Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia
Bibliographic record
Abstract
ABSTRACT: Pediatric patients with acute lymphoblastic leukemia and lymphoma (ALL/LL) and obesity are at increased risk for venous thromboembolism (VTE). The PREVAPIX-ALL trial was an open-label, randomized, controlled trial assessing the safety and efficacy of apixaban for VTE prevention in pediatric patients with ALL/LL. An a priori subgroup analysis of patients with obesity in the PREVAPIX-ALL trial was planned because of increased VTE risk in this group. Patients with obesity, aged ≥2 to <18 years, central venous catheter, and chemotherapy containing asparaginase were randomized to apixaban (prophylactic dose) vs standard of care (SOC; no anticoagulation) during induction chemotherapy. The primary efficacy end point was a composite of nonfatal symptomatic and asymptomatic VTE and VTE-related death. The primary and secondary safety outcomes were major bleeding and a composite of major and clinically relevant nonmajor (CRNM) bleeding, respectively. A total of 82 PREVAPIX-ALL participants presented with obesity, of whom 42 were randomized to apixaban. For the primary efficacy end point, a significant decrease in VTE events was present in the apixaban arm (1/42 [2.4%]) as compared with the SOC arm (10/40 [25%]; relative risk [RR], 0.09; 95% confidence interval [CI], 0.01-0.97; P = .007). There was a statistically significant treatment obesity interaction, P = .03. No statistically significant difference was observed for the primary efficacy end point among the nonobese group (RR, 0.85; 95% CI, 0.53-1.37; P = .50). No statistically significant difference in major or CRNM bleeding was observed. Apixaban prophylaxis in patients with obesity and ALL/LL resulted in a statistically significant VTE risk reduction with no increase bleeding. This trial was registered at www.clinicaltrials.gov as #NCT02369653.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot 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.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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) | 0.000 | 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 teacher head, 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".