Comparison · NCT01574274-dacf7bba
SC-PEG (Arm A) vs Oncaspar (Arm B): Number of Participants With Asparaginase-Related Toxicity
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. SC-PEG (Arm A) vs Oncaspar (Arm B): Number of Participants With Asparaginase-Related Toxicity. Trial comparisons, record NCT01574274-dacf7bba. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01574274-dacf7bba
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.376 | 0.291 | 0.47 | wilson | |
| Risk in group 2 | 0.377 | 0.294 | 0.469 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00105 | -0.126 | 0.125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.997 | 0.711 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 0.996 | 0.579 | 1.71 | log | |
| Number needed to treat, for one fewer participant with the outcome on SC-PEG (Arm A) than on Oncaspar (Arm B) | 956 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SC-PEG (Arm A) | Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification. | 41 | 109 | OG000 |
| Group 2 | Oncaspar (Arm B) | Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification. | 43 | 114 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Asparaginase-Related Toxicity
- Description
Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Events (CTCAE) v4.
- Time frame
- 30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.
- Population
- The analysis dataset is comprised of all patients who received post-induction asparaginase.
Source ClinicalTrials.gov
Trial
- Title
- SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma
- NCT number
- NCT01574274
- Phases
- PHASE2
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- Interventions
- SC-PEG, Oncaspar
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2022-09-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01574274?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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