Potential Identification of High Risk Populations for Acute Hemolytic Reactions Following Rh0 (D) Immune Globulin.
Bibliographic record
Abstract
Abstract Abstract 3685 Acute Hemolytic Reactions (AHR) post Rh(D) Immune Globulin (Rh IgIV; WinRho® SDF, Cangene Corporation, Winnipeg, MB, Canada) have been reported since its approval for ITP in 1995. Cangene evaluated all post-marketing safety reports to ascertain whether certain populations may be at risk of AHR occurrence. AHR's were defined as one or more of the following: hemoglobin decrease, haptoglobin decrease or elevation of bilirubin occurring within days of Rh IgIV administration. Cases of Intravascular Hemolysis (IVH) were defined as AHR reports with demonstrated plasma hemoglobinemia and/or hemoglobinuria. Purpose: Identify populations that may be at higher risk of developing Acute Hemolysis when treated with Rh IgIV for ITP. Methods: Adverse Events (AE) were categorized as Acute Hemolytic Reactions (AHR) and Non Hemolytic Reactions (NHR) cases and both were evaluated retrospectively to identify if co-morbid conditions or other risk factors were implicated. Analyses were performed looking at: gender, age group, Rh IgIV dose, co-morbidities grouped by system organ class. Results: Between 1995 and March 2010 there were 684 AE reported, AHR were 312/684 (46%) and NHR were 372/684 (54%). Of the 312 AHR reports, IVH was identified in 70 (22%) of cases. Conclusion: 91% of fatal outcome after AHR were found in patients with significant co-morbid conditions that contributed to death. Elderly patients (above 65 yrs) with following co morbid conditions appear to be more susceptible to AHR including definitive IVH and its complications. The following factors have been reported in the majority of Acute Haemolytic Reactions (AHR): This review implies that choosing the right patient, the right dose and close monitoring of higher risk patients will improve the safety outcomes among ITP patients treated with Rh IgIV. Disclosures: Ramachandran: Cangene Corporation: Employment. Li:Cangene Corporation: Employment. Muller:Cangene Corporation: Employment. Little:Cangene Corporation: Employment. Sinclair:Cangene Corporation: Employment. Genereux:Cangene Corporation: Employment.
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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 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".