<scp>BSH</scp> 2023 Oral abstracts book
Bibliographic record
Abstract
of LDH with a similarity margin of (0.77, 1.30).Secondary endpoints included: total complement, total haemoglobin, serum-free haemoglobin, haptoglobin, bilirubin, degree of hemoglobinuria, type III erythrocytes; LDH time profile; packed red blood cells transfusion; pharmacokinetics (PK); immunogenicity; and safety through the end of study (EOS).Results: Forty-two patients (20 in ABP 959/RP group; 22 in RP/ABP 959 group) were randomised across 25 centers.Thirty-nine patients (92.9%) completed the study.Similarity of efficacy in the crossover comparison was established with a point estimate of the GMR of time-adjusted AUEC (ABP 959 vs RP) of LDH of 0.9812, 90% CI, 0.9403-1.0239,being within the prespecified margin of similarity.Secondary efficacy endpoints were comparable between the treatment groups.Through EOS, 33 (80.5%) patients receiving ABP 959 and 39 (92.9%) patients receiving RP reported at least 1 adverse event (AE), most AEs were CTCAE grade 1 or 2 and the safety profile of ABP 959 was comparable to that of the RP.Of patients with a postbaseline result through EOS, no patients tested positive for neutralising or treatment-boosted ADAs.No new safety concerns were identified during the study.Conclusions: Similarity in clinical efficacy as measured by hemolysis in patients with PNH was established between ABP 959 and RP.Additionally, PK, immunogenicity, and safety were similar between ABP 959 and RP.The results of this study, along with previously demonstrated analytical, non-clinical, PK, and pharmacodynamics similarity, support a demonstration of no clinically meaningful differences between ABP 959 and RP.
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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 | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.877 | 0.674 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".