Trial Outcomes & Findings for A Safety, Tolerability and Efficacy Study in Chronic Obstructive Pulmonary Disease (COPD) Patients With QBM076. (NCT NCT01972776)
NCT ID: NCT01972776
Last Updated: 2016-03-24
Results Overview
Adverse events were counted and corresponding percentages were tabulated.
TERMINATED
PHASE2
48 participants
14 days
2016-03-24
Participant Flow
In part 1, participants were randomly assigned to one of two treatment arms in a ratio of 3:1 for each cohort. In part 2, participants were stratified by smoking status (current versus ex-smoker) and randomized in a ratio of 2:1 into one of two treatments.
Participant milestones
| Measure |
QBM076 Part 1 Cohort 1
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
QBM076 Part 2
Participants received QBM076 150 mg bid for 8 weeks.
|
Placebo Part 2
Participants received matching placebo bid for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
6
|
6
|
8
|
7
|
0
|
0
|
|
Part 1
COMPLETED
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
2
|
1
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
14
|
7
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
13
|
7
|
Reasons for withdrawal
| Measure |
QBM076 Part 1 Cohort 1
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
QBM076 Part 2
Participants received QBM076 150 mg bid for 8 weeks.
|
Placebo Part 2
Participants received matching placebo bid for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Part 1
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Part 2
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Part 2
Administrative problems
|
0
|
0
|
0
|
0
|
10
|
7
|
Baseline Characteristics
A Safety, Tolerability and Efficacy Study in Chronic Obstructive Pulmonary Disease (COPD) Patients With QBM076.
Baseline characteristics by cohort
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
n=7 Participants
Participants in each cohort received matching placebo bid for 14 days.
|
QBM076 Part 2
n=14 Participants
Participants received QBM076 150 mg bid for 8 weeks.
|
Placebo Part 2
n=7 Participants
Participants received matching placebo bid for 8 weeks.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
64 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
65 Years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
61 Years
STANDARD_DEVIATION 2.9 • n=4 Participants
|
64 Years
STANDARD_DEVIATION 5.5 • n=21 Participants
|
66 Years
STANDARD_DEVIATION 5.6 • n=8 Participants
|
64 Years
STANDARD_DEVIATION 5.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: All randomized part 1 participants
Adverse events were counted and corresponding percentages were tabulated.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
n=7 Participants
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (Part 1)
|
33 percentage of participants
|
50 percentage of participants
|
63 percentage of participants
|
71 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 1 (from pre-dose to 12 hours post dose)Population: All Part 1 participants who received active treatment.
Venous blood samples were collected for concentration-time profiles.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval, Tau (AUCtau) (Part 1)
|
431 ng*h/mL
Standard Deviation 158
|
2060 ng*h/mL
Standard Deviation 829
|
7640 ng*h/mL
Standard Deviation 6770
|
—
|
SECONDARY outcome
Timeframe: day 14 (from pre-dose to 72 hours post dose)Population: All Part 1 participants who received active treatment.
Venous blood samples were collected for concentration-time profiles.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
AUCtau, Steady State (AUCtau,ss) (Part 1)
|
601 ng*h/mL
Standard Deviation 112
|
2220 ng*h/mL
Standard Deviation 787
|
6660 ng*h/mL
Standard Deviation 4320
|
—
|
SECONDARY outcome
Timeframe: day 1 (from pre-dose to 12 hours post dose)Population: All Part 1 participants who received active treatment.
Venous blood samples were collected for concentration-time profiles.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Observed Maximum Plasma Concentration Following Drug Administration (Cmax) (Part 1)
|
69.5 ng/mL
Standard Deviation 28.8
|
366 ng/mL
Standard Deviation 192
|
1810 ng/mL
Standard Deviation 1790
|
—
|
SECONDARY outcome
Timeframe: day 14 (from pre-dose to 72 hours post dose)Population: All Part 1 participants who received active treatment.
Venous blood samples were collected for concentration-time profiles.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Cmax,ss (Part 1)
|
91.0 ng/mL
Standard Deviation 13.9
|
338 ng/mL
Standard Deviation 123
|
2380 ng/mL
Standard Deviation 2680
|
—
|
SECONDARY outcome
Timeframe: day 1 (from pre-dose to 12 hours post dose)Population: All Part 1 participants who received active treatment.
Venous blood samples were collected for concentration-time profiles.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Time to Reach the Maximum Concentration After Drug Administration (Tmax) (Part 1)
|
3.05 hours
Interval 2.0 to 6.0
|
3.01 hours
Interval 2.0 to 8.0
|
3.04 hours
Interval 2.02 to 10.1
|
—
|
SECONDARY outcome
Timeframe: day 14 (from pre-dose to 72 hours post dose)Population: All Part 1 participants who received active treatment.
Venous blood samples were collected for concentration-time profiles.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=8 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Tmax,ss (Part 1)
|
2.00 hours
Interval 2.0 to 4.0
|
2.00 hours
Interval 2.0 to 6.02
|
2.05 hours
Interval 0.5 to 6.02
|
—
|
SECONDARY outcome
Timeframe: baseline, day 14Population: All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.
Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CD11b expression on neutrophils. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=6 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
n=5 Participants
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Change From Baseline in Cluster of Differentiation 11b (CD11b) (Part 1)
|
-69 percentage change
|
-89 percentage change
|
-75 percentage change
|
-37 percentage change
|
SECONDARY outcome
Timeframe: baseline, day 14Population: All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.
Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CXCR2 receptor occupancy on neutrophils. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=6 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
n=6 Participants
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Change From Baseline in Chemokine (C-X-C Motif) Receptor 2 (CXCR2) Receptor Occupancy (Part 1)
|
98 percent change
|
104 percent change
|
129 percent change
|
37 percent change
|
SECONDARY outcome
Timeframe: baseline, day 14 pre-dosePopulation: All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.
FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry and performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=6 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
n=6 Participants
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Part 1)
|
-0.116 mL
Standard Error 0.05
|
-0.008 mL
Standard Error 0.05
|
0.117 mL
Standard Error 0.05
|
0.039 mL
Standard Error 0.05
|
SECONDARY outcome
Timeframe: baseline, day 14 pre-dosePopulation: All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.
Lung clearance index (LCI) is a measure of abnormal ventilation distribution derived from the multiple breath inert gas washout (MBW) technique. LCI is equal to the cumulative expired volume/functional residual capacity. LCI was measured at baseline and day 14. LCI was analyzed using a Bayesian model for repeated measurements. The model may investigate effects for pre-dose baseline, treatment, time, age, COPD class, treatment by time interaction, and baseline by time interaction. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
QBM076 Part 1 Cohort 1
n=6 Participants
Participants received QBM076 25 mg bid for 14 days.
|
QBM076 Part 1 Cohort 2
n=6 Participants
Participants received QBM076 75 mg bid for 14 days.
|
QBM076 Part 1 Cohort 3
n=6 Participants
Participants received QBM076 150 mg bid for 14 days.
|
Placebo Part 1
n=6 Participants
Participants in each cohort received matching placebo bid for 14 days.
|
|---|---|---|---|---|
|
Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) (Part 1)
|
1.145 index score
Standard Error 0.42
|
0.136 index score
Standard Error 0.42
|
0.660 index score
Standard Error 0.42
|
0.063 index score
Standard Error 0.42
|
SECONDARY outcome
Timeframe: baseline, day 56Population: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 1, day 56Population: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 1, day 56Population: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 1, day 56Population: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day 56Population: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day 56Population: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day 56Population: Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: QBM076 B.I.D 25 mg
Part 1: QBM076 B.I.D 75 mg
Part 1: QBM076 B.I.D 150 mg
Part 1: Placebo
Part 2: QBM076 B.I.D 150 mg
Part 2:QBM076 B.I.D Placebo
Serious adverse events
| Measure |
Part 1: QBM076 B.I.D 25 mg
n=6 participants at risk
Part 1: QBM076 B.I.D 25 mg
|
Part 1: QBM076 B.I.D 75 mg
n=6 participants at risk
Part 1: QBM076 B.I.D 75 mg
|
Part 1: QBM076 B.I.D 150 mg
n=8 participants at risk
Part 1: QBM076 B.I.D 150 mg
|
Part 1: Placebo
n=7 participants at risk
Part 1: Placebo
|
Part 2: QBM076 B.I.D 150 mg
n=14 participants at risk
Part 2: QBM076 B.I.D 150 mg
|
Part 2:QBM076 B.I.D Placebo
n=7 participants at risk
Part 2:QBM076 B.I.D Placebo
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
14.3%
2/14
|
0.00%
0/7
|
Other adverse events
| Measure |
Part 1: QBM076 B.I.D 25 mg
n=6 participants at risk
Part 1: QBM076 B.I.D 25 mg
|
Part 1: QBM076 B.I.D 75 mg
n=6 participants at risk
Part 1: QBM076 B.I.D 75 mg
|
Part 1: QBM076 B.I.D 150 mg
n=8 participants at risk
Part 1: QBM076 B.I.D 150 mg
|
Part 1: Placebo
n=7 participants at risk
Part 1: Placebo
|
Part 2: QBM076 B.I.D 150 mg
n=14 participants at risk
Part 2: QBM076 B.I.D 150 mg
|
Part 2:QBM076 B.I.D Placebo
n=7 participants at risk
Part 2:QBM076 B.I.D Placebo
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/14
|
14.3%
1/7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
14.3%
1/7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
14.3%
1/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
14.3%
1/7
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
|
General disorders
Catheter site eczema
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/14
|
0.00%
0/7
|
|
General disorders
Catheter site erythema
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
2/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
General disorders
Therapeutic response unexpected
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
7.1%
1/14
|
14.3%
1/7
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
14.3%
2/14
|
14.3%
1/7
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
14.3%
2/14
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
33.3%
2/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
7.1%
1/14
|
14.3%
1/7
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Vascular disorders
Hot flush
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/7
|
7.1%
1/14
|
14.3%
1/7
|
Additional Information
Study Director
Novartis
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER