11: Serious Adverse Events in Canadian Children Receiving Palivizumab for the Prevention of Respiratory Syncytial Virus Infection
Bibliographic record
Abstract
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.
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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".