Comparison · NCT01514188-sae
Doxorubicin vs INNO-206: 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. Doxorubicin vs INNO-206: serious adverse events. Trial comparisons, record NCT01514188-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01514188-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 | 0.2 | 0.105 | 0.348 | wilson | |
| Risk in group 2 | 0.398 | 0.299 | 0.505 | wilson | |
| Risk difference, group 1 minus group 2 | -0.198 | -0.341 | -0.0202 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.503 | 0.256 | 0.987 | log | |
| Odds ratio, group 1 over group 2 | 0.379 | 0.155 | 0.923 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Doxorubicin than on INNO-206 | 5.06 | 2.93 | 49.6 | 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 | Doxorubicin | Doxorubicin: Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles. | 8 | 40 | EG000 |
| Group 2 | INNO-206 | INNO-206: INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles | 33 | 83 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Source ClinicalTrials.gov
Trial
- Title
- Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
- NCT number
- NCT01514188
- Phases
- PHASE2
- Conditions
- Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma
- Interventions
- INNO-206, Doxorubicin
- Lead sponsor
- ImmunityBio, Inc.
- Results first posted
- 2024-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01514188?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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