Comparison · NCT02656017-e99611f1
Metformin vs Placebo: Rate of Serious Adverse Events (SAE)
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. Metformin vs Placebo: Rate of Serious Adverse Events (SAE). Trial comparisons, record NCT02656017-e99611f1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02656017-e99611f1
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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 | 0.0816 | 0.0322 | 0.192 | wilson | |
| Risk in group 2 | 0.0833 | 0.0329 | 0.196 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0017 | -0.124 | 0.12 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.98 | 0.26 | 3.69 | log | |
| Odds ratio, group 1 over group 2 | 0.978 | 0.23 | 4.16 | log | |
| Number needed to treat, for one fewer participant with the outcome on Metformin than on Placebo | 588 | 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 | Metformin | Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:~* Increase to 500mg twice daily at week 2~* Increase to 1000mg qAM, 500mg qPM at week 4~* Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months).~ * Increased titrations based on tolerability~Metformin: Monitoring of tolerability and symptoms. | 4 | 49 | OG000 |
| Group 2 | Placebo | Participants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations:~* Increase to 500mg twice daily at week 2~* Increase to 1000mg qAM, 500mg qPM at week 4~* Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months).~ * Increased titrations based on tolerability~Placebo: Monitoring of tolerability and symptoms. | 4 | 48 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Rate of Serious Adverse Events (SAE)
- Description
Serious adverse events (SAE) occurring from the time a participant signs the informed consent (at the screening visit) until the end of the study, meeting 1 or more of the criteria of: 1) Resulting in death, 2) Non-elective hospitalization, 3) Life threatening (if patient continued on study drug would result in death), 4) Harming or disabling persistently or permanently , 5) Exceeding the nature, severity or frequency of risk described in the protocol or 6) Resulting in congenital anomaly.
- Time frame
- 26 months
- Population
- Participants who received and took metformin or placebo
Source ClinicalTrials.gov
Trial
- Title
- Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
- NCT number
- NCT02656017
- Phases
- PHASE2
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Interventions
- Metformin, Placebo
- Lead sponsor
- Kyongtae Ty Bae, M.D., Ph.D.
- Results first posted
- 2022-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02656017?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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