Comparison · NCT01404260-sae
Arm A vs Arm B: 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. Arm A vs Arm B: serious adverse events. Trial comparisons, record NCT01404260-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01404260-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 | 0.128 | 0.0781 | 0.204 | wilson | |
| Risk in group 2 | 0.0455 | 0.0196 | 0.102 | wilson | |
| Risk difference, group 1 minus group 2 | 0.083 | 0.00725 | 0.163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.83 | 1.05 | 7.58 | log | |
| Odds ratio, group 1 over group 2 | 3.09 | 1.07 | 8.92 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A than on Arm B | 12.1 | 6.14 | 138 | 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 | Arm A | Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression | 14 | 109 | EG000 |
| Group 2 | Arm B | gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression | 5 | 110 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4years
Source ClinicalTrials.gov
Trial
- Title
- Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer
- NCT number
- NCT01404260
- Phases
- PHASE3
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Gefitinib, Gemcitabine +Carboplatin
- Lead sponsor
- Guangdong Association of Clinical Trials
- Results first posted
- 2017-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01404260?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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