Evidence map›Paper›PMID 26237402›Full record

Observational studyPloS one2015

Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.

Jinghan Jenny Chen, Parco Chan, Bosco Paes, Ian Mitchell, Abby Li, Krista L Lanctôt, CARESS investigators

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00420966 (Phase IV Study of Respiratory Syncytial Virus Monoclonal Antibody Therapy in High-risk Infants and Toddlers), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00420966 completednot on this map

Phase IV Study of Respiratory Syncytial Virus Monoclonal Antibody Therapy in High-risk Infants and Toddlers

TypeobservationalSponsorSunnybrook Health Sciences CentreRan2005 to 2017Enrolled25,003ConditionsLower Respiratory Tract Infection, Respiratory Syncytial Virus Infections
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 25 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Allergo Journal : interdisziplinare Zeitschrift fur Allergologie und Umweltmedizin : Organ der Deutschen Gesellschaft fur Allergie- und Immunitatsforschung · 2020
    Article
  6. Respiratory syncytial virus (RSV) infection in children with medical complexity.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2019
    Article
  7. Article
  8. Review
  9. Review
  10. Observational
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Jinghan Jenny ChenMedical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Parco ChanMedical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Bosco PaesDepartment of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
Ian MitchellDepartment of Pediatrics, University of Calgary, Calgary, Alberta, Canada.
Abby LiMedical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Krista L LanctôtMedical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
CARESS investigators
Sunnybrook Health Science Centre · CAMcMaster University · CAUniversity of Calgary · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.

methodsHigh-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, serious adverse event (SAE) monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were analyzed by Chi-square or Fisher Exact Tests to examine group differences in proportions.

results13025 infants received 57392 injections. Hospitalizations for respiratory-related illness (RIH) were reported in 915 patients, and SAEs other than RIH were reported in 52 patients. Of these, 6 (0.05%) patients had a total of 14 hypersensitivity reactions that were deemed possibly or probably related to palivizumab (incidence: 2.8 per 10,000 patient-months). The SAEs of 42 patients were assessed as not related to palivizumab. SAEs in the remaining 4 patients were not classifiable as their records were incomplete. There were no significant demographic predictors of SAE occurrence.

conclusionsUnder active surveillance, a small proportion of infants in the CARESS registry experienced SAEs that had a potential relationship with palivizumab and these appeared to be unpredictable in terms of onset. Palivizumab appears to be a safe and well-tolerated antibody for RSV prophylaxis in high-risk children in routine practice.

Indexed as

Drug HypersensitivityFemaleHospitalizationHumansIncidenceInfantMalePalivizumabProspective StudiesRegistriesRespiratory Syncytial Virus InfectionsPalivizumab

Identifiers

PMID26237402
PMCPMC4523213
OpenAlexW2227617731

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.