more than 65% of ICSRs referred both to classes vaccines. In particular, women were more represented in ICSRs referred to mRNA-1273 (83.3%) and to ChAdOx1-SARS-COV-2 (72.2%). The CLS outcome was more frequently favorable in mRNA ICSRs (33,3%) than the viral vector ones (13.3%). Among the ICSRs reporting CLS with unfavorable outcome, we found also 9 fatal cases (BNT162b2 = 1; ChAdOx1-SARS-COV-2 = 4; Ad26.COV2-S = 4). From disproportionality analysis emerged a lower CLS reporting probability after vaccination with mRNA vaccines compared to viral vector-based ones (ROR 0.5, 95% CI 0.3–0.7; p

Published
2022
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22. Two Years of Active Pharmacovigilance Surveillance and Therapeutic Reconciliation in Frail Populations: The MEAP 3.0 Study.

Author

Bombelli, Anna, Guarnieri, Greta, Lombardi, Niccolò, Sullo, Maria Giuseppa, Spina, Edoardo, Crescioli, Giada, Rafaniello, Concetta, Cicala, Giuseppe, Marangon, Veronica, Folchino, Rachele, Vecchio, Silvia, Mosini, Giulia, Radice, Sonia, and Clementi, Emilio

Subjects
CHILD patients, WATCHFUL waiting, DRUG side effects, OLDER patients, DRUG interactions
Abstract

Awareness related to the risk/benefit profile of therapies used in paediatric and elderly patients is limited. We carried out a study, called the MEAP 3.0 study, to collect and analyse evidence of adverse drug reactions (ADRs) and drug–drug interactions (DDIs) that occurred in frail populations under polypharmacy in a real-world setting. Data were retrieved from reports of ADRs and pharmacological counselling from patients treated in hospitals and territorial health services. We collected 2977 ADRs reports and identified 'anti-infectives for systemic use' and 'cardiovascular system' as the most frequently implicated pharmacological classes in under-18 and over-65 patients, respectively. We detected 2179 DDIs, of which 10.7% were related to at least one ADR: 22 were classified as 'contraindicated' (7 in the paediatric group and 15 in the elderly one), and 61 as 'major' (6 in the paediatric patients and 55 in the geriatric ones), while 151 DDIs were classified as 'moderate' (10 referred to paediatric population, and 109 to elderly patient) and as 'minor' (1 in paediatric patients, and 31 in the elderly ones). The MEAP 3.0 project demonstrates that pharmacovigilance surveillance and therapeutic reconciliation are valid strategies to avoid potential DDIs and the occurrence of ADRs, allowing for personalised medicine. [ABSTRACT FROM AUTHOR]

Published
2023
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23. COVID-19 Vaccines and Atrial Fibrillation: Analysis of the Post-Marketing Pharmacovigilance European Database

Author

Ruggiero, Rosanna, primary, Donniacuo, Maria, additional, Mascolo, Annamaria, additional, Gaio, Mario, additional, Cappetta, Donato, additional, Rafaniello, Concetta, additional, Docimo, Giovanni, additional, Riccardi, Consiglia, additional, Izzo, Imma, additional, Ruggiero, Donatella, additional, Paolisso, Giuseppe, additional, Rossi, Francesco, additional, De Angelis, Antonella, additional, and Capuano, Annalisa, additional

Published
2023
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30. COVID-19 and atrial fibrillation: Intercepting lines

Author

Donniacuo, Maria, primary, De Angelis, Antonella, additional, Rafaniello, Concetta, additional, Cianflone, Eleonora, additional, Paolisso, Pasquale, additional, Torella, Daniele, additional, Sibilio, Gerolamo, additional, Paolisso, Giuseppe, additional, Castaldo, Giuseppe, additional, Urbanek, Konrad, additional, Rossi, Francesco, additional, Berrino, Liberato, additional, and Cappetta, Donato, additional

Published
2023
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33. Therapeutic drug monitoring of second-generation antipsychotics in pediatric patients: an observational study in real-life settings

Author

Pozzi, Marco, Cattaneo, Dario, Baldelli, Sara, Fucile, Serena, Capuano, Annalisa, Bravaccio, Carmela, Sportiello, Liberata, Bertella, Silvana, Auricchio, Fabiana, Bernardini, Renato, Ferrajolo, Carmen, Guastella, Giuseppe, Mani, Elisa, Carnovale, Carla, Pisano, Simone, Rafaniello, Concetta, Riccio, Maria Pia, Rizzo, Renata, Scuderi, Maria Grazia, Sperandeo, Serena, Villa, Laura, Pascotto, Antonio, Molteni, Massimo, Rossi, Francesco, Radice, Sonia, and Clementi, Emilio

Published
2016
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34. Targeting High Glucose-Induced Epigenetic Modifications at Cardiac Levels: The Role of SGLT2 and SGLT2 Inhibitors

Author

Scisciola, Lucia, primary, Taktaz, Fatemeh, additional, Fontanella, Rosaria Anna, additional, Pesapane, Ada, additional, Surina, Surina, additional, Cataldo, Vittoria, additional, Ghosh, Puja, additional, Franzese, Martina, additional, Puocci, Armando, additional, Paolisso, Pasquale, additional, Rafaniello, Concetta, additional, Marfella, Raffaele, additional, Rizzo, Maria Rosaria, additional, Barbato, Emanuele, additional, Vanderheyden, Marc, additional, and Barbieri, Michelangela, additional

Published
2022
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39. Angiotensin receptor/Neprilysin inhibitor effects in CRTd non-responders: From epigenetic to clinical beside

Author

Sardu, Celestino, primary, Massetti, Massimo, additional, Scisciola, Lucia, additional, Trotta, Maria Consiglia, additional, Santamaria, Matteo, additional, Volpicelli, Mario, additional, Ducceschi, Valentino, additional, Signoriello, Giuseppe, additional, D’Onofrio, Nunzia, additional, Marfella, Ludovica, additional, Casolaro, Flavia, additional, Amico, Michele D.’, additional, Ruocco, Antonio, additional, Balestrieri, Maria Luisa, additional, Mauro, Ciro, additional, Rafaniello, Concetta, additional, Capuano, Annalisa, additional, Paolisso, Giuseppe, additional, and Marfella, Raffaele, additional

Published
2022
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41. Angiotensin receptor/Neprilysin inhibitor effects in CRTd non-responders: From epigenetic to clinical beside

Author

Sardu, Celestino, Massetti, Massimo, Scisciola, Lucia, Trotta, Maria Consiglia, Santamaria, Matteo, Volpicelli, Mario, Ducceschi, Valentino, Signoriello, Giuseppe, D'Onofrio, Nunzia, Marfella, Ludovica, Casolaro, Flavia, Amico, Michele D ', Ruocco, Antonio, Balestrieri, Maria Luisa, Mauro, Ciro, Rafaniello, Concetta, Capuano, Annalisa, Paolisso, Giuseppe, Marfella, Raffaele, Massetti, Massimo (ORCID:0000-0002-7100-8478), Sardu, Celestino, Massetti, Massimo, Scisciola, Lucia, Trotta, Maria Consiglia, Santamaria, Matteo, Volpicelli, Mario, Ducceschi, Valentino, Signoriello, Giuseppe, D'Onofrio, Nunzia, Marfella, Ludovica, Casolaro, Flavia, Amico, Michele D ', Ruocco, Antonio, Balestrieri, Maria Luisa, Mauro, Ciro, Rafaniello, Concetta, Capuano, Annalisa, Paolisso, Giuseppe, Marfella, Raffaele, and Massetti, Massimo (ORCID:0000-0002-7100-8478)

Abstract

Objectives: We evaluated whether Angiotensin receptor/Neprilysin inhibitors (ARNI) reduce heart failure (HF) hospitalizations and deaths in cardiac resynchronization therapy with defibrillator (CRTd) non-responders patients at 12 months of follow-up, modulating microRNAs (miRs) implied in adverse cardiac remodeling.Background: adverse cardiac remodeling characterized by left ventricle ejection fraction (LVEF) reduction, left ventricular end-systolic volume (LVESv) increase, and the 6-minute walking test (6MWT) reduction are relevant pathological mechanisms in CRTd non-responders and could be linked to changes in miRNAs (miRs), regulating cardiac fibrosis, apoptosis, and hypertrophy.Methods: miRs levels and clinical outcomes (LVEF, cardiac deaths, and 6MWT) were evaluated at baseline and one year of follow-up in CRTd non-responders divided into ARNI-users and Non-ARNI users.Results: At baseline, there were no differences in levels of inflammatory markers, miR-18, miR-145, and miR-181 (p > 0.05) between Non-ARNI users (n 106) and ARNI-users (n 312). At one year of follow-up, ARNI-users vs. Non-ARNI users showed lowest inflammatory markers (p < 0.01) and miR-181 levels (p < 0.01) and higher values of miR-18 (p < 0.01)and miR-145 (p < 0.01). At one year of follow-up, ARNI-users had a higher increase of LVEF (p < 0.01) and 6MWT (p < 0.01) along with a more significant reduction of LVESv (p < 0.01) compared to Non-ARNI users. Cox regression analysis evidenced that ARNI-based therapies increase the probability of anti-remodeling effects of CRTd. Based on symptomatic improvements, echocardiographic and functional classification improvements, 37 (34.9%) patients among ARNI-users became responders, while only twenty (6.4%) patients became responders among Non-ARNi-users.Conclusions: ARNI might influence epigenetic mechanisms modulating miRs implicated in the adverse cardiac remodeling responses to CRTd.

Published
2022

42. Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018

Author

Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier-Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgrò, Valentina, Lalagkas, Panagiotis Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Roque Pereira, Leonardo, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, Trifirò, Gianluca, Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier-Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgrò, Valentina, Lalagkas, Panagiotis Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Roque Pereira, Leonardo, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, and Trifirò, Gianluca

Abstract

Background: The European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA-requested PAS, commonly observational studies, must be recorded in this register. Multi-database studies (MDS) leveraging secondary data have become an important strategy to conduct PAS in recent years, as reflected by the type of studies registered in the EU PAS register. Objectives: To analyse and describe PAS in the EU PAS register, with focus on MDS. Methods: Studies in the EU PAS register from inception to 31st December 2018 were described concerning transparency, regulatory obligations, scope, study type (e.g., observational study, clinical trial, survey, systematic review/meta-analysis), study design, type of data collection and target population. MDS were defined as studies conducted through secondary use of >1 data source not linked at patient-level. Data extraction was carried out independently by 14 centres with expertise in pharmacoepidemiology, using publicly available information in the EU PAS register including study protocol, whenever available, using a standardised data collection form. For validation purposes, a second revision of key fields for a 15% random sample of studies was carried out by a different centre. The inter-rater reliability (IRR) was then calculated. Finally, to identify predictors of primary data collection-based studies/versus those based on secondary use of healthcare databases) or MDS (vs. non-MDS), odds ratios (OR) and 95% confidence intervals (CI) were calculated fitting univariate logistic regression models. Results: Overall, 1426 studies were identified. Clinical trials (N = 30; 2%), systematic reviews/meta-analyses (N = 16; 1%) and miscellaneous study designs (N = 46; 3%) were much less common than observational studies (N = 1227; 86%). The protocol was available for 63% (N = 360) of 572 observational studies requested by a competent authority. Overall, 36% (N = 446) of

Published
2022

43. Disentangling a Thorny Issue: Myocarditis and Pericarditis Post COVID-19 and Following mRNA COVID-19 Vaccines

Author

Rafaniello, Concetta, primary, Gaio, Mario, additional, Zinzi, Alessia, additional, Sullo, Maria Giuseppa, additional, Liguori, Valerio, additional, Ferraro, Marialuisa, additional, Petronzelli, Fiorella, additional, Felicetti, Patrizia, additional, Marchione, Pasquale, additional, Marra, Anna Rosa, additional, Rossi, Francesco, additional, De Angelis, Antonella, additional, and Capuano, Annalisa, additional

Published
2022
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44. Neurological Manifestations Related to Immune Checkpoint Inhibitors: Reverse Translational Research by Using the European Real-World Safety Data

Author

Ruggiero, Rosanna, primary, Stelitano, Barbara, additional, Fraenza, Federica, additional, di Mauro, Gabriella, additional, Scavone, Cristina, additional, Sportiello, Liberata, additional, Rafaniello, Concetta, additional, Di Napoli, Raffaella, additional, Danesi, Romano, additional, Del Re, Marzia, additional, Rossi, Francesco, additional, and Capuano, Annalisa, additional

Published
2022
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45. Overview of the EU PAS register post-authorization studies performed in Europe from September 2010 to December 2018

Author

SULTANA, Janet, CRISAFULLI, Salvatore, ALMAS, Mariana, ANTONAZZO, Ippazio Cosimo, BAAN, Esme, BARTOLINI, Claudia, BERTUCCIO, Maria Paola, BONIFAZI, Fedele, CAPUANO, Annalisa, DIDIO, Antonella, EHRENSTEIN, Vera, FELISI, Mariagrazia, FERRAJOLO, Carmen, FONTANA, Andrea, FRANCISCA, Remy, FOURRIER-REGLAT, Annie, FORTUNY, Joan, GINI, Rosa, HYERACI, Giulia, HOEVE, Christel, KONTOGIORGIS, Christos, ISGRO, Valentina, LALAGKAS, Panagiotis-Nikolaos, L'ABBATE, Luca, LAYTON, Deborah, LANDI, Annalisa, NARDUZZI, Silvia, PEREIRA, Leonardo Roque, POULENTZAS, Georgios, RAFANIELLO, Concetta, ROBERTO, Giuseppe, SCONDOTTO, Giulia, SPORTIELLO, Liberata, TOMA, Maddalena, TOUSSI, Massoud, VERHAMME, Katia, VOLPE, Elisabetta, and TRIFIRO, Gianluca

Subjects
post-authorization studies, EU PAS register, Multi-database studies
Published
2022

47. Pharmacological Basis of Breast Cancer Resistance to Therapies - An Overview

Author

Crucitta, Stefania, primary, Cucchiara, Federico, additional, Sciandra, Francesca, additional, Cerbioni, Annalisa, additional, Diodati, Lucrezia, additional, Rafaniello, Concetta, additional, Capuano, Annalisa, additional, Fontana, Andrea, additional, Fogli, Stefano, additional, Danesi, Romano, additional, and Re, Marzia Del, additional

Published
2022
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50. Predictors of mortality in atypical antipsychotic-treated community-dwelling elderly patients with behavioural and psychological symptoms of dementia: a prospective population-based cohort study from Italy

Author

Rafaniello, Concetta, Lombardo, Flavia, Ferrajolo, Carmen, Sportiello, Liberata, Parretta, Elisabetta, Formica, Ranieri, Potenza, Simona, Rinaldi, Barbara, Irpino, Antonio, Raschetti, Roberto, Vanacore, Nicola, Rossi, Francesco, and Capuano, Annalisa

Published
2014
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