Comparison · NCT01015118-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
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ConductScience Library. Nintedanib vs Placebo: serious adverse events. Trial comparisons, record NCT01015118-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01015118-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 | 0.42 | 0.388 | 0.453 | wilson | |
| Risk in group 2 | 0.349 | 0.306 | 0.394 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0713 | 0.0161 | 0.125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 1.04 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 1.35 | 1.07 | 1.71 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nintedanib than on Placebo | 14 | 8.01 | 62.3 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nintedanib | Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses. | 379 | 902 | EG001 |
| Group 2 | Placebo | Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses. | 157 | 450 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First drug administration until data cut-off 26September16, up to 62 months
Source ClinicalTrials.gov
Trial
- Title
- LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
- NCT number
- NCT01015118
- Phases
- PHASE3
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms
- Interventions
- Placebo, Paclitaxel, BIBF 1120, Carboplatin, Paclitaxel, Carboplatin
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2015-01-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01015118?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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