Comparison · NCT00065182-sae
IV Topotecan + IV Docetaxel vs IV Docetaxel: 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. IV Topotecan + IV Docetaxel vs IV Docetaxel: serious adverse events. Trial comparisons, record NCT00065182-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00065182-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 | 0.29 | 0.232 | 0.356 | wilson | |
| Risk in group 2 | 0.251 | 0.196 | 0.317 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0387 | -0.0489 | 0.125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.834 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 1.22 | 0.78 | 1.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IV Topotecan + IV Docetaxel than on IV Docetaxel | 25.8 | 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 | IV Topotecan + IV Docetaxel | Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study. | 58 | 200 | EG000 |
| Group 2 | IV Docetaxel | Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study. | 49 | 195 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 16 months
Source ClinicalTrials.gov
Trial
- Title
- Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
- NCT number
- NCT00065182
- Phases
- PHASE2
- Conditions
- Lung Cancer, Non-Small Cell, Non-Small-Cell Lung Cancer
- Interventions
- Topotecan/Docetaxel combination, Docetaxel
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-06-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00065182?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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