Comparison · NCT04682444-sae
Group 1 - Active Treatment vs Group 2 - 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. Group 1 - Active Treatment vs Group 2 - Placebo: serious adverse events. Trial comparisons, record NCT04682444-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04682444-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 | 0 | 0.0602 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0876 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0876 | 0.0602 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Group 1 - Active Treatment | Patient who were randomized into Group 1 ingested Amizon tablets 0.5 g (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 0.25 g of enisamium iodide.~Enisamium Iodide: Patients ingested Amizon tablets without chewing, after meal, as follows: 2 tablets (total dose 0.5 g) 3 times a day, for 7 days. Each tablet contains 0.25 g of Nmethyl-4-N-methyl-4-benzylcarbamidopyridinium iodide (INN enisamium iodide). | 0 | 60 | EG000 |
| Group 2 | Group 2 - Placebo | Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 0.5 g (2 tablets), 3 times a day, for 7 days.~Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 0.5 g (2 tablets), 3 times a day, for 7 days. | 0 | 40 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
- NCT number
- NCT04682444
- Phases
- PHASE2, PHASE3
- Conditions
- Acute Respiratory Viral Infections, Human Influenza
- Interventions
- Enisamium Iodide, Placebo
- Lead sponsor
- Joint Stock Company "Farmak"
- Results first posted
- 2026-01-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04682444?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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