Comparison · NCT02668393-e15d9571
150 mg Nintedanib + Docetaxel vs 200 mg Nintedanib + Docetaxel: Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle
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: Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle. Trial comparisons, record NCT02668393-e15d9571. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02668393-e15d9571
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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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.42 | 0.42 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0796 | 12.6 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.048 | 20.8 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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. | 1 | 6 | OG000 |
| 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. | 1 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle
- Description
Number of participants with DLT occurring during the first treatment cycle. DLT was defined as any of the following adverse events related to nintedanib:~* Non-haematological drug-related Common Terminology Criteria for AEs (CTCAE) grade 3 or greater~* diarrhoea CTCAE grade 2 for \>7 days despite supportive care~* nausea CTCAE grade 3 or greater despite supportive care~* vomiting CTCAE grade 2 or greater despite supportive care~* increase in Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) to CTCAE grade 3 or greater~* A increase in ALT and/or AST to CTCAE grade 2 or greater in conjunction with~* total bilirubin increase of CTCAE grade 1 or greater~* Platelets \<50 000/mm3 with bleeding (CTCAE ≥3)~* neutropenia of any grade or duration accompanied by fever \>38.5°C~* neutropenia grade 4 without fever of \>7 days duration~* Inability to resume nintedanib dosing within 21 days after stopping due to toxicity.
- Time frame
- First treatment cycle, the first 28 days following the start of trial medication.
- Population
- Maximum tolerated dose (MTD) Evaluation Set: All subjects who received at least one dose of study medication and were evaluable for MTD determination.
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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