Comparison · NCT00761280-sae
Trabedersen 10 µM vs 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
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ConductScience Library. Trabedersen 10 µM vs Chemotherapy: serious adverse events. Trial comparisons, record NCT00761280-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00761280-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 | 0.462 | 0.232 | 0.709 | wilson | |
| Risk in group 2 | 0 | 0 | 0.259 | wilson | |
| Risk difference, group 1 minus group 2 | 0.462 | 0.116 | 0.709 | 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 Trabedersen 10 µM than on Chemotherapy | 2.17 | 1.41 | 8.65 | 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 | Trabedersen 10 µM | 10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT. | 6 | 13 | EG000 |
| Group 2 | Chemotherapy | Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm. | 0 | 11 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Safety monitoring (including adverse events) started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
- NCT number
- NCT00761280
- Phases
- PHASE3
- Conditions
- Anaplastic Astrocytoma, Glioblastoma
- Interventions
- trabedersen, temozolomide, Drug delivery system for administration of AP 12009, Placement of Drug Delivery System, carmustine, lomustine
- Lead sponsor
- Isarna Therapeutics GmbH
- Results first posted
- 2014-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00761280?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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