Comparison · NCT05890586-sae
Arm B - Fluvoxamine 50 vs Arm B - 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. Arm B - Fluvoxamine 50 vs Arm B - Placebo: serious adverse events. Trial comparisons, record NCT05890586-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05890586-sae
On this page
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 | 0.00444 | 0.00151 | 0.013 | wilson | |
| Risk in group 2 | 0.00976 | 0.00448 | 0.0211 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00532 | -0.0171 | 0.00471 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.455 | 0.114 | 1.81 | log | |
| Odds ratio, group 1 over group 2 | 0.452 | 0.113 | 1.82 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm B - Fluvoxamine 50 than on Arm B - Placebo | 188 | 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 | Arm B - Fluvoxamine 50 | Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.~Fluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has APO and the other side has F50 with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days. | 3 | 676 | EG000 |
| Group 2 | Arm B - Placebo | Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.~Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug. | 6 | 615 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 90 days
Source ClinicalTrials.gov
Trial
- Title
- ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine)
- NCT number
- NCT05890586
- Phases
- PHASE3
- Conditions
- Covid19
- Interventions
- Fluvoxamine, Placebo
- Lead sponsor
- Susanna Naggie, MD
- Results first posted
- 2023-08-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05890586?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT05890586-sae