Comparison · NCT01023308-sae
PAN+BTZ vs PBO+BTZ: 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. PAN+BTZ vs PBO+BTZ: serious adverse events. Trial comparisons, record NCT01023308-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01023308-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 | 0.598 | 0.548 | 0.646 | wilson | |
| Risk in group 2 | 0.416 | 0.368 | 0.467 | wilson | |
| Risk difference, group 1 minus group 2 | 0.182 | 0.111 | 0.25 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.44 | 1.24 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 2.09 | 1.56 | 2.79 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PAN+BTZ than on PBO+BTZ | 5.5 | 3.99 | 9.01 | 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 | PAN+BTZ | Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day. | 228 | 381 | EG000 |
| Group 2 | PBO+BTZ | Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.. | 157 | 377 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Safety Set consists of all patients who received at least one dose of any component of the study treatment. 10 patients were randomized but did not receive treatment. 6 patients from PAN+BTZ+Dex and 4 patients from PBO+BTZ+Dex
Source ClinicalTrials.gov
Trial
- Title
- Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
- NCT number
- NCT01023308
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Panobinostat, Bortezomib, Dexamethasone, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2015-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01023308?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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