Trial Outcomes & Findings for Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients (NCT NCT01746095)
NCT ID: NCT01746095
Last Updated: 2020-01-13
Results Overview
Change from Baseline at Day 29 of the dosing period (start of AeroVanc/Placebo administration is considered Day 1 of the dosing period) in the number of MRSA colony forming units (CFU) in sputum culture.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Day 29 of treatment period
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
AeroVanc 32 mg
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
Placebo inhalation powder BID
|
AeroVanc 64 mg
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
24
|
23
|
|
Overall Study
COMPLETED
|
16
|
16
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients
Baseline characteristics by cohort
| Measure |
AeroVanc 32 mg
n=20 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=20 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=24 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=23 Participants
Placebo inhalation powder BID
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
24 participants
n=5 Participants
|
23 participants
n=4 Participants
|
87 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 29 of treatment periodPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Change from Baseline at Day 29 of the dosing period (start of AeroVanc/Placebo administration is considered Day 1 of the dosing period) in the number of MRSA colony forming units (CFU) in sputum culture.
Outcome measures
| Measure |
AeroVanc 32 mg
n=17 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=17 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=15 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=22 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in MRSA Sputum Density.
|
-0.25 Log10 CFU/mL
Standard Error 0.181
|
-0.30 Log10 CFU/mL
Standard Error 0.182
|
-0.63 Log10 CFU/mL
Standard Error 0.232
|
0.16 Log10 CFU/mL
Standard Error 0.201
|
SECONDARY outcome
Timeframe: Day 8 of treatment periodPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Outcome measures
| Measure |
AeroVanc 32 mg
n=20 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=17 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=24 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=22 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in MRSA Sputum Density.
|
-0.27 Log10 CFU/mL
Standard Error 0.208
|
-0.28 Log10 CFU/mL
Standard Error 0.223
|
-1.04 Log10 CFU/mL
Standard Error 0.193
|
0.08 Log10 CFU/mL
Standard Error 0.200
|
SECONDARY outcome
Timeframe: Day 15 of treatment periodPopulation: Modified ITT (MITT) population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Outcome measures
| Measure |
AeroVanc 32 mg
n=19 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=16 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=19 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=22 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in MRSA Sputum Density.
|
-0.55 Log10 CFU/mL
Standard Error 0.259
|
0.09 Log10 CFU/mL
Standard Error 0.279
|
-1.14 Log10 CFU/mL
Standard Error 0.229
|
0.26 Log10 CFU/mL
Standard Error 0.216
|
SECONDARY outcome
Timeframe: Day 29 of treatment periodPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Absolute change from baseline in FEV1 percent predicted
Outcome measures
| Measure |
AeroVanc 32 mg
n=18 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=17 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=16 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=21 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in FEV1
|
0.53 percentage of predicted FEV1
Standard Error 1.343
|
1.15 percentage of predicted FEV1
Standard Error 1.356
|
-0.68 percentage of predicted FEV1
Standard Error 1.1449
|
-2.61 percentage of predicted FEV1
Standard Error 1.314
|
SECONDARY outcome
Timeframe: Day 29 of treatment periodPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Absolute change from baseline in FVC percent predicted
Outcome measures
| Measure |
AeroVanc 32 mg
n=18 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=17 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=16 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=21 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in FVC
|
-0.07 percentage of predicted FVC
Standard Error 1.273
|
1.67 percentage of predicted FVC
Standard Error 1.283
|
-0.47 percentage of predicted FVC
Standard Error 1.594
|
-2.48 percentage of predicted FVC
Standard Error 1.423
|
SECONDARY outcome
Timeframe: Day 29 of treatment periodPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD) Chronic Respiratory Infection Symptom Scores (CRISS). The minimum score is 0 and the maximum is 100, where a higher score means a worse outcome.
Outcome measures
| Measure |
AeroVanc 32 mg
n=17 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=17 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=17 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=21 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD-CRISS) Scores
|
-6.59 score on a scale
Standard Error 2.620
|
-3.02 score on a scale
Standard Error 2.614
|
-0.55 score on a scale
Standard Error 2.701
|
-5.43 score on a scale
Standard Error 2.552
|
SECONDARY outcome
Timeframe: Entire study: Day 1 of treatment period through 8 week post-treatment follow up visitPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Outcome measures
| Measure |
AeroVanc 32 mg
n=20 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=20 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=24 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=23 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Time From Start of Dosing to First Administration of Other Antimicrobial Medications (Oral, Intravenous and/or Inhaled) Due to Respiratory Symptoms.
|
69.5 days
Interval 34.0 to 107.0
|
80.0 days
Interval 23.0 to
95% CI not calculable because 50% of patients were censored at time of study completion.
|
48.0 days
Interval 14.0 to 66.0
|
NA days
Interval 43.0 to
Median and 95% CI not calculable because more than 50% of patients were censored at time of study completion.
|
SECONDARY outcome
Timeframe: Entire study: Day 1 of treatment period through 8 week post-treatment follow up visitPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Outcome measures
| Measure |
AeroVanc 32 mg
n=20 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=20 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=24 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=23 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Time From Start of Dosing to Exacerbation of Signs/Symptoms (Fuchs Criteria).
|
107.0 days
Interval 13.0 to 107.0
|
NA days
Interval 13.0 to
Median and 95% CI not calculable because more than 50% of patients were censored at time of study completion.
|
49.0 days
Interval 14.0 to 84.0
|
NA days
Interval 37.0 to
Median and 95% CI not calculable because more than 50% of patients were censored at time of study completion.
|
SECONDARY outcome
Timeframe: Day 29 of the dosing periodPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Outcome measures
| Measure |
AeroVanc 32 mg
n=17 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=17 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=15 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=22 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in High Sensitivity CRP
|
-0.34 mg/dL
Standard Error 0.132
|
-0.18 mg/dL
Standard Error 0.130
|
0.15 mg/dL
Standard Error 0.223
|
-0.09 mg/dL
Standard Error 0.184
|
SECONDARY outcome
Timeframe: Day 29 of the dosing periodPopulation: Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.
Outcome measures
| Measure |
AeroVanc 32 mg
n=17 Participants
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=17 Participants
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=16 Participants
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=21 Participants
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Change From Baseline in Blood Neutrophils
|
0.20 10^9 cells/L
Standard Error 0.569
|
1.23 10^9 cells/L
Standard Error 0.561
|
-0.29 10^9 cells/L
Standard Error 0.557
|
0.04 10^9 cells/L
Standard Error 0.487
|
Adverse Events
AeroVanc 32 mg
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo to 32 mg
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
AeroVanc 64 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo to 64 mg
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AeroVanc 32 mg
n=20 participants at risk
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=20 participants at risk
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=24 participants at risk
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=23 participants at risk
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
15.0%
3/20 • Number of events 3
|
10.0%
2/20 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
Other adverse events
| Measure |
AeroVanc 32 mg
n=20 participants at risk
Vancomycin hydrochloride inhalation powder 32 mg BID
|
Placebo to 32 mg
n=20 participants at risk
Placebo inhalation powder BID
|
AeroVanc 64 mg
n=24 participants at risk
Vancomycin hydrochloride inhalation powder 64 mg BID
|
Placebo to 64 mg
n=23 participants at risk
Placebo inhalation powder BID
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.0%
9/20 • Number of events 14
|
35.0%
7/20 • Number of events 12
|
37.5%
9/24 • Number of events 11
|
43.5%
10/23 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
40.0%
8/20 • Number of events 10
|
20.0%
4/20 • Number of events 5
|
29.2%
7/24 • Number of events 7
|
30.4%
7/23 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
30.0%
6/20 • Number of events 6
|
35.0%
7/20 • Number of events 7
|
25.0%
6/24 • Number of events 6
|
21.7%
5/23 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
4/20 • Number of events 4
|
10.0%
2/20 • Number of events 2
|
20.8%
5/24 • Number of events 6
|
13.0%
3/23 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
30.0%
6/20 • Number of events 7
|
15.0%
3/20 • Number of events 3
|
16.7%
4/24 • Number of events 4
|
4.3%
1/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
5.0%
1/20 • Number of events 1
|
15.0%
3/20 • Number of events 3
|
12.5%
3/24 • Number of events 4
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.0%
3/20 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
4.2%
1/24 • Number of events 1
|
17.4%
4/23 • Number of events 4
|
|
General disorders
Fatigue
|
25.0%
5/20 • Number of events 6
|
20.0%
4/20 • Number of events 6
|
33.3%
8/24 • Number of events 8
|
13.0%
3/23 • Number of events 3
|
|
General disorders
Exercise tolerance decreased
|
25.0%
5/20 • Number of events 5
|
5.0%
1/20 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Chest discomfort
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
16.7%
4/24 • Number of events 4
|
0.00%
0/23
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
15.0%
3/20 • Number of events 3
|
25.0%
5/20 • Number of events 5
|
20.8%
5/24 • Number of events 5
|
8.7%
2/23 • Number of events 2
|
|
Investigations
Forced expiratory volume decreased
|
20.0%
4/20 • Number of events 4
|
10.0%
2/20 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Weight decreased
|
20.0%
4/20 • Number of events 6
|
5.0%
1/20 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
20.0%
4/20 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
8.3%
2/24 • Number of events 3
|
13.0%
3/23 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
17.4%
4/23 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20
|
0.00%
0/20
|
12.5%
3/24 • Number of events 3
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/20
|
0.00%
0/20
|
8.3%
2/24 • Number of events 2
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Malaise
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Product taste abnormal
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Blood potassium increased
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Peak expiratory flow rate decreased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/24
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
0.00%
0/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place