Comparison · NCT03317444-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
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ConductScience Library. TRC101 Treatment Arm vs Placebo Treatment Arm: serious adverse events. Trial comparisons, record NCT03317444-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03317444-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 | 0.0242 | 0.00826 | 0.0687 | wilson | |
| Risk in group 2 | 0.0215 | 0.00592 | 0.0751 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00269 | -0.0532 | 0.0499 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.192 | 6.6 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.185 | 6.89 | log | |
| Number needed to harm, for one more participant with a serious adverse event on TRC101 Treatment Arm than on Placebo Treatment Arm | 372 | 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 | The first dose of blinded study drug (2 packets of TRC101 \[6 g\]) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. | 3 | 124 | EG000 |
| Group 2 | Placebo Treatment Arm | The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. | 2 | 93 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Data are the number of patients with adverse events occurring on or after the date of the first dose of TRC101 or placebo up to 14 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
- NCT number
- NCT03317444
- Phases
- PHASE3
- Conditions
- Metabolic Acidosis
- Interventions
- TRC101, Placebo
- Lead sponsor
- Tricida, Inc.
- Results first posted
- 2021-04-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03317444?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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