Comparison · NCT02231164-sae
Nintedanib vs Placebo: 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. Nintedanib vs Placebo: serious adverse events. Trial comparisons, record NCT02231164-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02231164-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 | 0.5 | 0.188 | 0.812 | wilson | |
| Risk in group 2 | 0.5 | 0.188 | 0.812 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.442 | 0.442 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.323 | 3.1 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.104 | 9.61 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nintedanib | Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | 3 | 6 | EG001 |
| Group 2 | Placebo | Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | 3 | 6 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first drug administration until 28 days after last drug administration, up to 7 months.
Source ClinicalTrials.gov
Trial
- Title
- LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
- NCT number
- NCT02231164
- Phases
- PHASE3
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- docetaxel, docetaxel, placebo, nintedanib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2017-02-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02231164?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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