Comparison · NCT01335477-sae
Nintedanib 150mg Bid 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 150mg Bid vs Placebo: serious adverse events. Trial comparisons, record NCT01335477-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01335477-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 | 0.298 | 0.251 | 0.349 | wilson | |
| Risk in group 2 | 0.329 | 0.27 | 0.393 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0309 | -0.111 | 0.0473 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.906 | 0.704 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.866 | 0.6 | 1.25 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nintedanib 150mg Bid than on Placebo | 32.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nintedanib 150mg Bid | Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events. | 98 | 329 | EG001 |
| Group 2 | Placebo | Oral administration of Placebo matching nintedanib soft gelatine capsules. | 72 | 219 | EG000 |
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 425 days
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II
- NCT number
- NCT01335477
- Phases
- PHASE3
- Conditions
- Pulmonary Fibrosis
- Interventions
- placebo, BIBF 1120
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2015-02-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01335477?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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