Comparison · NCT01483560-sae
Metformin 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. Metformin vs Placebo: serious adverse events. Trial comparisons, record NCT01483560-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01483560-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 | 0.155 | 0.113 | 0.209 | wilson | |
| Risk in group 2 | 0.148 | 0.107 | 0.203 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00693 | -0.0619 | 0.0751 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.669 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.622 | 1.79 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Metformin than on Placebo | 144 | 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 | Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily~Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group | 34 | 219 | EG000 |
| Group 2 | Placebo | Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo | 31 | 209 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Source ClinicalTrials.gov
Trial
- Title
- REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
- NCT number
- NCT01483560
- Phases
- PHASE3
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Metformin, Placebo
- Lead sponsor
- University of Glasgow
- Results first posted
- 2019-06-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01483560?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
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