Comparison · NCT01574274-sae
SC-PEG (Arm A) vs Oncaspar (Arm B): serious adverse events
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): serious adverse events. Trial comparisons, record NCT01574274-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01574274-sae
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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 | 0.294 | 0.22 | 0.381 | wilson | |
| Risk in group 2 | 0.225 | 0.159 | 0.308 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0691 | -0.042 | 0.178 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.848 | 2.02 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 0.802 | 2.57 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SC-PEG (Arm A) than on Oncaspar (Arm B) | 14.5 | 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. | 35 | 119 | EG000 |
| 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. | 27 | 120 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days.
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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