Comparison · NCT00981058-sae
Necitumumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: 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. Necitumumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: serious adverse events. Trial comparisons, record NCT00981058-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00981058-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 | 0.487 | 0.445 | 0.529 | wilson | |
| Risk in group 2 | 0.384 | 0.344 | 0.426 | wilson | |
| Risk difference, group 1 minus group 2 | 0.103 | 0.0434 | 0.161 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 1.1 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 1.52 | 1.19 | 1.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Necitumumab + Gemcitabine + Cisplatin than on Gemcitabine + Cisplatin | 9.75 | 6.22 | 23.1 | 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 | Necitumumab + Gemcitabine + Cisplatin | Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles. | 262 | 538 | EG000 |
| Group 2 | Gemcitabine + Cisplatin | Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles. | 208 | 541 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline Up To 156 Months
Source ClinicalTrials.gov
Trial
- Title
- First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
- NCT number
- NCT00981058
- Phases
- PHASE3
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Necitumumab, Gemcitabine, Cisplatin
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2016-06-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00981058?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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