Comparison · NCT01767155-sae
AEZS-108 / Zoptarelin Doxorubicin vs Doxorubicin/ Standard Chemotherapy: 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. AEZS-108 / Zoptarelin Doxorubicin vs Doxorubicin/ Standard Chemotherapy: serious adverse events. Trial comparisons, record NCT01767155-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01767155-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 | 0.365 | 0.308 | 0.426 | wilson | |
| Risk in group 2 | 0.301 | 0.248 | 0.361 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0639 | -0.0186 | 0.145 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.944 | 1.56 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.919 | 1.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on AEZS-108 / Zoptarelin Doxorubicin than on Doxorubicin/ Standard Chemotherapy | 15.7 | 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 | AEZS-108 / Zoptarelin Doxorubicin | 267 mg/m\^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles~AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles | 92 | 252 | EG000 |
| Group 2 | Doxorubicin/ Standard Chemotherapy | 60 mg/m\^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles~doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles | 75 | 249 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approx. over 3 years, during the whole duration of the trial.
Source ClinicalTrials.gov
Trial
- Title
- Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
- NCT number
- NCT01767155
- Phases
- PHASE3
- Conditions
- Endometrial Cancer
- Interventions
- AEZS-108 / zoptarelin doxorubicin, doxorubicin
- Lead sponsor
- AEterna Zentaris
- Results first posted
- 2018-07-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01767155?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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