Comparison · NCT02495103-sae
Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: 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. Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: serious adverse events. Trial comparisons, record NCT02495103-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02495103-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 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk in group 2 | 0.5 | 0.15 | 0.85 | wilson | |
| Risk difference, group 1 minus group 2 | -0.167 | -0.61 | 0.411 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.102 | 4.35 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.0225 | 11.1 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily than on Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib | 1 | 3 | EG000 |
| Group 2 | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | Phase I Component~Vandetanib: PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.~Metformin: Phase I: Metformin starting dose 250mg by mouth (PO) twice daily in combination with Vandetanib | 2 | 4 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately 24 months.
Source ClinicalTrials.gov
Trial
- Title
- Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
- NCT number
- NCT02495103
- Phases
- PHASE1, PHASE2
- Conditions
- Renal Cell Carcinoma, Hereditary Leiomyomatosis, Renal Cell Cancer
- Interventions
- Vandetanib, Metformin, Vandetanib/Metformin
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-01-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02495103?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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