Trial · NCT03313180
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
NCT03313180, Phase 3, Completed, Boehringer Ingelheim; results first posted 2024-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis. Trials, record NCT03313180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03313180
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
- NCT number
- NCT03313180
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 444 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Lung Diseases, Interstitial
- Interventions
- Nintedanib
- First posted
- 2017-10-18
- Last updated
- 2024-02-20
- Other registries' IDs
- eudract:2016-003403-66
- Results first posted
- 2024-02-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Any Adverse Event (AE) Over the Course of the Trial | First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months. | Number of patients with any adverse event (AE) over the course of the trial. |
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 | Number of Patients With Any Adverse Event (AE) Over the Course of the Trial | First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months. | Treated Set (TS): all patients who signed informed consent and received at least 1 dose of trial medication | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Any Adverse Event (AE) Over the Course of the Trial | Nintedanib | 441 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib | 444 | |
| Overall Study | COMPLETED | Nintedanib | 265 | |
| Overall Study | NOT COMPLETED | Nintedanib | 179 |
Source ClinicalTrials.gov
Adverse events246
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 | Anaemia | Blood and lymphatic system disorders | Nintedanib | 24 | 444 | |
| other | Abdominal pain | Gastrointestinal disorders | Nintedanib | 52 | 444 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Nintedanib | 24 | 444 | |
| other | Diarrhoea | Gastrointestinal disorders | Nintedanib | 338 | 444 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Nintedanib | 43 | 444 | |
| other | Nausea | Gastrointestinal disorders | Nintedanib | 122 | 444 | |
| other | Vomiting | Gastrointestinal disorders | Nintedanib | 100 | 444 | |
| other | Fatigue | General disorders | Nintedanib | 46 | 444 | |
| other | Pyrexia | General disorders | Nintedanib | 28 | 444 | |
| other | Bronchitis | Infections and infestations | Nintedanib | 46 | 444 |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib | 23 | 444 |
| Total, other adverse events | Nintedanib | 425 | 444 |
| Total, serious adverse events | Nintedanib | 198 | 444 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37294870 | 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/NCT03313180
GET https://conductscience.org/api/trials/v1/NCT03313180/events?page=2