Comparison · NCT04167514-sae
Alpha-1 Antitrypsin (AAT) 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. Alpha-1 Antitrypsin (AAT) vs Placebo: serious adverse events. Trial comparisons, record NCT04167514-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04167514-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 | 0.175 | 0.1 | 0.286 | wilson | |
| Risk in group 2 | 0.333 | 0.234 | 0.451 | wilson | |
| Risk difference, group 1 minus group 2 | -0.159 | -0.298 | -0.00899 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.524 | 0.278 | 0.986 | log | |
| Odds ratio, group 1 over group 2 | 0.423 | 0.186 | 0.961 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Alpha-1 Antitrypsin (AAT) than on Placebo | 6.3 | 3.36 | 111 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Alpha-1 Antitrypsin (AAT) | Participants received AAT twice weekly through Day 28. Responding participants (CR/PR) continued to receive a once weekly dose of AAT through Day 56. | 11 | 63 | EG000 |
| Group 2 | Placebo | Participants received albumin solution administered IV to match the IMP twice weekly through Day 28. Responding participants (CR/PR) continued to receive a once-weekly dose of matching placebo through Day 56. | 23 | 69 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From randomization to 12 months (end of study [EOS] follow-up): AEs and Serious AEs (SAEs) reported from randomization until 30 days post last dose. Beginning at 31 days from the last dose of the study drug through the EOS follow-up, only SAEs related to the study drug and unanticipated SAEs (regardless of relationship) required reporting. All-cause mortality includes any deaths, regardless of the timing, including those reported beyond the 12 months, up to 16 months for the last reported death.
Source ClinicalTrials.gov
Trial
- Title
- Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
- NCT number
- NCT04167514
- Phases
- PHASE3
- Conditions
- Graft Versus Host Disease (GVHD)
- Interventions
- Alpha-1 antitrypsin (AAT), Placebo
- Lead sponsor
- CSL Behring
- Results first posted
- 2025-08-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04167514?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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