Comparison · NCT02730299-sae
Omidubicel vs Unmanipulated CBU(s): 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. Omidubicel vs Unmanipulated CBU(s): serious adverse events. Trial comparisons, record NCT02730299-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02730299-sae
On this page
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 | 0.904 | 0.794 | 0.958 | wilson | |
| Risk in group 2 | 0.911 | 0.807 | 0.961 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00687 | -0.128 | 0.11 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.992 | 0.88 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.922 | 0.251 | 3.39 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Omidubicel than on Unmanipulated CBU(s) | 146 | 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 | Omidubicel | omidubicel is a cryopreserved stem/progenitor cell based product comprised of:~1. ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF)~2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) Non-cultured Fraction (NF) consisting of mature myeloid and lymphoid cells. | 47 | 52 | EG000 |
| Group 2 | Unmanipulated CBU(s) | Unmanipulated cord blood unit(s) | 51 | 56 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5 Years post-transplant for All-cause mortality Up to 1 year post-transplant for all other safety events reported
Source ClinicalTrials.gov
Trial
- Title
- Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
- NCT number
- NCT02730299
- Phases
- PHASE3
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndrome (MDS), Lymphoma, Acute Leukemia
- Interventions
- NiCord® (omidubicel), Cord Blood Unit
- Lead sponsor
- Gamida Cell ltd
- Results first posted
- 2022-10-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02730299?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02730299-sae