Baseline Characteristics And Interim Analysis Results Of The Fingolimod Cohort In The World-Wide Post-Approval Safety Program (PASSAGE) (P2.202)
Bibliographic record
Abstract
Objective Describe baseline characteristics and interim analysis results of fingolimod cohort in the PASSAGE studies. Background Fingolimod 0.5mg, the first approved oral therapy for relapsing multiple sclerosis (MS), has a well-characterized safety profile in a large clinical development program. PASSAGE includes 2 post-authorization safety studies evaluating long-term (minimum 5 years) safety and effectiveness of fingolimod in routine practice. Additionally, PASSAGE includes a US patient-reported outcome sub-study evaluating treatment effect on disability, health-related quality of life, productivity, treatment satisfaction and preference and a Canadian resource utilization sub-study. Design/Methods PASSAGE is a long-term, prospective, multi-national program consisting of two (one predominantly in the US and the other predominantly in Europe) parallel-cohort studies in MS patients newly starting on fingolimod or being treated with another approved DMT. PASSAGE plans to recruit 7,500 patients (fingolimod-cohort=5000; other-DMT-cohort=2500) across 28 countries and is expected to be completed by 2020. Updated results from anticipated >1000 fingolimod patients will be presented. Results As of Feb 2013, 470 patients receiving fingolimod were enrolled in 8 countries. Mean age was 41.5±11 years, higher in US patients (46.5 years) than in European patients (39.3 years). Majority of patients were females (69.1%). Mean MS duration since first symptoms was 12.3 years, average number of relapses one year prior to study was 1.0 while mean baseline EDSS score was 3.2. Overall treatment exposure was 145 patient-years. In safety set, AEs were reported for 21.9% (n= 75) and SAEs for 4.1% (n=14) patients. Bradycardia was reported in 8 (2.3%) patients. Conclusions The baseline characteristics are consistent with those of MS patients treated with DMTs in clinical practice, but differ slightly (older age, longer MS duration and higher mean EDSS scores) from fingolimod Phase 3 studies populations. Safety results are in line with those reported for fingolimod to date. These real-world data further support fingolimod as a safe option for eligible MS patients in clinical practice. Study supported by Novartis Pharma AG.
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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 | 0.008 | 0.010 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.002 |
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".