Comparison · NCT02010242-sae
GKT137831 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. GKT137831 vs Placebo: serious adverse events. Trial comparisons, record NCT02010242-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02010242-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 | 0.0441 | 0.0151 | 0.122 | wilson | |
| Risk in group 2 | 0.0735 | 0.0318 | 0.161 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0294 | -0.121 | 0.0588 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.6 | 0.149 | 2.41 | log | |
| Odds ratio, group 1 over group 2 | 0.582 | 0.133 | 2.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on GKT137831 than on Placebo | 34 | 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 | GKT137831 | GKT137831 100 mg capsules twice a day~GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment | 3 | 68 | EG000 |
| Group 2 | Placebo | Placebo capsule twice a day~Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment. | 5 | 68 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately 9-10 months
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
- NCT number
- NCT02010242
- Phases
- PHASE2
- Conditions
- Type 2 Diabetes Mellitus With Diabetic Nephropathy
- Interventions
- GKT137831, Placebo
- Lead sponsor
- Calliditas Therapeutics AB
- Results first posted
- 2025-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02010242?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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