Trial Outcomes & Findings for Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection (NCT NCT01059565)
NCT ID: NCT01059565
Last Updated: 2014-03-11
Results Overview
The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2014-03-11
Participant Flow
Participants were enrolled at 34 sites in the United States and 1 site in Canada. The first participant was screened on 22 February 2010. The last participant observation was on 28 December 2010.
102 participants were screened and 101 were randomized. Of those participants randomized, 100 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
Participant milestones
| Measure |
AZLI
Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase.
|
Placebo
Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase.
|
|---|---|---|
|
24-Week Randomized Phase
STARTED
|
49
|
52
|
|
24-Week Randomized Phase
Randomized and Treated
|
48
|
52
|
|
24-Week Randomized Phase
COMPLETED
|
39
|
45
|
|
24-Week Randomized Phase
NOT COMPLETED
|
10
|
7
|
|
24-Week Open-Label Phase
STARTED
|
39
|
45
|
|
24-Week Open-Label Phase
COMPLETED
|
34
|
42
|
|
24-Week Open-Label Phase
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
AZLI
Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase.
|
Placebo
Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase.
|
|---|---|---|
|
24-Week Randomized Phase
Randomized but not treated
|
1
|
0
|
|
24-Week Randomized Phase
Adverse Event
|
5
|
0
|
|
24-Week Randomized Phase
Withdrawal by Subject
|
3
|
1
|
|
24-Week Randomized Phase
Lost to Follow-up
|
0
|
1
|
|
24-Week Randomized Phase
Noncompliance with Study Drug Regimen
|
1
|
5
|
|
24-Week Open-Label Phase
Adverse Event
|
2
|
0
|
|
24-Week Open-Label Phase
Worsening health (physician decision)
|
1
|
1
|
|
24-Week Open-Label Phase
Withdrawal by Subject
|
1
|
0
|
|
24-Week Open-Label Phase
Subject noncompliance
|
1
|
0
|
|
24-Week Open-Label Phase
Unable to clean device (hospitalization)
|
0
|
1
|
|
24-Week Open-Label Phase
Pulmonologist/participant decision
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection
Baseline characteristics by cohort
| Measure |
AZLI
n=48 Participants
Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
24.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Age, Customized
≥ 6 to ≤ 12 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
> 12 to < 18 years
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Age, Customized
≥ 18 years
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
46 participants
n=5 Participants
|
50 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
49 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Forced expiratory volume in 1 second (FEV1) percent predicted
|
60.67 percentage of FEV1 % predicted
STANDARD_DEVIATION 21.71 • n=5 Participants
|
52.59 percentage of FEV1 % predicted
STANDARD_DEVIATION 23.71 • n=7 Participants
|
56.47 percentage of FEV1 % predicted
STANDARD_DEVIATION 23.02 • n=5 Participants
|
|
FEV1
|
2.13 liters
STANDARD_DEVIATION 0.93 • n=5 Participants
|
1.93 liters
STANDARD_DEVIATION 0.96 • n=7 Participants
|
2.02 liters
STANDARD_DEVIATION 0.95 • n=5 Participants
|
|
Forced vital capacity (FVC)
|
3.23 liters
STANDARD_DEVIATION 1.18 • n=5 Participants
|
2.99 liters
STANDARD_DEVIATION 1.14 • n=7 Participants
|
3.11 liters
STANDARD_DEVIATION 1.16 • n=5 Participants
|
|
Forced expiratory flow 25% to 75% (FEF25-75)
|
1.33 liters per second
STANDARD_DEVIATION 0.95 • n=5 Participants
|
1.31 liters per second
STANDARD_DEVIATION 1.22 • n=7 Participants
|
1.32 liters per second
STANDARD_DEVIATION 1.09 • n=5 Participants
|
|
Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score
|
58.3 units on a scale
STANDARD_DEVIATION 21.4 • n=5 Participants
|
59.0 units on a scale
STANDARD_DEVIATION 17.6 • n=7 Participants
|
58.6 units on a scale
STANDARD_DEVIATION 19.4 • n=5 Participants
|
|
Body Mass Index (BMI)
|
21.9 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
20.7 kg/m^2
STANDARD_DEVIATION 3.2 • n=7 Participants
|
21.3 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Burkholderia spp colony-forming units (CFU) in sputum
|
6.39 log_10 CFU per gram
STANDARD_DEVIATION 2.47 • n=5 Participants
|
6.41 log_10 CFU per gram
STANDARD_DEVIATION 2.52 • n=7 Participants
|
6.40 log_10 CFU per gram
STANDARD_DEVIATION 2.48 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24.
Outcome measures
| Measure |
AZLI
n=48 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24
|
0.16 percent change in FEV1% predicted
Standard Error 1.50
|
-0.75 percent change in FEV1% predicted
Standard Error 1.43
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
The total number of systemic and/or inhaled antibiotic courses for respiratory events from baseline to Week 24 was analyzed. A single antibiotic course may represent the use of multiple antibiotics.
Outcome measures
| Measure |
AZLI
n=48 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events
|
54 antibiotic treatment courses
|
73 antibiotic treatment courses
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The change (AUCave) in CFQ-R RSS scores from baseline to Week 24 was analyzed. The range of scores (units) within the RSS domain is 0 to 100 with higher scores indicating fewer symptoms.
Outcome measures
| Measure |
AZLI
n=45 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of Change in CFQ-R RSS Scores From Baseline to Week 24
|
2.97 units on a scale
Standard Error 1.70
|
2.79 units on a scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The relative change (AUCave) from baseline to Week 24 in mean (SE) FEV1 was analyzed. FEV1 is defined as the maximal volume of air that can be exhaled in 1 second.
Outcome measures
| Measure |
AZLI
n=47 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of Relative Change From Baseline to Week 24 in FEV1
|
0.36 percent change in FEV1 (liters)
Standard Error 1.49
|
-0.41 percent change in FEV1 (liters)
Standard Error 1.42
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The relative change (AUCave) from baseline to Week 24 in mean (SE) FVC was analyzed. FVC is defined as the volume of air that can forcibly be blown out after taking a full breath.
Outcome measures
| Measure |
AZLI
n=47 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of Relative Change From Baseline to Week 24 in FVC
|
0.77 percent change in FVC (liters)
Standard Error 1.42
|
0.17 percent change in FVC (liters)
Standard Error 1.35
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The relative change (AUCave) from baseline to Week 24 in mean (SE) FEF25-75 was analyzed. FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC.
Outcome measures
| Measure |
AZLI
n=47 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of Relative Change From Baseline to Week 24 in FEF25-75
|
1.40 percent change in FEF25-75 (liters/sec)
Standard Error 2.37
|
-0.55 percent change in FEF25-75 (liters/sec)
Standard Error 2.25
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The change (AUCave) from baseline to Week 24 in the physical functioning score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R physical functioning domain is 0 to 100 with higher scores indicating better QOL.
Outcome measures
| Measure |
AZLI
n=46 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of the Change From Baseline to Week 24 in Physical Functioning Score as Assessed by the CFQ-R
|
1.06 units on a scale
Standard Error 1.57
|
-1.93 units on a scale
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The change (AUCave) from baseline to Week 24 in the weight score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R weight domain is 0 to 100 with higher scores indicating better QOL.
Outcome measures
| Measure |
AZLI
n=44 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=47 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of the Change From Baseline to Week 24 in Weight Score as Assessed by the CFQ-R
|
0.54 units on a scale
Standard Error 2.90
|
3.11 units on a scale
Standard Error 2.80
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The change (AUCave) from baseline to Week 24 in the treatment burden score as assessed by the CFQ-R was analyzed. The range of scores (units) in the CFQ-R treatment burden domain is 0 to 100 with higher scores indicating better QOL.
Outcome measures
| Measure |
AZLI
n=46 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
AUCave of the Change From Baseline to Week 24 in Treatment Burden Score as Assessed by the CFQ-R
|
-2.73 units on a scale
Standard Error 1.73
|
-6.35 units on a scale
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The change in BMI from baseline to Week 24 was analyzed.
Outcome measures
| Measure |
AZLI
n=39 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=45 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
Change in BMI From Baseline to Week 24
|
0.34 kg/m^2
Standard Error 0.16
|
0.21 kg/m^2
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available change data were analyzed.
The change in Burkholderia spp. CFU in sputum from baseline to Week 24 was analyzed.
Outcome measures
| Measure |
AZLI
n=15 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=20 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
Change in Burkholderia Spp. CFU in Sputum From Baseline to Week 24
|
1.41 log_10 CFU per gram of sputum
Standard Error 0.58
|
0.48 log_10 CFU per gram of sputum
Standard Error 0.50
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
The percentage of days participants used antibiotics from baseline to Week 24 was analyzed. Antibiotics ongoing at baseline or started on or after first dose date were included in the analysis. A single antibiotic course could represent the use of multiple antibiotics. Days of antibiotic use included unique days.
Outcome measures
| Measure |
AZLI
n=47 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
Percentage of Days Participants Used Antibiotics
|
44.4 percentage of days
Standard Deviation 35.2
|
56.3 percentage of days
Standard Deviation 34.8
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
The percentage of days hospitalized from baseline to Week 24 was analyzed.
Outcome measures
| Measure |
AZLI
n=48 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=52 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
Percent of Days Hospitalized
|
4.9 percentage of days
Standard Deviation 10.3
|
4.8 percentage of days
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
The percentage of days participants missed school or work from baseline to Week 24 was analyzed.
Outcome measures
| Measure |
AZLI
n=32 Participants
AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
Placebo
n=40 Participants
Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
|
|---|---|---|
|
Percentage of Missed School or Work Days
|
1.9 percentage of days
Standard Deviation 3.3
|
4.7 percentage of days
Standard Deviation 7.2
|
Adverse Events
AZLI
Serious events: 17 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 21 serious events
Other events: 46 other events
Deaths: 0 deaths
AZLI/AZLI
Serious events: 19 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo/AZLI
Serious events: 24 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZLI
n=48 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24.
|
Placebo
n=52 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24.
|
AZLI/AZLI
n=39 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
|
Placebo/AZLI
n=45 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
General disorders
Chest pain
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Infections and infestations
Infective pulmonary exacerbation of cycstic fibrosis
|
20.8%
10/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
20.5%
8/39 • Baseline to Week 24
|
24.4%
11/45 • Baseline to Week 24
|
|
Infections and infestations
Pneumonia
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Infections and infestations
Sepsis
|
2.1%
1/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Infections and infestations
Sinusitis
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Psychiatric disorders
Mental status changes
|
2.1%
1/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.1%
1/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.1%
1/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
1/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
14.6%
7/48 • Baseline to Week 24
|
26.9%
14/52 • Baseline to Week 24
|
23.1%
9/39 • Baseline to Week 24
|
20.0%
9/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
General disorders
Cholethiasis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Infections and infestations
Influenza
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Infections and infestations
Viral infection
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Reproductive system and breast disorders
Haematspermia
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
Other adverse events
| Measure |
AZLI
n=48 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24.
|
Placebo
n=52 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24.
|
AZLI/AZLI
n=39 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
|
Placebo/AZLI
n=45 participants at risk
For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
3/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
13.3%
6/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
4/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
3/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
8.9%
4/45 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
4/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
7.7%
3/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
General disorders
Chest discomfort
|
27.1%
13/48 • Baseline to Week 24
|
15.4%
8/52 • Baseline to Week 24
|
15.4%
6/39 • Baseline to Week 24
|
20.0%
9/45 • Baseline to Week 24
|
|
General disorders
Chest pain
|
14.6%
7/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
33.3%
13/39 • Baseline to Week 24
|
22.2%
10/45 • Baseline to Week 24
|
|
General disorders
Chills
|
12.5%
6/48 • Baseline to Week 24
|
3.8%
2/52 • Baseline to Week 24
|
20.5%
8/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Constipation
|
6.2%
3/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
11.1%
5/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
70.8%
34/48 • Baseline to Week 24
|
61.5%
32/52 • Baseline to Week 24
|
79.5%
31/39 • Baseline to Week 24
|
75.6%
34/45 • Baseline to Week 24
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
8/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
20.5%
8/39 • Baseline to Week 24
|
15.6%
7/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
6/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
13.3%
6/45 • Baseline to Week 24
|
|
Nervous system disorders
Dizziness
|
10.4%
5/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.2%
14/48 • Baseline to Week 24
|
28.8%
15/52 • Baseline to Week 24
|
43.6%
17/39 • Baseline to Week 24
|
46.7%
21/45 • Baseline to Week 24
|
|
General disorders
Exercise tolerance decreased
|
10.4%
5/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
General disorders
Fatigue
|
20.8%
10/48 • Baseline to Week 24
|
21.2%
11/52 • Baseline to Week 24
|
35.9%
14/39 • Baseline to Week 24
|
26.7%
12/45 • Baseline to Week 24
|
|
Investigations
Forced expiratory volume decreased
|
4.2%
2/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
12.8%
5/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
27.1%
13/48 • Baseline to Week 24
|
32.7%
17/52 • Baseline to Week 24
|
28.2%
11/39 • Baseline to Week 24
|
17.8%
8/45 • Baseline to Week 24
|
|
Nervous system disorders
Headache
|
12.5%
6/48 • Baseline to Week 24
|
13.5%
7/52 • Baseline to Week 24
|
20.5%
8/39 • Baseline to Week 24
|
13.3%
6/45 • Baseline to Week 24
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
3/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
3/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
8.3%
4/48 • Baseline to Week 24
|
3.8%
2/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Psychiatric disorders
Insomnia
|
8.3%
4/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
11.1%
5/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
12/48 • Baseline to Week 24
|
26.9%
14/52 • Baseline to Week 24
|
41.0%
16/39 • Baseline to Week 24
|
31.1%
14/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Nausea
|
22.9%
11/48 • Baseline to Week 24
|
19.2%
10/52 • Baseline to Week 24
|
17.9%
7/39 • Baseline to Week 24
|
15.6%
7/45 • Baseline to Week 24
|
|
General disorders
Non-cardiac chest pain
|
6.2%
3/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
7.7%
3/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
31.2%
15/48 • Baseline to Week 24
|
21.2%
11/52 • Baseline to Week 24
|
38.5%
15/39 • Baseline to Week 24
|
33.3%
15/45 • Baseline to Week 24
|
|
General disorders
Pain
|
12.5%
6/48 • Baseline to Week 24
|
3.8%
2/52 • Baseline to Week 24
|
7.7%
3/39 • Baseline to Week 24
|
11.1%
5/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersectretion
|
4.2%
2/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.2%
3/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
7.7%
3/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
4/48 • Baseline to Week 24
|
1.9%
1/52 • Baseline to Week 24
|
12.8%
5/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
Investigations
Pulmonary function test decreased
|
10.4%
5/48 • Baseline to Week 24
|
15.4%
8/52 • Baseline to Week 24
|
7.7%
3/39 • Baseline to Week 24
|
20.0%
9/45 • Baseline to Week 24
|
|
General disorders
Pyrexia
|
39.6%
19/48 • Baseline to Week 24
|
32.7%
17/52 • Baseline to Week 24
|
41.0%
16/39 • Baseline to Week 24
|
42.2%
19/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
10.4%
5/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
17.9%
7/39 • Baseline to Week 24
|
13.3%
6/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
14.6%
7/48 • Baseline to Week 24
|
26.9%
14/52 • Baseline to Week 24
|
33.3%
13/39 • Baseline to Week 24
|
24.4%
11/45 • Baseline to Week 24
|
|
Infections and infestations
Rhinitis
|
0.00%
0/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrheoa
|
16.7%
8/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
25.6%
10/39 • Baseline to Week 24
|
20.0%
9/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
8/48 • Baseline to Week 24
|
9.6%
5/52 • Baseline to Week 24
|
30.8%
12/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
Nervous system disorders
Sinus headache
|
16.7%
8/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
23.1%
9/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Infections and infestations
Sinusitis
|
2.1%
1/48 • Baseline to Week 24
|
7.7%
4/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
11.1%
5/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
2.1%
1/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
8.9%
4/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
47.9%
23/48 • Baseline to Week 24
|
38.5%
20/52 • Baseline to Week 24
|
48.7%
19/39 • Baseline to Week 24
|
31.1%
14/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway cough syndrome
|
8.3%
4/48 • Baseline to Week 24
|
11.5%
6/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
7/48 • Baseline to Week 24
|
9.6%
5/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
8.9%
4/45 • Baseline to Week 24
|
|
Investigations
Weight decreased
|
6.2%
3/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
15.6%
7/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.8%
10/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
20.5%
8/39 • Baseline to Week 24
|
13.3%
6/45 • Baseline to Week 24
|
|
General disorders
Asthenia
|
8.3%
4/48 • Baseline to Week 24
|
5.8%
3/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
8.9%
4/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
7.7%
3/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
General disorders
Malaise
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
General disorders
Oedema peripheral
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Investigations
Breath sounds abmormal
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Investigations
Vitamin D decreased
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
10.3%
4/39 • Baseline to Week 24
|
8.9%
4/45 • Baseline to Week 24
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Infections and infestations
Candidiasis
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
0.00%
0/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
2.2%
1/45 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
11.1%
5/45 • Baseline to Week 24
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
5.1%
2/39 • Baseline to Week 24
|
4.4%
2/45 • Baseline to Week 24
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
7.7%
3/39 • Baseline to Week 24
|
0.00%
0/45 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/48 • Baseline to Week 24
|
0.00%
0/52 • Baseline to Week 24
|
2.6%
1/39 • Baseline to Week 24
|
6.7%
3/45 • Baseline to Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER