Trial Outcomes & Findings for Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria (NCT NCT03219164)
NCT ID: NCT03219164
Last Updated: 2022-06-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
149 participants
Primary outcome timeframe
28 days post treatment (Weeks 4 to 6 for the 14 Day treatment group and Weeks 4 to 8 for the 28 Day treatment group)
Results posted on
2022-06-14
Participant Flow
Participants were enrolled at study sites in Europe, Israel, and the United States. The first participant was screened on 28 November 2017. The last study visit occurred on 23 September 2021.
149 participants were screened.
Participant milestones
| Measure |
AZLI 14 Days + Placebo 14 Days
75 milligrams per milliliter (mg/ml) of aztreonam was administered thrice daily (TID) for 14 days followed by placebo to match (PTM) aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received aztreonam for inhalation solution (AZLI) and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
|
Overall Study
COMPLETED
|
49
|
57
|
|
Overall Study
NOT COMPLETED
|
25
|
18
|
Reasons for withdrawal
| Measure |
AZLI 14 Days + Placebo 14 Days
75 milligrams per milliliter (mg/ml) of aztreonam was administered thrice daily (TID) for 14 days followed by placebo to match (PTM) aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received aztreonam for inhalation solution (AZLI) and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
16
|
12
|
|
Overall Study
Withdrew Consent by Parent/Guardian
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrew Assent
|
1
|
0
|
Baseline Characteristics
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
Baseline characteristics by cohort
| Measure |
AZLI 14 Days + Placebo 14 Days
n=74 Participants
75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
n=75 Participants
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.3 years
STANDARD_DEVIATION 5.34 • n=93 Participants
|
6.5 years
STANDARD_DEVIATION 4.91 • n=4 Participants
|
6.9 years
STANDARD_DEVIATION 5.13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
66 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
69 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=93 Participants
|
17 participants
n=4 Participants
|
33 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=93 Participants
|
14 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=93 Participants
|
4 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Region of Enrollment
France
|
6 participants
n=93 Participants
|
5 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 28 days post treatment (Weeks 4 to 6 for the 14 Day treatment group and Weeks 4 to 8 for the 28 Day treatment group)Population: Evaluable Analysis Set included participants who completed study drug with at least 75% compliance, did not use any anti-PA antibiotics while on study treatment with AZLI.
Outcome measures
| Measure |
AZLI 14 Days + Placebo 14 Days
n=68 Participants
75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
n=71 Participants
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Percentage of Participants With Pseudomonas Aeruginosa (PA)-Negative Cultures Through 28 Days Post-Treatment in the 14-Day Treatment Group vs 28-Day Treatment Group
|
55.9 percentage of participants
Interval 43.3 to 67.9
|
63.4 percentage of participants
Interval 51.1 to 74.5
|
SECONDARY outcome
Timeframe: Last dose date of AZLI up to Week 112Population: Participants in the Evaluable Analysis Set were analyzed.
The primary eradication was achieved when all cultures through 28 days post AZLI treatment were PA negative. Recurrence after PA eradication was defined as first positive PA culture result in participant who successfully met primary endpoint and had no PA-positive culture from local lab at Week 4 through Week 6 for AZLI 14 Days group or through Week 8 for AZLI 28 Days group.
Outcome measures
| Measure |
AZLI 14 Days + Placebo 14 Days
n=68 Participants
75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
n=71 Participants
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Time From Primary Eradication to PA Recurrence Over a 108-Week Post-Treatment Follow-up Period
|
19.3 months
Interval 10.5 to
Not Available as the calculated percentiles of event rate were not reached.
|
NA months
Interval 4.9 to
Not Available as the calculated percentiles of event rate were not reached.
|
SECONDARY outcome
Timeframe: 28 days post treatment (Weeks 4 to 6 for the 14 Day treatment group)Population: AZLI 14 Day treatment group: Evaluable Analysis Set. No data was collected for the AZLI 28 Day treatment group for this outcome measure.
Outcome measures
| Measure |
AZLI 14 Days + Placebo 14 Days
n=68 Participants
75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Percentage of Participants With PA-negative Cultures Through 28 Days Post-Treatment in the 14-Day Treatment Group vs Historical Pooled Data for PA Eradication at 28 Days Post-Treatment in Participants Treated With Tobramycin Nebulizer Solution (TNS)
|
55.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Last dose date of AZLI up to Week 112Population: ELITE Study Matching Analysis Set included participants from Evaluable Analysis Set (who did not meet evaluability criteria due to \< 75% compliance, use of anti-PA antibiotics while on AZLI treatment, missing PA culture result during initial eradication phase) who also satisfied the published criteria for efficacy analysis population in ELITE study.
In ELITE study (NCT00391976), participants with cystic fibrosis who had early PA infection received TNS. Published criteria for efficacy analysis population in ELITE study included: * Participants must be ≥ 6 months at randomization * No history of positive anti-PA antibody (no anti-PA immunoglobulin G \[IgG\] antibody interpretation at Screening/Baseline) on record * Did not use anti-pseudomonal antibiotics through 28 days after completion of active treatment and within 2 years of Screening * Non-missing PA culture result at 28 days after last dose of AZLI * PA negative through 28 days after completion of active treatment * No important protocol deviation related to compliance with study drug administration * Documented new onset of positive respiratory tract culture for PA within 30 days of Screening defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year).
Outcome measures
| Measure |
AZLI 14 Days + Placebo 14 Days
n=23 Participants
75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
n=25 Participants
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Time to PA Recurrence for a Sub-Group of Participants Matching the Population in the TNS ELITE Study Over a 108-Week Post-Treatment Follow-up Period
|
19.3 months
Interval 10.5 to
Not Available as the calculated percentiles of event rate were not reached.
|
15.2 months
Interval 4.7 to
Not Available as the calculated percentiles of event rate were not reached.
|
Adverse Events
AZLI 14 Days + Placebo 14 Days
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
AZLI 28 Days
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZLI 14 Days + Placebo 14 Days
n=74 participants at risk
75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
n=75 participants at risk
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
1.4%
1/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
0.00%
0/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
0.00%
0/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Subileus
|
1.4%
1/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
0.00%
0/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Abscess
|
0.00%
0/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
1.3%
1/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
1.4%
1/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
0.00%
0/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Pseudomonas infection
|
1.4%
1/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
1.3%
1/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
1.3%
1/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Investigations
Pseudomonas test positive
|
1.4%
1/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
0.00%
0/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
1.3%
1/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
Other adverse events
| Measure |
AZLI 14 Days + Placebo 14 Days
n=74 participants at risk
75 mg/ml of aztreonam was administered TID for 14 days followed by PTM aztreonam TID for 14 days, both aztreonam and PTM aztreonam were delivered via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI and PTM aztreonam via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
AZLI 28 Days
n=75 participants at risk
75 mg/ml of aztreonam was administered TID for 28 days via the PARI Altera® Nebulizer System. Participants below 2 years received AZLI via the SmartMask® Baby, 2 to below 6 years via the SmartMask Kids® and above 6 years via the nebulizer mouthpiece.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
5/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
1.3%
1/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
General disorders
Pyrexia
|
5.4%
4/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
8.0%
6/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Influenza
|
1.4%
1/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
6.7%
5/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Rhinitis
|
6.8%
5/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
0.00%
0/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
4/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
4.0%
3/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
12/74 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
14.7%
11/75 • Adverse Events: First dose date up to 28 days plus 30 days; All-Cause Mortality: Randomization up to 112 weeks
Adverse Events: Safety Analysis Set included participants who were randomized and received at least one dose of study drug. All-Cause Mortality: Intent-To-Treat Analysis Set included all participants who were randomized in the study.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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