Comparison · NCT04272775-sae
Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and 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
Cite this record
ConductScience Library. Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: serious adverse events. Trial comparisons, record NCT04272775-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04272775-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 | 0.571 | 0.25 | 0.842 | wilson | |
| Risk in group 2 | 0.286 | 0.0822 | 0.641 | wilson | |
| Risk difference, group 1 minus group 2 | 0.286 | -0.193 | 0.624 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.526 | 7.6 | log | |
| Odds ratio, group 1 over group 2 | 3.33 | 0.362 | 30.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1: Ixazomib 4.0 mg than on Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | 3.5 | 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 | Cohort 1: Ixazomib 4.0 mg | Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87. | 4 | 7 | EG000 |
| Group 2 | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62. | 2 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44)
Source ClinicalTrials.gov
Trial
- Title
- A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- NCT number
- NCT04272775
- Phases
- PHASE1
- Conditions
- Relapsed and/or Refractory Multiple Myeloma
- Interventions
- Ixazomib, Lenalidomide, Dexamethasone
- Lead sponsor
- Takeda
- Results first posted
- 2020-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04272775?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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