Comparison · NCT00923351-sae
Arm A - Participants Who Did Not Receive rhIL-7 vs Arm B - Participants Who Received rhIL-7: serious adverse events
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 A - Participants Who Did Not Receive rhIL-7 vs Arm B - Participants Who Received rhIL-7: serious adverse events. Trial comparisons, record NCT00923351-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00923351-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 | 1 | 0.61 | 1 | wilson | |
| Risk in group 2 | 0.462 | 0.288 | 0.645 | wilson | |
| Risk difference, group 1 minus group 2 | 0.538 | 0.107 | 0.712 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.17 | 1.43 | 3.28 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Arm A - Participants Who Did Not Receive rhIL-7 than on Arm B - Participants Who Received rhIL-7 | 1.86 | 1.4 | 9.35 | 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 A - Participants Who Did Not Receive rhIL-7 | Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count \> 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12. | 6 | 6 | EG000 |
| Group 2 | Arm B - Participants Who Received rhIL-7 | Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine\[Day 0\]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B). | 12 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Date treatment consent signed to date off study, approximately 49.5 months.
Source ClinicalTrials.gov
Trial
- Title
- Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
- NCT number
- NCT00923351
- Phases
- PHASE1, PHASE2
- Conditions
- Neuroblastoma, Sarcoma, Rhabdomyosarcoma-Embryonal, Rhabdomyosarcoma- Alveolar, Neuroectodermal Tumors, Primitive, Peripheral
- Interventions
- Tumor Purged/CD25 Depleted Lymphocytes, Tumor Purged/CD25 Depleted Lymphocytes with Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine, rhIL-7, Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2013-09-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00923351?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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