Comparison · NCT02166463-sae
Arm I (ABVE-PC) vs ARM II (Bv-AVEPC): 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. Arm I (ABVE-PC) vs ARM II (Bv-AVEPC): serious adverse events. Trial comparisons, record NCT02166463-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02166463-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 | 0.0383 | 0.0215 | 0.0673 | wilson | |
| Risk in group 2 | 0.224 | 0.18 | 0.275 | wilson | |
| Risk difference, group 1 minus group 2 | -0.185 | -0.239 | -0.133 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.171 | 0.0924 | 0.318 | log | |
| Odds ratio, group 1 over group 2 | 0.138 | 0.0713 | 0.268 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (ABVE-PC) than on ARM II (Bv-AVEPC) | 5.39 | 4.18 | 7.53 | 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 | Arm I (ABVE-PC) | Patients receive doxorubicin hydrochloride IV over on days 1-2, bleomycin sulfate IV or SC on days 1 and 8, vincristine sulfate IV on days 1 and 8, etoposide IV on days 1-3, prednisone orally PO BID or methylprednisolone IV on days 1-7, and cyclophosphamide IV on days 1 and 2. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. | 11 | 287 | EG000 |
| Group 2 | ARM II (Bv-AVEPC) | Patients receive brentuximab vedotin IV on day 1. Patients also receive doxorubicin hydrochloride, etoposide, prednisone or methylprednisolone, and cyclophosphamide as in Arm I and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 5 cycles in the absence of disease progression or unacceptable toxicity. | 66 | 295 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years. Ineligible patients are excluded. 5 patients (Arm I: 2 patients; Arm II: 3 patients) were also excluded from adverse events reporting due to never receiving any treatment, but their mortality status was observed. All-Cause Mortality includes all deaths collected on the study.
Source ClinicalTrials.gov
Trial
- Title
- Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
- NCT number
- NCT02166463
- Phases
- PHASE3
- Conditions
Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin Lymphoma, Childhood Hodgkin Lymphoma, Classic Hodgkin Lymphoma
- Interventions
Bleomycin Sulfate, Brentuximab Vedotin, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Methylprednisolone, Pharmacological Study, Prednisone, Quality-of-Life Assessment, Questionnaire Administration, Vincristine Sulfate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-05-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02166463?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/NCT02166463-sae