Comparison · NCT03643965-sae
Nefecon vs Placebo Oral Capsule: 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. Nefecon vs Placebo Oral Capsule: serious adverse events. Trial comparisons, record NCT03643965-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03643965-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 | 0.0989 | 0.0635 | 0.151 | wilson | |
| Risk in group 2 | 0.0495 | 0.0262 | 0.0913 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0495 | -0.00537 | 0.106 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.923 | 4.33 | log | |
| Odds ratio, group 1 over group 2 | 2.11 | 0.922 | 4.83 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nefecon than on Placebo Oral Capsule | 20.2 | 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 | Nefecon | Nefecon 16 mg once daily by mouth for 9 months.~Nefecon: Nefecon 16 mg for daily administration by mouth for 9 months. | 18 | 182 | EG000 |
| Group 2 | Placebo Oral Capsule | Placebo oral capsule once daily by mouth for 9 months.~Placebo oral capsule: Placebo capsules for daily administration by mouth for 9 months. | 9 | 182 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were recorded from time of first dose of study treatment until 2 years after first dose (end of study). Treatment emergent AEs were those that occurred after the first dose of study drug until 14 days after the last dose, including tapering. SAEs were recorded from time of patient informed consent until end of study, i.e until 2 years and 3 months (including follow-up period)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
- NCT number
- NCT03643965
- Phases
- PHASE3
- Conditions
- Primary IgA Nephropathy
- Interventions
- Nefecon, Placebo oral capsule
- Lead sponsor
- Calliditas Therapeutics AB
- Results first posted
- 2024-12-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03643965?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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