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P1502Open-label ODYSSEY APPRISE study: interim data from the first 843 participants

2017· article· en· W2764046765 on OpenAlexaboutno aff
Bertrand Cariou, Maurizio Averna, P. Henry, D. Gaudet, José López‐Sendón, D. Drouot, Daniela Chibedi-De-Roche, Rita Samuel, Stéphane Saubadu, K. Kralova, Kurt Huber, Axel Mertens, R Češka

Bibliographic record

VenueEuropean Heart Journal · 2017
Typearticle
Languageen
FieldSocial Sciences
TopicDelphi Technique in Research
Canadian institutionsnot available
FundersBispebjerg HospitalGentofte HospitalRegeneron PharmaceuticalsTexas A and M UniversitySanofi
KeywordsMedicineInterim

Abstract

fetched live from OpenAlex

Background: PCSK9 inhibitors have been recommended as an option by the ESC/EAS Task Force in very high-risk subjects with atherosclerotic cardiovascular (CV) disease and those with HeFH with persistent high LDL-C levels despite maximally tolerated statin and ezetimibe therapies. Purpose: ODYSSEY APPRISE (NCT02476006) was the first European-Canadian collaborative study to provide subjects with severe hypercholesterolaemia at very high CV risk access to the PCSK9 inhibitor alirocumab (ALI) prior to commercial availability (study treatment: ≥12 weeks; ≤30 months) and to assess ALI safety and tolerability. Methods: APPRISE was an open-label, single-arm study, conducted in a real-life setting in 16 European countries and Canada. The study population included subjects with inadequately controlled lipid levels, despite maximally tolerated statins with or without additional lipid-lowering therapies, excluding PCSK9 inhibitors. Based on physician's judgement, participants received either ALI 75 or 150 mg every 2 weeks (Q2W). Study endpoints included efficacy at Week (W)12 and safety.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.013
metaresearch head score (Gemma)0.005
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesScience and technology studies, Scholarly communication, Open science, Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.112
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0130.005
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0060.001
Scholarly communication0.0030.001
Open science0.0070.003
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.002

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.

Opus teacher head0.695
GPT teacher head0.565
Teacher spread0.130 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designNot applicable
Domainnot available
GenreEmpirical

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".

Quick stats

Citations0
Published2017
Admission routes1
Has abstractyes

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