P624. Impaired intestinal barrier function promotes procoagulatory state in Inflammatory Bowel Diseases
Bibliographic record
Abstract
Results: IRRs were reported for 28 (5%) and 33 (4%) patients treated with VDZ in GEMINI 1 (UC) and GEMINI 2 (CD), respectively.In each study, >70% of all IRRs occurred during or within the first 2 hours after the end of an infusion.The most common IRRs were nausea (CD n=8; <1%) and headache (UC n=2, <1%; CD n=4, <1%; Table).One patient with CD had an IRR that was considered serious and resulted in study drug discontinuation.Her symptoms, including dyspnoea, bronchospasm, hives, flushing, rash, and increased blood pressure and heart rate, began 13 minutes after the start of an infusion and resolved about 3 hours later with treatment.No serious IRRs were reported in patients with UC.Premedication, predominantly antihistamines and corticosteroids, was used in 5% and 7% of VDZ-treated UC and CD patients, respectively, a rate similar to that in PBO-treated patients (5% UC and 6% CD).Conclusions: IRRs occurred in ≤5% of patients receiving VDZ infusions; 70% of all IRRs occurred within 2 hours.Premedication was administered infrequently.These results indicate that VDZ infusions were generally well tolerated by patients.The clinical study was funded by Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.).Medical writing assistance was provided by inVentiv Medical Communications and supported by
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| 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".