Comparison · NCT01553149-df56cc21
Arm I (Low-dose Lenalidomide) vs Arm II (High-dose Lenalidomide): Number of Patients Who Demonstrate Early Progression
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm I (Low-dose Lenalidomide) vs Arm II (High-dose Lenalidomide): Number of Patients Who Demonstrate Early Progression. Trial comparisons, record NCT01553149-df56cc21. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01553149-df56cc21
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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 | 0.108 | 0.0429 | 0.247 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0541 | -0.109 | 0.217 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.461 | 4.88 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 0.411 | 6.2 | log | |
| Number needed to treat, for one more participant with the outcome on Arm I (Low-dose Lenalidomide) than on Arm II (High-dose Lenalidomide) | 18.5 | 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 | 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 | OG000 |
| 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 | 4 | 37 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients Who Demonstrate Early Progression
- Description
Number of patients with disease progression during the first six months of protocol therapy. Disease progression is defined as ≥ 25% increase in the sum of the products of the largest diameters of the measurable lesions or the appearance of one or more new lesions when compared with the measurements of lesions at the time of enrollment.
- Time frame
- Up to 180 days after enrollment
- Population
- Only eligible patients are considered in the analysis of this outcome measure
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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