Comparison · NCT01929226-1055f7bd
ETI-204 vs Placebo: Number of Participants With Anti-ETI-204 Antibodies
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. ETI-204 vs Placebo: Number of Participants With Anti-ETI-204 Antibodies. Trial comparisons, record NCT01929226-1055f7bd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01929226-1055f7bd
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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 | 0.00952 | 0.00262 | 0.0341 | wilson | |
| Risk in group 2 | 0 | 0 | 0.052 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00952 | -0.043 | 0.0341 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on ETI-204 than on Placebo | 105 | 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 | ETI-204 | Participants were administered a single intravenous (IV) infusion of 16 mg/kg ETI-204 in 0.9% sterile sodium chloride in a total volume of 250 mL over 90 minutes. ,~Following a protocol amendment, 147(70%) participants were premedicated with 50 mg oral diphenhydramine approximately 30 | 2 | 210 | OG000 |
| Group 2 | Placebo | Participants were administered a single intravenous (IV) infusion of ETI-204 Placebo in 0.9% sterile sodium chloride in a total volume of 250 mL over 90 minutes. ,~Following a protocol amendment, 48(68.6%) participants were premedicated with 50 mg oral diphenhydramine approximately 30 minutes prior to the start of the infusion. | 0 | 70 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Anti-ETI-204 Antibodies
- Description
Serum anti-ETI-204 antibody titers were determined for all subjects in the safety population. Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values post-treatment ≥ 4-times higher than baseline at Day 8, 43 or 71, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.
- Time frame
- On Day 1 prior to the start of infusion and on Days 8, 43, and 71.
- Population
- All participants who received study drug and were included in the safety population.
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
- NCT number
- NCT01929226
- Phases
- PHASE1
- Conditions
- Inhalational Anthrax
- Interventions
- ETI-204, Placebo
- Lead sponsor
- Elusys Therapeutics
- Results first posted
- 2019-04-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01929226?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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