Trial Outcomes & Findings for Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan (NCT NCT04559581)
NCT ID: NCT04559581
Last Updated: 2026-02-06
Results Overview
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'.
Recruitment status
COMPLETED
Target enrollment
425 participants
Primary outcome timeframe
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.
Results posted on
2026-02-06
Participant Flow
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.
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.
Participant milestones
| Measure |
Ofev Capsules
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
|
|---|---|
|
Overall Study
STARTED
|
408
|
|
Overall Study
COMPLETED
|
165
|
|
Overall Study
NOT COMPLETED
|
243
|
Reasons for withdrawal
| Measure |
Ofev Capsules
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
|
|---|---|
|
Overall Study
Adverse Event
|
130
|
|
Overall Study
Adverse event / Patient's wish
|
15
|
|
Overall Study
Adverse event / Other personal reasons
|
2
|
|
Overall Study
Improved
|
2
|
|
Overall Study
No visit after last visit
|
17
|
|
Overall Study
No visit after last visit / Other personal reasons
|
3
|
|
Overall Study
Other personal reasons
|
36
|
|
Overall Study
Patient's wish
|
38
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ofev Capsules
n=408 Participants
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
|
|---|---|
|
Age, Continuous
|
71.9 Years
STANDARD_DEVIATION 10.2 • n=408 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=408 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=408 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
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'.
Outcome measures
| Measure |
Ofev Capsules
n=408 Participants
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
|
|---|---|
|
Incidence of Adverse Drug Reactions (ADRs)
|
246 Participants
|
Adverse Events
Ofev Capsules
Serious events: 139 serious events
Other events: 192 other events
Deaths: 59 deaths
Serious adverse events
| Measure |
Ofev Capsules
n=408 participants at risk
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac failure
|
2.2%
9/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cor pulmonale
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Eye disorders
Cataract
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Eye disorders
Glaucoma
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
4/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Dysphagia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
Chest pain
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
Death
|
0.74%
3/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
General physical health deterioration
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
Malaise
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
Performance status decreased
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
Physical deconditioning
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
General disorders
Pyrexia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Cholangitis
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.74%
3/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Bacterial infection
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
COVID-19
|
3.4%
14/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Cholangitis infective
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Enterocolitis viral
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Fungal infection
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Herpes zoster
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumonia aspiration
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Infectious pleural effusion
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Lung abscess
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumonia
|
3.2%
13/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumonia bacterial
|
2.5%
10/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Respiratory tract infection
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Sepsis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Septic shock
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Urinary tract infection
|
0.74%
3/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Investigations
Blood pressure decreased
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Investigations
Platelet count decreased
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Musculoskeletal and connective tissue disorders
Dermatomyositis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Altered state of consciousness
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Parkinson's disease
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Psychiatric disorders
Completed suicide
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Psychiatric disorders
Delirium
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Psychiatric disorders
Depression
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Renal and urinary disorders
Nephritis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Renal and urinary disorders
Renal impairment
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.74%
3/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
16.4%
67/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.98%
4/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
7/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Microscopic polyangiitis
|
0.49%
2/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Vascular pain
|
0.25%
1/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
Other adverse events
| Measure |
Ofev Capsules
n=408 participants at risk
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
|
|---|---|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.8%
32/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Liver disorder
|
6.1%
25/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.4%
26/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.1%
123/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Nausea
|
8.8%
36/408 • 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.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER