P089 <break /> Effect of baseline GAP index stage on decline in lung function with nintedanib in patients with idiopathic pulmonary fibrosis (IPF)
Bibliographic record
Abstract
Introduction: In the replicate, randomized, placebo-controlled, Phase III INPULSIS® trials, the annual rate of decline in forced vital capacity (FVC) was significantly reduced with nintedanib 150 mg bid. Methods: A post-hoc subgroup analysis of patients by GAP (gender, age, physiology) stage I versus II/III at baseline was undertaken using pooled data from the INPULSIS® trials. Results: At baseline, 500 patients (nintedanib 304, placebo 196) had GAP stage I and 560 patients (nintedanib 334, placebo 226) had GAP stage II/III, of whom 71 patients had stage III. There was no treatment-by-subgroup interaction for the primary endpoint (p = 0.8847); in patients with GAP stage I, the adjusted annual rate of decline in FVC was -110.1 mL/year with nintedanib and -218.5 mL/year with placebo (difference: 108.4 mL/year [95% CI: 58.7, 158.0]) while in patients with GAP stage II/III, it was -116.6 mL/year with nintedanib and -227.6 mL/year with placebo (difference: 111.1 mL/year [95% CI: 63.8, 158.3]). Consistent results were observed for changes from baseline in FVC over time (Figure). There was no significant treatment-by-subgroup interaction for time to first acute exacerbation over 52 weeks (p = 0.1408). The difference in adjusted mean change from baseline in St George’s Respiratory Questionnaire (SGRQ) total score at week 52 was numerically higher in patients with GAP stage II/III (-2.67 [95% CI: -5.07, -0.27]) compared to patients with GAP stage I (0.09 [95% CI: -2.20, 2.38]); treatment-by-subgroup interaction (p = 0.0617).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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) | 0.000 | 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 teacher head, 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".