Comparison · NCT02668393-sae
150 mg Nintedanib + Docetaxel vs 200 mg Nintedanib + 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. 150 mg Nintedanib + Docetaxel vs 200 mg Nintedanib + Docetaxel: serious adverse events. Trial comparisons, record NCT02668393-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02668393-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 | 0.429 | 0.158 | 0.75 | wilson | |
| Risk in group 2 | 0.286 | 0.0822 | 0.641 | wilson | |
| Risk difference, group 1 minus group 2 | 0.143 | -0.304 | 0.523 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.352 | 6.4 | log | |
| Odds ratio, group 1 over group 2 | 1.88 | 0.204 | 17.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 150 mg Nintedanib + Docetaxel than on 200 mg Nintedanib + Docetaxel | 7 | 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 | 150 mg Nintedanib + Docetaxel | In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 100 mg twice a day, a second dose reduction was not allowed. | 3 | 7 | EG000 |
| Group 2 | 200 mg Nintedanib + Docetaxel | In a treatment cycle of 28 days, 200 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 150 mg twice a day with a possible second dose reduction to 100 mg twice a day. | 2 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first administration of study drug till the last administration + a residual effect period (REP) of 28 days, up to 330 days.
Source ClinicalTrials.gov
Trial
- Title
- Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
- NCT number
- NCT02668393
- Phases
- PHASE1
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Docetaxel, Nintedanib, Nintedanib, Nintedanib, Nintedanib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2021-01-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02668393?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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