Comparison · NCT01989754-sae
Canagliflozin (Experimental) vs Placebo (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. Canagliflozin (Experimental) vs Placebo (Placebo): serious adverse events. Trial comparisons, record NCT01989754-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01989754-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 | 0.246 | 0.231 | 0.262 | wilson | |
| Risk in group 2 | 0.267 | 0.251 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0211 | -0.0435 | 0.00137 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.921 | 0.844 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.895 | 0.796 | 1.01 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Canagliflozin (Experimental) than on Placebo (Placebo) | 47.4 | 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 | Canagliflozin (Experimental) | Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated). | 714 | 2,904 | EG001 |
| Group 2 | Placebo (Placebo) | Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment. | 775 | 2,903 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately 3 years
Source ClinicalTrials.gov
Trial
- Title
- A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
- NCT number
- NCT01989754
- Phases
- PHASE4
- Conditions
- Diabetes Mellitus, Type 2, Albuminuria
- Interventions
- Placebo, Canagliflozin, 100 mg, Canagliflozin, 300 mg
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2018-12-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01989754?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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