Once-daily QVA149 has a good safety profile in patients with COPD
Bibliographic record
Abstract
Introduction Once-daily (OD) QVA149 is a dual bronchodilator combining the long-acting β 2 -agonist indacaterol (IND) and long-acting muscarinic antagonist glycopyrronium (GLY) for the treatment of COPD. Here we evaluated the safety profile of QVA149 compared with its monocomponents (IND and GLY), open-label tiotropium and salmeterol/fluticasone. Methods This evaluation of 6-month safety data for QVA149 consisted of data from three pivotal Phase III studies (SHINE, ILLUMINATE and ENLIGHTEN) and a safety study in Japanese patients (ARISE). Safety was assessed by recording adverse events (AEs) and serious AEs (SAEs), electrocardiograms, hematology, clinical chemistry, urinalysis, physical condition, and vital signs (pulse and blood pressure). Results The table shows the summary of safety results. The overall safety profile was similar across all groups. Table. AEs, SAEs and deaths, n (%) QVA149 (N=1076) Indacaterol (N=476) Glycopyrronium (N=473) Tiotropium (N=519) Salmeterol/ Fluticasone (N=264) Total AEs 593 (55.1) 291 (61.1) 290 (61.3) 295 (56.8) 159 (60.2) AEs leading to permanent discontinuation of study drug 37 (3.4) 24 (5.0) 14 (3.0) 10 (1.9) 27 (10.2) Total SAEs 59 (5.5) 26 (5.5) 29 (6.1) 20 (3.9) 14 (5.3) Deaths 3 (0.3) 2 (0.4) 1 (0.2) 3 (0.6) 1 (0.4) Cardio- and cerebrovascular (CCV) AEs 19 (1.8) 12 (2.5) 14 (3.0) 9 (1.7) 6 (2.3) CCV SAEs 6 (0.6) 4 (0.8) 6 (1.3) 3 (0.6) 3 (1.1) Major adverse cardiac events (MACE)-total 3 (0.3) 2 (0.4) 3 (0.6) 3 (0.6) 1 (0.4) Atrial fibrillation/flutter events 9 (0.8) 7 (1.5) 10 (2.1) 7 (1.3) 7 (2.7) Conclusion Once-daily QVA149 had a good safety profile with no safety signals compared with its monocomponents IND and GLY, tiotropium, and salmeterol/fluticasone.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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".