CSL112 vs Placebo: Number of Participants With Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.437 | 0.427 | 0.447 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.435 | 0.425 | 0.445 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00204 | -0.0124 | 0.0165 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1 | 0.972 | 1.04 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.951 | 1.07 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on CSL112 than on Placebo | 490 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | CSL112 | Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks. | 3,938 | 9,010 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks. | 3,927 | 9,027 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Adverse Events | ClinicalTrials.gov |
| Description | An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | ClinicalTrials.gov |
| Time frame | From the start of treatment through 90 days | ClinicalTrials.gov |
| Population | Analysis was performed on the Safety analysis set (SAS). The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome | ClinicalTrials.gov |
| NCT number | NCT03473223 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Acute Coronary Syndrome | ClinicalTrials.gov |
| Interventions | Apolipoprotein A-I [human] (apoA-I), Placebo | ClinicalTrials.gov |
| Lead sponsor | CSL Behring | ClinicalTrials.gov |
| Results first posted | 2025-01-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03473223?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.