Trial · NCT02607722
All-Case Surveillance of Ofev in Patients With IPF in Japan
NCT02607722, Completed, Boehringer Ingelheim; results first posted 2024-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. All-Case Surveillance of Ofev in Patients With IPF in Japan. Trials, record NCT02607722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02607722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- All-Case Surveillance of Ofev in Patients With IPF in Japan
- NCT number
- NCT02607722
- Status
- Completed
- Enrollment
- 10,117 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Nintedanib
- First posted
- 2015-11-18
- Last updated
- 2024-10-15
- Results first posted
- 2024-10-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Any Suspected Adverse Drug Reactions (ADRs) | Up to 104 weeks | Number of patients with any suspected Adverse Drug Reactions (ADRs) is presented. |
| Secondary | Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104 | At baseline and at week 104 | Absolute change from baseline in Forced Vital Capacity (FVC) at Week 104 is presented. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured in Milliliter by spirometry. |
Source ClinicalTrials.gov
Outcomes2
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 Suspected Adverse Drug Reactions (ADRs) | Up to 104 weeks | Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set. | Participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104 | At baseline and at week 104 | Effectiveness set: This patient set included all patients with Ofev Capsules in the safety set who were suffering from the approved indication. Further important protocol deviations (IPDs) leading to exclusion from this analysis set were predefined. Only patients with FVC and %FVC value at baseline and post treatment in effectiveness set were included in this analysis. | MilliLiter (mL) | MEAN |
Source ClinicalTrials.gov
Results by group2
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 Suspected Adverse Drug Reactions (ADRs) | IPF Patients Receiving Nintedanib | 3852 | Participants | ||
| Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104 | IPF Patients Receiving Nintedanib | -152.5 | Standard Deviation 323.0 | MilliLiter (mL) |
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 | IPF Patients Receiving Nintedanib | 10,117 | |
| Overall Study | Treated | IPF Patients Receiving Nintedanib | 5,753 | |
| Overall Study | COMPLETED | IPF Patients Receiving Nintedanib | 1,535 | |
| Overall Study | NOT COMPLETED | IPF Patients Receiving Nintedanib | 8,582 |
Source ClinicalTrials.gov
Adverse events448
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 | Diarrhoea | Gastrointestinal disorders | IPF Patients Receiving Nintedanib | 2,036 | 5,734 | |
| other | Nausea | Gastrointestinal disorders | IPF Patients Receiving Nintedanib | 347 | 5,734 | |
| other | Hepatic function abnormal | Hepatobiliary disorders | IPF Patients Receiving Nintedanib | 829 | 5,734 | |
| other | Liver disorder | Hepatobiliary disorders | IPF Patients Receiving Nintedanib | 437 | 5,734 | |
| other | Decreased appetite | Metabolism and nutrition disorders | IPF Patients Receiving Nintedanib | 579 | 5,734 | |
| serious | Acquired haemophilia | Blood and lymphatic system disorders | IPF Patients Receiving Nintedanib | 1 | 5,734 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | IPF Patients Receiving Nintedanib | 1 | 5,734 | |
| serious | Anaemia | Blood and lymphatic system disorders | IPF Patients Receiving Nintedanib | 5 | 5,734 | |
| serious | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | IPF Patients Receiving Nintedanib | 1 | 5,734 | |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | IPF Patients Receiving Nintedanib | 1 | 5,734 |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IPF Patients Receiving Nintedanib | 1,137 | 5,734 |
| Total, other adverse events | IPF Patients Receiving Nintedanib | 3,239 | 5,734 |
| Total, serious adverse events | IPF Patients Receiving Nintedanib | 2,326 | 5,734 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02607722
GET https://conductscience.org/api/trials/v1/NCT02607722/events?page=2