Comparison · NCT00364013-sae
Panitumumab Plus FOLFOX vs FOLFOX Alone: 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. Panitumumab Plus FOLFOX vs FOLFOX Alone: serious adverse events. Trial comparisons, record NCT00364013-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00364013-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 | 0.448 | 0.408 | 0.488 | wilson | |
| Risk in group 2 | 0.339 | 0.302 | 0.378 | wilson | |
| Risk difference, group 1 minus group 2 | 0.109 | 0.0528 | 0.164 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 1.14 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 1.25 | 2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Panitumumab Plus FOLFOX than on FOLFOX Alone | 9.19 | 6.1 | 18.9 | 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 | Panitumumab Plus FOLFOX | Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. | 262 | 585 | EG000 |
| Group 2 | FOLFOX Alone | Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity. | 198 | 584 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The median treatment period was around 7.7 months in the Panitumumab arm, and around 6.7 months in the Chemo alone arm.
Source ClinicalTrials.gov
Trial
- Title
- PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
- NCT number
- NCT00364013
- Phases
- PHASE3
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Panitumumab, FOLFOX regimen
- Lead sponsor
- Amgen
- Results first posted
- 2014-03-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00364013?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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