Trial Outcomes & Findings for Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis (NCT NCT00391976)
NCT ID: NCT00391976
Last Updated: 2011-08-29
Results Overview
Microbiological samples were obtained from sputum or by deep throat cough swab technique. Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group. Kaplan-Meier estimates were used.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
123 participants
Primary outcome timeframe
From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27)
Results posted on
2011-08-29
Participant Flow
123 patients were enrolled and received tobramycin 300 mg twice a day for 28 days. Patients who received treatment but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into one of the two treatment groups but were followed-up during routine clinic visits.
Participant milestones
| Measure |
Tobramycin 300 mg for 28 Days
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 300 mg for 56 Days
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized Patients
Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
35
|
|
Overall Study
Randomized
|
45
|
43
|
0
|
|
Overall Study
Safety Population
|
44
|
43
|
35
|
|
Overall Study
COMPLETED
|
18
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
25
|
35
|
Reasons for withdrawal
| Measure |
Tobramycin 300 mg for 28 Days
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 300 mg for 56 Days
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized Patients
Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Withdrawal of consent
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Inappropriate enrollment
|
1
|
1
|
0
|
|
Overall Study
Protocol deviation/violation
|
4
|
2
|
1
|
|
Overall Study
Recurrence/no eradication of infection
|
21
|
19
|
0
|
|
Overall Study
Unable to classify
|
0
|
0
|
1
|
|
Overall Study
Positive P. aeruginosa antibody test
|
0
|
0
|
31
|
Baseline Characteristics
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Tobramycin 300 mg for 28 Days
n=45 Participants
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 300 mg for 56 Days
n=43 Participants
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized Patients
n=35 Participants
Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
8.70 years
STANDARD_DEVIATION 7.22 • n=93 Participants
|
8.65 years
STANDARD_DEVIATION 10.54 • n=4 Participants
|
9.09 years
STANDARD_DEVIATION 5.76 • n=27 Participants
|
8.79 years
STANDARD_DEVIATION 8.14 • n=483 Participants
|
|
Age, Customized
6 months - < 6 years
|
19 participants
n=93 Participants
|
18 participants
n=4 Participants
|
11 participants
n=27 Participants
|
48 participants
n=483 Participants
|
|
Age, Customized
6 years - < 18 years
|
20 participants
n=93 Participants
|
21 participants
n=4 Participants
|
21 participants
n=27 Participants
|
62 participants
n=483 Participants
|
|
Age, Customized
≥ 18 years
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
3 participants
n=27 Participants
|
13 participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
59 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27)Population: Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (\> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.
Microbiological samples were obtained from sputum or by deep throat cough swab technique. Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group. Kaplan-Meier estimates were used.
Outcome measures
| Measure |
Tobramycin 300 mg for 28 Days
n=34 Participants
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 300 mg for 56 Days
n=31 Participants
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized
Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
|
|---|---|---|---|
|
Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab
|
26.12 Months
Interval 14.69 to
An upper limit for the CI could not be estimated because of insufficient number of events.
|
25.82 Months
Interval 18.17 to
An upper limit for the CI could not be estimated because of insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: From 1 month after the end of treatment until the end of the study (Month 27)Population: Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (\> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.
One month after the end of treatment was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.
Outcome measures
| Measure |
Tobramycin 300 mg for 28 Days
n=34 Participants
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 300 mg for 56 Days
n=31 Participants
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized
Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
|
|---|---|---|---|
|
Percentage of Patients With Pseudomonas (P.) Aeruginosa Eradicated From Deep Throat Cough Swab or Sputum
At 1 month after the end of treatment
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
|
Percentage of Patients With Pseudomonas (P.) Aeruginosa Eradicated From Deep Throat Cough Swab or Sputum
At final visit
|
68 Percentage of participants
|
71 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From 1 month after the end of treatment until the end of the study (Month 27)Population: Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (\> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.
Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.
Outcome measures
| Measure |
Tobramycin 300 mg for 28 Days
n=14 Participants
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 300 mg for 56 Days
n=7 Participants
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized
Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
|
|---|---|---|---|
|
Time to Recurrence of Pseudomonas (P.) Aeruginosa (New or Same Genotype) in Sputum or Deep Throat Cough Swab Based on Confirmatory Assessment by the Central Laboratory
|
9.84 Months
95% Confidence Interval 2.47 • Interval 2.73 to 22.57
|
16.62 Months
95% Confidence Interval 2.61 • Interval 6.41 to 18.17
|
—
|
SECONDARY outcome
Timeframe: From Baseline to the final visit (end of the study, Month 27)Population: Safety population: All patients who were enrolled in the study and received at least 1 dose of study medication.
The percentage of patients with changes in tobramycin MIC values from Baseline to the final visit could not be compared as there was insufficient data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to end of study (27 months)Population: All patients who were randomized and received at least one dose of study medication. Non-randomized patients were not included in the analysis.
Core study defined as from Baseline through to one month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group). Follow-up phase began at the end of the core study through to the end of the study (Month 27).
Outcome measures
| Measure |
Tobramycin 300 mg for 28 Days
n=44 Participants
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 300 mg for 56 Days
n=43 Participants
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized
Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
|
|---|---|---|---|
|
Number of Participants Hospitalized for Pulmonary Exacerbations
Core Study
|
0 Participants
|
2 Participants
9.2
|
—
|
|
Number of Participants Hospitalized for Pulmonary Exacerbations
Follow-up
|
5 Participants
|
2 Participants
|
—
|
Adverse Events
Tobramycin 28 Days Up To Month 3
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Tobramycin 56 Days Up To Month 3
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Non-randomized Patients up to Month 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Tobramycin 28 Days After Month 3
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Tobramycin 56 Days After Month 3
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tobramycin 28 Days Up To Month 3
n=44 participants at risk
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 56 Days Up To Month 3
n=43 participants at risk
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized Patients up to Month 3
n=35 participants at risk
Patients who started the study and received tobramycin 300 mg twice a day for 28 days but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups.
|
Tobramycin 28 Days After Month 3
n=35 participants at risk
Patients who received tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
|
Tobramycin 56 Days After Month 3
n=36 participants at risk
Patients received tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
2.3%
1/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
General disorders
PYREXIA
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.8%
1/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
BRAIN ABSCESS
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.3%
1/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
4.5%
2/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
STENOTROPHOMONAS INFECTION
|
2.3%
1/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
VARICELLA
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.3%
1/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.3%
1/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Surgical and medical procedures
HYDROCELE OPERATION
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.8%
1/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
Other adverse events
| Measure |
Tobramycin 28 Days Up To Month 3
n=44 participants at risk
Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Tobramycin 56 Days Up To Month 3
n=43 participants at risk
Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
|
Non-randomized Patients up to Month 3
n=35 participants at risk
Patients who started the study and received tobramycin 300 mg twice a day for 28 days but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups.
|
Tobramycin 28 Days After Month 3
n=35 participants at risk
Patients who received tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
|
Tobramycin 56 Days After Month 3
n=36 participants at risk
Patients received tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
VOMITING
|
2.3%
1/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.3%
1/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
8.3%
3/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
General disorders
PYREXIA
|
6.8%
3/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
9.3%
4/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.7%
2/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.8%
1/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
BRONCHITIS
|
4.5%
2/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
8.6%
3/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
11.1%
4/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.8%
3/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.6%
2/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.3%
1/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.7%
2/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.6%
2/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
RHINITIS
|
15.9%
7/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
7.0%
3/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
8.6%
3/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.6%
2/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.7%
2/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
TONSILLITIS
|
2.3%
1/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
11.4%
4/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.8%
1/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.1%
4/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
4.7%
2/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
11.4%
4/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
11.1%
4/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Infections and infestations
VARICELLA
|
0.00%
0/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
8.3%
3/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Nervous system disorders
HEADACHE
|
6.8%
3/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.3%
1/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.5%
9/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
4.7%
2/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
25.7%
9/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
19.4%
7/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
11.4%
5/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
11.6%
5/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
4.5%
2/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
2.9%
1/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.6%
2/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
4.5%
2/44 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/43 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
5.7%
2/35 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
0.00%
0/36 • From Baseline to the end of the study (Month 27)
Adverse events (AE) were recorded for the safety population which included all patients who received at least 1 dose of study medication. For patients withdrawn from the study who continued in the follow-up phase, all AEs were recorded until Month 3. After Month 3, only AEs recorded related to study drug were recorded.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER