Trial Outcomes & Findings for SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity (NCT NCT02819856)
NCT ID: NCT02819856
Last Updated: 2026-07-16
Results Overview
Number of participants with ototoxicity: Sensorineural hearing loss using pure-tone audiometry according to the American Speech-Language-Hearing Association (ASHA) criteria for ototoxicity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
4 weeks post-tobramycin
Results posted on
2026-07-16
Participant Flow
Participant milestones
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
9
|
10
|
|
Overall Study
COMPLETED
|
7
|
7
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
Baseline Characteristics
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
Baseline characteristics by cohort
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=8 Participants
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=8 Participants
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 Participants
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=10 Participants
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 8.0 • n=9 Participants
|
27.4 years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
27.7 years
STANDARD_DEVIATION 8.0 • n=267 Participants
|
35.2 years
STANDARD_DEVIATION 11.1 • n=265 Participants
|
30.3 years
STANDARD_DEVIATION 9.7 • n=568 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
16 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
19 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
32 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
31 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=9 Participants
|
8 participants
n=27 Participants
|
9 participants
n=267 Participants
|
10 participants
n=265 Participants
|
35 participants
n=568 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-tobramycinPopulation: Overall Number of Participants Analyzed includes all participants who completed this outcome measure at the indicated time frame. Discrepancies with the Participant Flow module involve participants who completed the study, but did not complete this outcome measure (missing data and/or protocol violations): \* 1 subject in the 600 mg group was not able to complete this outcome measure due to COVID-19 restrictions (audiology clinic closure).
Number of participants with ototoxicity: Sensorineural hearing loss using pure-tone audiometry according to the American Speech-Language-Hearing Association (ASHA) criteria for ototoxicity.
Outcome measures
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=7 Participants
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=7 Participants
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 Participants
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=7 Participants
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Sensorineural Hearing Loss Using Pure-tone Audiometry
|
7 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-tobramycinPopulation: Overall Number of Participants Analyzed includes all participants who completed this outcome measure at the indicated time frame. Discrepancies with the Participant Flow module involve participants who completed the study, but did not complete this outcome measure (missing data and/or protocol violations): \* 1 subject in the 600 mg group was not able to complete this outcome measure due to COVID-19 restrictions (audiology clinic closure).
Number of participants with ototoxicity: Decreases in Distortion Product Otoacoustic Emissions (DPOAE), defined as a greater than or equal to 5 dB decrease in DPOAE amplitude in at least one test frequency.
Outcome measures
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=7 Participants
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=7 Participants
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 Participants
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=7 Participants
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Distortion Product Otoacoustic Emissions
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-tobramycinPopulation: Overall Number of Participants Analyzed includes all participants who completed this outcome measure at the indicated time frame. Discrepancies with the Participant Flow module involve participants who completed the study, but did not complete this outcome measure (missing data and/or protocol violations): * 1 subject in the 600 mg group was not able to complete this outcome measure due to COVID-19 restrictions (audiology clinic closure). * 1 subject in the 600 mg group: missing data
Number of participants with ototoxicity: Decreases in speech discrimination using the Words in Noise test (WIN) score (0-35, where higher scores are a better outcome), defined as a 10% or greater decrease in WIN score from participant's baseline score.
Outcome measures
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=7 Participants
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=7 Participants
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 Participants
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=6 Participants
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Speech Discrimination
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-tobramycinPopulation: Overall Number of Participants Analyzed includes all participants who completed this outcome measure at the indicated time frame. Discrepancies with the Participant Flow module involve participants who completed the study, but did not complete this outcome measure (missing data and/or protocol violations): \* 1 subject in the 600 mg group was not administered this outcome measure (protocol violation)
Number of participants with ototoxicity: Increases in Tinnitus Functional Index (TFI) score (0-100, where higher scores are a worse outcome), defined as an increase of 10 points or more from baseline.
Outcome measures
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=7 Participants
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=7 Participants
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 Participants
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=7 Participants
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Tinnitus Severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-tobramycinPopulation: Overall Number of Participants Analyzed includes all participants who completed this outcome measure at the indicated time frame. Discrepancies with the Participant Flow module involve participants who completed the study, but did not complete this outcome measure (missing data and/or protocol violations): \* 1 subject in the 600 mg group was not administered this outcome measure (protocol violation)
Number of participants with vestibulotoxicity: Increases in Vertigo Symptom Scale - Short Form score (0-60, where higher scores are a worse outcome), defined as an increase of 6 points or more from baseline.
Outcome measures
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=7 Participants
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=7 Participants
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 Participants
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=7 Participants
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Vertigo Severity
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-tobramycinPopulation: Overall Number of Participants Analyzed includes all participants who completed this outcome measure at the indicated time frame. Discrepancies with the Participant Flow module involve participants who completed the study, but did not complete this outcome measure (missing data and/or protocol violations): * 1 subject in the placebo group was not administered this outcome measure (protocol violation) * 1 subject in the 600 mg group: missing data
Evaluation of lung function using spirometry, assessed using the change from baseline in Forced Expiratory Volume in 1 second (FEV1).
Outcome measures
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=6 Participants
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=7 Participants
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 Participants
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=7 Participants
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Changes in Lung Function
|
0.33 liters/second
Standard Deviation 0.86
|
0.06 liters/second
Standard Deviation 0.35
|
0.14 liters/second
Standard Deviation 0.22
|
0.13 liters/second
Standard Deviation 0.44
|
Adverse Events
SPI-1000 Capsule 0mg Ebselen Placebo
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
SPI-1005 Ebselen 200mg Capsule x1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SPI-1005 Ebselen 200mg Capsule x2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SPI-1005 Ebselen 200mg Capsule x3
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=8 participants at risk
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=8 participants at risk
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 participants at risk
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=10 participants at risk
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
Other adverse events
| Measure |
SPI-1000 Capsule 0mg Ebselen Placebo
n=8 participants at risk
0mg Ebselen SPI-1000 bid po x 21d
Placebo: 0 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x1
n=8 participants at risk
200mg SPI-1005 bid po x 21d Low Dose Arm
SPI-1005 Ebselen 200mg Capsule x1: 200 mg SPI-1005 bid po x21d
|
SPI-1005 Ebselen 200mg Capsule x2
n=9 participants at risk
400mg SPI-1005 bid po x 21d Mid Dose Arm
SPI-1005 Ebselen 200mg Capsule x2: 400 mg SPI-1005 bid po x 21d
|
SPI-1005 Ebselen 200mg Capsule x3
n=10 participants at risk
600mg SPI-1005 bid po x 21d High Dose Arm
SPI-1005 Ebselen 200mg Capsule x3: 600 mg SPI-1005 bid po x 21d
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
General disorders
Face oedema
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
General disorders
Malaise
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
General disorders
Medical device site pain
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
General disorders
Temperature intolerance
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Blood glucose increased
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
22.2%
2/9 • Number of events 3 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Nervous system disorders
Hypoaesthesia oral
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Reproductive system and breast disorders
Epididymal tenderness
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/8 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/9 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
0.00%
0/10 • Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60