Actualización de seguridad - Revisión de seguridad de HEALTH CANADA encontró un posible vínculo entre el uso de canakinumab y el riesgo de DRESS
Bibliographic record
Abstract
Revisión del riesgo potencial de Reacción a Medicamentos con Eosinofilia y Síntomas Sistémicos (DRESS) por canakinumab (Ilaris®).Esta revisión se realizó con motivo de la actualización de la etiqueta por parte de EMA, sumado a los informes de seguridad del fabricante. Se evaluaron 27 casos, de los cuales 4 podrían estar relacionados con el medicamento, todos en pacientes pediátricos. Uno de estos casos resultó en muerte, aunque no se pudo confirmar si DRESS fue un factor contribuyente. La revisión concluyó que, existe un posible vínculo entre canakinumab y el riesgo de DRESS, por lo que la agencia está trabajando en la actualización de la monografía del producto para añadir una advertencia sobre los casos encontrados.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.029 | 0.058 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.004 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".