Comparison · NCT01735630-sae
ELND005 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. ELND005 vs Placebo: serious adverse events. Trial comparisons, record NCT01735630-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01735630-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 | 0.0971 | 0.0615 | 0.15 | wilson | |
| Risk in group 2 | 0.0286 | 0.0123 | 0.0651 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0686 | 0.0175 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.4 | 1.28 | 9.01 | log | |
| Odds ratio, group 1 over group 2 | 3.66 | 1.32 | 10.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ELND005 than on Placebo | 14.6 | 8.07 | 57 | 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 | ELND005 | ELND005 film coated tablets, BID for 12 weeks~ELND005 | 17 | 175 | EG000 |
| Group 2 | Placebo | Matched placebo BID for 12 weeks~Placebo | 5 | 175 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
- NCT number
- NCT01735630
- Phases
- PHASE2
- Conditions
- Alzheimer's Disease
- Interventions
- ELND005, Placebo
- Lead sponsor
- OPKO Health, Inc.
- Results first posted
- 2016-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01735630?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01735630-sae