Trial · NCT01619085
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
NCT01619085, Phase 3, Completed, Boehringer Ingelheim; results first posted 2018-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis. Trials, record NCT01619085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01619085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
- NCT number
- NCT01619085
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 752 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Nintedanib
- First posted
- 2012-06-14
- Last updated
- 2022-03-25
- Other registries' IDs
- eudract:2011-002766-21
- Results first posted
- 2018-07-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days. | This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events (AEs) | From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days. | Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 parent trials. | Percentage of patients (%) | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events (AEs) | Total (1199.32/.34) | Any AEs | 98.5 | Percentage of patients (%) | |
| Incidence of Adverse Events (AEs) | Total (1199.32/.34) | AEs leading to discontinuation of trial drug | 42.6 | Percentage of patients (%) | |
| Incidence of Adverse Events (AEs) | Total (1199.32/.34) | Serious AEs | 68.9 | Percentage of patients (%) | |
| Incidence of Adverse Events (AEs) | Total (1199.32/.34) | Fatal AEs | 23.8 | Percentage of patients (%) |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total (1199.32/.34/.35/.187) | 752 | |
| Overall Study | Treated | Total (1199.32/.34/.35/.187) | 751 | |
| Overall Study | COMPLETED | Total (1199.32/.34/.35/.187) | 227 | |
| Overall Study | NOT COMPLETED | Total (1199.32/.34/.35/.187) | 525 |
Source ClinicalTrials.gov
Adverse events3,184
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Total (1199.32/.34) | 63 | 734 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (1199.32/.34) | 32 | 304 | |
| other | Abdominal pain | Gastrointestinal disorders | Nintedanib 150 Bid (1199.32/.34) | 31 | 430 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (1199.187) | 0 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Nintedanib 100 Bid (1199.35) | 0 | 2 | |
| other | Abdominal pain | Gastrointestinal disorders | Nintedanib 150 Bid (1199.35/.187) | 0 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Total (1199.35/.187) | 0 | 17 | |
| other | Abdominal pain | Gastrointestinal disorders | Total (1199.32/.34/.35/.187) | 63 | 751 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Total (1199.32/.34) | 48 | 734 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo (1199.32/.34) | 21 | 304 |
1 to 10 of 3,184Source ClinicalTrials.gov
See all 3,184 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total (1199.32/.34) | 182 | 734 |
| Total, all-cause mortality | Placebo (1199.32/.34) | 78 | 304 |
| Total, all-cause mortality | Nintedanib 150 Bid (1199.32/.34) | 104 | 430 |
| Total, all-cause mortality | Placebo (1199.187) | 0 | 7 |
| Total, all-cause mortality | Nintedanib 100 Bid (1199.35) | 0 | 2 |
| Total, all-cause mortality | Nintedanib 150 Bid (1199.35/.187) | 0 | 8 |
| Total, all-cause mortality | Total (1199.35/.187) | 0 | 17 |
| Total, all-cause mortality | Total (1199.32/.34/.35/.187) | 182 | 751 |
| Total, other adverse events | Total (1199.32/.34) | 671 | 734 |
| Total, other adverse events | Placebo (1199.32/.34) | 281 | 304 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30224318 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01619085
GET https://conductscience.org/api/trials/v1/NCT01619085/events?page=2