Gefapixant efficacy and safety in participants with history of refractory or unexplained chronic cough for ≥1 vs <1 year
Bibliographic record
Abstract
Background: Gefapixant was studied in two phase 3 trials in individuals with refractory or unexplained chronic cough (RCC/UCC) for ≥1 y and a phase 3b trial in individuals with cough history >8 wk but RCC/UCC for <1 y. Trial comparisons can inform if gefapixant response is influenced by RCC/UCC duration. Aims and objectives: To compare efficacy/safety of gefapixant after 12 wk of treatment in RCC/UCC for ≥1 vs <1 y. Methods: Participants with RCC/UCC for ≥1 y (NCT03449134, NCT03449147; pooled) or <1 y (NCT04193202) who received gefapixant 45 mg BID or placebo (pbo) were analyzed. Change from baseline in patient-reported outcomes (PROs; Leicester Cough Questionnaire [primary endpoint for <1-y trial], cough severity Visual Analog Scale, and Cough Severity Diary) and safety were evaluated at Wk 12. Results: Other than cough duration (mean [SD]: 11 [9] y vs 7 [3] mo; median [range]: 8 [2-65] y vs 8 [1-12] mo), demographics and baseline cough characteristics were similar across trials (≥1 y: gefapixant, n=682; pbo, n=678; <1 y: gefapixant, n=206; pbo, n=209). Gefapixant improved PROs vs pbo with similar efficacy, regardless of RCC/UCC duration (Figure). For gefapixant, adverse event (AE) incidence was 80% (≥1 y) and 64% (<1 y); for the taste AEs (≥1 y, 64%; <1 y, 54%), >95% were mild or moderate. Conclusions: Results suggest similar favorable response to gefapixant regardless of RCC/UCC duration.
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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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 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".