PF333 RISK OF BLEEDING COMPLICATIONS AND ATRIAL FIBRILLATION ASSOCIATED WITH IBRUTINIB TREATMENT: A SYSTEMATIC REVIEW AND META‐ANALYSIS
Bibliographic record
Abstract
Background: The use of ibrutinib is rapidly increasing because of its high potency to treat chronic lymphocytic leukaemia and other lymphoproliferative disorders. The application is however hampered by major adverse events such as bleeding complications and atrial fibrillation. The frequency and predictors of these adverse events are unknown. Aims: We aimed to study the frequency and predictors of bleeding complications and atrial fibrillation in patients treated with ibrutinib. Methods: Following a prespecified protocol, we systematically searched the literature for case series, cohort studies, as well as randomized controlled trials reporting on patients treated with ibrutinib using MEDLINE and EMBASE databases. We retrieved all relevant data in parallel. Methodological quality was observed using the Newcastle‐Ottawa Scale (NOS). Proportions of patients with bleeding events as well as atrial fibrillation were pooled in relevant subgroups using the binominal distribution and Freeman‐Tukey double arcsine transformation. Results: Among 1870 records screened, and 263 articles assessed in full‐text, 58 were finally included, comprising 4918 patients treated with ibrutinib. Methodological quality according to NOS was rated as poor to moderate. Bleeding events varied substantially with any bleedings reported between 2.8% and 78%, and major bleedings between 0% and 25% (Figure 1). New onset of atrial fibrillation was reported between 0% and 11%. Pooled estimates were 25% for any bleedings (95% confidence interval [CI] 19%, 32%); 3% for major bleedings (95% CI 2%, 4%), and 5% for atrial fibrillation (95% CI 4%, 6%). Predictors of adverse events were not apparent. Summary/Conclusion: Reporting of bleeding events and atrial fibrillation varied substantially among studies. These observations, in combination with the estimates obtained suggests a relevant risk of bleeding events as well as atrial fibrillation in patients treated with ibrutinib. image
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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 | 0.009 | 0.021 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.014 | 0.035 |
| Bibliometrics | 0.006 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".