Lung Diseases, Interstitial
Conditions
Brief summary
The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).
Interventions
DRUGNintedanib
Ofev Capsules as prescribed by the treating physician
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.
Exclusion criteria
* Diagnosis of Idiopathic Pulmonary Fibrosis * Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Drug Reactions (ADRs) | From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks. | Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'. |
Countries
Japan
Participant flow
Recruitment details
This was a non-interventional study based on newly collected data of patients under routine care to confirm safety of Ofev Capsules (nintedanib) in the real-world setting in Japanese patients with Progressive Fibrosing Interstitial Lung Disease.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. 425 patients were registered, Case Report Forms were collected for 409, and 1 was registered twice, so 408 patients started the treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.9 Years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 196 Participants |
| Sex: Female, Male Male | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 59 / 408 |
| other Total, other adverse events | 192 / 408 |
| serious Total, serious adverse events | 139 / 408 |
Outcome results
None listed