Comparison · NCT02411084-sae
BEGEDINA® (Begelomab) vs Conventional Second-line Treatment: 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. BEGEDINA® (Begelomab) vs Conventional Second-line Treatment: serious adverse events. Trial comparisons, record NCT02411084-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02411084-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 | 0.889 | 0.672 | 0.969 | wilson | |
| Risk in group 2 | 0.722 | 0.491 | 0.875 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.0986 | 0.411 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 0.885 | 1.71 | log | |
| Odds ratio, group 1 over group 2 | 3.08 | 0.511 | 18.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on BEGEDINA® (Begelomab) than on Conventional Second-line Treatment | 6 | 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 | BEGEDINA® (Begelomab) | The most frequent adverse events recorded after administration of BEGEDINA® were platelet count decreased (19.4% cases), anemia (16.7% cases), leukocytes count decreased (11.1% cases). Cytomegalovirus infection was found in 16.7% cases and peripheral edema in 13.9% cases.There were recorded 25 serious adverse events. At the end of the study rate of serious adverse events which determined early discontinuation in BEGEDINA® group was 22.2 % ( 4 subjects). At the end of the study (approx. day 180), death occurred in 36.1 % (13 subjects) in BEGEDINA® group. | 16 | 18 | EG000 |
| Group 2 | Conventional Second-line Treatment | The most frequent adverse events recorded in the conventional treatment arm were peripheral edema(22.2% cases), pyrexia (19.4% cases). Cytomegalovirus infection was found in 13.9% cases.There were recorded 29 serious adverse events. At Day 28, death occurred in 11.1% cases in this treatment group. At the end of the study rate of serious adverse events which determined early discontinuation in conventional treatment arm was 5.6~% (one subject). Mortality (approx. day 180) was 22.2 % (8 subjects) in the conventional treatment group. | 13 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All adverse events were collected in a 6 months period (180 days).
Source ClinicalTrials.gov
Trial
- Title
- Study of BEGEDINA® vs "Conventional Treatment" for Treating Steroid-Resistant Acute GvHD
- NCT number
- NCT02411084
- Phases
- PHASE3
- Conditions
- Graft vs Host Disease
- Interventions
- Begelomab, Conventional Second-line Treatment
- Lead sponsor
- Adienne SA
- Results first posted
- 2020-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02411084?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/NCT02411084-sae