Comparison · NCT03390842-sae
TRC101 Treatment Arm vs Placebo Treatment Arm: 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. TRC101 Treatment Arm vs Placebo Treatment Arm: serious adverse events. Trial comparisons, record NCT03390842-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03390842-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 | 0.0179 | 0.00491 | 0.0628 | wilson | |
| Risk in group 2 | 0.0494 | 0.0194 | 0.12 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0315 | -0.104 | 0.0225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.362 | 0.0679 | 1.93 | log | |
| Odds ratio, group 1 over group 2 | 0.35 | 0.0625 | 1.96 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TRC101 Treatment Arm than on Placebo Treatment Arm | 31.7 | 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 | TRC101 Treatment Arm | TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit. | 2 | 112 | EG000 |
| Group 2 | Placebo Treatment Arm | Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit. | 4 | 81 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up visit in the extension study, TRCA-301E.
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety Extension to Study TRCA-301
- NCT number
- NCT03390842
- Phases
- PHASE3
- Conditions
- Metabolic Acidosis
- Interventions
- TRC101, Placebo
- Lead sponsor
- Tricida, Inc.
- Results first posted
- 2021-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03390842?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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