Comparison · NCT01031680-sae
Experimental vs Placebo Comparator: 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. Experimental vs Placebo Comparator: serious adverse events. Trial comparisons, record NCT01031680-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01031680-sae
On this page
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 | 0.0587 | 0.0406 | 0.0841 | wilson | |
| Risk in group 2 | 0.0563 | 0.0387 | 0.0812 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00242 | -0.0283 | 0.0333 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.618 | 1.76 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.6 | 1.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Experimental than on Placebo Comparator | 413 | 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 | Experimental | Dapagliflozin, 10 mg tablet, oral, once daily | 27 | 460 | EG000 |
| Group 2 | Placebo Comparator | Placebo, Matching placebo tablet, oral, once daily | 26 | 462 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
- NCT number
- NCT01031680
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension, Inadequate Glycaemic Control
- Interventions
- Dapagliflozin, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2013-08-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01031680?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01031680-sae