Comparison · NCT02175004-sae
Previous Inotersen-Inotersen 300 mg vs Previous Placebo-Inotersen 300 mg: 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. Previous Inotersen-Inotersen 300 mg vs Previous Placebo-Inotersen 300 mg: serious adverse events. Trial comparisons, record NCT02175004-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02175004-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 | 0.541 | 0.436 | 0.643 | wilson | |
| Risk in group 2 | 0.36 | 0.241 | 0.499 | wilson | |
| Risk difference, group 1 minus group 2 | 0.181 | 0.00705 | 0.338 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.989 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 2.1 | 1.02 | 4.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Previous Inotersen-Inotersen 300 mg than on Previous Placebo-Inotersen 300 mg | 5.52 | 2.96 | 142 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Previous Inotersen-Inotersen 300 mg | Participants received SC doses of 300 mg inotersen once weekly for up to 260 weeks. Participants who received inotersen in ISIS 420915-CS2 study were included in this group. | 46 | 85 | EG001 |
| Group 2 | Previous Placebo-Inotersen 300 mg | Participants received SC doses of 300 mg inotersen once weekly for up to 260 weeks. Participants who received inotersen-matching placebo in ISIS 420915-CS2 study were included in this group. | 18 | 50 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)
- NCT number
- NCT02175004
- Phases
- PHASE3
- Conditions
- FAP, Familial Amyloid Polyneuropathy, TTR, Transthyretin, Amyloidosis
- Interventions
- Inotersen
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Results first posted
- 2023-02-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02175004?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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