Comparison · NCT05779007-7c9d6454
Nintedanib Initiators Cohort vs Pirfenidone Initiators Cohort: Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months
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 Initiators Cohort vs Pirfenidone Initiators Cohort: Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months. Trial comparisons, record NCT05779007-7c9d6454. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05779007-7c9d6454
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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 | 0.217 | 0.196 | 0.239 | wilson | |
| Risk in group 2 | 0.269 | 0.246 | 0.292 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0518 | -0.0836 | -0.02 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.807 | 0.707 | 0.921 | log | |
| Odds ratio, group 1 over group 2 | 0.754 | 0.633 | 0.897 | log | |
| Number needed to treat, for one fewer participant with the outcome on Nintedanib Initiators Cohort than on Pirfenidone Initiators Cohort | 19.3 | 12 | 50.1 | from the risk difference interval |
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 Initiators Cohort | IPF patients from the Optum Research Database (ORD) who presented at least one nintedanib prescription during the identification period (the date of first prescription for nintedanib was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period. | 301 | 1,389 | OG000 |
| Group 2 | Pirfenidone Initiators Cohort | IPF patients from the Optum Research Database (ORD) who presented at least one pirfenidone prescription during the identification period (the date of first prescription for pirfenidone was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period. | 373 | 1,389 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months
- Description
Number of patients with sub-optimal dose was be defined as patients with an average daily dose not following the prescribing information of nintedanib and pirfenidone for at least 90 consecutive days, corresponding to ≤ 66.67% dose strength for pirfenidone and ≤ 66.67% dose strength for nintedanib.~Number of patients with sub-optimal dosing by month 12 is reported.
- Time frame
- From individual index date up to 12 months.
- Population
Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients \>= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021.
Source ClinicalTrials.gov
Trial
- Title
- Dose Reduction and Discontinuation With Anti-Fibrotic Medications
- NCT number
- NCT05779007
- Phases
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Pirfenidone, Nintedanib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2025-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05779007?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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