Comparison · NCT03847909-sae
DCR-PHXC 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. DCR-PHXC vs Placebo: serious adverse events. Trial comparisons, record NCT03847909-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03847909-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 | 0.0435 | 0.00772 | 0.21 | wilson | |
| Risk in group 2 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk difference, group 1 minus group 2 | -0.123 | -0.407 | 0.0818 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.261 | 0.0262 | 2.59 | log | |
| Odds ratio, group 1 over group 2 | 0.227 | 0.0184 | 2.81 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on DCR-PHXC than on Placebo | 8.12 | 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 | DCR-PHXC | Participants aged \>=12 years weighing \>=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants \>=12 years weighing \<50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150. | 1 | 23 | EG000 |
| Group 2 | Placebo | Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150. | 2 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day 1 up to end of the study (Day 180)
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2
- NCT number
- NCT03847909
- Phases
- PHASE2
- Conditions
- Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2), Kidney Diseases, Urologic Diseases, Genetic Disease
- Interventions
- DCR-PHXC, Sterile Normal Saline (0.9% NaCl)
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2024-05-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03847909?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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