Comparison · NCT01553149-sae
Arm I (Low-dose Lenalidomide) vs Arm II (High-dose Lenalidomide): 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. Arm I (Low-dose Lenalidomide) vs Arm II (High-dose Lenalidomide): serious adverse events. Trial comparisons, record NCT01553149-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01553149-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 | 0.162 | 0.0765 | 0.311 | wilson | |
| Risk in group 2 | 0.432 | 0.287 | 0.591 | wilson | |
| Risk difference, group 1 minus group 2 | -0.27 | -0.45 | -0.0617 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.375 | 0.165 | 0.852 | log | |
| Odds ratio, group 1 over group 2 | 0.254 | 0.0854 | 0.755 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Low-dose Lenalidomide) than on Arm II (High-dose Lenalidomide) | 3.7 | 2.22 | 16.2 | from the risk difference interval |
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 | Arm I (Low-dose Lenalidomide) | Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies | 6 | 37 | EG000 |
| Group 2 | Arm II (High-dose Lenalidomide) | Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Given PO~Pharmacological Study: Correlative studies | 16 | 37 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs and OAEs: Up to 6 months post-treatment planned as 3 years; All-Cause Mortality: up to 5 years
Source ClinicalTrials.gov
Trial
- Title
- Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma
- NCT number
- NCT01553149
- Phases
- PHASE2
- Conditions
- Neurofibromatosis Type 1, Recurrent Childhood Pilocytic Astrocytoma, Recurrent Childhood Visual Pathway Glioma
- Interventions
- Lenalidomide, Pharmacological Study
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-11-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01553149?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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