Comparison · NCT02614547-2194033e
SAGE-547 vs Placebo: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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. SAGE-547 vs Placebo: Number of Participants With Treatment-Emergent Adverse Events (TEAEs). Trial comparisons, record NCT02614547-2194033e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02614547-2194033e
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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 | 0.4 | 0.168 | 0.687 | wilson | |
| Risk in group 2 | 0.727 | 0.434 | 0.903 | wilson | |
| Risk difference, group 1 minus group 2 | -0.327 | -0.618 | 0.083 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.55 | 0.237 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.25 | 0.04 | 1.56 | log | |
| Number needed to treat, for one fewer participant with the outcome on SAGE-547 than on Placebo | 3.06 | 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 | SAGE-547 | Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours). | 4 | 10 | OG001 |
| Group 2 | Placebo | Participants received infusion rates of placebo matched to SAGE-547. | 8 | 11 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
- Time frame
- Up to 30 days
- Population
- Safety population included all randomized participants who started the study drug infusion.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
- NCT number
- NCT02614547
- Phases
- PHASE2
- Conditions
- Severe Postpartum Depression
- Interventions
- SAGE-547, Placebo
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Results first posted
- 2021-09-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02614547?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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