Comparison · NCT02100839-0d27dee8
AEM-28 vs Normal Saline: Number of Participants Who Incurred at Least One Treatment Emergent Event
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. AEM-28 vs Normal Saline: Number of Participants Who Incurred at Least One Treatment Emergent Event. Trial comparisons, record NCT02100839-0d27dee8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02100839-0d27dee8
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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 | 0.892 | 0.753 | 0.957 | wilson | |
| Risk in group 2 | 0.667 | 0.417 | 0.848 | wilson | |
| Risk difference, group 1 minus group 2 | 0.225 | -0.00343 | 0.483 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.34 | 0.919 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 4.13 | 0.927 | 18.4 | log | |
| Number needed to treat, for one more participant with the outcome on AEM-28 than on Normal Saline | 4.44 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AEM-28 | Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection | 33 | 37 | OG000 |
| Group 2 | Normal Saline | Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection | 10 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Incurred at Least One Treatment Emergent Event
- Description
Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics.
- Time frame
- Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57
- Population
Source ClinicalTrials.gov
Trial
- Title
- Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
- NCT number
- NCT02100839
- Phases
- PHASE1, PHASE2
- Conditions
- Hypercholesterolemia, Hyperlipoproteinemia Type II
- Interventions
- AEM-28, Normal Saline
- Lead sponsor
- LipimetiX Development, LLC
- Results first posted
- 2015-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02100839?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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