Comparison · NCT04390113-sae
Posoleucel (ALVR105) vs Placebo: 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. Posoleucel (ALVR105) vs Placebo: serious adverse events. Trial comparisons, record NCT04390113-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04390113-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 | 0.491 | 0.366 | 0.617 | wilson | |
| Risk in group 2 | 0.487 | 0.339 | 0.638 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00405 | -0.192 | 0.199 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.665 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.45 | 2.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Posoleucel (ALVR105) than on Placebo | 247 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Posoleucel (ALVR105) | All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push. | 28 | 57 | EG000 |
| Group 2 | Placebo | All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed \<40 kg at the time of screening received 2×10\^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10\^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push. | 19 | 39 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 24 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
- NCT number
- NCT04390113
- Phases
- PHASE3
- Conditions
- BK Virus Infection, Hemorrhagic Cystitis
- Interventions
- Posoleucel (ALVR105), Placebo
- Lead sponsor
- AlloVir
- Results first posted
- 2024-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04390113?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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