Vortioxetine Treatment vs SSRI Treatment: Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period
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 | 0.0000876 | 0.000024 | 0.000319 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0002 | 0.000136 | 0.000295 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000112 | -0.000227 | 0.000128 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.438 | 0.104 | 1.85 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.438 | 0.104 | 1.85 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Vortioxetine Treatment than on SSRI Treatment | 8,890 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Vortioxetine Treatment | Data in the medical database for participants with depression who received Vortioxetine as part of a routine medical care. | 2 | 22,827 | OG000 | ClinicalTrials.gov |
| Group 2 | SSRI Treatment | Data in the medical database for participants with depression who received SSRI as part of a routine medical care. | 25 | 124,950 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period | ClinicalTrials.gov |
| Description | Number of participants who experienced of intracranial hemorrhage in Vortioxetine Tablet Treatment group and SSRI Treatment group were reported. Total follow-up period was defined as the period to follow up each participant to confirm the onset of intracranial hemorrhage (after the index date to the end of observation period, up to 360 days). | ClinicalTrials.gov |
| Time frame | 360 Days | ClinicalTrials.gov |
| Population | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression | ClinicalTrials.gov |
| NCT number | NCT05932407 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | Major Depressive Disorder | ClinicalTrials.gov |
| Interventions | Vortioxetine Tablet, SSRI | ClinicalTrials.gov |
| Lead sponsor | Takeda | ClinicalTrials.gov |
| Results first posted | 2025-03-03 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05932407?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.