11: Serious Adverse Events in Canadian Children Receiving Palivizumab for the Prevention of Respiratory Syncytial Virus Infection
Notice bibliographique
Résumé
A landmark in the prevention of severe respiratory syncytial virus (RSV) infection was established with the release of palivizumab, a recombinant, humanized, genetically-engineered monoclonal antibody. Palivizumab has been deemed safe in clinical trials without major, serious adverse events (SAEs). The primary objective is to evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk Canadian children. Subjects were recruited into a prospective registry (CARESS) with monthly follow-up during the 2008–2013 RSV seasons. AEs were monitored from enrollment until 30 days after the last palivizumab dose. AEs involving death, life-threatening events, hospitalization or prolongation of hospital stay, persistent or significant disability or incapacity, or medical/surgical intervention to prevent serious outcome, qualified as SAEs and were assessed for severity and relationship to palivizumab. SAEs possibly or probably related to palivizumab were reported to the coordinating centre within 24 hours of occurrence. Possibly or probably related SAEs were also assessed for severity: mild, transient, well-tolerated events; moderate, SAEs interrupting usual activities; severe, incapacitating or life-threatening events. Classification was independently performed by the registry clinicians. Data were analyzed by standard descriptive methods. χ2 or Fisher Exact Tests were used to examine group differences in proportions. 13,025 infants were enrolled and received 57,392 injections: premature infants ≤35 weeks gestational age (n=8224; 63.1%), children aged <2 years with chronic lung disease (n=978; 7.5%), hemodynamically significant congenital heart disease (CHD, n=1442; 11.1%) and those with other pre-existing high-risk medical disorders (n=2381; 18.3%). 915 patients were hospitalized for a respiratory illness (RIH rate: 7.03%) of which 196 tested RSV-positive (RSVH rate: 1.76%). All RIHs were not or probably not related to palivizumab. 62 single or multiple SAEs were documented in 52 infants. Fourteen events in six patients out of the 62 SAEs were hypersensitivity reactions that were deemed possibly (n=10) or probably (n=4) related to palivizumab, resulting in a reporting rate of 0.00028 events per patient-month. The 14 hypersensitivity reactions included 11 as moderate and 3 as mild. The remaining 48 serious events in 46 patients were categorized as not related (n=39), probably not related (n=5), and unclassifiable (n=4). Using an active surveillance system, a very small proportion of infants in the CARESS registry experienced SAEs that had a clear relationship with palivizumab and these events appear to be idiosyncratic. In routine practice, palivizumab appears to be a safe and well-tolerated antibody for RSV prophylaxis in high-risk children.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».