Comparison · NCT00148798-sae
Cetuximab Plus Chemotherapy vs Chemotherapy 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. Cetuximab Plus Chemotherapy vs Chemotherapy Alone: serious adverse events. Trial comparisons, record NCT00148798-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00148798-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 | 0.593 | 0.551 | 0.633 | wilson | |
| Risk in group 2 | 0.434 | 0.394 | 0.475 | wilson | |
| Risk difference, group 1 minus group 2 | 0.159 | 0.1 | 0.216 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.37 | 1.22 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 1.9 | 1.5 | 2.41 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cetuximab Plus Chemotherapy than on Chemotherapy Alone | 6.29 | 4.63 | 9.97 | 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 | Cetuximab Plus Chemotherapy | cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects. | 325 | 548 | EG000 |
| Group 2 | Chemotherapy Alone | cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects. | 244 | 562 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time from first dose up to 30 days after the last dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
- NCT number
- NCT00148798
- Phases
- PHASE3
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Interventions
- cetuximab + cisplatin + vinorelbine, cisplatin + vinorelbine
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2011-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00148798?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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