Trial Outcomes & Findings for Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis (NCT NCT03047031)

NCT ID: NCT03047031

Last Updated: 2025-05-16

Results Overview

Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients is reported. An adverse reaction is defined as at least a reasonable possibility of a causal relationship between a suspected medicinal product and an adverse event. Incidence rate was calculated using the number of patients with ADRs events per treatment divided by time at risk expressed as \[100 patient-years (pt-yrs)\]. Time at risk was calculated as below: If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
• Results posted on: 2025-05-16

Participant Flow

This active surveillance study aimed to collect the safety data of Idiopathic Pulmonary Fibrosis (IPF) patients who were treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017).

No patients were enrolled in Group A (nintedanib) & Group I (pirfenidone). The nintedanib patients in group B and group C were combined together in the participant flow and baseline characteristics, since the outcome measures and the adverse events were planned in the protocol of the study to be reported for all nintedanib treated patients.

Participant milestones

Measure	All Nintedanib Treated Patients (Group B + Group C) This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.	Group II- Pirfenidone Patients This arm includes patients who started treatment with pirfenidone after the 23rd of January 2017 and are continuing the drug treatment at the time of participation in the active surveillance.	Group III - Pirfenidone Patients This arm includes patients who were newly prescribed with pirfenidone at the time of participation in the active surveillance.
Overall Study STARTED	14	4	3
Overall Study COMPLETED	2	0	0
Overall Study NOT COMPLETED	12	4	3

Reasons for withdrawal

Measure	All Nintedanib Treated Patients (Group B + Group C) This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.	Group II- Pirfenidone Patients This arm includes patients who started treatment with pirfenidone after the 23rd of January 2017 and are continuing the drug treatment at the time of participation in the active surveillance.	Group III - Pirfenidone Patients This arm includes patients who were newly prescribed with pirfenidone at the time of participation in the active surveillance.
Overall Study Other than listed	1	0	0
Overall Study Lost to Follow-up	4	0	0
Overall Study Patient refusal to continue taking trial medication	2	0	0
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	2	0	0
Overall Study Change to other medication	2	0	0
Overall Study Patients were not followed as planned in the protocol	0	4	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Nintedanib Treated Patients (Group B + Group C) n=14 Participants This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.	Group II- Pirfenidone Patients n=4 Participants This arm includes patients who started treatment with pirfenidone after the 23rd of January 2017 and are continuing the drug treatment at the time of participation in the active surveillance.	Group III - Pirfenidone Patients n=3 Participants This arm includes patients who were newly prescribed with pirfenidone at the time of participation in the active surveillance.	Total n=21 Participants Total of all reporting groups
Age, Continuous	64.7 Years STANDARD_DEVIATION 9.59 • n=14 Participants	65.3 Years STANDARD_DEVIATION 4.57 • n=4 Participants	68.0 Years STANDARD_DEVIATION 12.29 • n=3 Participants	65.3 Years STANDARD_DEVIATION 8.91 • n=21 Participants
Sex: Female, Male Female	6 Participants n=14 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	6 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=14 Participants	4 Participants n=4 Participants	3 Participants n=3 Participants	15 Participants n=21 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Population: Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Outcome measures were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients is reported. An adverse reaction is defined as at least a reasonable possibility of a causal relationship between a suspected medicinal product and an adverse event.

Incidence rate was calculated using the number of patients with ADRs events per treatment divided by time at risk expressed as [100 patient-years (pt-yrs)].

Time at risk was calculated as below:

If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.

Outcome measures

Measure

All Nintedanib Treated Patients (Group B + Group C) n=14 Participants This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.

Incidence Rate of All ADRs in Nintedanib Treated Patients

11.0 patients with ADR events/100 pt-years Interval 0.28 to 61.46

PRIMARY outcome

Timeframe: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Population: Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Outcome measures were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

Incidence rate of all Serious Adverse Events (SAEs) in nintedanib treated patients is reported.

A SAE was defined as any adverse event which:

• results in death,
• is life-threatening,
• requires in-patient hospitalization, or
• prolongation of existing hospitalisation,
• results in persistent or significant disability or incapacity, or
• is a congenital anomaly/birth defect.

Incidence rate was calculated using the number of patients with SAEs events per treatment divided by time at risk expressed as [100 patient-years (pt-yrs)].

Time at risk was calculated as below:

If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.

Outcome measures

Measure

All Nintedanib Treated Patients (Group B + Group C) n=14 Participants This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.

Incidence Rate of All SAEs in Nintedanib Treated Patients

11.4 patients with SAEs events/100 pt-years Interval 0.29 to 63.65

SECONDARY outcome

Timeframe: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Population: Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Outcome measures were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

Percentage of patients with Adverse Events (AEs) leading to permanent dose reductions of study drug is reported.

Outcome measures

Measure

All Nintedanib Treated Patients (Group B + Group C) n=14 Participants This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.

Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug

0 percentage of patients

SECONDARY outcome

Timeframe: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Population: Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Outcome measures were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

Percentage of patients with Adverse Events (AEs) causing dose interruption of study drug is reported.

Outcome measures

Measure

All Nintedanib Treated Patients (Group B + Group C) n=14 Participants This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.

Percentage of Patients With AEs Causing Dose Interruption of Study Drug

0 percentage of patients

SECONDARY outcome

Timeframe: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Population: Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Outcome measures were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

Percentage of patients with adverse events (AEs) leading to permanently discontinuation of study drug is reported.

Percentages are rounded to one decimal places.

Outcome measures

Measure

All Nintedanib Treated Patients (Group B + Group C) n=14 Participants This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.

Percentage of Patients With AEs Leading to Permanently Discontinuation of Study Drug

7.1 percentage of patients

Adverse Events

All Nintedanib Treated Patients (Group B + Group C)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure

All Nintedanib Treated Patients (Group B + Group C) n=14 participants at risk This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.

Respiratory, thoracic and mediastinal disorders Interstitial lung disease

7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

Other adverse events

Measure	All Nintedanib Treated Patients (Group B + Group C) n=14 participants at risk This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	21.4% 3/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
Gastrointestinal disorders Vomiting	7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
General disorders Chest pain	7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
Respiratory, thoracic and mediastinal disorders Throat irritation	7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
Skin and subcutaneous tissue disorders Solar dermatitis	7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
Gastrointestinal disorders Nausea	7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.
Metabolism and nutrition disorders Decreased appetite	7.1% 1/14 • From the day Nintedanib was initiated until 52 weeks, up to 52 weeks. Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib. Adverse events were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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.
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