Thrombotic and Hemorrhagic Events for Patients on Pediatric Oncology Group (POG) Protocols 9201, 9605, 9406.
Bibliographic record
Abstract
Abstract Thromboembolism (TE) and hemorrhage are known complications following L-asparaginase (L-asp) therapy, but the incidence and epidemiology of these events in children are not clearly defined. POG protocols 9201, 9605, and 9406 were phase III studies for low, standard, and higher risk patients with acute lymphoblastic leukemia (ALL). Protocol 9201 enrolled 649 patients, 9605: 1087, and 9406: 911. All 3 studies used a common 4 week induction protocol (POG 9400) of native L-asp (6000 IU/m2 IM x 6 doses), weekly vincristine, and daily prednisone. Doxorubicin was added for patients meeting higher risk criteria based on age, initial white blood cell count, and CNS/testicular status. Patients on 9201 and 9605 received no L-asp after induction. 9406 patients received 3 doses of PEG L-asp (1000 or 2500 IU/m2 IM) during consolidation. The incidence of TE and hemorrhage on 9201 was 2.2% (14/649), on 9605 1.9% (21/1087) and on 9406 5.3% (48/911). In all three protocols, TE was more common than hemorrhage. Hemorrhages were more frequent in POG 9406. # Patients # Thromboses # Hemorrhages # Total Events # in Induction 9201 649 13 1 14 6 9605 1087 17 4 21 10 9406 911 34 14 48 27 Total 2647 64 19 83 43 The largest proportion of events occurred during the month of induction therapy. 70% of induction events (30/43) occurred in patients who received 4 drug therapy. Of the 43 induction events, 21/26 patients with reported coagulation studies had abnormal fibrinogen levels <100mg/dL, 7 of those were <50mg/dL. Antithrombin levels were not reported. 28 of 64 TE were likely central venous line (CVL) related [6 tip of catheter, 16 axillary/subclavian vein, 2 superior vena cava, 2 atrium, 1 internal jugular vein, 1 basilic vein]. Locations of remaining TE included: 13 CNS [4 venous sinus, 9 cerebral]; 10 lower extremity; 4 upper extremity; 1 pulmonary embolism; 8 site not specified. Locations of hemorrhages included: 8 CNS [7 intracranial, 1 subdural]; 2 GI [1 gastric, 1 esophageal perforation]; 2 acute epistaxis; 2 site not specified; and 1 of each of the following: CVL site, pulmonary, splenic, vitreous eye, and hemothorax. Statistical analyses correlating number of L-asp doses to induction events and correlates with gender, age, race, and congenital abnormality are being evaluated. Figure Figure
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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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".