Bayer Healthcare Research Articles

Influence of Contrast Media Temperature and Concentration on Patient Comfort and Safety in Computed Tomography: CATCHY II Trial.

Previous research on the necessity to reduce the viscosity of contrast media (CM) by either prewarming CM before injection during computed tomography (CT) or by using less concentrated CM has yielded conflicting results. In addition, there is limited evidence on patient comfort. The aim of the study was to examine if prewarming CM, with varying CM concentrations, is superior to CM at room temperature, with respect to patient comfort and safety in CT. All elective patients scheduled for contrast-enhanced CT scans at Maastricht University Medical Center+ between October 27, 2021 and October 31, 2022 were eligible for inclusion when a questionnaire evaluating patient comfort was completed. This 1-year period was divided into 4 intervals (4 groups): group 1 (370 mg I/mL, 37°C), group 2 (370 mg I/mL, room temperature), group 3 (300 mg I/mL, 37°C), and group 4 (300 mg I/mL, room temperature). All CT scans were performed using state of the art equipment (Siemens Healthineers; SOMATOM Force and SOMATOM Definition AS, Forchheim, Germany). Contrast media injections were performed using a dual-head power injector (Stellant; Bayer Healthcare, Berlin, Germany) and individualized to body weight and/or tube voltage, depending on the CM protocols. After the CT scan, patients completed a questionnaire covering the primary outcomes comfort, pain, and adverse events such as feelings of heat, nausea, vomiting, itchiness, urticaria, difficulty breathing, dizziness, goosebumps, or an odd taste. Technicians were asked to report any adverse events, including extravasation and allergic-like reactions. The secondary outcome involved attenuation (in Hounsfield unit, HU), which was evaluated by assessing the HU of the coronary arteries for vascular CT, and liver enhancement in portal venous CT. The Kruskal-Wallis test was used for continuous scale outcomes and χ 2 tests for examining adverse events. Results showed no significant differences examining comfort score ( P = 0.054), pain sensation ( P = 0.469), extravasation ( P = 0.542), or allergic-like reaction ( P = 0.253). Significant differences among the 4 groups were found with respect to heat sensation and dizziness ( P = 0.005 and P = 0.047, respectively), showing small effect sizes. All other adverse effects showed no significant results. No significant differences were observed in coronary attenuation among the 4 groups in coronary CT angiography ( P = 0.113). When analyzing attenuation in portal venous CT scans, significant differences were found among the 4 groups ( P = 0.008). Administrating prewarmed CM is nonsuperior compared with CM at room temperature in relation to patient comfort and safety, regardless of CM concentration. These findings suggest that prewarming CM before usage is unnecessary, which will improve the efficiency of daily clinical workflow and brings environmentally friendly benefits.

The role of carbondioxide insufflation in preventing postoperative peritoneal adhesions in rats

Aims: Adhesion is the pathological connections that occur during the healing with scar formation of peritoneal surface defects. CO2 is used the most frequently in laparoscopic operations for insufflation. It is believed that it causes to changes in the inflammatory reply of the pneumo-peritoneum, defects in acid-base balance and decrease in peritoneal macrophage functions. CO2 is the only gas whose immunologic effects have been shown. It has been proven in experimental studies that the CO2 insufflation causes to local peritoneal acidosis without affecting the systemic status. Moreover, it has also been shown that it decreases the pneumo-peritoneum TNF-α and IL-6 production; however, increases the IL-10 production which is an anti-inflammatory cytokine. In the literature, the relation between the laparoscopy and the postoperative adhesions has always been explained by taking the suggestion of its causing to less tissue trauma as a basis when compared with the open surgery. The inflammatory reply of the CO2 has been less dealt with. In this study, we wanted to find the answer to the question whether the capno-peritoneum has a role in preventing the postoperative adhesion formation only by using CO2 without a a laparoscopic operation. 
 Methods: 30 female Wistar Albino type rats whose weights varied between 250±20 were used in the study. The rats were divided into 5 groups. Each group had 6 rats. Rats were placed in standard polycarbon cages in groups of 6. The room temperature was kept in 21°C. The rats were fed with standard pellet food during the study and tap water was provided to them. The operational anesthesia was performed by injecting intramuscular Ketamine Hydrochloride (Ketalar, Parke Davis and Eczacıbaşı, İstanbul) 50 mg/kg and Xylazine hydrochloride (Rompun, Bayer HealthCare) 5 mg/kg. 
 Results: A meaningful difference (p

Comparison of gastrointestinal adverse events between fast release tablets and regular acetylsalicylic acid (aspirin) galenics after short-term use: a meta-analysis of randomized clinical trials.

This study aimed at determining whether there is a difference in the safety profile between fast release (FR) aspirin tablets and regular galenic formulations of aspirin. This study was based on a clinical study database pool (Bayer HealthCare) including 84clinical studies and 16,095human subjects. The meta-analysis included 72studies applying a single dose of aspirin of at most 1000mg and was, therefore, based on individual data from 9288subjects. Of these, 6029subjects took aspirin and 3259subjects took placebo. Endpoints were adverse events (AEs) of any kind and, especially of gastrointestinal (GI) nature. Event incidence and odds ratios (OR) based on Mantel-Haenszel risk estimates were calcuated. Subjects on aspirin FR had a significantly decreased OR of 0.65 [0.48, 0.90] [95% confidence interval] for all AEs and of 0.39 [0.20, 0.79] for drug-related all AEs versus placebo. The risk of all GI AEs tended to be reduced for subjects on aspirin FR (0.65 [0.41; 1.03]), but not for drug-related GI AEs. Subject on aspirin mono and aspirin mono (plain only, w/o FR) showed an increased risk of drug-related all AEs compared to placebo (1.34 [1.11; 1.62] and 1.43 [1.13; 1.80]). However, subjects on aspirin FR and those on regular aspirin had almost the same risk of all determined AEs. In conclusion, aspirin FR tablets showed a comparable GI tolerability to regular galenic formulations of aspirin after short-term treatment. Major GI complication did not occur after intake of any galenic formulation of aspirin.

Clinical outcomes and treatment patterns in REASSURE: planned interim analysis of a real-world observational study of radium-223 in metastatic castration-resistant prostate cancer.

Radium-223, a targeted alpha therapy, is approved to treat bone-dominant metastatic castration-resistant prostate cancer (mCRPC), based on significantly prolonged overall survival versus placebo and a favourable safety profile in the phase 3 ALSYMPCA study. ALSYMPCA was conducted when few other treatment options were available, and prospectively collected data are limited on the use of radium-223 in the current mCRPC treatment landscape. We sought to understand long-term safety and treatment patterns in men who received radium-223 in real-world clinical practice. REASSURE (NCT02141438) is a global, prospective, observational study of radium-223 in men with mCRPC. Primary outcomes are adverse events (AEs), including treatment-emergent serious AEs (SAEs) and drug-related AEs during and ≤30 days after radium-223 completion, grade 3/4 haematological toxicities ≤6 months after last radium-223 dose, drug-related SAEs after radium-223 therapy completion, and second primary malignancies. Data collection commenced on Aug 20, 2014, and the data cutoff date for this prespecified interim analysis was Mar 20, 2019 (median follow-up 11.5 months [interquartile range 6.0-18.6]), 1465 patients were evaluable. For second primary malignancies, 1470 patients were evaluable, 21 (1%) of whom had a total of 23 events. During radium-223 therapy, 311 (21%) of 1465 patients had treatment-emergent SAEs, and 510 (35%) had drug-related AEs. In the 6 months after completion of radium-223 therapy, 214 (15%) patients had grade 3/4 haematological toxicities. Eighty patients (5%) had post-treatment drug-related SAEs. Median overall survival was 15.6 months (95% confidence interval 14.6-16.5) from radium-223 initiation. Patient-reported pain scores declined or stabilised. Seventy (5%) patients had fractures. REASSURE offers insight into radium-223 use in global real-world clinical practice with currently available therapies. At this interim analysis, with a median follow-up of almost 1 year, 1% of patients had second primary malignancies, and safety and overall survival findings were consistent with clinical trial experience. Final analysis of REASSURE is due in2024. Bayer HealthCare.

Experimental oral delivery of the systemic acaricide moxidectin to free-ranging white-tailed deer (Artiodactyla: Cervidae) parasitized by Amblyomma americanum (Ixodida: Ixodidae).

Orally delivered, host-targeted, systemic acaricide treatment has potential to be an effective areawide tick abatement strategy. Past efforts using ivermectin for livestock were reported effective at controlling both Amblyomma americanum (L.) and Ixodes scapularis Say on Odocoileus virginianus (Zimmermann). However, the labeled 48-day withdrawal period for human consumption largely prevented utilization of this strategy targeting I. scapularis in autumn, when peak adult host-seeking activity coincides with regulated white-tailed deer hunting seasons. The modern-day compound moxidectin is the active ingredient in the pour-on formulation Cydectin (5 mg moxidectin/ml; Bayer Healthcare LLC), with a labeled 0-day withdrawal period for human consumption of treated cattle. We sought to re-examine the systemic acaricide approach for tick management by determining if we could successfully deliver Cydectin to free-ranging white-tailed deer. Over 2 yr in late spring/early summer, coinciding with adult and nymphal A. americanum activity, we fed Cydectin-coated corn to free-ranging white-tailed deer in coastal Connecticut. Through serum analysis, we documented moxidectin levels at or above those previously reported effective for control of ectoparasites (5-8 ppb for moxidectin and ivermectin) in 24 of 29 white-tailed deer captured (83%) while exposed to treated corn. While we did not document differences in burdens of parasitizing A. americanum based on moxidectin sera levels, we did document fewer engorged specimens on deer with increased sera levels. The systemic use of moxidectin for tick management in critical reproductive hosts has the potential to be effective in an areawide capacity while also permitting human consumption of treated venison.

Pregnancy Outcomes in Multiple Sclerosis patients with or without exposure to Disease Modifying Therapies during pregnancy (N2.003)

Pregnancy Outcomes in Multiple Sclerosis patients with or without exposure to Disease Modifying Therapies during pregnancy (N2.003)

Serum metabolic profile in early multiple sclerosis as predictor of long-term disease progression in BENEFIT (P5-3.013)

Serum metabolic profile in early multiple sclerosis as predictor of long-term disease progression in BENEFIT (P5-3.013)

Infusion-Related Reactions With Ocrelizumab: Risk Factors, Symptom Management and Patient Choices in the ENSEMBLE PLUS Study (P7-3.003)

Infusion-Related Reactions With Ocrelizumab: Risk Factors, Symptom Management and Patient Choices in the ENSEMBLE PLUS Study (P7-3.003)

Low Disease Activity Over 4 Years of Ocrelizumab Therapy in Treatment-Naive Patients With Early-Stage Relapsing-Remitting Multiple Sclerosis; the Phase IIIb ENSEMBLE Study (S46.004)

Low Disease Activity Over 4 Years of Ocrelizumab Therapy in Treatment-Naive Patients With Early-Stage Relapsing-Remitting Multiple Sclerosis; the Phase IIIb ENSEMBLE Study (S46.004)

Impact of Assisted Reproductive Technologies (ART) on Relapse Risk in Women with Multiple Sclerosis (S31.005)

Impact of Assisted Reproductive Technologies (ART) on Relapse Risk in Women with Multiple Sclerosis (S31.005)

Lack of B-cell Depletion with Ocrelizumab (P7-3.006)

Lack of B-cell Depletion with Ocrelizumab (P7-3.006)

Serum neurofilament light chain (NfL)and CSF glial fibrillary acidic protein (GFAP) together improve the prediction of long-term clinical outcomes in multiple sclerosis (S9.001)

Serum neurofilament light chain (NfL)and CSF glial fibrillary acidic protein (GFAP) together improve the prediction of long-term clinical outcomes in multiple sclerosis (S9.001)

Pregnancy Outcomes and Disease Course in NMOSD and MOGAD in CANOPTICS (N2.002)

Pregnancy Outcomes and Disease Course in NMOSD and MOGAD in CANOPTICS (N2.002)

Risk assessment in pulmonary arterial hypertension: A step towards clinical implementation based on the 2022 ESC/ERS pulmonary hypertension guidelines.

Risk assessment in pulmonary arterial hypertension: A step towards clinical implementation based on the 2022 ESC/ERS pulmonary hypertension guidelines.

MP29-13 REAL-WORLD STUDY ON DAROLUTAMIDE, ENZALUTAMIDE, AND APALUTAMIDE FOR NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS USING A UROLOGY NETWORK IN THE UNITED STATES (DEAR STUDY)

You have accessJournal of UrologyCME1 Apr 2023MP29-13 REAL-WORLD STUDY ON DAROLUTAMIDE, ENZALUTAMIDE, AND APALUTAMIDE FOR NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS USING A UROLOGY NETWORK IN THE UNITED STATES (DEAR STUDY) Neal D. Shore, Nasreen Khan, Niculae Constantinovici, Javeed Khan, Guifang Chen, Julie Xu, Jorge Ortiz, Alicia K. Morgans, and Daniel J. George Neal D. ShoreNeal D. Shore More articles by this author , Nasreen KhanNasreen Khan More articles by this author , Niculae ConstantinoviciNiculae Constantinovici More articles by this author , Javeed KhanJaveed Khan More articles by this author , Guifang ChenGuifang Chen More articles by this author , Julie XuJulie Xu More articles by this author , Jorge OrtizJorge Ortiz More articles by this author , Alicia K. MorgansAlicia K. Morgans More articles by this author , and Daniel J. GeorgeDaniel J. George More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003257.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Second-generation androgen receptor inhibitors (ARIs) are recommended for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) due to their ability to prolong overall survival and metastasis-free survival. Besides efficacy, drug tolerance is also important for these patients as they are often asymptomatic from their disease. However, there is limited information on real-world (RW) outcomes from the use of different ARIs. DEAR is the first study using a single data source to assess RW utilization and outcomes of darolutamide (daro), enzalutamide (enza), and apalutamide (apa) in patients with nmCRPC. METHODS: This is a retrospective chart review study using electronic medical records from the Precision Point Specialty network of US urology practices. Eligible patients had nmCRPC, no prior novel hormonal therapy, and initiated first ARI treatment from August 2019 to March 2022. Patients were stratified into 3 cohorts based on the first prescribed ARI in the nmCRPC stage. This interim report describes the proportions of patients who discontinued initial ARI treatment, patients who progressed to metastatic CRPC (mCRPC), and the estimated probability of discontinuation/progression at 6, 12, 18, and 24 months using Kaplan-Meier estimates. RESULTS: In total, 666 patients were included (daro/enza/apa, n=276/280/110). Median age (80/79/80 years), White race (68%/69%/74%), and median prostate-specific antigen doubling time (6.7/6.0/7.8 months) were similar in the daro/enza/apa cohorts at baseline. Median length of follow-up was similar (Table). Overall, fewer patients discontinued treatment in the daro cohort (27.9%) vs 37.9%/45.5% for enza/apa, and fewer patients progressed to mCRPC in the daro cohort (18.1%) compared with enza or apa (28.9%/25.5%). Generally, the estimated probability of discontinuation/progression was numerically lower for daro compared with enza or apa. CONCLUSIONS: In this interim analysis, despite similar baseline characteristics, fewer daro patients discontinued treatment or progressed to mCRPC compared with enza or apa. Source of Funding: Bayer HealthCare © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e386 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal D. Shore More articles by this author Nasreen Khan More articles by this author Niculae Constantinovici More articles by this author Javeed Khan More articles by this author Guifang Chen More articles by this author Julie Xu More articles by this author Jorge Ortiz More articles by this author Alicia K. Morgans More articles by this author Daniel J. George More articles by this author Expand All Advertisement PDF downloadLoading ...

Impact of an Expanded Definition of Family History on Outcomes of Active Surveillance for Prostate Cancer.

Despite family history being an established risk factor for prostate cancer, the role of a broader definition of family history inclusive of not just prostate cancer but other genetically related malignancies has not been investigated in the active surveillance population. Here, we evaluate the impact of an expanded definition of family history on active surveillance outcomes. Patients undergoing active surveillance for prostate cancer at Massachusetts General Hospital from 1997-2019 with detailed data available on family cancer history were identified. Primary outcome was biopsy progression-free survival, and secondary outcomes were treatment-free survival, adverse pathological features at prostatectomy, and biochemical recurrence after treatment. Statistical analyses were conducted using the Kaplan-Meier method and Cox regression. Among 855 evaluable patients, 300 (35.1%) patients had any family history of prostate cancer, and 95 (11.1%) had a family history of related malignancies suggestive of a hereditary cancer syndrome. Family history of prostate cancer alone was not associated with biopsy progression, whereas family history suggestive of a hereditary cancer syndrome was associated with a significantly increased risk of biopsy progression (HR 1.43, 95%CI 1.01-2.02), independent of other known clinicopathological risk factors in multivariable analysis. Similarly, family history suggestive of a hereditary cancer syndrome was associated with significantly lower treatment-free survival (HR 1.58, 95%CI 1.14-2.18) in multivariable analysis. No significant association was found between family history and adverse features on surgical pathology or biochemical recurrence. An expanded family history suggestive of a hereditary cancer syndrome is an independent predictor of biopsy progression during active surveillance. Men with such a family history may still be offered active surveillance but should be counseled regarding the higher risk of disease progression.

Globalization and the Future of Medical Writing

Medical writers play a key role in global regulatory submissions across the pharmaceutical industry. Before the COVID pandemic, many companies were working toward development of global regulatory submissions, with their medical writers playing a key role in this process. During the pandemic, the need for greater collaboration in fully remote working conditions, inclusion and transparency, and the unprecedented demand for speed and quality of clinical development has brought global ways of working into even greater focus. A panel of medical writers, including department and regional heads and subject matter experts, were invited to consider how other influences on our industry may drive the evolution of medical writing yet further as a global profession in the coming years. This article summarizes the panel’s responses to 5 questions on the future direction of the profession. Contributors include: Jeannene Butler, Otsuka Pharmaceutical Development & Commercialization, Princeton, NJ Kelley Hill, Alexion, AstraZeneca Rare Disease, Boston, MA Garima Pallavi, Parexel International India Development & Commercialization Safety Services Private Limited, Bangalore, India Grishma Kanchan, Parexel International India Development & Commercialization Safety Services Private Limited, Bangalore, India Jonathan Mackinnon, Parexel International S.L., Madrid, Spain Renee Primus, Bristol Myers Squibb, Princeton, NJ Matthew Renda, Alexion, AstraZeneca Rare Disease, Boston, MA Linda Yih, Parexel International LLC Nan Wang, Bayer Healthcare Co. Ltd., Beijing, China

Çocukluk Çağı Kanserlerinde NTRK Somatik Füzyonları ve Tümör Agnostik Tedavi

Neurotrophic tyrosine receptor kinase (NTRK) gene rearrangements have been recently identified and developed as one of the biomarkers that have been utilized as new targets for cancer therapy. NTRK gene fusions have taken their place in individualized targeted therapy by being used as a predictive (diagnostic) biomarker as well as a treatment target. Selective inhibitors of NTRK fusion proteins have potent efficacy in the treatment of NTRK fusion-positive solid tumors. Detection of these fussions have become important since the finding of new drugs for which U.S. Food and Drug Administration (FDA) granted approval are used on the treatment of patients who has NTRK fussions positive cansers. Clinical trials have shown that first generation tyrosine receptor kinase (TRK) inhibitors, larotrectinib (Vitrakvi, Bayer HealthCare Pharmaceutical Inc, New Jersey, U.S.) and entrectinib (Rozlytrek, Genentech Inc, California, U.S.), have potent efficacy in the treatment of NTRK fusion positive cancers. In the future, with the increase in the number of comprehensive studies on these drugs further information will become available and beneficial.

Signs of chronic thromboembolic pulmonary hypertension in acute pulmonary embolism: results from the FOCUS study

Abstract Background/Introduction Chronic thromboembolic pulmonary hypertension (CTEPH) is considered to be a late complication of acute pulmonary embolism (PE). However, up to one third of CTEPH patients do not report prior symptomatic venous thromboembolism (VTE). Furthermore, a substantial proportion of patients presenting with an acute PE event may exhibit radiological signs of chronicity at baseline computed tomography pulmonary angiography (CTPA). Purpose To determine the prevalence of baseline radiological parameters indicating chronic thrombosis or pulmonary hypertension, and ultimately pre-existing CTEPH, among patients with acute PE enrolled in the prospective multicentre Follow-Up after Acute Pulmonary Embolism (FOCUS) cohort study. Methods Patients with acute symptomatic PE and absence of a known history of CTEPH, enrolled at two large FOCUS centres, were included. The assessment of index CTPA scans was conducted by two independent expert radiologists who were unaware of the clinical characteristics and the follow-up data of the patients. CTPA parameters indicating chronicity were prespecified on the basis of recently proposed criteria in the literature. A third independent expert radiologist provided an assessment in case of disagreement between the first two. Baseline radiological data were prospectively validated with the aid of two-year prospective clinical follow-up data focusing on CTEPH and the post-PE syndrome (co-primary outcomes of the FOCUS study). Results A total of 303 patients (median age: 63 years, 44.6% women) were included. In >95% of the patients, the expert radiologists could confirm signs of acute PE at baseline CTPA. Radiological signs of chronic thrombi or pulmonary hypertension at baseline were detected in 46 (15.2%) patients. In 8 patients, the expert radiologists agreed on the presence of pre-existing CTEPH based on their interpretation of the overall radiological pattern. During follow-up, five (1.7%; 95% CI 0.7–3.8%) of 303 patients were diagnosed with CTEPH, over a median time of 95 days after baseline. Four of them were among the 8 patients in whom the radiological experts suspected pre-existing CTEPH at baseline, and among the 46 patients in whom CTPA findings suggesting chronic thrombi or chronic pulmonary hypertension were present at baseline. The use of the predefined individual parameters of chronicity from the literature also helped identifying patients with chronic disease, and could be used as a tool for screening acute PE patients for pre-existing CTEPH. Conclusion A substantial proportion of patients who are diagnosed with CTEPH during follow-up after acute PE may already have pre-existing CTEPH at the time of the index event. An intensified follow-up programme and focussed screening for CTEPH should be considered in patients with signs of chronicity at baseline CTPA. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer Health Care

Two-year quality of life after acute pulmonary embolism: results from the FOCUS study

Abstract Background/Introduction No firm prospective evidence exists on the long-term course of disease-specific and generic quality of life (QoL) or their determinants in patients with acute pulmonary embolism (PE). Reliable data on this topic is essential for early identification of patients at risk of deviating from the expected course and prevention of clinical events affecting QoL recovery after PE. Purpose We examined the two-year course of QoL and the impact of events occurring after the acute phase of PE in patients from the prospective multicentre FOllow-up after aCUte pulmonary emboliSm (FOCUS) study. Methods All patients with complete QoL assessment at 3, 12 and 24 months (N=462) were included in the analysis of the two-year course of QoL; all patients with QoL assessment at 12 months, 24 months, or both (N=740) contributed to a multivariable linear mixed-effects regression for the investigation of determinants of long-term QoL. Disease-specific QoL was assessed with the Pulmonary Embolism Quality of Life (PEmb-QoL) instrument (global score: 0 = best, 100 = worst QoL), generic health-related QoL with the Euro Quality of life group (EuroQol) five-dimensions utility index (EQ-5D-5L; 0 = worst, 1 = best QoL) and the EuroQol visual analogue scale (0 = worst, 100 = best QoL). Incident events (recurrent PE, bleeding, stroke, new cancer diagnosis, and re-hospitalization) were modelled as time-varying covariates from discharge to month 12 and from month 12 to month 24. Results Among 462 patients with complete QoL assessment [200 (43.3%) women, median age 61.5 (IQR: 49–72) years, high-risk PE 15/462 (3.2%)], the median (IQR) PEmb-QoL score at 3, 12, and 24 months was 20 (9–36), 14 (5–30) and 13 (5–28), with a similar trend across all sub-dimensions (Figure 1); the mean (95% CI) EQ-5D-5L utility index 0.86 (0.84–0.88), 0.88 (0.87–0.90) and 0.87 (0.85–0.89); the mean (95% CI) EuroQoL visual analogue scale 74.2 (72.5–75.9), 76.8 (75.2–78.4) and 76.3 (74.6–78.0). Upon multivariable analysis in 740 patients with QoL data at 12 or 24 months, QoL according to all three scales was worse in women, patients of older age, with cardiopulmonary disease, with higher BMI, and in smokers, but did not change significantly at 24 vs 12 months. Incident PE recurrence or stroke did not considerably affect any of the QoL dimensions, whereas re-hospitalization for any cause worsened disease-specific QoL, a new cancer diagnosis worsened both scales of generic QoL, and bleeding worsened generic QoL as assessed by the Visual Analogue Scale (Table 1). Conclusion Generic and disease-specific QoL after PE improved in the first year and then plateaued in the second year. Disease-specific QoL was adversely affected by re-hospitalization for any cause but was robust to new cancer diagnosis and bleedings, which instead worsened generic QoL. These findings may support long-term management of patients with PE and contribute to design and interpretation of interventional studies. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer Health Care