An observational study in Adverse Drug Event, sponsored by Complejo Hospitalario Universitario de Badajoz. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Complejo Hospitalario Universitario de Badajoz · Observational
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Among 16 studies in Drug-Related Side Effects and Adverse Reactions with a site in Spain — 6 open to participants now, 8 under way, none of them phase 3. Drug-Related Side Effects and Adverse Reactions · Spain.
Among the 16 studies in Drug-Related Side Effects and Adverse Reactions with a site in Spain, this one is one of 2 that started in 2021, is one of 5 observational ones, and was the 9th registered.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
Browse Drug-Related Side Effects and Adverse Reactions studies →6 of the 16 studies in Drug-Related Side Effects and Adverse Reactions with a site in Spain are open now. Recruiting first, the newest first:
Adcytherix SAS · Sites in Spain, Australia
Ages 18+
Eli Lilly and Company · Sites in Spain, United States, Australia and 7 more countries
Ages 18+
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental · Sites in Spain
Ages 18+
Parc Sanitari Pere Virgili · Sites in Spain
Ages 65+
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Sites in Spain
Ages 65+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 55 Drug-Related Side Effects and Adverse Reactions studies recruiting now, 37 (67%) set no upper age limit and 15 (27%) stop at 75 or younger; 14 take children under 18; 4 take healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 1
First in 2001; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 6,445 is above the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Median enrollment 290 across the 11 interventional studies, 1,000 across the 5 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 16 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Complejo Hospitalario Universitario de Badajoz as lead sponsor.
Complejo Hospitalario Universitario de Badajoz has 1 study filed under Drug-Related Side Effects and Adverse Reactions — fewer than ten, so there is no comparison to draw.
3 of the studies in Drug-Related Side Effects and Adverse Reactions with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07169851Eli Lilly and CompanyA Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer | 2026-12 |
| NCT07582887Fundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalImpact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response | 2026-12-31 |
| NCT07008144Consorci Sanitari de l'Alt Penedès i GarrafIntroducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 16 studies in Drug-Related Side Effects and Adverse Reactions with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.
Consecutive sampling is a widely used non-probability sampling that, if performed correctly, can be considered as random sampling. In this case, patients are selected as they come for consultation and as long as they meet the inclusion criteria.
SES patients are eligible for inclusion in the study, so that a minimum of 3000 participants are expected to be included in the study in order to ensure adequate frequency of genetic polymorphisms of pharmacogenetic relevance. During the Deployment Phase of the Prescription Support Program, it is estimated that an additional 4,000 to 8,000 patients will be included, with a target of 0.1% of the population of Extremadura.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign and agree to participate, provided they meet the following inclusion criteria:
General criteria for all patients:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primary health care
Oncology
Mental health
Internal medicine
Nephrology
Neurology
Emergencies
Cardiology
Rheumatology
Transplants
Infectious
Clinical pharmacology
University of extremadura
Urology
Neurology-Vascular
Pediatrics
Pneumology
Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
To analyze the implementation in the clinical routine of a pharmacogenetics and personalized medicine program in SES patients, evaluating the overall impact on the health system, and at the individual level, general modifications in the clinical response and its temporal evolution.
Time frame: December 2024
Started May 2021 (actual). Primary completion is estimated for Dec 2024, 43 months after the start.
Of 65 non-industry observational studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24. This study's planned 43 months is below that.
Counting every sponsor, half of 69 studies reached it within 45 months; a quarter within 24 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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