Comparison · NCT02622724-sae
FP-1201-lyo 10 μg 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
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ConductScience Library. FP-1201-lyo 10 μg vs Placebo: serious adverse events. Trial comparisons, record NCT02622724-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02622724-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 | 0.535 | 0.453 | 0.614 | wilson | |
| Risk in group 2 | 0.507 | 0.428 | 0.585 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0281 | -0.0848 | 0.14 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.848 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.709 | 1.77 | log | |
| Number needed to harm, for one more participant with a serious adverse event on FP-1201-lyo 10 μg than on Placebo | 35.5 | 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 | FP-1201-lyo 10 μg | FP-1201-lyo 10 μg (Interferon beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.~Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Interferon beta-1a: Investigational drug | 77 | 144 | EG000 |
| Group 2 | Placebo | Placebo will be administered once daily as an intravenous bolus injection for 6 days.~Investigational placebo product is lyophilisate for solution for injection which will be reconstituted in water for injection.~Placebo: Placebo for investigational drug | 77 | 152 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The Adverse Event (AE) reporting period extended up to study Day 28. In accordance with the protocol, the investigators reported AEs occurring after Day 28 only if the investigator considered a causal relationship with the study drug. All deaths were reported as SAEs throughout the study, up until Day 360.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)
- NCT number
- NCT02622724
- Phases
- PHASE3
- Conditions
- Respiratory Distress Syndrome, Adult
- Interventions
- Interferon beta-1a, Placebo
- Lead sponsor
- Faron Pharmaceuticals Ltd
- Results first posted
- 2020-03-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02622724?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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