Trial Outcomes & Findings for Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF (NCT NCT02579603)
NCT ID: NCT02579603
Last Updated: 2018-02-13
Results Overview
Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12. On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2018-02-13
Participant Flow
Participant milestones
| Measure |
Nintedanib
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
Number of Patients Treated
|
51
|
53
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Nintedanib
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
|---|---|---|
|
Overall Study
Not treated
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Other than stated
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
Baseline characteristics by cohort
| Measure |
Nintedanib
n=51 Participants
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
n=53 Participants
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 Years
STANDARD_DEVIATION 6.8 • n=93 Participants
|
68.9 Years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
68.9 Years
STANDARD_DEVIATION 6.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Treated set : The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment.
Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12. On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive).
Outcome measures
| Measure |
Nintedanib
n=51 Participants
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
n=53 Participants
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
|---|---|---|
|
Percentage of Patients With On-treatment Gastrointestinal (GI) AEs (SOC GI Disorders) From Baseline to Week 12
|
52.9 percentage of participants
|
69.8 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, prior to intake of study medication on week 2 and week 4Population: Pharmacokinetic Set (PKS): This analysis set included all patients who had been treated with study medication and who provided evaluable data for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.
Predose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline (Visit 3), Week 2 (Visit 4) and Week 4 (Visit 5)
Outcome measures
| Measure |
Nintedanib
n=51 Participants
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
n=53 Participants
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
|---|---|---|
|
Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4
baseline
|
7.08 ng/mL
Geometric Coefficient of Variation 56.0
|
7.65 ng/mL
Geometric Coefficient of Variation 72.5
|
|
Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4
Week 2
|
7.25 ng/mL
Geometric Coefficient of Variation 52.7
|
8.17 ng/mL
Geometric Coefficient of Variation 69.8
|
|
Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4
Week 4
|
5.92 ng/mL
Geometric Coefficient of Variation 73.5
|
7.13 ng/mL
Geometric Coefficient of Variation 63.9
|
SECONDARY outcome
Timeframe: Prior to intake of study medication on week 2 and week 4Population: PKS set
Predose plasma concentrations at steady state (Cpre,ss) of pirfenidone at Week 2 (Visit 4) and Week 4 (Visit 5)
Outcome measures
| Measure |
Nintedanib
n=53 Participants
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
|---|---|---|
|
Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone
Week 2
|
1120 ng/mL
Geometric Coefficient of Variation 122
|
—
|
|
Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone
Week 4
|
1220 ng/mL
Geometric Coefficient of Variation 90.7
|
—
|
Adverse Events
Nintedanib
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Nintedanib + Pirfenidone
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib
n=51 participants at risk
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
n=53 participants at risk
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
0.00%
0/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
0.00%
0/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
1.9%
1/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
0.00%
0/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
0.00%
0/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
1.9%
1/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
1.9%
1/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Vascular disorders
Phlebitis
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
0.00%
0/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
Other adverse events
| Measure |
Nintedanib
n=51 participants at risk
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily).
|
Nintedanib + Pirfenidone
n=53 participants at risk
Patients were orally administered Nintedanib 2x150 mg soft gelatine capsule daily (1 capsule of 150 mg twice daily) with the possibility to reduce to 2x100 mg daily (1 capsule of 100 mg twice daily) in combination with pirfenidone. The pirfenidone dose was titrated up to 2403 mg daily according to the following schedule: 801 mg (1 capsule of 267 mg 3 times daily) from Visit 3 until the phone call visit ; 1602 mg daily (2 capsules of each 267 mg 3 times daily) after the phone call visit; 2403 mg daily (3 capsules of each 267 mg 3 times daily) starting at Visit 4 after the PK sampling had been performed.The dose of pirfenidone could have been reduced to 1 or 2 capsule(s) 3 times daily.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
7.5%
4/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
3/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
7.5%
4/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
4/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
13.2%
7/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
31.4%
16/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
37.7%
20/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Nausea
|
11.8%
6/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
41.5%
22/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
6/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
28.3%
15/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
General disorders
Asthenia
|
5.9%
3/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
1.9%
1/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
General disorders
Fatigue
|
11.8%
6/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
18.9%
10/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
General disorders
Pyrexia
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Infections and infestations
Bronchitis
|
3.9%
2/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
9.4%
5/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
2/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
7.5%
4/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
3/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
0.00%
0/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Investigations
Weight decreased
|
5.9%
3/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
7.5%
4/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.8%
5/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
11.3%
6/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Nervous system disorders
Dizziness
|
5.9%
3/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
0.00%
0/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
13.2%
7/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
3/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
7.5%
4/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.7%
8/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
3.8%
2/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/51 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
5.7%
3/53 • From first dose administration of the study medication to 28 days after last drug administration; up to 124 days.
Treated set was used. The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment
|
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