Integrated safety across six clinical trials of alpha-1 augmentation therapy
Bibliographic record
Abstract
Background Augmentation therapy with alpha-1 proteinase inhibitor (A 1 -PI) slows emphysema progression in A 1 -PI-deficient patients. Aim This integrated safety summary assessed rates of adverse events (AEs) across six clinical studies of intravenous A 1 -PI Z (Zemaira®, CSL Behring). Methods The data set includes RAPID ( NCT00261833 ), the single largest clinical trial of A 1 -PI augmentation therapy, its ongoing extension study ( NCT00670007 ), and four smaller trials. Results Overall, the incidence of AEs with A 1 -PI Z was not higher than with placebo; most AEs were linked to patients' respiratory conditions. The most common related AEs were headache and dizziness. Six patients died during the studies; none was considered treatment-related. There were five serious AEs judged by the investigators to be at least possibly related to A 1 -PI Z (enterocolitis, pancreatitis, 'adverse drug reaction', back pain, pulmonary fibrosis) and one with placebo (musculoskeletal chest pain). There was no A 1 -PI antibody formation or viral transmission. Safety across six clinical studies of A1-PI therapy A1-PI Z (N=221, SY=426.9, NI=20899) Placebo (N=87, SY=149.1, NI=7276) A1-PI P (Prolastin®; N=32, SY=3.7, NI=160) Events Incidence Per Infusion Events Incidence Per Infusion Events Incidence Per Infusion Any AE 2709 0.1296 1071 0.1472 87 0.5438 At least possibly related AE 124 0.0059 53 0.0073 6 0.0375 SAE* 68 0.0033 21 0.0029 4 0.0250 At least possibly related SAE 5 0.0002 1 0.0001 0 0 N=subjects per group; SY=subject years; NI=number of infusions; AE=adverse events; SAE=serious AE; *At least possibly related or occurring during/within 72 h after infusion Conclusions The AE profile of highly purified A 1 -PI Z is similar to placebo.
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 | 0.065 | 0.073 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".