Comparison · NCT01369888-sae
IL-15 Following Young TIL (0.25 mcg) vs IL-15 Following Young TIL (0.50 mcg): 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. IL-15 Following Young TIL (0.25 mcg) vs IL-15 Following Young TIL (0.50 mcg): serious adverse events. Trial comparisons, record NCT01369888-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01369888-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 | 0.207 | 1 | wilson | |
| Risk in group 2 | 0 | 0 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 1 | -0.0305 | 1 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| 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 IL-15 Following Young TIL (0.25 mcg) than on IL-15 Following Young TIL (0.50 mcg) | 1 | 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 | IL-15 Following Young TIL (0.25 mcg) | 0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m\^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients. | 1 | 1 | EG000 |
| Group 2 | IL-15 Following Young TIL (0.50 mcg) | 0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m\^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients. | 0 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma
- NCT number
- NCT01369888
- Phases
- PHASE1, PHASE2
- Conditions
- Metastatic Melanoma, Skin Cancer
- Interventions
- Cyclophosphamide, Fludarabine, Tumor Infiltrating Lymphocytes, IL-15
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01369888?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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