Comparison · NCT01960348-sae
Patisiran (ALN-TTR02) 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. Patisiran (ALN-TTR02) vs Placebo: serious adverse events. Trial comparisons, record NCT01960348-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01960348-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 | 0.365 | 0.292 | 0.445 | wilson | |
| Risk in group 2 | 0.403 | 0.3 | 0.514 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0377 | -0.171 | 0.0922 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.906 | 0.642 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.852 | 0.484 | 1.5 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Patisiran (ALN-TTR02) than on Placebo | 26.5 | 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 | Patisiran (ALN-TTR02) | All patients who received at least 1 dose of patisiran (ALN-TTR02) | 54 | 148 | EG000 |
| Group 2 | Placebo | All patients who received at least 1 dose of placebo | 31 | 77 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All Adverse Events (AEs) that occurred from start of study drug administration through End of Study (Day 567), or Follow-up (Day 602) if patient did not enter open-label extension study. AEs for patients with Rapid Disease Progression at Month 9 who stopped dosing were collected through Day 294 (42 days after last dose).
Source ClinicalTrials.gov
Trial
- Title
- APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
- NCT number
- NCT01960348
- Phases
- PHASE3
- Conditions
- TTR-mediated Amyloidosis, Amyloidosis, Hereditary, Amyloid Neuropathies, Familial, Familial Amyloid Polyneuropathies, Amyloid Neuropathies, Amyloidosis, Hereditary, Transthyretin-Related
- Interventions
- patisiran (ALN-TTR02), Sterile Normal Saline (0.9% NaCl)
- Lead sponsor
- Alnylam Pharmaceuticals
- Results first posted
- 2018-09-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01960348?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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