Comparison · NCT02802345-sae
Nintedanib+Placebo vs Nintedanib+Sildenafil: 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+Placebo vs Nintedanib+Sildenafil: serious adverse events. Trial comparisons, record NCT02802345-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02802345-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 | 0.324 | 0.251 | 0.406 | wilson | |
| Risk in group 2 | 0.27 | 0.203 | 0.35 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0535 | -0.0546 | 0.16 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.83 | 1.73 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.768 | 2.18 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nintedanib+Placebo than on Nintedanib+Sildenafil | 18.7 | 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 | Nintedanib+Placebo | Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with placebo matching to Sildenafil for 24 weeks. | 44 | 136 | EG000 |
| Group 2 | Nintedanib+Sildenafil | Patients administered 150 milligram (mg) soft gelatine capsule orally twice daily (bid), with a possibility of dose reduction to 100 mg capsule bid along with 20 mg thrice daily (tid) Sildenafil for 24 weeks. | 37 | 137 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first drug administration to 28 days after the last trial medication administration, 227 days.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment
- NCT number
- NCT02802345
- Phases
- PHASE3
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Nintedanib, Placebo, Sildenafil
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2019-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02802345?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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