Comparison · NCT01564537-sae
Ixazomib+ Lenalidomide + Dexamethasone vs Placebo + Lenalidomide + Dexamethasone: 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. Ixazomib+ Lenalidomide + Dexamethasone vs Placebo + Lenalidomide + Dexamethasone: serious adverse events. Trial comparisons, record NCT01564537-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01564537-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 | 0.568 | 0.516 | 0.618 | wilson | |
| Risk in group 2 | 0.563 | 0.511 | 0.613 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00519 | -0.0669 | 0.0772 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.888 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.761 | 1.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ixazomib+ Lenalidomide + Dexamethasone than on Placebo + Lenalidomide + Dexamethasone | 193 | 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 | Ixazomib+ Lenalidomide + Dexamethasone | Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months). | 205 | 361 | EG000 |
| Group 2 | Placebo + Lenalidomide + Dexamethasone | Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months). | 202 | 359 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the date of signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
- NCT number
- NCT01564537
- Phases
- PHASE3
- Conditions
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Interventions
- Ixazomib, Lenalidomide, Dexamethasone, Placebo
- Lead sponsor
- Takeda
- Results first posted
- 2016-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01564537?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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