Comparison · NCT01516216-sae
Chemotherapy + Standard Dose Vitamin D vs Chemotherapy + Higher Dose Vitamin D: 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. Chemotherapy + Standard Dose Vitamin D vs Chemotherapy + Higher Dose Vitamin D: serious adverse events. Trial comparisons, record NCT01516216-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01516216-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 | 0.582 | 0.463 | 0.693 | wilson | |
| Risk in group 2 | 0.691 | 0.574 | 0.788 | wilson | |
| Risk difference, group 1 minus group 2 | -0.109 | -0.263 | 0.0522 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.842 | 0.651 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.622 | 0.307 | 1.26 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Chemotherapy + Standard Dose Vitamin D than on Chemotherapy + Higher Dose Vitamin D | 9.17 | 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 | Chemotherapy + Standard Dose Vitamin D | FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons. | 39 | 67 | EG000 |
| Group 2 | Chemotherapy + Higher Dose Vitamin D | FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose.~Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons. | 47 | 68 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were evaluated at day 1 of each cycle on treatment and up to 30 days after the last dose. Maximum treatment duration is 28.5 months with median 7.3 months. All-Cause Mortality was assessed up to 56.7 months and Serious and Other (Not Including Serious) adverse events were assessed up to 29.5 months (the additional 30 days of monitoring included in the maximum treatment duration).
Source ClinicalTrials.gov
Trial
- Title
- Study of Vitamin D in Untreated Metastatic Colorectal Cancer
- NCT number
- NCT01516216
- Phases
- PHASE2
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- FOLFOX + bevacizumab, Vitamin D
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2022-03-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01516216?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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