The observed incidence of anaphylaxis and serum sickness in patients receiving omalizumab in a tertiary allergy and asthma clinic in Canada
Bibliographic record
Abstract
In a post-marketing analysis last updated in July 2007, the FDA reported that an estimated 0.2% of patients suffered treatment related anaphylaxis and rare incidence of serum sickness. To substantiate this, the occurrence of treatment related anaphylaxis and serum sickness in our large Canadian allergy and asthma tertiary clinic was assessed. A retrospective chart review of our database of omalizumab administration between 1998 and June 2014 was performed. During clinical trials and with our post market experience, between 1998 and June 2014, over 21,000 injections of omalizumab to more than 250 patients were administered and no cases of anaphylaxis or serum sickness like symptoms were observed. Meticulous care was taken by our omalizumab administration clinic to ensure optimal safety based on the emphasized warnings of anaphylaxis, as well as, the indicated warnings and precautions for serum sickness. Data collected in this analysis observed no cases of anaphylaxis or serum sickness like symptoms in the treatment of over 250 patients, during a period of 15.5 years, who combined received 21,000 injections of omalizumab thus confirming the low incidence of both anaphylaxis and serum sickness.
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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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".