Trial Outcomes & Findings for The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19 (NCT NCT04619680)
NCT ID: NCT04619680
Last Updated: 2026-04-30
Results Overview
Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
COMPLETED
PHASE4
103 participants
Baseline and 180 days
2026-04-30
Participant Flow
Participant milestones
| Measure |
Nintedanib
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
45
|
49
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Nintedanib
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Moved out of state
|
1
|
1
|
Baseline Characteristics
The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19
Baseline characteristics by cohort
| Measure |
Nintedanib
n=51 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=52 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 11.4 • n=14 Participants
|
59.0 years
STANDARD_DEVIATION 9.9 • n=34 Participants
|
58.5 years
STANDARD_DEVIATION 10.6 • n=69 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=14 Participants
|
20 Participants
n=34 Participants
|
38 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=14 Participants
|
32 Participants
n=34 Participants
|
65 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=14 Participants
|
15 Participants
n=34 Participants
|
33 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=14 Participants
|
37 Participants
n=34 Participants
|
70 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
5 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=14 Participants
|
15 Participants
n=34 Participants
|
25 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=14 Participants
|
31 Participants
n=34 Participants
|
66 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: Baseline and 180 daysPopulation: Intention-to-Treat Analysis Population
Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Outcome measures
| Measure |
Nintedanib
n=51 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=52 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
|
147.55 mL
Interval 62.89 to 232.21
|
167.72 mL
Interval 85.01 to 250.43
|
SECONDARY outcome
Timeframe: within 90-180 daysPopulation: Intention-to-Treat Analysis Population
Death within 90 days and 180 days from enrollment due to a respiratory cause
Outcome measures
| Measure |
Nintedanib
n=51 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=52 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Number of Deaths Due to Respiratory Cause
within 90 days
|
1 Participants
|
0 Participants
|
|
Number of Deaths Due to Respiratory Cause
within 180 days
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Results available for participants who completed scan; 1 due to incomplete lung image
Quantitative Change in chest CT visual score graded by blinded chest radiologists. Data driven texture analysis (DTA) is a patented deep learning method to quantify lung fibrosis. DTA score is reported in percentage ranging from 0% to 100%. A minimally clinical important difference when comparing CT scans from the same subject is 4%. A higher percentage suggests worsening lung injury.
Outcome measures
| Measure |
Nintedanib
n=45 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=48 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Number of Participants With Change in Chest CT Visual Score
Same
|
36 Participants
|
32 Participants
|
|
Number of Participants With Change in Chest CT Visual Score
Decreased
|
6 Participants
|
13 Participants
|
|
Number of Participants With Change in Chest CT Visual Score
Increased
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Estimates are adjusted for average baseline value. Results available for participants who completed scan. Missing data due to inadequate image quality.
Quantitative Change in chest CT visual score graded by blinded chest radiologists. Data driven texture analysis (DTA) is a patented deep learning method to quantify lung fibrosis. DTA score is reported in percentage ranging from 0% to 100%. A minimally clinical important difference when comparing CT scans from the same subject is 4%. A higher percentage suggests worsening lung injury.
Outcome measures
| Measure |
Nintedanib
n=35 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=43 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Chest CT Visual Score
|
-4.49 percent change
Interval -6.66 to -2.33
|
-4.06 percent change
Interval -6.0 to -2.12
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: Results available for participants who completed instrument. Missingness is due to missing scores on domains that prevent the total score from being calculated or patients had missing/incomplete questionnaire at baseline.
The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations. Change in SGRQ at Day 180 as compared to baseline
Outcome measures
| Measure |
Nintedanib
n=48 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=49 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in St. George's Respiratory Questionnaire (SGRQ)
|
-7.79 score on a scale
Interval -11.65 to -3.94
|
-9.13 score on a scale
Interval -12.91 to -5.36
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: Results available for participants who completed instrument. Missingness is due to missing scores on domains that prevent the total score from being calculated or patients had missing/incomplete questionnaire at baseline.
The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status. Change in KBILD score at Day 180 as compared to baseline.
Outcome measures
| Measure |
Nintedanib
n=47 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=51 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in King's Brief Interstitial Lung Disease Questionnaire (KBILD)
|
6.33 score on a scale
Interval 3.03 to 9.62
|
7.32 score on a scale
Interval 4.16 to 10.48
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: Results available for participants who completed instrument. Missingness is due to missing scores on domains that prevent the total score from being calculated or patients had missing/incomplete questionnaire at baseline.
The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life. Change in LCQ at Day 180 as compared to baseline
Outcome measures
| Measure |
Nintedanib
n=47 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=49 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in Leicester Cough Questionnaire (LCQ)
|
1.48 score on a scale
Interval 0.67 to 2.29
|
1.55 score on a scale
Interval 0.78 to 2.33
|
SECONDARY outcome
Timeframe: Day 180Population: Results for participants who completed SF36v2.
The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status in 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Raw scale scores range from 0 - 100, with higher scores indicating less disability. Scores are averaged and converted to T scores to two composites: Physical Health and Mental Health. T score is a conversion of scores to a standardized scale with a mean of 50 and a standard deviation of 10. A higher score indicates better health.
Outcome measures
| Measure |
Nintedanib
n=5 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=6 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Short Form (SF) 36 Health Survey
Physical Health
|
39.6 score on a scale
Standard Deviation 12.9
|
42.2 score on a scale
Standard Deviation 10.8
|
|
Short Form (SF) 36 Health Survey
Mental Health
|
47.6 score on a scale
Standard Deviation 17
|
43.6 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: Results available for participants who completed instrument. Missingness is due to missing scores on domains that prevent the total score from being calculated or patients had missing/incomplete questionnaire at baseline.
Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4-point response 0 - 3. Scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more symptoms for anxiety or depression. Change in HADS at Day 180 as compared to baseline.
Outcome measures
| Measure |
Nintedanib
n=47 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=51 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Anxiety
|
-0.87 score on a scale
Interval -1.79 to 0.04
|
-1.74 score on a scale
Interval -2.61 to -0.87
|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Depression
|
-0.57 score on a scale
Interval -1.6 to 0.46
|
-0.75 score on a scale
Interval -1.74 to 0.23
|
SECONDARY outcome
Timeframe: day 90 and 180Population: Results for participants with blood work completed at Day 90. Results for participants with bloodwork completed at Day 180.
Number of participants with Increase in liver transaminases
Outcome measures
| Measure |
Nintedanib
n=47 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=51 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Number of Participants With Increase in Liver Transaminases (AST and ALT) > 3 Times the Upper Limit of Normal
Day 180
|
0 Participants
|
0 Participants
|
|
Number of Participants With Increase in Liver Transaminases (AST and ALT) > 3 Times the Upper Limit of Normal
Day 90
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 180Number of participants with Thrombotic events: venous or arterial thrombosis
Outcome measures
| Measure |
Nintedanib
n=45 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=49 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Number of Participants With Thrombotic Events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 90 and 180Population: Results for participants who returned for Day 90 and Day 180 study visit.
Number of participants with 10% weight loss
Outcome measures
| Measure |
Nintedanib
n=47 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=51 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Number of Participants With 10% Weight Loss at 90 Days and 180 Days
Day 90
|
3 Participants
|
0 Participants
|
|
Number of Participants With 10% Weight Loss at 90 Days and 180 Days
Day 180
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 180Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents
Outcome measures
| Measure |
Nintedanib
n=45 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=49 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Number of Participants With GI Events
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and day 180Population: The 6MWT was included later in the protocol with 77 participants contributing data to the analysis.
The distance covered over a time of 6 minutes at day 180 as compared to baseline.
Outcome measures
| Measure |
Nintedanib
n=36 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=41 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in 6 Minute Walk Test (6MWT)
|
79.98 feet
Interval -7.29 to 167.25
|
42.58 feet
Interval -41.75 to 126.9
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: Data reported for participants who completed instrument for both timepoints.
The FACIT-F is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Questions are scored on a 5-point Likert scale. The total score range is from 0-52, with higher score indicating lower fatigue level. Change in FACIT-F at Day 180 as compared to baseline.
Outcome measures
| Measure |
Nintedanib
n=39 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=44 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F)
|
0.60 score on a scale
Interval -1.91 to 3.11
|
3.03 score on a scale
Interval 0.66 to 5.4
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Intention-to-Treat Analysis Population
Change in Forced Vital Capacity (FVC) at 90 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Outcome measures
| Measure |
Nintedanib
n=51 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=52 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
|
80.97 mL
Interval -2.55 to 164.48
|
62.98 mL
Interval -17.37 to 143.34
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: Assessment for DLCO was included later in the protocol with 72 participants contributing data to the analysis.
Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 180 days as compared to baseline. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) measures the transfer of carbon monoxide from alveolar gas to hemoglobin in pulmonary capillary blood. DLCO is measured by having the patient fully inhale a low concentration of carbon monoxide and an inert tracer gas. The results of a lung diffusion test are given in a percentage of what is the expected DLCO to be (predicted value). Normal DLCO: Between 75% and 140% of the predicted value. Mildly reduced DLCO: 60% to 75% or the lower limit of normal (LLN) predicted value. Severely reduced DLCO: Less than 40% of the predicted value.
Outcome measures
| Measure |
Nintedanib
n=36 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=36 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
|
0.54 % predicted value
Interval -2.65 to 3.73
|
2.12 % predicted value
Interval -1.06 to 5.31
|
SECONDARY outcome
Timeframe: within 90-180 daysPopulation: Intention-to-Treat Analysis Population
Number of deaths within 90 days and 180 days from enrollment due to a any cause
Outcome measures
| Measure |
Nintedanib
n=51 Participants
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=52 Participants
Placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Number of Deaths Due to Any Cause
within 90 days
|
1 Participants
|
0 Participants
|
|
Number of Deaths Due to Any Cause
within 180 days
|
1 Participants
|
0 Participants
|
Adverse Events
Nintedanib
Placebo
Serious adverse events
| Measure |
Nintedanib
n=51 participants at risk
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=52 participants at risk
placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Endocrine Disorders
Hypoglycemia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Eye Disorders
Worsening General weakness, Ptosis, and Diplopia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Gastrointestinal Disorders
Diarrhea
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Hepatobiliary Disorders
Acute Emphysematous Cholecystitis
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Hepatobiliary Disorders
Elevated LFTs
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Hepatobiliary Disorders
Hyperbilirubinemia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Immune System Disorders
Hypersensitivity Reaction
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Infections and Infestations
Pneumonia
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Infections and Infestations
Sepsis
|
2.0%
1/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Infections and Infestations
Viral URI
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Musculoskeletal and Connective Tissue Disorders
Closed Spinal Fracture
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Musculoskeletal and Connective Tissue Disorders
Laminectomy
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Musculoskeletal and Connective Tissue Disorders
Thoracic Compression Fracture
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Renal and Urinary Disorders
Acute Kidney Injury
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Acute Hypoxemic Failure
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Acute on Chronic Respiratory Failure
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Respiratory Failure
|
2.0%
1/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Vascular Disorders
Venous Thrombosis
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
Other adverse events
| Measure |
Nintedanib
n=51 participants at risk
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
Placebo
n=52 participants at risk
placebo equivalent 150mg PO twice a day, taken with food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
|
|---|---|---|
|
Respiratory, Thoracic and Mediastinal Disorders
Shortness of Breath
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Sinus Congestion
|
3.9%
2/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Sleep Apnea
|
3.9%
2/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Epistaxis
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Hemoptysis
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Increased Phlegm
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Nasal Blood-Tinged Secretions
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Nasopharyngitis
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Non-Cardiac Chest Pain
|
3.9%
2/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
PND
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Respiratory Infection
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Tracheal Stenosis
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Upper Respiratory Infection
|
11.8%
6/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Wheezing
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Worsening Shortness of Breath
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Skin and Subcutaneous Tissue Disorders
Atopic Dermatitis
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Skin and Subcutaneous Tissue Disorders
Bruising
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Skin and Subcutaneous Tissue Disorders
Dry Skin
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Skin and Subcutaneous Tissue Disorders
Foot biopsy
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Skin and Subcutaneous Tissue Disorders
Rash
|
3.9%
2/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Blood and Lymphatic System Disorders
Elevated Platelets
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Blood and Lymphatic System Disorders
Leukocytosis
|
2.0%
1/51 • 180 days
|
9.6%
5/52 • 180 days
|
|
Blood and Lymphatic System Disorders
Thrombocytopenia
|
2.0%
1/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Cardiac Disorders
Increased Hypertension
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Ear and Labyrinth Disorders
Dysphonia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Ear and Labyrinth Disorders
Otitis Media
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Endocrine Disorders
Abnormal Calcium
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Endocrine Disorders
Hypercalcemia
|
7.8%
4/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Endocrine Disorders
Hyperglycemia
|
3.9%
2/51 • 180 days
|
5.8%
3/52 • 180 days
|
|
Endocrine Disorders
Hypocalcemia
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Endocrine Disorders
Hypoglycemia
|
2.0%
1/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
Eye Disorders
Right Eye Blurriness
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Abdominal Pain
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Acid Reflux
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Acute Gastroenteritis
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Black Stool
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Blood in Stool
|
0.00%
0/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
Gastrointestinal Disorders
Constipation
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Diarrhea
|
49.0%
25/51 • 180 days
|
19.2%
10/52 • 180 days
|
|
Gastrointestinal Disorders
GERD
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
GI Sympton
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Gastroesophageal Reflux
|
0.00%
0/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
Gastrointestinal Disorders
Gastrointestinal Nonspecific Inflammation
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
H Pylori
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Gastrointestinal Disorders
Intermittent Post-Dose Stomach pain
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Metabolic Alkalosis
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Gastrointestinal Disorders
Nausea
|
23.5%
12/51 • 180 days
|
15.4%
8/52 • 180 days
|
|
Gastrointestinal Disorders
Non-Cardiac Chest Pain
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Gastrointestinal Disorders
Vomiting
|
11.8%
6/51 • 180 days
|
7.7%
4/52 • 180 days
|
|
General Disorders
Decreased Energy
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Decreased Libido
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Dry Mouth
|
3.9%
2/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Fall
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Fatigue
|
3.9%
2/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Incorrect Drug Administration
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Increase Fatigue
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Injection Site Pain
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Insomnia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Interrupted Sleep
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Left Ear Pain
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Post-Prandial Sleepiness
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Sore Throat
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Elevated LFTs
|
17.6%
9/51 • 180 days
|
7.7%
4/52 • 180 days
|
|
General Disorders
Increase in ALT to > 3x ULN
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Abnormal Eosinophil Lab Value
|
2.0%
1/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Hives
|
0.00%
0/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
General Disorders
COVID Infection
|
2.0%
1/51 • 180 days
|
7.7%
4/52 • 180 days
|
|
General Disorders
Fungal Infection of Toes
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Influenza
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Pneumonia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Sinusitis
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Strep Throat Infection
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Urinary Tract Infection
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Viral URI
|
3.9%
2/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Decreased Appetite
|
13.7%
7/51 • 180 days
|
7.7%
4/52 • 180 days
|
|
General Disorders
Decreased Bicarbonate
|
3.9%
2/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Decreased Chloride
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Elevated Chloride
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Failure to Thrive
|
9.8%
5/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
General Disorders
Hypernatremia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Hypokalemia
|
3.9%
2/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
General Disorders
Weight Gain
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Back Pain
|
0.00%
0/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
General Disorders
Bilateral Leg Pain
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Body Pain
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Coccydynia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Flank Pain
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Left Lower Back Musculoskeletal Pain
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Lumbar Back Pain
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Plantar Fascitis
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Rheumatoid Arthritis
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Tenderness of the Knee
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
General Disorders
Vertebral Compression Fractures
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Worsening of Intermittent Leg Pain
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
General Disorders
Worsening of Musculoskeletal Pain
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Squamous Cell Carcinoma
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Nervous System Disorders
Dizziness
|
0.00%
0/51 • 180 days
|
5.8%
3/52 • 180 days
|
|
Nervous System Disorders
Headache
|
7.8%
4/51 • 180 days
|
9.6%
5/52 • 180 days
|
|
Nervous System Disorders
Lightheadedness
|
2.0%
1/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Nervous System Disorders
Possible Meningioma
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Nervous System Disorders
Vertigo
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Psychiatric Disorders
Bad Dreams
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Psychiatric Disorders
Worsening of Depression
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Renal and Urinary Disorders
Acute Kidney Injury
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Renal and Urinary Disorders
Elevated BUN
|
2.0%
1/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Renal and Urinary Disorders
Elevated Creatinine
|
0.00%
0/51 • 180 days
|
5.8%
3/52 • 180 days
|
|
Renal and Urinary Disorders
Elevated Serum Potassium
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Renal and Urinary Disorders
Hematuria
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Renal and Urinary Disorders
Increased Creatinine
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Renal and Urinary Disorders
Low GFR
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Renal and Urinary Disorders
UTI
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Renal and Urinary Disorders
Urinary Frequency
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Bronchitis
|
2.0%
1/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Chest Tightness
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Congestion
|
2.0%
1/51 • 180 days
|
3.8%
2/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Cough
|
27.5%
14/51 • 180 days
|
17.3%
9/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea
|
9.8%
5/51 • 180 days
|
7.7%
4/52 • 180 days
|
|
Respiratory, Thoracic and Mediastinal Disorders
Elevated CO2
|
2.0%
1/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Blood and Lymphatic System Disorders
Elevated Hgb
|
3.9%
2/51 • 180 days
|
0.00%
0/52 • 180 days
|
|
Blood and Lymphatic System Disorders
Abnormal WBC
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
|
Blood and Lymphatic System Disorders
Anemia
|
0.00%
0/51 • 180 days
|
1.9%
1/52 • 180 days
|
Additional Information
Dr. Maria Padilla
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place