Comparison · NCT01314105-sae
Nintedanib 150mg vs Nintedanib 200mg: 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 150mg vs Nintedanib 200mg: serious adverse events. Trial comparisons, record NCT01314105-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01314105-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 | 0.333 | 0.138 | 0.609 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0952 | -0.291 | 0.471 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.399 | 4.15 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.22 | 10.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nintedanib 150mg than on Nintedanib 200mg | 10.5 | 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 | Nintedanib 150mg | Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days. | 3 | 7 | EG000 |
| Group 2 | Nintedanib 200mg | Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days. | 4 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first drug administration until 28 days after the last drug administration, up to 31months
Source ClinicalTrials.gov
Trial
- Title
- BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer
- NCT number
- NCT01314105
- Phases
- PHASE1
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms
- Interventions
- BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2014-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01314105?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.
For software
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