Trial Outcomes & Findings for Effect of BIBW 2948 BS in COPD (NCT NCT00423137)
NCT ID: NCT00423137
Last Updated: 2021-11-19
Results Overview
Change from baseline in volume of mucin per surface area of basal lamina. Volume of mucin per surface area of basal lamina (vs mu,bala) was determined by stereologic quantification of Periodic Acid Schiff's (AB/PAS) reagent staining in endobronchial biopsies at visit 2 (baseline) and at the end of the 4-week period of randomized treatment (visit 5).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
At baseline (visit 2) and at visit 5.
Results posted on
2021-11-19
Participant Flow
A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of a 4-week treatment of 15 and 30 mg two times daily (b.i.d) BIBW2948 BS on epithelial mucin stores and the safety and efficacy in Chronic Obstructive Pulmonary (COPD) patients with symptoms associated with chronic bronchitis
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participant milestones
| Measure |
Placebo 15 Milligram b.i.d
Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Placebo 30 Milligram b.i.d
Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 15 Milligram b.i.d
Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 30 Milligram b.i.d
Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
13
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
6
|
2
|
Reasons for withdrawal
| Measure |
Placebo 15 Milligram b.i.d
Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Placebo 30 Milligram b.i.d
Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 15 Milligram b.i.d
Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 30 Milligram b.i.d
Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event Study disease worse
|
1
|
0
|
3
|
1
|
|
Overall Study
Adverse Event Other
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Effect of BIBW 2948 BS in COPD
Baseline characteristics by cohort
| Measure |
Placebo 15 Milligram b.i.d
n=11 Participants
Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Placebo 30 Milligram b.i.d
n=12 Participants
Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 15 Milligram b.i.d
n=13 Participants
Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 30 Milligram b.i.d
n=12 Participants
Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.5 Years
STANDARD_DEVIATION 7.30 • n=5 Participants
|
56.4 Years
STANDARD_DEVIATION 7.00 • n=7 Participants
|
54.0 Years
STANDARD_DEVIATION 7.99 • n=5 Participants
|
59.0 Years
STANDARD_DEVIATION 7.83 • n=4 Participants
|
56.2 Years
STANDARD_DEVIATION 7.54 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in volume of mucin per surface area of basal lamina. Volume of mucin per surface area of basal lamina (vs mu,bala) was determined by stereologic quantification of Periodic Acid Schiff's (AB/PAS) reagent staining in endobronchial biopsies at visit 2 (baseline) and at the end of the 4-week period of randomized treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=23 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=25 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina
|
2.565 micrometer^3/micrometer^2
Standard Error 1.836
|
1.180 micrometer^3/micrometer^2
Standard Error 1.676
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline of volume of mucin per volume of epithelium (Vv mu, ep) in endobronchial biopsies. The volume of mucin per volume of epithelium (Vv mu, ep), as measured by stereological quantification of AB/PAS staining in endobronchial biopsies was performed at baseline (visit 2) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=22 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=14 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline of Volume of Mucin Per Volume of Epithelium (Vv mu, ep) in Endobronchial Biopsies
|
0.013 millimeter^3/millimeter^3
Standard Error 0.028
|
-0.036 millimeter^3/millimeter^3
Standard Error 0.026
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in bronchoalveolar lavage (BAL) cell differential (in %). Differential cell counts were performed on bronchoalveolar lavage samples obtained during visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=20 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=11 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Eosinophil [%]
|
0.46 Percentage of cells
Interval -0.22 to 1.14
|
2.03 Percentage of cells
Interval 0.48 to 3.58
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Epithelial [%]
|
-3.22 Percentage of cells
Interval -10.33 to 3.89
|
-0.71 Percentage of cells
Interval -4.7 to 3.28
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Lymphocyte [%]
|
-0.15 Percentage of cells
Interval -0.45 to 0.15
|
-0.42 Percentage of cells
Interval -2.14 to 1.3
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Macrophage [%]
|
2.48 Percentage of cells
Interval -5.38 to 10.34
|
-8.68 Percentage of cells
Interval -26.57 to 9.21
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Neutrophil [%]
|
0.15 Percentage of cells
Interval -0.92 to 1.22
|
7.47 Percentage of cells
Interval -7.5 to 22.44
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
Squamous [%]
|
0.31 Percentage of cells
Interval -0.32 to 0.94
|
0.40 Percentage of cells
Interval -0.54 to 1.34
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in bronchoalveolar lavage (BAL) cell count. Total cell counts were performed on bronchoalveolar lavage (BAL) samples obtained during visit 2 (baseline) and at the end of the 4-week period of randomised treatment.
Outcome measures
| Measure |
Placebo Total
n=20 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=11 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Eosinophil
|
0.001 Cells per milliliter
Interval -0.001 to 0.003
|
0.005 Cells per milliliter
Interval 0.0 to 0.01
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Epithelial
|
-0.001 Cells per milliliter
Interval -0.008 to 0.006
|
-0.007 Cells per milliliter
Interval -0.026 to 0.012
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Lymphocyte
|
-0.001 Cells per milliliter
Interval -0.002 to 0.001
|
0.001 Cells per milliliter
Interval -0.004 to 0.005
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Macrophage
|
0.016 Cells per milliliter
Interval -0.188 to 0.22
|
-0.206 Cells per milliliter
Interval -0.446 to 0.034
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Neutrophil
|
-0.001 Cells per milliliter
Interval -0.005 to 0.003
|
0.004 Cells per milliliter
Interval -0.021 to 0.028
|
|
Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
Squamous
|
0.000 Cells per milliliter
Interval 0.0 to 0.001
|
0.000 Cells per milliliter
Interval -0.001 to 0.002
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in log MUC2 Mucin gene expression (RNA) obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC2) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=20 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=12 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Log MUC2 Mucin Gene Expression (RNA) Obtained in Epithelial Brushings
|
0.076 Log (fold change)
Standard Error 0.343
|
0.411 Log (fold change)
Standard Error 0.325
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in log mucin gene (MUC5AC) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC5AC) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=20 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=12 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Log Mucin Gene (MUC5AC) Expression Level Obtained in Epithelial Brushings
|
0.074 Log (fold change)
Standard Error 0.275
|
-0.067 Log (fold change)
Standard Error 0.247
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in log mucin gene (MUC5B) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC5B) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=20 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=12 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Log Mucin Gene (MUC5B) Expression Level Obtained in Epithelial Brushings
|
-0.377 Log (fold change)
Standard Error 0.309
|
0.194 Log (fold change)
Standard Error 0.296
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in log mucin gene (MUC8) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC8) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=20 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=12 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Log Mucin Gene (MUC8) Expression Level Obtained in Epithelial Brushings
|
0.639 Log (fold change)
Standard Error 0.961
|
1.720 Log (fold change)
Standard Error 0.865
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change in percentage of cells with bright spots with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).
Outcome measures
| Measure |
Placebo Total
n=16 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=9 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - Cells With Bright Spots With Marker
|
103.122 Percentage of baseline level
Standard Error 9.889
|
51.039 Percentage of baseline level
Standard Error 13.19
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change in number of EGRF spots at nucleus. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).
Outcome measures
| Measure |
Placebo Total
n=16 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=9 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - EGRF Spots at Nucleus
|
112.955 Percentage of baseline level
Standard Error 13.15
|
45.943 Percentage of baseline level
Standard Error 17.53
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change in number of EGRF spots with marker per cell. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).
Outcome measures
| Measure |
Placebo Total
n=16 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=9 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGRF Spots With Marker
|
106.671 Percentage of baseline level
Standard Error 11.05
|
44.100 Percentage of baseline level
Standard Error 14.74
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change in total area bright spots with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).
Outcome measures
| Measure |
Placebo Total
n=16 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=9 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - Total Area Bright Spots With Marker
|
95.397 Percentage of baseline level
Standard Error 11.28
|
55.330 Percentage of baseline level
Standard Error 15.04
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change in number of EGFR spots per cell. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in % control as (visit5/visit2\*100).
Outcome measures
| Measure |
Placebo Total
n=16 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=9 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots
|
117.074 Percentage of baseline level
Standard Error 12.78
|
59.614 Percentage of baseline level
Standard Error 17.04
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change in number of EGFR spots at nucleus per cell with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in % control as (visit5/visit2\*100).
Outcome measures
| Measure |
Placebo Total
n=16 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=9 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots at Nucleus With Marker
|
110.045 Percentage of baseline level
Standard Error 10.27
|
54.713 Percentage of baseline level
Standard Error 13.69
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in number of goblet cells per surface area of basel lamina, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=21 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=11 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Number of Goblet Cells Per Surface Area of Basel Lamina
|
0.001 cells/micrometer^2
Standard Error 0.0008
|
0.001 cells/micrometer^2
Standard Error 0.0008
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in number of goblet cells per volume of epithelium, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=21 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=11 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Number of Goblet Cells Per Volume of Epithelium
|
14332.8 Cells/micrometer^3
Standard Error 12812
|
879.408 Cells/micrometer^3
Standard Error 12583
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in goblet cell volume, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=21 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=11 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Goblet Cell Volume
|
-607.26 micrometer^3
Standard Error 239.71
|
-685.87 micrometer^3
Standard Error 236.65
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline of Interleukin-8 (IL-8) levels in bronchoalveolar lavage. IL-8 levels, were measured by enzyme linked immunosorbent assay in bronchoalveolar lavage samples at visit 2 (baseline) and at the end of the 4-week period of treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=21 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=12 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline of Interleukin-8 (IL-8) Levels in Bronchoalveolar Lavage
|
-0.069 nanogram per milliliter
Standard Error 0.070
|
0.126 nanogram per milliliter
Standard Error 0.077
|
SECONDARY outcome
Timeframe: At baseline (visit 2) and at visit 5.Population: The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.
Change from baseline in Myeloperoxidase (MPO) levels in bronchoalveolar lavage. Myeloperoxidase (MPO) activity levels were measured by enzyme linked immunosorbent or radioimmunoassay assay in bronchoalveolar lavage samples at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).
Outcome measures
| Measure |
Placebo Total
n=21 Participants
All patients on placebo treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=12 Participants
All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
|---|---|---|
|
Change From Baseline in Myeloperoxidase (MPO) Levels in Bronchoalveolar Lavage
|
-0.003 microgram per deciliter
Standard Error 0.003
|
0.005 microgram per deciliter
Standard Error 0.003
|
Adverse Events
Placebo 15 Milligram b.i.d
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo 30 Milligram b.i.d
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Total
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
BIBW2948 15 Milligram b.i.d
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
BIBW2948 30 Milligram b.i.d
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
BIBW2948 Total
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Total
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo 15 Milligram b.i.d
n=11 participants at risk
Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Placebo 30 Milligram b.i.d
n=12 participants at risk
Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Placebo Total
n=23 participants at risk
All patients on Placebo Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d).
|
BIBW2948 15 Milligram b.i.d
n=13 participants at risk
Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 30 Milligram b.i.d
n=12 participants at risk
Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=25 participants at risk
All patients on BIBW2948 Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d).
|
Total
n=48 participants at risk
All patients in the study combined. (Placebo + BIBW2948)
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
Other adverse events
| Measure |
Placebo 15 Milligram b.i.d
n=11 participants at risk
Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Placebo 30 Milligram b.i.d
n=12 participants at risk
Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
Placebo Total
n=23 participants at risk
All patients on Placebo Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d).
|
BIBW2948 15 Milligram b.i.d
n=13 participants at risk
Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 30 Milligram b.i.d
n=12 participants at risk
Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.
|
BIBW2948 Total
n=25 participants at risk
All patients on BIBW2948 Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d).
|
Total
n=48 participants at risk
All patients in the study combined. (Placebo + BIBW2948)
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bundle branch block right
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Ear and labyrinth disorders
Tinnitus
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.2%
2/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
General disorders
Chest pain
|
18.2%
2/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
13.0%
3/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
6.2%
3/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
General disorders
Chills
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
General disorders
Influenza like illness
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
General disorders
Oedema peripheral
|
18.2%
2/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.7%
2/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.2%
2/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
General disorders
Pyrexia
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
15.4%
2/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
12.0%
3/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
4/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Infections and infestations
Hordeolum
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Infections and infestations
Nasopharyngitis
|
18.2%
2/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.7%
2/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
15.4%
2/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.0%
2/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
4/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
15.4%
2/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.0%
2/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.2%
2/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.2%
2/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
25.0%
3/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
13.0%
3/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
15.4%
2/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
16.7%
2/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
16.0%
4/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
14.6%
7/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Renal and urinary disorders
Renal colic
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.0%
2/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.2%
2/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
33.3%
4/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
26.1%
6/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
30.8%
4/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
16.7%
2/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
24.0%
6/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
25.0%
12/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
16.7%
2/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
13.0%
3/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.0%
2/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
10.4%
5/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
18.2%
2/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.7%
2/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
23.1%
3/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
12.0%
3/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
10.4%
5/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.2%
2/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
9.1%
1/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.2%
2/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
16.7%
2/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
17.4%
4/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
4/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
7.7%
1/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.3%
1/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/23 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
0.00%
0/13 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
8.3%
1/12 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
4.0%
1/25 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
2.1%
1/48 • From first drug intake until last drug intake + 14 days, up to 4 weeks + 14 days.
The treated set (TS), included all treated patients.
|
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