Comparison · NCT02415127-sae
Interferon γ-1b 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
Cite this record
ConductScience Library. Interferon γ-1b vs Placebo: serious adverse events. Trial comparisons, record NCT02415127-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02415127-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 | 0.0213 | 0.00377 | 0.111 | wilson | |
| Risk in group 2 | 0.0444 | 0.0123 | 0.148 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0232 | -0.128 | 0.0723 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.479 | 0.045 | 5.1 | log | |
| Odds ratio, group 1 over group 2 | 0.467 | 0.0409 | 5.34 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Interferon γ-1b than on Placebo | 43.2 | 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 | Interferon γ-1b | SC doses of ACTIMMUNE® TIW for a total of 26 weeks. | 1 | 47 | EG000 |
| Group 2 | Placebo | SC doses of placebo TIW for a total of 26 weeks. | 2 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment emergent adverse events (TEAEs) are presented. Adverse events (AEs) occurring or worsening after the dose on Day 1 through the end of the study (Week 26) were considered TEAEs. Serious TEAEs were collected through 2 weeks after study discontinuation (Week 28).
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia
- NCT number
- NCT02415127
- Phases
- PHASE3
- Conditions
- Friedreich's Ataxia
- Interventions
- Interferon γ-1b, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2017-12-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02415127?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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