Comparison · NCT03339401-sae
Brincidofovir vs Standard of Care: 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. Brincidofovir vs Standard of Care: serious adverse events. Trial comparisons, record NCT03339401-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03339401-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 | 0.75 | 0.531 | 0.888 | wilson | |
| Risk in group 2 | 0.667 | 0.354 | 0.879 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0833 | -0.222 | 0.425 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.664 | 1.91 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.27 | 8.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Brincidofovir than on Standard of Care | 12 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Brincidofovir | Brincidofovir (BCV) for the treatment of adenovirs (AdV) infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Brincidofovir (BCV) treatment began no later than 100 days post-transplant and was to continue for a maximum of 16 weeks. Brincidofovir (BCV) was discontinued once AdV viremia was confirmed undetectable.~Subjects who did NOT receive concurrent cyclosporine on Day 1:~* If ≥48kg body weight, one 100mg oral tablet BIW (or 10mL of 10mg/mL oral suspension if unable to take tablets).~* If \<48kg body weight, 2mg/kg oral volume of 10mg/mL oral suspension BIW.~Subjects who received cyclosporine on Day 1 (or initiated cyclosporine at any time):~* 1.4mg/kg (maximum of 70mg) oral volume of 10mg/mL oral suspension BIW.~* 2mg/kg (maximum of 100mg) oral volume of 10mg/mL oral suspension BIW if discontinued cyclosporine. | 15 | 20 | EG000 |
| Group 2 | Standard of Care | Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.~Management of these subjects was prescribed by the investigator as being in the best interests of the subject and may have included a watch-and-wait approach, with or without decreased immunosuppression (ergo, no treatment), or treatment administration with other available antivirals, most commonly cidofovir intravenously.~Decisions regarding SoC, including administration of therapy, dose and regimen of therapy, modification of immunosuppression, and monitoring was the responsibility of the clinical team caring for the subject, according to institutional guidelines, local practices, and applicable guidelines for the management of AdV infection. | 6 | 9 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization to 16 weeks post-randomization.
Source ClinicalTrials.gov
Trial
- Title
- The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation
- NCT number
- NCT03339401
- Phases
- PHASE2
- Conditions
- Adenovirus
- Interventions
- Standard of Care, Brincidofovir
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2021-01-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03339401?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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