Comparison · NCT04152200-sae
Cohort A: Lumasiran vs Cohort B: Lumasiran: 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. Cohort A: Lumasiran vs Cohort B: Lumasiran: serious adverse events. Trial comparisons, record NCT04152200-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04152200-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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.533 | 0.301 | 0.752 | wilson | |
| Risk difference, group 1 minus group 2 | -0.367 | -0.624 | 0.0931 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.313 | 0.0491 | 1.99 | log | |
| Odds ratio, group 1 over group 2 | 0.175 | 0.0163 | 1.88 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort A: Lumasiran than on Cohort B: Lumasiran | 2.73 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cohort A: Lumasiran | Patients not on dialysis received open-label lumasiran based on weight. Patients weighing \<10 kg received loading doses of lumasiran subcutaneous (SC) injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg monthly during the 6-month primary analysis period and monthly during the 54-month extension period. Patients in maintenance dosing who transitioned from \<10 kg to ≥10 kg continued to receive monthly doses at 3.0 mg/kg until the next visit that coincided with a dose for patients weighing ≥10 kg. Thereafter, patients followed every-3-months dosing until the end of the study. Patients weighing ≥10 to \<20 kg received loading doses of lumasiran SC injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 6.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period. Patients weighing ≥20 kg received loading doses of lumasiran SC injection 3.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period. Patients with weight increases crossing the threshold for the next weight-based dosing category (\<10 kg to ≥10 kg or \<20 kg to ≥20 kg) followed the new dosing regimen for the remainder of the study or until the next dosing category threshold was reached. | 1 | 6 | EG000 |
| Group 2 | Cohort B: Lumasiran | Patients on dialysis received open-label lumasiran based on weight. Patients weighing \<10 kg received loading doses of lumasiran subcutaneous (SC) injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg monthly during the 6-month primary analysis period and monthly during the 54-month extension period. Patients in maintenance dosing who transitioned from \<10 kg to ≥10 kg continued to receive monthly doses at 3.0 mg/kg until the next visit that coincided with a dose for patients weighing ≥10 kg. Thereafter, patients followed every-3-months dosing until the end of the study. Patients weighing ≥10 to \<20 kg received loading doses of lumasiran SC injection 6.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 6.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period. Patients weighing ≥20 kg received loading doses of lumasiran SC injection 3.0 mg/kg monthly for 3 months, followed by maintenance doses of lumasiran SC injection 3.0 mg/kg at Months 3 and 6 in the 6-month primary analysis period and every three months during the 54-month extension period. Patients with weight increases crossing the threshold for the next weight-based dosing category (\<10 kg to ≥10 kg or \<20 kg to ≥20 kg) followed the new dosing regimen for the remainder of the study or until the next dosing category threshold was reached. | 8 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Non-serious adverse events (AEs) are reported from the administration of the first dose of study drug up to approximately 6 months. Serious adverse events (SAEs) are reported from the time when the informed consent is signed up to approximately 6 months.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
- NCT number
- NCT04152200
- Phases
- PHASE3
- Conditions
- Primary Hyperoxaluria Type 1, Primary Hyperoxaluria
- Interventions
- Lumasiran
- Lead sponsor
- Alnylam Pharmaceuticals
- Results first posted
- 2022-07-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04152200?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.govNone 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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