Comparison · NCT02049905-sae
Aldoxorubicin vs Investigator's Choice of Treatment: 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. Aldoxorubicin vs Investigator's Choice of Treatment: serious adverse events. Trial comparisons, record NCT02049905-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02049905-sae
On this page
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 | 0.427 | 0.363 | 0.494 | wilson | |
| Risk in group 2 | 0.329 | 0.268 | 0.395 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0987 | 0.00597 | 0.189 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 1.01 | 1.67 | log | |
| Odds ratio, group 1 over group 2 | 1.52 | 1.02 | 2.27 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Aldoxorubicin than on Investigator's Choice of Treatment | 10.1 | 5.29 | 167 | 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 | Aldoxorubicin | Aldoxorubicin is administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously on Day 1 every 21-day cycles until tumor progression or unacceptable toxicity occurs.~Aldoxorubicin | 91 | 213 | EG000 |
| Group 2 | Investigator's Choice of Treatment | These treatments include:~1. Dacarbazine administered at 1000 mg/m2 by intravenous infusion (IVI), over 90±15 minutes on Day 1 every 21 days until tumor progression or unacceptable toxicity occurs;~2. Pazopanib, 800 mg orally each day until tumor progression or unacceptable toxicity occurs;~3. Gemcitabine, 900 mg/m2 by IVI over 90 minutes on Days 1 and 8, plus docetaxel, 100 mg/m2 by IVI over 1 hour on Day 8 of a 28 day cycle until tumor progression or unacceptable toxicity occurs;~4. Doxorubicin, 75 mg/m2 by IVI over 5 to 30 minutes every 21 days for a maximum cumulative dose of 550 mg/m2 or unacceptable toxicity occurs; or~5. Ifosfamide 2.0 g/m2 administered over 2 to 4 hours on Days 1-4 of a 21 day cycle + mesna per standard site administration regimen until tumor progression or unacceptable toxicity occurs.~Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide) | 68 | 207 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All AEs that occurred after any administration of the study medication were to be followed until the event resolves, until the subject began alternative treatment, or until 30 days after the last dose of study medication. The SAE reporting period ended if the subject began an alternative therapy or 30 days after the last administration of study drug, up to 640 days.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
- NCT number
- NCT02049905
- Phases
- PHASE3
- Conditions
- Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma
- Interventions
- Aldoxorubicin, Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
- Lead sponsor
- ImmunityBio, Inc.
- Results first posted
- 2024-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02049905?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02049905-sae