Comparison · NCT00339183-sae
Panitumumab Plus FOLFIRI vs FOLFIRI 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 FOLFIRI vs FOLFIRI Alone: serious adverse events. Trial comparisons, record NCT00339183-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00339183-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 | 0.395 | 0.356 | 0.435 | wilson | |
| Risk in group 2 | 0.295 | 0.259 | 0.332 | wilson | |
| Risk difference, group 1 minus group 2 | 0.101 | 0.0464 | 0.154 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.34 | 1.14 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 1.56 | 1.23 | 1.99 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Panitumumab Plus FOLFIRI than on FOLFIRI Alone | 9.94 | 6.49 | 21.5 | 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 FOLFIRI | Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks. | 232 | 587 | EG000 |
| Group 2 | FOLFIRI Alone | Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks. | 175 | 594 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The median treatment period was approximately 6.2 months in the Panitumumab plus FOLFIRI arm, and 4.7 months in the FOLFIRI Alone arm.
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
- NCT number
- NCT00339183
- Phases
- PHASE3
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Panitumumab, FOLFIRI
- Lead sponsor
- Amgen
- Results first posted
- 2014-05-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00339183?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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