scholarly journals COVID-19 vaccine reactogenicity – a cohort event monitoring study in the Netherlands using patient reported outcomes

Vaccine ◽  
2022 ◽  
Author(s):  
Leàn Rolfes ◽  
Linda Härmark ◽  
Agnes Kant ◽  
Leontine van Balveren ◽  
Wil Hilgersom ◽  
...  
Keyword(s):  
The Netherlands ◽  
Patient Reported Outcomes ◽  
Event Monitoring ◽  
Patient Reported ◽  
Monitoring Study ◽  
Cohort Event Monitoring

Safety of Artemisinin-Based Combination Therapies in Nigeria: A Cohort Event Monitoring Study

Drug Safety ◽  
2013 ◽  
Vol 36 (9) ◽  
pp. 747-756 ◽  
Author(s):  
Peter Usman Bassi ◽  
Adeline I. Osakwe ◽  
Ambrose Isah ◽  
Comfort Suku ◽  
Musa Kalat ◽  
...  
Keyword(s):  
Combination Therapies ◽  
Event Monitoring ◽  
Monitoring Study ◽  
Cohort Event Monitoring

scholarly journals Safety profile of non-vitamin K oral anticoagulants (NOACs) from a patient perspective: a web-based cohort event monitoring study

2019 ◽  
Vol 18 (9) ◽  
pp. 869-874
Author(s):  
Leàn Rolfes ◽  
Corine Ekhart ◽  
Judith Hendriks ◽  
Petra van der Horst ◽  
Eugène van Puijenbroek
Keyword(s):  
Vitamin K ◽  
Safety Profile ◽  
Patient Perspective ◽  
Oral Anticoagulants ◽  
Event Monitoring ◽  
Web Based ◽  
Monitoring Study ◽  
Cohort Event Monitoring

scholarly journals Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA)

Drug Safety ◽  
2018 ◽  
Vol 41 (9) ◽  
pp. 871-880 ◽  
Author(s):  
H. Hilda Ampadu ◽  
Alexander N. O. Dodoo ◽  
Samuel Bosomprah ◽  
Samantha Akakpo ◽  
Pierre Hugo ◽  
...  
Keyword(s):  
Public Health ◽  
Real World ◽  
Health Facilities ◽  
Event Monitoring ◽  
Public Health Facilities ◽  
Monitoring Study ◽  
Injectable Artesunate ◽  
Cohort Event Monitoring

scholarly journals Pyronaridine–artesunate real-world safety, tolerability, and effectiveness in malaria patients in 5 African countries: A single-arm, open-label, cohort event monitoring study

PLoS Medicine ◽  
2021 ◽  
Vol 18 (6) ◽  
pp. e1003669
Author(s):  
Gaston Tona Lutete ◽  
Ghyslain Mombo-Ngoma ◽  
Serge-Brice Assi ◽  
Jude D. Bigoga ◽  
Felix Koukouikila-Koussounda ◽  
...  
Keyword(s):  
Body Weight ◽  
Clinical Practice ◽  
Real World ◽  
Uncomplicated Malaria ◽  
Open Label ◽  
Event Monitoring ◽  
Republic Of Congo ◽  
Link Type ◽  
Monitoring Study ◽  
Cohort Event Monitoring

Background In Phase II/III randomized controlled clinical trials for the treatment of acute uncomplicated malaria, pyronaridine–artesunate demonstrated high efficacy and a safety profile consistent with that of comparators, except that asymptomatic, mainly mild-to-moderate transient increases in liver aminotransferases were reported for some patients. Hepatic safety, tolerability, and effectiveness have not been previously assessed under real-world conditions in Africa. Methods and findings This single-arm, open-label, cohort event monitoring study was conducted at 6 health centers in Cameroon, Democratic Republic of Congo, Gabon, Ivory Coast, and Republic of Congo between June 2017 and April 2019. The trial protocol as closely as possible resembled real-world clinical practice for the treatment of malaria at the centers. Eligible patients were adults or children of either sex, weighing at least 5 kg, with acute uncomplicated malaria who did not have contraindications for pyronaridine–artesunate treatment as per the summary of product characteristics. Patients received fixed-dose pyronaridine–artesunate once daily for 3 days, dosed by body weight, without regard to food intake. A tablet formulation was used in adults and adolescents and a pediatric granule formulation in children and infants under 20 kg body weight. The primary outcome was the hepatic event incidence, defined as the appearance of the clinical signs and symptoms of hepatotoxicity confirmed by a >2× rise in alanine aminotransferase/aspartate aminotransferase (ALT/AST) versus baseline in patients with baseline ALT/AST >2× the upper limit of normal (ULN). As a secondary outcome, this was assessed in patients with ALT/AST >2× ULN prior to treatment versus a matched cohort of patients with normal baseline ALT/AST. The safety population comprised 7,154 patients, of mean age 13.9 years (standard deviation (SD) 14.6), around half of whom were male (3,569 [49.9%]). Patients experienced 8,560 malaria episodes; 158 occurred in patients with baseline ALT/AST elevations >2×ULN. No protocol-defined hepatic events occurred following pyronaridine–artesunate treatment of malaria patients with or without baseline hepatic dysfunction. Thus, no cohort comparison could be undertaken. Also, as postbaseline clinical chemistry was only performed where clinically indicated, postbaseline ALT/AST levels were not systematically assessed for all patients. Adverse events of any cause occurred in 20.8% (1,490/7,154) of patients, most frequently pyrexia (5.1% [366/7,154]) and vomiting (4.2% [303/7,154]). Adjusting for Plasmodium falciparum reinfection, clinical effectiveness at day 28 was 98.6% ([7,369/7,746] 95% confidence interval (CI) 98.3 to 98.9) in the per-protocol population. There was no indication that comorbidities or malnutrition adversely affected outcomes. The key study limitation was that postbaseline clinical biochemistry was only evaluated when clinically indicated. Conclusions Pyronaridine–artesunate had good tolerability and effectiveness in a representative African population under conditions similar to everyday clinical practice. These findings support pyronaridine–artesunate as an operationally useful addition to the management of acute uncomplicated malaria. Trial registration ClinicalTrials.gov NCT03201770.

In wealthier countries, patients perceive worse impact of the disease although they have lower objectively assessed disease activity: results from the cross-sectional COMORA study

2015 ◽  
Vol 75 (4) ◽  
pp. 715-720 ◽  
Author(s):  
Polina Putrik ◽  
Sofia Ramiro ◽  
Monika Hifinger ◽  
Andras P Keszei ◽  
Ihsane Hmamouchi ◽  
...  
Keyword(s):  
The Netherlands ◽  
Disease Activity ◽  
Global Assessment ◽  
Patient Reported Outcomes ◽  
Patient Global Assessment ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Cross Sectional ◽  
Disease Outcomes ◽  
Patient Reported

ObjectivesTo investigate patterns in patient-reported and physician-reported disease outcomes in patients with rheumatoid arthritis (RA) from countries with different level of socioeconomic development.MethodsData from a cross-sectional multinational study (COMOrbidities in RA) were used. Contribution of socioeconomic welfare (gross domestic product (GDP); low vs high) of country of residence to physician-reported (tender joint count, swollen joint count (SJC), erythrocyte sedimentation rate, disease activity score based on 28 joints assessment (DAS28)-3v based on these three components and physician global assessment) and patient-reported (modified Health Assessment Questionnaire (mHAQ), patient global assessment and fatigue) disease outcomes was explored in linear regressions, adjusting for relevant confounders.ResultsIn total, 3920 patients with RA from 17 countries (30 to 411 patients per country) were included, with mean age of 56 years (SD13) and 82% women. Mean SJC varied between 6.7 (Morocco) and 0.9 (The Netherlands), mean mHAQ ranged between 0.7 (Taiwan) and 1.5 (The Netherlands). Venezuela had the lowest (1.7) and the Netherlands the highest score on fatigue (5.0). In fully adjusted models, lower GDP was associated with worse physician-reported outcomes (1.85 and 2.84 more swollen and tender joints, respectively, and 1.0 point higher DAS28-3v), but only slightly worse performance-based patient-reported outcome (0.15 higher mHAQ), and with better evaluation-based patient-reported outcomes (0.43 and 0.97 points lower on patient global assessment and fatigue, respectively).ConclusionsIn patients with RA, important differences in physician-reported and patient-reported outcomes across countries were seen, with overall a paradox of worse physician-reported outcomes but better patient-reported outcomes in low-income countries, while results indicate that these outcomes in multinational studies should be interpreted with caution. Research on explanatory factors of this paradox should include non-disease driven cultural factors influencing health.

scholarly journals PCN388 - PATIENT REPORTED OUTCOMES IN THE CASTRATION RESISTANT PROSTATE CANCER REGISTRY (PRO-CAPRI) IN THE NETHERLANDS

2018 ◽  
Vol 21 ◽  
pp. S80
Author(s):  
M. Kuppen ◽  
H.M. Westgeest ◽  
A. Van den Eertwegh ◽  
R. Moorselaar ◽  
N. Mehra ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
The Netherlands ◽  
Cancer Registry ◽  
Patient Reported Outcomes ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Patient Reported
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