Comparison · NCT01824875-sae
Arm A (Temozolomide) vs Arm B (Temozolomide and Capecitabine): 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. Arm A (Temozolomide) vs Arm B (Temozolomide and Capecitabine): serious adverse events. Trial comparisons, record NCT01824875-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01824875-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 | 0.221 | 0.138 | 0.333 | wilson | |
| Risk in group 2 | 0.451 | 0.34 | 0.566 | wilson | |
| Risk difference, group 1 minus group 2 | -0.23 | -0.372 | -0.073 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.489 | 0.292 | 0.819 | log | |
| Odds ratio, group 1 over group 2 | 0.345 | 0.165 | 0.723 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (Temozolomide) than on Arm B (Temozolomide and Capecitabine) | 4.35 | 2.69 | 13.7 | from the risk difference interval |
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 | Arm A (Temozolomide) | ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. | 15 | 68 | EG000 |
| Group 2 | Arm B (Temozolomide and Capecitabine) | ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. | 32 | 71 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Source ClinicalTrials.gov
Trial
- Title
- Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
- NCT number
- NCT01824875
- Phases
- PHASE2
- Conditions
- Gastrinoma, Glucagonoma, Insulinoma, Islet Cell Carcinoma, Pancreatic Polypeptide Tumor, Recurrent Islet Cell Carcinoma, Somatostatinoma
- Interventions
- temozolomide, capecitabine
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Results first posted
- 2022-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01824875?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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