Comparison · NCT00468169-sae
A: Cetuximab+FHX vs B: Cetuximab + PX: 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. A: Cetuximab+FHX vs B: Cetuximab + PX: serious adverse events. Trial comparisons, record NCT00468169-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00468169-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 | 0.123 | 0.0608 | 0.232 | wilson | |
| Risk in group 2 | 0.264 | 0.164 | 0.396 | wilson | |
| Risk difference, group 1 minus group 2 | -0.141 | -0.287 | 0.00691 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.465 | 0.203 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.39 | 0.144 | 1.06 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on A: Cetuximab+FHX than on B: Cetuximab + PX | 7.07 | 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 | A: Cetuximab+FHX | Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) | 7 | 57 | EG000 |
| Group 2 | B: Cetuximab + PX | Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.~Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) | 14 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 24 months
Source ClinicalTrials.gov
Trial
- Title
- Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
- NCT number
- NCT00468169
- Phases
- PHASE2
- Conditions
- Head and Neck Cancer
- Interventions
- Cetuximab, 5-FU, Hydroxyurea, Twice-daily radiation, Cisplatin, Accelerated fraction radiotherapy with concomitant boost
- Lead sponsor
- University of Chicago
- Results first posted
- 2019-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00468169?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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