48-week administration of olodaterol QD via Respimat® vs placebo and formoterol BID in patients with COPD: Pooled safety analysis
Bibliographic record
Abstract
Background: The novel LABA olodaterol (O) has an acceptable safety profile in clinical studies of ≤4 weeks (wks). Objective: To evaluate the long-term safety of O QD in patients (pts) with GOLD 2-4 COPD. Methods: 4 randomised, double-blind, placebo (P)-controlled, parallel-group studies (1: NCT00782210 ; 2: NCT00782509 ; A: NCT00793624 ; B: NCT00796653 ) investigated O (5 or 10 µg) QD via Respimat®, formoterol (F; 12 μg) BID via Aerolizer® (A and B) or P for 48 wks. Pts continued to receive usual care background COPD maintenance therapy including SAMA, LAMA, ICS and xanthines. An independent Mortality Adjudication Committee (MAC) evaluated fatalities before trial unblinding. Safety data from the pooled dataset are presented. Results: 3104 pts were included. Pts with AE (%) P n=885 O 5 n=876 O 10 n=883 F n=460 Total n=3104 Total AEs 70.8 71.0 72.7 69.1 71.2 SAEs 16.4 15.8 16.6 15.0 16.1 Fatal AEs 1.5 1.5 1.9 2.2 1.7 Related AEs* Cardiac disorders 1.4 1.4 1.4 1.7 1.4 Respiratory, thoracic and mediastinal disorders 3.8 2.4 2.2 4.8 3.1 *Treated set No significant safety signals were identified. AEs, SAEs and deaths were balanced across groups, including treatment-related respiratory and cardiac disorders (particularly relevant to β-agonists). Based on MedDRA classification, there was 83% concordance between MAC and site investigator (SI) at System Organ Class (SOC) level although concordance was lower (70%) at Preferred Term level. There was a shift to a ‘cardiac’ SOC in 8 cases (15%) based on the SI determination. Conclusions: The safety profile for O 5 and 10 µg QD was satisfactory and comparable to F BID and P. Funding: Boehringer Ingelheim.
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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 | 0.016 | 0.017 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.022 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".