Comparison · NCT01592045-sae
UTC ch14.18 vs NCI ch14.18: 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. UTC ch14.18 vs NCI ch14.18: serious adverse events. Trial comparisons, record NCT01592045-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01592045-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 | 0.63 | 0.442 | 0.785 | wilson | |
| Risk in group 2 | 0.444 | 0.276 | 0.627 | wilson | |
| Risk difference, group 1 minus group 2 | 0.185 | -0.0763 | 0.414 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 0.85 | 2.36 | log | |
| Odds ratio, group 1 over group 2 | 2.13 | 0.715 | 6.32 | log | |
| Number needed to harm, for one more participant with a serious adverse event on UTC ch14.18 than on NCI ch14.18 | 5.4 | 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 | UTC ch14.18 | United Therapeutics Manufactured ch14.18 | 17 | 27 | EG000 |
| Group 2 | NCI ch14.18 | NCI Manufactured ch14.18 | 12 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) and serious adverse events (SAEs) were reported at the time of informed consent through 30 days after the last dose of study therapy.
Source ClinicalTrials.gov
Trial
- Title
- ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
- NCT number
- NCT01592045
- Phases
- PHASE1, PHASE2
- Conditions
- Neuroblastoma
- Interventions
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Aldesleukin (IL-2), Isotretinoin
- Lead sponsor
- United Therapeutics
- Results first posted
- 2015-09-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01592045?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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